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From the 5/7/2021 release of VAERS data:

Found 1,944 cases where Vaccine is FLU(H1N1) or FLU3 or FLU4 or FLUA3 or FLUA4 or FLUC3 or FLUC4 or FLUN(H1N1) or FLUN3 or FLUN4 or FLUR3 or FLUR4 or FLUX or FLUX(H1N1) or H5N1 and Patient Died



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 38984 (history)  
Form: Version 1.0  
Age: 49.0  
Sex: Male  
Location: California  
Vaccinated:1991-11-08
Onset:1991-11-15
   Days after vaccination:7
Submitted: 1992-01-17
   Days after onset:63
Entered: 1992-01-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918147 / UNK - / A

Administered by: Public       Purchased by: Private
Symptoms: Apnoea, Guillain-Barre syndrome, Myasthenic syndrome, Neuropathy, Paraesthesia, Pneumonia, Pyrexia, Speech disorder
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Malignancy related conditions (narrow), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1992-01-04
   Days after onset: 50
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: ATB for pneumonia p/hosp
Current Illness: UNK
Preexisting Conditions: heart murmmer, takes Naprosyn
Allergies:
Diagnostic Lab Data: CSF nl, ABG''s nl; CBC-WBC 9,200, HGB 16.1, HCT 44.9; plat 218,000; ESR-6; IgG 421 dec; Drug screen neg; nerve conduction velocity study; suggests GBS, acute polyneuropathy;
CDC Split Type:

Write-up: 15NOV91 tingling fingers & toes lt side numbness rt hand & foot; fatigue & muscular weakness; inc temp speech became more difficult; 19NOV91 placed on ventilator, only able to move lips shrug shoulder (tracheotomy); pneumonia;


VAERS ID: 37846 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Arizona  
Vaccinated:1991-10-18
Onset:1991-11-14
   Days after vaccination:27
Submitted: 1991-12-03
   Days after onset:19
Entered: 1991-12-09
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 1F21209 / 1 - / IM

Administered by: Private       Purchased by: Public
Symptoms: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Procardia, Ascriptin
Current Illness: NONE
Preexisting Conditions: previous hx brainstomy tia w/flaccid FEB91
Allergies:
Diagnostic Lab Data: MRI Scan-neg; LP-normal; NCV loss of F waves, slowing;
CDC Split Type:

Write-up: 3 wks post inject pt devel paralysis;


VAERS ID: 36736 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: California  
Vaccinated:1991-11-11
Onset:1991-11-12
   Days after vaccination:1
Submitted: 1991-11-25
   Days after onset:13
Entered: 1991-12-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 10300080808020 / 1 LA / -

Administered by: Unknown       Purchased by: Private
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications:
Current Illness: ESRD
Preexisting Conditions: chronic renal failure NKA
Allergies:
Diagnostic Lab Data: bells palsy
CDC Split Type:

Write-up: Pt recvd Influenza A&B vax on 8NOV91 & 12NOV91 aobut 4PM pt devel a droopy mouth on rt side; Pt consulted MD & was referred to neurologist who dx bells palsy;


VAERS ID: 38163 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:1991-11-06
Onset:1991-11-08
   Days after vaccination:2
Submitted: 1991-11-15
   Days after onset:7
Entered: 1991-12-30
   Days after submission:45
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918136 / 6 - / -

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Cerebral haemorrhage, Cerebrovascular accident, Hypertension, Vascular anomaly
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Hypertension (narrow), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-11-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Trilafor
Current Illness: NONE
Preexisting Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: GA91323

Write-up: Pt''s husband reported pt was well until apparent stroke 8NOV91 @ 12noon; pt then died 9NOV91 @ 235AM; no autopsy was done; Cause of death listed as possible aneurysm;


VAERS ID: 38737 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Female  
Location: North Carolina  
Vaccinated:1991-10-28
Onset:1991-10-28
   Days after vaccination:0
Submitted: 1991-12-10
   Days after onset:43
Entered: 1992-01-13
   Days after submission:34
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918132 / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Aphthous stomatitis, Dysgeusia, Glossitis, Malaise, Myalgia, Pyrexia, Tongue disorder, Tongue oedema
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: UNK
Preexisting Conditions: pt does not have an allergy to eggs
Allergies:
Diagnostic Lab Data:
CDC Split Type: 891354001J

Write-up: Pt reported tongue felt different p/recvd flu vax 28OCT91 that evening pt devel a fever & ill feeling; following day pts tongue became raw & swollen w/welts & blisters; approx 2 wks later exp difficulty breathing & chest tightness;


VAERS ID: 43953 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Unknown  
Vaccinated:1991-10-14
Onset:1991-10-25
   Days after vaccination:11
Submitted: 1992-07-08
   Days after onset:257
Entered: 1992-08-06
   Days after submission:29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE) / LEDERLE LABORATORIES - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-10-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NA~ ()~~~In patient
Other Medications: NA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: NA
CDC Split Type: 920262501

Write-up: cerebrovascular accident (lt hemisphere) in pt, 10 days p/vax w/fluvirin; pt was vaxed on 14OCT91 & died 25OCT91; no other clinical info available;


VAERS ID: 42220 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Wyoming  
Vaccinated:1991-10-18
Onset:1991-10-21
   Days after vaccination:3
Submitted: 1991-10-22
   Days after onset:1
Entered: 1992-05-28
   Days after submission:219
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE) / LEDERLE LABORATORIES 314964 / 2 LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Apnoea
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-10-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications: UNK
Current Illness: denied any
Preexisting Conditions: denied allergy to eggs, mercury; heart & lungs diseases history;
Allergies:
Diagnostic Lab Data: unk
CDC Split Type: WY9115

Write-up: No s/s of rxn known about; pt gurgled in sleep, pronounced dead @ hosp;


VAERS ID: 36623 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: South Dakota  
Vaccinated:1991-10-07
Onset:1991-10-20
   Days after vaccination:13
Submitted: 1991-11-07
   Days after onset:18
Entered: 1991-11-25
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918129 / 4 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Hyperglycaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-10-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Capoten, Hunalin N 45U, Hunalin R 10U
Current Illness: Cardiopulmonary arrest
Preexisting Conditions: diabetes (insulin) hypertension alzheimers
Allergies:
Diagnostic Lab Data: fasting Blood sugar-133 (pt IDDM)
CDC Split Type: SD91025

Write-up: 20OCT91 pt expired;


VAERS ID: 38733 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Mississippi  
Vaccinated:1991-10-13
Onset:1991-10-14
   Days after vaccination:1
Submitted: 1991-12-05
   Days after onset:52
Entered: 1992-01-13
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918138 / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Right ventricular failure, Somnolence, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Pulmonary hypertension (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-10-17
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 891361004J

Write-up: 1 day p/receiving flu vax, pt exp sleepiness & c/o not feeling well; vomiting 2 days p/vax & the vomitus was noted to be brown; pt died on 17OCT91; COD congestive heart failure;


VAERS ID: 38734 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Female  
Location: Mississippi  
Vaccinated:1991-10-13
Onset:1991-10-13
   Days after vaccination:0
Submitted: 1991-12-05
   Days after onset:53
Entered: 1992-01-13
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918138 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Dyspnoea, Haematemesis, Hyperhidrosis, Pallor, Right ventricular failure, Tremor
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-10-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: pt had diabetes, congestive heart failure & a peptic ulcer;
Allergies:
Diagnostic Lab Data:
CDC Split Type: 891361005J

Write-up: w/in hrs of receiving flu vax pt began shaking & exp vomiting w/a small amount of blood noted; following morning pt exp chest pain, SOB, paleness & clamminess; pt was hospitalized & died 15OCT91; COD congestive heart failure;


VAERS ID: 38735 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: Mississippi  
Vaccinated:1991-10-08
Onset:1991-10-13
   Days after vaccination:5
Submitted: 1991-12-05
   Days after onset:53
Entered: 1992-01-13
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918138 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Haematuria, Hypotension, Pharyngitis, Rhinitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal infections (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-10-26
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: 891361002J

Write-up: Approx 5 days p/flu vax pt devel cold sx from which pt never recovered; On 25OCT91 pt exp hematuria & hypotension & died following day; COD was not felt to be secondary to the flu vax;


VAERS ID: 36624 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: South Dakota  
Vaccinated:1991-10-08
Onset:1991-10-09
   Days after vaccination:1
Submitted: 1991-10-28
   Days after onset:19
Entered: 1991-11-25
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918129 / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diarrhoea, Nausea, Right ventricular failure, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Pulmonary hypertension (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-10-14
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HCTZ
Current Illness: NONE
Preexisting Conditions: arthritis, hypertension
Allergies:
Diagnostic Lab Data: total bilirubin results inconclusive;
CDC Split Type: SD91026

Write-up: Nausea, vomiting, diarrhea started 9OCT or 10OCT, diarrhea stopped but was still nauseated; MD ordered Phenergan supp 13OCT91; congestive heart failure was reason for death;


VAERS ID: 44547 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:1991-09-30
Onset:1991-09-30
   Days after vaccination:0
Submitted: 1992-08-19
   Days after onset:324
Entered: 1992-08-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 5181P2 / 6 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Hypotension, Myocardial infarction, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-09-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Cadizem, Lanoxin, Diabetias;
Current Illness:
Preexisting Conditions: diabetes & long hx of heart disease;
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO4401

Write-up: found sitting in chair not breathing; pale & no pulse; ambulance attendants performed CPR because they found pulse; not successful; cause of death as listed on certificate is acute myocardial infarction; not related to vax;


VAERS ID: 36644 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Georgia  
Vaccinated:1991-09-23
Onset:1991-09-25
   Days after vaccination:2
Submitted: 1991-10-01
   Days after onset:6
Entered: 1991-11-26
   Days after submission:56
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 0127P / 3 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dehydration, Hypoxia, Malaise, Respiratory disorder, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-09-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastroenteritis
Preexisting Conditions: moderate to marked atherosclerosis, coronary artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: GA91311

Write-up: Pt became ill 2 days following inject; admitted to hosp because of dehydration; died 28SEP91; death certificate-ventricular fibrillation, hypoxia, aspiration, gastric contents;


VAERS ID: 37800 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Iowa  
Vaccinated:1991-08-27
Onset:1991-09-03
   Days after vaccination:7
Submitted: 1991-11-26
   Days after onset:84
Entered: 1991-12-06
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918122 / 1 - / A

Administered by: Private       Purchased by: Private
Symptoms: Brain oedema, Confusional state, Convulsion, Headache, Hypotension, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-09-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: asthma
Allergies:
Diagnostic Lab Data: Autopsy-culture neg; massive cerebral swelling, perivascular lymphocyte cuffing;
CDC Split Type: IA910040

Write-up: 3SEP91 onset of severe rt sided h/a; emesis x 1; 4SEP91 awoke confused, devel generalized sz became hypotensive;


VAERS ID: 50793 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: Iowa  
Vaccinated:1991-08-27
Onset:1991-09-03
   Days after vaccination:7
Submitted: 1993-03-07
   Days after onset:551
Entered: 1993-03-15
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH - / 1 - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Coma, Convulsion, Encephalitis, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-09-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: poss of asthma (allergy to cats)
Allergies:
Diagnostic Lab Data: autopsy report concluded that pt died of post vaccinal encephalitis;
CDC Split Type:

Write-up: severe h/a 3SEP91 AM-PM; vomiting p/MN; seizures 7AM on 4SEP91; coma-death 1225PM on 4SEP91;


VAERS ID: 29143 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Michigan  
Vaccinated:1990-11-25
Onset:1990-12-01
   Days after vaccination:6
Submitted: 1991-03-07
   Days after onset:96
Entered: 1991-03-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS - / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cyanosis, Dysphonia, Myasthenic syndrome, Neoplasm malignant, Vocal cord paralysis
SMQs:, Anaphylactic reaction (broad), Malignancy related conditions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Non-haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: considering myasthenia gravis as the etiology.CT SCAn &MRI of upper chest&neck initially-neg.F/U CT SCAN of upper chest:tumor involving SVC&both recurrent laryngeal nerves@thoracic inlet.
CDC Split Type: 914090008

Write-up: Bilat paramedian vocal cord paralysis reported in pt receiving Fluogen. Had flu vax in Nov90 & became hoarse late Dec90. Seen mid Jan & found to have bilat paramedian vocal cord paralysis. As of 18Feb91, pt better. Dx=myasthenia gravis?


VAERS ID: 27275 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Minnesota  
Vaccinated:1990-11-26
Onset:1990-11-26
   Days after vaccination:0
Submitted: 1990-12-26
   Days after onset:30
Entered: 1991-01-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 01870P / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Cardiac arrest
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-11-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Ascriptin, Metamucil
Current Illness:
Preexisting Conditions: No allergies, murmur, parkinson''s dsiease, arthritis, early cataracts, excision sebaceous cyst of back, benign keratosis of face.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt vaccinated with FLUOGEN apparent cardiac arrest - no breath/pulse 8PM - CPR initiated - transported to hosp where he expired.


VAERS ID: 28753 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: California  
Vaccinated:1990-11-23
Onset:1990-11-24
   Days after vaccination:1
Submitted: 1990-11-30
   Days after onset:6
Entered: 1991-03-04
   Days after submission:94
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0F11203 / 1 RA / -

Administered by: Other       Purchased by: Public
Symptoms: Cough, Depression, Dizziness, Dyspnoea, Hyperhidrosis, Pallor, Pharyngitis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-11-29
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Robitussin; Amoxicillin, 02, "routine cardiac meds"
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA9130

Write-up: Began URI w/fever 24NOV90, treated w/ Robitussin. Coughing, fever & depression continued 26NOV90 rx Amoxicillin. Better & up walking 28NOV but @ 5PM was pale, dizzy, sweaty & had SOB.


VAERS ID: 31684 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Male  
Location: Iowa  
Vaccinated:1990-11-01
Onset:1990-11-18
   Days after vaccination:17
Submitted: 1991-06-03
   Days after onset:196
Entered: 1991-06-24
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0F11211 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Vascular occlusion
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-12-10
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: No medications
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy report
CDC Split Type: IA910018

Write-up: Cervical spine cord infarction & subsequent death;


VAERS ID: 43970 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: North Carolina  
Vaccinated:1990-10-11
Onset:1990-11-15
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 1992-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0F11208 / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Myasthenic syndrome
SMQs:, Peripheral neuropathy (narrow), Malignancy related conditions (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-03-16
   Days after onset: 121
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: many, including LP, EMG;
CDC Split Type:

Write-up: progressive LE weakness, GBS;


VAERS ID: 29350 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Colorado  
Vaccinated:1990-11-07
Onset:1990-11-10
   Days after vaccination:3
Submitted: 1991-03-22
   Days after onset:132
Entered: 1991-03-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 025808 / 4 - / A

Administered by: Private       Purchased by: Private
Symptoms: Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-11-29
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 49 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Dyazide
Current Illness: NONE
Preexisting Conditions: Hypertension, mild
Allergies:
Diagnostic Lab Data: MRI & convalescent serum consistent
CDC Split Type:

Write-up: Three days p/flu shot was given, pt came down w/what was consistent w/Herpes encephalitis; Autopsy also consistent with Herpes; Does not think encephalitis was related to "flu shot";


VAERS ID: 27529 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:1990-11-06
Onset:1990-11-07
   Days after vaccination:1
Submitted: 1991-01-18
   Days after onset:72
Entered: 1991-01-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0F11226 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Right ventricular failure
SMQs:, Cardiac failure (narrow), Pulmonary hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-12-10
   Days after onset: 33
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO3759

Write-up: Hospitalized 7NOV90 w/dx of CHF. In & out hosp over next few wks. Released again on 7DEC90 but readmitted 9DEC90 & died CHF. Not able to provide any other symptoms.


VAERS ID: 26721 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Iowa  
Vaccinated:1990-10-24
Onset:1990-11-02
   Days after vaccination:9
Submitted: 1990-11-14
   Days after onset:12
Entered: 1990-11-26
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4908187 / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypertension, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Hypertension (narrow), Demyelination (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Referred to McKennon Hosp for neurology evaluation.
CDC Split Type:

Write-up: Pt vaccinated with Influenza developed funny feeling in both lower extremities, clumsy with both legs which feel numb and tingly. BP 180/100. Rest of exam negative. Lungs are clear. Reflexes diminished. IMP: possible GBS.


VAERS ID: 35528 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:1990-10-17
Onset:1990-10-31
   Days after vaccination:14
Submitted: 1991-10-10
   Days after onset:343
Entered: 1991-10-16
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 4919P2 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Myasthenic syndrome
SMQs:, Peripheral neuropathy (narrow), Malignancy related conditions (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-11-08
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO3956

Write-up: Pt died on 8NOV90; admitted to Hosp 31OCT90 w/rt sided weakness; Family requested that no heroic measures be used; condition rapidly progressed w/subsequent death; dx GBS; hx of alcohol abuse;


VAERS ID: 29150 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Minnesota  
Vaccinated:1990-10-24
Onset:1990-10-26
   Days after vaccination:2
Submitted: 1990-11-20
   Days after onset:25
Entered: 1991-03-15
   Days after submission:115
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0F11200 / 2 LA / -

Administered by: Public       Purchased by: Public
Symptoms: Cardiac failure, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MN90002

Write-up: Admitted to hosp on 26OCT90 died on 26OCT90; MI w/cardiac arrest.


VAERS ID: 26655 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: Michigan  
Vaccinated:1990-10-18
Onset:1990-10-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 1990-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0F112117 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Back pain
SMQs:, Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Calan SR 240MG 1/2 tab daily.
Current Illness:
Preexisting Conditions: Hx of hypertension, cigarette smoking.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt vaccinated with Fluzone 1 wk after injection, had sudden death. 1 & 2 days before death c/o fatigue, low back pain and upper shoulder pain.


VAERS ID: 27141 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:1990-10-22
Onset:1990-10-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 1990-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE) / LEDERLE LABORATORIES 287974 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-10-25
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: rash /w penicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt vax /w Flushot, B/P was 124/76, that evening @ 6:00 felt nauseated, @ 11:00 pm body ached all over, next day felt fine. Tues eve/Wed morn - he died


VAERS ID: 29811 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: California  
Vaccinated:1990-10-19
Onset:1990-10-20
   Days after vaccination:1
Submitted: 1991-03-08
   Days after onset:139
Entered: 1991-04-08
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4908200 / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Influenza, Myasthenic syndrome, Neoplasm malignant, Neuropathy, Neuropathy peripheral, Pain, Pyrexia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related conditions (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: UKN
Current Illness:
Preexisting Conditions: pt has hx of malignant tumor of uterus, tx w/chemoterapy; Current MRIs show no recurrence of tumor or metastases;
Allergies:
Diagnostic Lab Data:
CDC Split Type: 891078001B

Write-up: Neuropathy peripheral; pt developed flu-like sx w/in 24 hrs of receiving vax; third day, low grade fever developed which has persisted to date; Also aches, pain & weakness in her rt arm, & peripheral neuritis-dx branchial plexus neuropathy;


VAERS ID: 26318 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Alabama  
Vaccinated:1990-10-09
Onset:1990-10-11
   Days after vaccination:2
Submitted: 1990-10-17
   Days after onset:6
Entered: 1990-10-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0F11216 / 1 - / IM A

Administered by: Private       Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-10-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Dipyridamold, Furosemide,Dioctolose, Chloraseptic, Methyldopa ,MOM, Aldomet
Current Illness: Rt lacunar Infarct Temp Area, Hypertens.
Preexisting Conditions: Rt Hemispheric stroke /w lt hemiparesis, lt facial weakness, aphasia, dysarthria, hypertension, limited ambulatory ability 2nd to stoke
Allergies:
Diagnostic Lab Data: All lab work WNL
CDC Split Type:

Write-up: Pt vaccinated with Influenza Trivalent A&B at 11:00AM on 9OCT90 fever noted at 8:00AM 11OCT90 Pt died 2:30AM 12OCT90.


VAERS ID: 29960 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Maryland  
Vaccinated:1990-10-02
Onset:1990-10-09
   Days after vaccination:7
Submitted: 1991-01-14
   Days after onset:97
Entered: 1991-04-18
   Days after submission:93
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS PD02580P / 1 LA / -

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Pneumonia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: pneumonia, chronic bronchitis
Preexisting Conditions: heart disease, chronic renal failure /w ADCVD, nephrosclerotic vasc disease,HTN,pulmonary emphysema, peripheral vasc disease
Allergies:
Diagnostic Lab Data: none
CDC Split Type: MD91019

Write-up: Acute myocardial infarction assoc /w ischemic heart disease. Cardiogenic shock&congestive heart failure due to acute MI.Viral pneumonia assoc /w recent Inflenza vax complicated by 2ndary bacterial pneumonia leading to resp failure..see WORM


VAERS ID: 26713 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Maryland  
Vaccinated:1990-10-02
Onset:1990-10-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 1990-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 02580P / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Pneumonia, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-10-09
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: Pt hx of COPD, CABG, Chronic renal fialure, had flu shots in the past without problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 904090003

Write-up: Pt vaccinated with Fluogen 10-2-90 & on 10-7-90 had nausea. On 10-8-90, had dyspnea & "a lump in his chest" seen in ER; Dx as having RLL infiltrate & R/O AMI. Had respiratory failure & cardiac arrest & died on 10-9-90.


VAERS ID: 26463 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: Michigan  
Vaccinated:1990-10-01
Onset:1990-10-01
   Days after vaccination:0
Submitted: 1990-10-17
   Days after onset:16
Entered: 1990-11-02
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4908209 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Apnoea, Atelectasis, Hypoventilation, Influenza, Pneumonia, Pyrexia, Rhinitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-10-16
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: NONE SPECIFIED
Current Illness: CANCER
Preexisting Conditions: PT WAS TERMINALLY ILL W/ MALIGNANT BRAIN TUMOR
Allergies:
Diagnostic Lab Data: CHEST X-RAY: PNEUMONIA, BILAT BASILAR ATELECTASIS. WBC 13,900/CU.MM. LYMPHS = 9800/CU MM
CDC Split Type: 890291001B

Write-up: Pt dev flu-like resp sxs more than a wk /p being admin Flu vax. Pt expired, cause unknown, 16OCT90. F/U 05NOV90: PT WAS TERMINALLY ILL W/ MALIGNANT BRAIN TUMOR, DEV RESP COMPLICATIONS, SHALLOW BREATHING, T 101.8 & CONGESTION 12 D P/ VAX


VAERS ID: 26159 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: Arizona  
Vaccinated:1990-09-20
Onset:1990-09-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 1990-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS - / UNK - / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Apnoea
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-09-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Methyprednisolone, Verapamil, Proventil, Albuterol, Anhydrous Theophylline
Current Illness: Severe Bronchial Asthma
Preexisting Conditions: Pt was hospitalized 2-3 yrs ago for hypertensive Crisis & Severe Bronchial Asthma.
Allergies:
Diagnostic Lab Data: HGT=5''6"; WGT=99lbs; Morning of 20SEP90 BP=142/86;P=72/min®.
CDC Split Type: 904090001

Write-up: Pt vaccinated with FLUOGEN who has severe bronchial asthma seen in MD ofc well VS stable & chest clear, death & respiratory arrest.


VAERS ID: 46247 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Michigan  
Vaccinated:1988-11-15
Onset:1989-01-17
   Days after vaccination:63
Submitted: 1992-10-07
   Days after onset:1358
Entered: 1992-10-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 1108P / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Infection, Influenza
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 924090030

Write-up: pt recvd flu vax & pt was 1 of 5 who devel influenza & died;


VAERS ID: 46248 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Michigan  
Vaccinated:1988-11-15
Onset:1989-01-17
   Days after vaccination:63
Submitted: 1992-10-07
   Days after onset:1358
Entered: 1992-10-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 1108P / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Infection, Influenza
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 924090029

Write-up: pt recvd flu vax & was 1 of 5 who devel influenza & died;


VAERS ID: 46249 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Michigan  
Vaccinated:1988-11-15
Onset:1989-01-17
   Days after vaccination:63
Submitted: 1992-10-07
   Days after onset:1358
Entered: 1992-10-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 1108P / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Infection, Influenza
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 924090028

Write-up: pt recvd flu vax & was 1 of 5 who devel influenza & died;


VAERS ID: 46250 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Michigan  
Vaccinated:1988-11-15
Onset:1989-01-17
   Days after vaccination:63
Submitted: 1992-10-07
   Days after onset:1358
Entered: 1992-10-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 1108P / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Infection, Influenza
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 924090027

Write-up: pt recvd flu vax & was 1 of 5 pts who devel influenza & died;


VAERS ID: 46251 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Michigan  
Vaccinated:1988-11-15
Onset:1989-01-17
   Days after vaccination:63
Submitted: 1992-10-07
   Days after onset:1358
Entered: 1992-10-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS 1108P / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Infection, Influenza
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 924090026

Write-up: pt recvd flu vax & was 1 of 5 pts who devel influenza & died;


VAERS ID: 27159 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: North Carolina  
Vaccinated:1990-11-26
Onset:0000-00-00
Submitted: 1990-12-17
Entered: 1990-12-26
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES OF11208 / UNK - / -

Administered by: Private       Purchased by: Public
Symptoms: Bronchitis, Cough, Influenza
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1990-12-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Phenylpropanolamine w/ Guaiafenisin (generic Entex LA)
Current Illness: ganglion wrist
Preexisting Conditions: Penicillin by hx
Allergies:
Diagnostic Lab Data: WBC 6,200; HGB 17.4; x-ray negative
CDC Split Type:

Write-up: Pt vaccinated w/FLUZONE developed cold next day - upper respir then cough. Seen by MD; normal WBC & HGB, but had cough w/ yellow mucous. Chest x-ray negative. Treated for bacterial bronchitis; improved for 2 days. Found dead 2 days later.


VAERS ID: 38763 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1992-01-07
Entered: 1992-01-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918137 / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1852S / UNK RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Coordination abnormal, Dysarthria, Gait disturbance, Paralysis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1992-01-02
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Complete work-up by oncologist for neoplasm was neg; MRI of head, cysternogram & CSR exam neg;
CDC Split Type:

Write-up: 48 hrs following vax pt devel mild gait ataxia; this progressed over the ensuing wks to profound ataxia leading to inability to walk; limb ataxia dev together w/dysarthria which progressed nearly complet bulbar paralysis;


VAERS ID: 39713 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Michigan  
Vaccinated:1991-12-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1992-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 1F21218 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Electroencephalogram abnormal, Encephalitis, Encephalopathy, Movement disorder, Paraesthesia, Thinking abnormal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Diabinese, Procardia XL, Tenormin, Capoten, Provachol, Aldactone, Lasix;
Current Illness:
Preexisting Conditions: Type II DM-incr chol, HTN, CHF;
Allergies:
Diagnostic Lab Data: EEG-?temporal lobe problem, MRI; lab eval none positive;
CDC Split Type:

Write-up: Pt devel encephalopathy thought to be encephalitis-unknown cause; (initially c/o numbness rt hand x 2 wks opposite arm from inject then deterioration of motor skills & mental status over 5 days;


VAERS ID: 39742 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Hawaii  
Vaccinated:1991-10-22
Onset:0000-00-00
Submitted: 1991-11-25
Entered: 1992-03-02
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918147 / UNK RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Sepsis, Shock, Urinary tract infection
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-11-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: APAP, Dulcolax, MOM, Theodur
Current Illness: COPD, rt femoral neck fracture, pneumoni
Preexisting Conditions: NKA; hx bilat pneumonia, COPD, hx hepatitis 1983, cataracts 1977, confusion, disorientation, incontinent, poor appetite;
Allergies:
Diagnostic Lab Data:
CDC Split Type: HI9202

Write-up: Provisional admission dx COPD, s/p rt femoral neck fracture; since prior vax, pt had been deteriorating clinically (intermittent confusion, disorientation, incontinent, poor appetite); final dx septic shock, UTI; pt died 9NOV91;


VAERS ID: 39743 (history)  
Form: Version 1.0  
Age: 104.0  
Sex: Female  
Location: Hawaii  
Vaccinated:1991-10-27
Onset:0000-00-00
Submitted: 1991-11-25
Entered: 1992-03-02
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918147 / UNK GM / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Arteriosclerosis, Bronchitis, Cardiac arrest, Dehydration
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-11-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK~ ()~~0.00~In Patient
Other Medications: Dulcolax, APAP, MOM, Synthroid, Colase, MVI, CA supplement, Cipro;
Current Illness: pneumonia, malnutrition, s/p femur fract
Preexisting Conditions: NKA, alzheimer''s dementia, chronic dermatitis, HTN, osteoporosis, osteoarthritis, hypothyroidism, incontinent, fragil skin w/some tears, poor appetite, & non ambulatory;
Allergies:
Diagnostic Lab Data:
CDC Split Type: HI9203

Write-up: Adm dx: ORIF-rt supracondylar fracture, gastric ulcer; final dx cardiorespiratory arrest, acute bronchitis, demantia-alzheimer''s type, secondary dx malnutrition, dehydrat, ASCVD, osteoporosis, osteoarthritis;


VAERS ID: 39744 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Male  
Location: Hawaii  
Vaccinated:1991-10-28
Onset:0000-00-00
Submitted: 1991-11-25
Entered: 1992-03-02
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918147 / UNK RA / IM

Administered by: Other       Purchased by: Public
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-11-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: Ceclor, Pseudoephedrine
Current Illness: CVA w/progressive dementia, rt lobe pne
Preexisting Conditions: chronic cerebral ischemia w/progressive dementia, hx UTI, anemia of chronic disease, very lethargic, poor appetite; NKA;
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HI9204

Write-up: adm dx rt lower lob pneumonia; final dx pneumonia, cerebrovascular accident; pt died 8NOV91;


VAERS ID: 39745 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Hawaii  
Vaccinated:1991-10-29
Onset:0000-00-00
Submitted: 1991-11-25
Entered: 1992-03-02
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4918147 / UNK - / IM

Administered by: Other       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1991-11-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: UNK~ ()~~~In patient
Other Medications: Zantac, fortax, digoxin, theophylline, solu-medrol, Capoten, Lasix;
Current Illness: Pneumonia, COPD;
Preexisting Conditions: Allergic to crab, shrimp, lobster; COPD, cardiomyopathy, hx HTN, degenerative joint dis, CHF; resp status secondary to pneumonia & pulmonary congestion;
Allergies:
Diagnostic Lab Data:
CDC Split Type: HI9205

Write-up: adm dx dilated cardiomyopathy; COPD, chronic CHF, hx HTN,DJD; pt died 5NOV91;


VAERS ID: 47474 (history)  
Form: Version 1.0  
Age: 24.0  
Sex: Female  
Location: Maine  
Vaccinated:1992-11-05
Onset:0000-00-00
Submitted: 1992-11-09
Entered: 1992-11-25
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4928115 / UNK - / IM A

Administered by: Other       Purchased by: Other
Symptoms: Endocarditis, Influenza, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness: hodgkins disease/asplenic
Preexisting Conditions: pt had hodgkins disease & is asplenic;
Allergies:
Diagnostic Lab Data:
CDC Split Type: 892315007E

Write-up: pt recvd flu vax & devel flu-like sx; the following morning pt collapsed & was adm to the hosp; pt is on a respirator & is critically ill;


VAERS ID: 50086 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1992-11-30
Entered: 1993-02-18
   Days after submission:80
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4928231 / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 893022001E

Write-up: pt recvd flu vax & 5 mins later pt died; Wyeth is awaiting f/u info;


VAERS ID: 58135 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1993-12-07
Entered: 1993-12-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS - / 4 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Infection, Marrow hyperplasia, Pericardial effusion, Pneumonia, Pulmonary haemorrhage, Respiratory disorder, Thrombocytopenia, Thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Myelodysplastic syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1993-11-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: Nitrodur patch 0.2 mg, tenormin 25 mg daily, aspirin 25 mg every other day;
Current Illness: None
Preexisting Conditions: MI & CVA 1991
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO5163

Write-up: died; devel thrombocytopenia 2 wks p/vax; No autopsy performed;


VAERS ID: 61772 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1994-01-03
Entered: 1994-04-12
   Days after submission:98
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / PFIZER/WYETH 4938088 / UNK - / -
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH 324906 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Pneumonia
SMQs:, Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1993-12-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasix, Coumaden, Potassium, Lanoxin;
Current Illness:
Preexisting Conditions: hx heart disease-MI 1SEP93; OCT93 congestive heart failure; SEP93 bypass surgery;
Allergies:
Diagnostic Lab Data: Chest XR; lung biopsy;
CDC Split Type:

Write-up: following flu vax & pneumonia devel resp failure; lung biopsy-usual interstital pneumonitis; died 18DEC93;


VAERS ID: 75559 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Alaska  
Vaccinated:1994-10-26
Onset:0000-00-00
Submitted: 1994-05-19
Entered: 1995-07-03
   Days after submission:410
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 4F51023 / UNK RA / -

Administered by: Public       Purchased by: Public
Symptoms: Chest pain, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1994-11-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AK95021

Write-up: pt expired approx 2 1/2wks p/vax; pt died of MI; had chest pain approx 1 wk prior to MI; coded & expired;


VAERS ID: 75560 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Alaska  
Vaccinated:1994-11-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1995-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 4F51023 / UNK LA / -

Administered by: Public       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1994-11-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions: end-stage liver disease, COPD, on 02
Allergies:
Diagnostic Lab Data:
CDC Split Type: AK95022

Write-up: pt expired approx 1 wk p/vax given; clinic reports pt''s death was expected; pt was in end-stage liver disease, COPD, on 02


VAERS ID: 78453 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 1995-10-10
Entered: 1995-10-30
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Embolism, Hyperventilation, Hypotension, Infection, Pneumonia, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications: unk
Current Illness: COPD
Preexisting Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: 895289005S

Write-up: pt recvd vax & devel poss complications of the pre-existing COPD & was hospital;addtl info recvd 13OCT95 revealed that pt died while in hosp


VAERS ID: 80766 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 1996-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E2715HA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt recvd vax; supposed death;


VAERS ID: 94506 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:1996-10-03
Onset:0000-00-00
Submitted: 1997-01-26
Entered: 1997-01-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKE-DAVIS - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Anorexia, Rhinitis, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE~ ()~~~In patient
Other Medications:
Current Illness: NONE
Preexisting Conditions: allergy PCN
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: congested, lethargic, not eating;


VAERS ID: 106308 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Mississippi  
Vaccinated:1997-10-20
Onset:0000-00-00
Submitted: 1997-12-03
Entered: 1998-01-12
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E20037KA / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Adrenal insufficiency, Asthenia, Coordination abnormal, Guillain-Barre syndrome, Hypertonia, Myasthenic syndrome, Neuropathy, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related conditions (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Hypoglycaemia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: grip strength 80-85%;thininning of muscle bulk to first dorsal interosseous muscle;thyroid nl;CPK nl;sed rate 50;total white count 7,800 w/H&H 12.9 & 39.1;rheumatoid factor neg;EKG nonspecific ST changes plus LAD:
CDC Split Type: MS97056

Write-up: pt exp worsening weakness x 2mo w/diff walking x2wk;pt exp joint stiffness;devel some numbness in hands & feet;pt noted to have flipped T waves in lateral chest leads;pt hosp;muscle weakness;GBS, ataxic;control dec;polyradiculoneuropathy;


VAERS ID: 116744 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Male  
Location: Texas  
Vaccinated:1998-10-20
Onset:0000-00-00
Submitted: 1998-10-27
Entered: 1998-11-24
   Days after submission:28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / CONNAUGHT LABORATORIES 0975790 / UNK RA / IM
TD: TD ADSORBED (NO BRAND NAME) / CONNAUGHT LABORATORIES 0924000 / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Stupor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1998-10-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: unk~ ()~~~In patient
Other Medications: unk
Current Illness: NONE
Preexisting Conditions: schizophrenia;pt brother states pt stated had been advised to have heart surgery;
Allergies:
Diagnostic Lab Data:
CDC Split Type: TX98164

Write-up: arrived @ ER via ambulance CPR in progress reported unconscious, unresponsive by family who called ambulance;CPR discontinued 815AM;no post mortem exam done;


VAERS ID: 132417 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Male  
Location: Kentucky  
Vaccinated:1999-10-18
Onset:0000-00-00
Submitted: 1999-11-29
Entered: 2000-01-06
   Days after submission:38
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUOGEN) / PARKDALE PHARMACEUTICALS 031779P / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Right ventricular failure
SMQs:, Cardiac failure (narrow), Pulmonary hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-10-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~~~In patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY990062

Write-up: Death due to CHF, no autopsy.


VAERS ID: 164027 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New Hampshire  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-12-18
Entered: 2000-12-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ4854614DEC2000

Write-up: Post vax, the pt died. No further information was available at the date of this report. The reporter indicated that 9 pts experienced this event, however, they are not presently identifiable. 15 day follow-up states that the pt experienced flu-like symptoms as did a total of 9 pts.


VAERS ID: 164043 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2000-12-19
Entered: 2000-12-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ4993318DEC2000

Write-up: Post vax, the pt developed Guillain-Barre syndrome. No further information was available at the date of this report. FU received indicated the patient was an elderly female who received 1999-2000 formula influenza virus vaccine. See related case HQ5472103JAN2001.


VAERS ID: 164159 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Female  
Location: Georgia  
Vaccinated:2000-11-30
Onset:0000-00-00
Submitted: 2000-12-20
Entered: 2000-12-28
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0435AA / UNK LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: CAD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None reported.


VAERS ID: 164478 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-01-03
Entered: 2001-01-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ5472103JAN2001

Write-up: A nurse reported that a pt received an injection of 2000-2001 formula influenza virus vaccine in 2000 and subsequently, developed Guillain-Barre syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by FDA. See cancelled report, HQ4993318DEC2000. Follow-up received on 1/2/01, indicated that the pt was an elderly female who received 1999-2000 formula influenza virus vaccine. Five to 6 months, post vax, she developed Guillain-Barre syndrome. She died.


VAERS ID: 165308 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Florida  
Vaccinated:2000-12-13
Onset:0000-00-00
Submitted: 2001-01-25
Entered: 2001-01-30
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / AVENTIS PASTEUR U0448AA / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Guillain-Barre syndrome, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tiazac, Vioxx, Cozaar, Lipitor
Current Illness: unspecified shortness of breath
Preexisting Conditions: allergy to Motrin, HPTN, OA, gastritis, diverticulosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: U2001002100

Write-up: Sometime following vaccination, the pt developed [[name]] Barre Syndrome. The pt was hospitalized on 1/22/01. Further information is requested. F/U correspondence rec''d on 2/27/01 additional pt and the vaccine administrator info were provided. From faxed f/u correspondence rec''d on 6/18/01 for the doctor,stated that the pt was transferred from one hospital to another hospital on 2/8/01. Teh following info was sent to the doctor on 6/26/01. Date of admission to hospital 2/9/01, date of expiration 3/28/01 at 12:28pm. Dx at time of death Guillian-Barre'' syndrome immediate cause of death due to respiratory failure due to problems associated with [[name]] -Barre'' syndrome. Follow up 07/26/2001: "final diagnosis was GBS. Diagnosis was not made by a neurologist. it is not known if the patient experienced any other illnesses previous to GBS."


VAERS ID: 165976 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-02-08
Entered: 2001-02-20
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Difficulty in walking, Guillain-Barre syndrome, Hypoaesthesia, Pain
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: myelodysplastic syndrome
Allergies:
Diagnostic Lab Data: Guillain Barre Syndrome
CDC Split Type:

Write-up: On 01/28, this patient had progressive weakness of the lower extremities, aching and pain of lower extremities, numbness, and difficulty walking. The symptoms have been ongoing for 3 months.


VAERS ID: 186861 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2002-06-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Infection, Influenza like illness, Red blood cell count decreased, White blood cell disorder
SMQs:, Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-03-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Decades of undefined anemia (in family)
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu shot first week in October 10/98, by 10/12/98 huge infected mass forms on chest rather got flu symptoms immediately after shot. WBC doubled over night and WBC kept rising, RBC falling until dead 5 months later. March 10, 1999 cortizons injected to knee March 14, 1999 dead.


VAERS ID: 194965 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2002-12-12
Entered: 2002-12-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ5595503DEC2002

Write-up: A consumer reported that a male adult received Influenza Virus vaccine, Trivalent, Types A & B (1995-1996 formula) vaccine (date of immunization not identified). Subsequent to immunization he experienced paralysis and the patient died in connection with a flu vaccination. The consumer also reported that this individual experienced adverse events following immunization with smallpox in 1950. See Case ID HQ5610404DEC2002. This report was received from a department at a manufacturer. No additional information was available as of the date of this report.


VAERS ID: 206325 (history)  
Form: Version 1.0  
Age: 98.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2002-11-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure congestive, Coronary artery disease, Lung disorder, Myocardial infarction, Oesophageal disorder, Pneumonia, Respiratory failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-05-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuteral; Lasix; Klor-Con; Tylenol PM; Roxanol; Levsin; Ativan
Current Illness:
Preexisting Conditions: Coronary Artery Disease; Triple Coronary Bypass; Unstable Angina; Myocardial Infarction; Congestive Heart Failure; Acute Coronary Syndrome; Esophageal Stricture; Dyspnea; COPD; DJD; Pneumonia; Dysphagia; Dementia
Allergies:
Diagnostic Lab Data: Physical Exam: Temp: 97.6, Pulse 72, R 24, BP 112/78; HEENT: Pupils reacting to light. Resident is free of communicable disease including active Tuberculosis: Yes.
CDC Split Type: 200300899

Write-up: A 98 year old female received RSV vaccine or Placebo and Influenza Vaccine on 11/4/02 and 212 days later died. Records have been requested and will send follow-up when more information received. The Investigator assessed the event as unrelated to the study product. Follow up information received 7/11/02. Subject expired 5/6/03 at nurse home. Diagnosis: Respiratory failure, chronic obstructive pulmonary disease, congestive heart failure, myocardial infarction, pneumonia, acute coronary syndrome, esophageal stricture. Follow up on 08/22/2003: "Hospice Services RN Admission Assessment 05/06/03: DNR signed: Yes; Terminal Diagnosis: ES, CHF; Other Diagnosis: Acute Coronary Syndrome, Esophageal Stricture, Dyspnea, COPD; Radiation TX: None; Functional Limitations: Bowel/Bladder Incontinence, Ambulation, Speech; Activities permitted: Total bedrest; Mental Status: Unresponsive; Physical Assessment: Skin: Cool, Dry, Skin tugor: fair; Wound Care Record: Cleanse skin tear to R arm with NSS, apply triple antibiotic ointment, cover with dry dressing BID, D/C when healed; Sensor: hearing unknown, speech: nonverbal; Cardiovascular: Pulse-weak, Pedal Pulse-absent left and right. Fingers and feet cyanotic; Respiration: shallow at rest, cough: non, non-smoker; Lung sounds: diminished, crackles. Oxygen 4 L/min; Nutrition/Hydration: No intake; Gastrointestinal: Abdomen soft. Bowel sounds: x4 Quadrants, Hypoactive, Bowel incontinence; Genito-urinary: Urine amber, clear, indwelling catheter; Abuse screen: no suspected abuse/neglect; Pain assessment: "no indication of pain"; Additional Assessment: no labwork scheduled; Activities of Daily Living: unable to ambulate, transfer, dressing, eating, toileting, bathing; Psycho social status: Caregiver understands illness is terminal: Yes; Care Needs: Symptom management; Caregiver''s emotional response to current health status: continue with plan for symptom managment; Spiritual issues: last rights given 05/06/2003. Interval History and Physican Exam: 06/01/2003. History of Present Illness: 98 year old female treated for Resp. Failure, and DJD and now here for further managment. Past Medical History: CHF, DJD, Pneumonia, Dysphagia, Dementia; We are unable to obtain a death certificate for subject. Our site has made several phone calls to the son of the deceased subject referenced above and have received no response to our calls for a death certificate. We have no other contact person and we are not aware that an autopsy was performed. The only information that we have was received from the Health Center and was faxed to you on 07/11/2003. The note written by the Dr. states that the subject expired in this facility on 05/06/2003. You should already have this for your file. If you need us to fax it again, please let us know.


VAERS ID: 207834 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: California  
Vaccinated:2002-11-14
Onset:0000-00-00
Submitted: 2003-08-11
Entered: 2003-08-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UB245AA / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Military       Purchased by: Unknown
Symptoms: Bacterial infection, Cough, Drug ineffective, Dyspnoea, Laboratory test abnormal, Pharyngitis, Rash maculo-papular, Respiratory distress, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-12-15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Diagnostic Laboratory: PCR was positive for Neisseria Meningococcal infection serogroup C.
CDC Split Type: 200301574

Write-up: From initial information received on 8/7/03 from a medical professional, regarding an adverse event occurring in the US, it was reported that an 18year old male patient received MENOMUNE, lot number UB245AA, FLUZONE (lot number not reported), TUBERSOL (lot number not reported), HEPATITIS A VACCINE (lot number and manufacturer not reported, HEPATITIS B VACCINE (lot number and manufacturer not reported), MMR (lot number not reported), and PNEUMOVAX (lot number not reported) administered on 11/14/02. All vaccines were administered on the same date. The patient died on 12/15/02. The CDC investigation confirmed that the patient was positive for serogroup C, Meningococcal infection. The onset date of signs and symptoms were not reported. An autopsy was performed, however, results were not available at the time of this report. Follow-up information: Information has been received from a health professional concerning an 18 year old male patient who was healthy with no adverse entry who on 11/14/2002 was vaccinated with a dose of MMRII (Lot # not reported). Concomitant therapy on 11/14/2002 included a dose of hepatitis A vaccine (inactive) (manufacturer unknown) (Lot # not reported), a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) (Lot # not reported), a dose of pneumococcal vaccine 23 polyvalent (MSD) (Lot # not reported), a dose of tuberculin in purified protein derivative (TUBERSOL) (Lot # not reported), a dose of influenza virus vaccine (FLUZONE) (Lot # not reported) and a dose of meningococcal polysaccharide vaccine (MENOMUME-A/C/Y/W-135) (Lot # UB245AA). Subsequently the patient died on 12/15/2002. It was confirmed that the patient was positive for serogroup C Meningococcal infection. The onset date of signs and symptoms were not reported. An autopsy was performed; however, the results were not available at the time of the report. From additional information received on 08/12/2003 from a pathology department, it was reported that the patient presented with an acute onset of a rash on his feet that spread to his face over a period of a few hours, after a 3 day history of a cough and sore throat. The symptoms progressed rapidly to severe respiratory distress and shock. The patient was treated with advanced cardiac life support in the ICU (intensive care unit) and died within three hours of presenting to the hospital. The patient died at 1:01 pm on 12/15/2002; the autopsy was done the following day and showed that the cause of death was Neisseria Meningitidis Septicemia (Meningococcemia). Gross autopsy findings included evidence acute shock syndrome with diffuse petechia and hemorrhage to multiple organs, visceral congestions, shock kidneys, and a blothcy erythematous rash to the organs and a few scattered foci of acute inflammation within the myocardium and meninges. The clinical presentation, autopsy findings, and laboratory PCR results were consistent with Neisseria Meningitidis (meningococcal) Septicemia (special pathogens branch # M10158). The manner of death was natural. The CDC confirmed that the patient was positive for serogroup C Meningococcal infection. Final anatomical diagnosis from the autopsy report included: Diffuse discrete petechiae and small hemorrhages involving multiple organs, serosa and mucosal surfaces (intestines, mesentery, epicardium, myocardium, renal cortex, adrenals, lungs, pharynx, bronchi, skeletal muscle and conjuctica), pulmonary edema and visceral congestion, bilateral pleural and pericardial effusions, blotchy erythematous rash on face, trunk, arms and legs, shock kidneys with diffuse pale cortices. there was no purulent meningeal exudates present. The PCR results were positive for Neisseria Meningitidis Serogroup C. Microscopic findings included: Numerous fibrin micro thrombi in heart, lungs, liver, glomeruli, brain and oropharynx and scattered small foci of acute inflammation in meninges and myocardium associated with hemorrhage and focal myocyte necrosis. Microscopic descriptions included: Trachea-diffuse mucosal and submucosal hemorrhage without inflammation. Lung-diffuse alveolar damage with numerous scattered fibrin and conspicous granulocytes present in red pulp. Liver-sinusoidal congestion with sinusoids distended by granulocytes and scattered fibrin micro thrombi. Prostate and bladder-mucosal and glandular autolysis, no pathologic diagnosis. There were no radiographs taken. Toxicology results included: Volatiles-the blood and vitereous fluid were examined for the presence of ethanol at a cutoff of 20 mg/dl. No ethanol was detected. The following drugs were detected: Positive Lidocaine-Lidocaine was detected in the liver by gas chromatography and confirmed by gas chromatography/mass spectrometry. Positive Atropine-Atropine was detected in the liver by gas chromatography/mass.


VAERS ID: 207987 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: New York  
Vaccinated:2002-10-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Cough, Diarrhoea, Dysphonia, Dyspnoea, Fatigue, Feeling cold, Lung disorder, Nasal congestion, Pharyngolaryngeal pain, Pneumonia, Productive cough, Pyrexia, Respiratory disorder, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Duoneb, Flovent, Zoloft, Guaifenesin, Ativan, Tylenol Extra strength, Inhaled gentamicin
Current Illness:
Preexisting Conditions: COPD, O2 Dependent, CHF, Aortic Stenosis, Osteoarthritis, Angioplasty 1996. Relevant history from previous hospitalizations: On 12/20/2002 the patient was cultured for illness 65 days after vaccination. On 12/23/2002 he went to MD and was placed on Zithromax. Patient was recultred and placed on Levaquin 12/27/2002. On 12/31/2002 the patient went to visit MD (scheduled visit), and was admitted to the hospital, 76 days after vaccination, with initial symptoms of a sore throat, hoarseness, nasal stuffiness, cough, tiredness. Patient became short of breath as cold progressed. He had a chest x-ray done twice with a diagnosis of Pneumonica-Sputum culture-pseudomonas. He was treated with one dose of Ciprofloxacin and a course of Levaquin and required supplemental oxygen. Outcome-Recovered with Residual Effects on 01/10/2003. Patient never fully returned to baseline. Investigator assessed the event as unrelated to the study product. He was admitted to the hospital again on 04/08/2003. On 02/19/2003, 126 days after vaccination, he was cultured for respiratory illness. He complained of increased sputum, cough with chills and feverishness, while on antibiotics per MD. He did not get better after 2 courses of antibiotics, became increasingly SOB and was admitted to the hospital on 03/08/2003 (143 days after vaccination) due to increased shortness of breath. He was placed on increased oxygen, ahd 2 chest x-rayx and was started on inhaled Gentamicin. While in the hospital had ORSA (Oxacillin Resistant Staph Aureaus) and Pneumonia was diagnosed. Patient had 3 chest x-rayx, MRI, CAT scan. He was released from hospital after 7 days on inhaled Gentamicin and Prednisone, home oxygen and use of Acapella flutter valve. The investigator assessed the event as unrelated to the study products. Date Discharged 03/14/2003. The third hospitalization occurred on 04/04/2003, 170 days after vaccination. He experienced vomiting, diarrhea, abdominal pain, a temperature of 103 F, oxygen saturation of 82% and was admitted to the hospital. Questionable ischemic bowel or diverticulitis. Patient transferred to ICU for observation. Thought to be septic. NG tube placed. Received multiple blood transfusions. The investigator assessed the event as unrelated to the study product.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301313

Write-up: An 83 year old male received RSV 11 Vaccine or Placebo and Influenza Vaccine on 10/16/2002 and 267 days later died on 07/10/2003. The pt''s obituary was seen in the paper. No further info is available at this time but site will contact the family for further details. The Investigator assessed the event as unrelated to the study product. The pt had 3 prior hospitalizations, in 12/31/2002 admitted with a diagnosis of pneumonia (sputum culture pseudomonas), in March for a respiratory illness which did not improve after 2 courses of antibiotics. While in the hospital he had Oxacillin resistant Staph. Aureus and Pneumonia was diagnosed. He was also hospitalized on 04/04/2003 with symptoms of vomiting, diarrhea, abdominal pain, temperature of 103 F. and an oxygen saturation of 82%. A 15-day follow up report received 8/29/2003 adds: Additional info received 8/12/2003. The Investigator spoke with family member regarding pt''s death. Pt was admitted to hospice on 07/01/2003 due to increased SOB and respiratory problems. Pt remained in hospice until death on 07/10/2003. Death certificate states Severe COPD as cause of death. Investigator assessed the event as unrelated to the study product. Follow up on 09/17/2003: "Additional information received 09/08/2003. Copy of Certificate of Death: Cause of Death: Severe Chronic Obstructive Pulmonary Disease. Other Significant Conditions Contributing to Death But Not Related to Cause: Recurrent Pneumonia." Death Certificate received on 9/12/2003 states COD was COPD.


VAERS ID: 208171 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Florida  
Vaccinated:2002-10-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Cardiac failure, Condition aggravated, Lung disorder, Polyp, Weight decreased
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasix, Theophylline, Combivent, Oxygen, Aerobid, Guaifenesin, Rabeprazole, Prednosone
Current Illness:
Preexisting Conditions: Emphysema, Chronic Obstructive Pulmonary Disease, Additional information received 08/22/2003. Previous history: Discharge Summary: 04/24/2002. Date of Admission: 04/15/2002. Date of Discharge: FINAL DIAGNOSIS: 1) Exacerbation of chronic obstructive pulmonary disease with bronchitis. 2) Gastrointestinal bleed secondary to polyps. PLAN: He will be discharged on Atrovent metered dose inhaler two puffs p.o. q6h, Ventolin metered dose inhaler two puffs p.o. q6h. Theophylline 300 mg p.o. three times daily, Ceftin 500 mg p.o. three times daily for the next five days and Prednisone 6 mg p.o. once a day to be tapered as an outpatient. Diet and activity can be as tolerated. He will follow up with myself and with MD. HOSPITAL COURSE: He was admitted for exacerbation of COPD. He was placed on bronchodilators, antibiotics, oxygen and IV Theophylline and steroids. He showed a steady improvement as his medication was tapered on the final hosptial day. He was back to his baseline and did not have dyspnea on exertion. While in the hospital, he had an episode of GI bleeding. MD was consulted. Colonoscopy was done. He had noted to have a rectal mass and multiple colon polyps and anal stenosis. Biopsies were done. H&H remained stable. At this time, no further in-hospital management is planned and he can be followed as an outpatient. H&P: Chief complaint: Dyspnea. HISTORY: A 76 year old male who developed several days of increasing shortness of breath with chills. He had not been keeping up with his medications. He presented to the ER where treatment there did not resolve his symptoms and he was referred to me for exacerbation of chronic obstructive pulmonary disease with probable underlying bronchitis. He has had a productive cough. MEDICATIONS: Emphysema, Theophylline, Combivent, Albuterol. PAST MEDICAL HISTORY: Emphysema, Back pain. FAMILY HISTORY: Non contributory. SOCIAL HISTORY: He is a former smoker but has not smoked in several years. REVIEW OF SYSTEMS: Chiefly remarkable for the chronic back pain, otherwise not remarkable. PHYSICAL EXAMINATION: General: appeared well. Vital signs: Pulse 136, Respirations 36, blood pressure 160.82. Temperature: 98.6. HEENT: Not remarkable. Neck: No JVD or bruit. Heart: Had a regular rate and rhythm. Abdomen: soft, good bowel sounds. Lungs: Crackles an wheezing in all fields. Neurological: not remarkable. Extremities: no edema.
Allergies:
Diagnostic Lab Data: First CPK was negative. Blood gas revealed hypoxia. However, he was not acidotic. Chem-7 was okay. CBC and elevated white blood count of 17. Theophylline was 10.
CDC Split Type: 200301625

Write-up: This subject is a 76 year old male who died on 7/24/03 due to his emphysema while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/10/02. The subject died 287 days post immunization. The subject''s family phoned on 8/15/03 to notify the investigator that the subject expired from emphysema on 7/24/03. The event was reported by the investigator as unrelated to the study product. A 15-day follow up report received 8/26/03 adds: Additional info received 08/22/2003. Previous medical history received and available in source documents. Discharge Summary: 04/24/2002. History and Physical: 04/24/2002. Progress Notes: 1/4/00, 1/25/00, 3/6/00, 3/1/01, 6/29/02, 7/8/02. Final diagnoses: 1. Exacerbation of chronic obstructive pulmonary disease with bronchitis. 2. Gastrointestinal bleed secondary to polyps. He will be discharged on Atrovent metered dose inhaler two puffs p.o. q6h. Ventolin metered dose inhaler two puffs spo q6h. Theophylline 300mg po bid, Ceftin 500mg po bid for the next five days and Prednisone 6mg po once a day to be tapered as an outpatient. Diet and activity can be as tolerated. He will follow-up with myself and with Dr. Hospital Course: He was admitted for exacerbation of COPD. He was placed on bronchodilators, antibiotics, oxygen and IV Theophylline and steroids. He showed a steady improvement as his medication was tapered on the final hospital day. He was back to his baseline and did not have dyspnea on exertion. While in the hospital, he had an episode of GI bleeding. Dr. was consulted. Colonoscopy was done. He had noted to have a rectal mass and multiple colon polyps and anal stenosis. Biopsies were done. H&H remained stable. At this time, no further in-hospital management is planned and he can be followed as an outpatient. Impression: 1. Severe COPD. 2. Weight loss. Maintain Prednisone at 20mg per day. Continue on Pulmicort, Atrovent, and Albuterol. Follow-up again in one month. Death certificate states congestive heart failure. Additional info received 9/19/03. Follow up report. Diagnosis: Emphysema, chronic obstructive pulmonary disease, congestive heart failure. Progress notes: 9/19/03. Patients certificate of death received and noted. Immediate cause linked as COPD and congestive heart failure. Review reveals no evidence of cong. failure in this facility. Pt received his injection of RSV vaccine in Oct. 2002. Deceased July 24, 2003. Death certificate received. Cause of death: End stage chronic obstructive pulmonary disease, congestive heart failure. The investigator assessed the events as unrelated to the study products. Follow up on 09/17/2003: "Additional information received 09/05/2003. Family reports death certificate states: A-End stage of chronic osbructive pulmonary disease. B-Congestive heart failure. Copy pending. Diagnosis: Chronic Obstructive Pulmonary Disease, Emphysema. The death was reported by the investigator as not related to the study product."


VAERS ID: 208279 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Colorado  
Vaccinated:2002-11-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cor pulmonale, Hypertension, Pneumonia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Pulmonary hypertension (narrow), Hypertension (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-07-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV, Placebo, Micronase, Glucophage, Inderal, Prinivil, Combivent, Mobic, Celexa, vicodin, Oxybutynin, Estring, oxygen
Current Illness:
Preexisting Conditions: COPD, hypertension, diabetes type II, neuropathy, depression, obesity, spinal stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301742

Write-up: This subject is a 73 year old female who died at home 240 days post immunization on 7/11/03 while enrolled in the RSV 11 study. The subject received the RSV vaccine or Placebo and influenza vaccine on 11/13/02. The subject was diagnosed with pneumonia a few days before her death. Subject was not admitted to hospital and was found in her home on 7/11/03. The death was reported by the investigator as not related to the study product. Death certificate states cause of death as "Probable complications of hypertensive heart disease." Other significant conditions, chronic obstructive pulmonary disease, obesity. No autopsy performed. Additional documents received and with source documents: Certificate of Death: 8/20/03.


VAERS ID: 210330 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: California  
Vaccinated:2003-10-03
Onset:0000-00-00
Submitted: 2003-10-13
Entered: 2003-10-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Arrhythmia, Gastritis, Hypertension, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Had flu vaccine 100303. C/O N & V after vaccine. Deceased 100703 AM cause of death not known. The autopsy report states cardiac arrhythmia and hypertensive heart disorder. Medical Record received on 10/20/2003 states gastritis.


VAERS ID: 212153 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Unknown  
Location: California  
Vaccinated:2002-10-25
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2003-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Lung disorder, Pneumonia, Pulmonary hypertension
SMQs:, Pulmonary hypertension (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV/Placebo; Prednisone; Lasix; Spironolactule; Arpamil, Fosamax, Septha
Current Illness:
Preexisting Conditions: Emphysema, CHF, COPD, interstitial lung fibrosis, diabetes type 2.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302839

Write-up: This subject is a 79 year old male who died while enrolled in the RSV 11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 10/25/02. Investigator is waiting for medical records. The death was reported by the investigator as not related to the study vaccine. A 15-day follow up report received 11/13/2003 adds no new info. The hospital discharge summary received on 11/20/03 states pneumonia, and pulmonary hypertension. A follow-up received 11/20/2003 adds: Acute pneumonia, pulmonary HTN.


VAERS ID: 212277 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2003-10-22
Onset:0000-00-00
Submitted: 2004-10-01
Entered: 2003-11-14
   Days after submission:321
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1123AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Respiratory failure, Stevens-Johnson syndrome, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amoxicillin, two neurological medications
Current Illness:
Preexisting Conditions: The patient was a teacher and received the vaccine at her school. At the time of vaccination, the patient was reportedly taking amoxicillin and two new neurological medications however, the indications for each were not specified.
Allergies:
Diagnostic Lab Data: No autopsy was performed.
CDC Split Type: 200302904

Write-up: It was reported that a 43 year old female pt received Fluzone on 10/23/03. An unspecified amount of time later, the pt developed a fever of 104 deg F and was taken by ambulance to the hospital. She was diagnosed with Stevens-Johnson syndrome. The pt died on 11/3/03. The reporter stated that the death certificate lists the cause of death as "toxic epidermal necrolysis and severe respiratory failure." No other info was reported. A telephone call was placed to the reporter on 11/7/03, to request copies of the death certificate and autopsy report if available and any additional info. Later that day, the reporter provided the lot number info. The product was administered IM in the left deltoid on 10/22/03. The pt was admitted to the hospital on 10/25/03. The primary physician''s info and vaccine supplier were also provided. On 11/7/03, during telephone contact with the primary physician, it was reported that the pt was on several other medications at the time of vaccination, including amoxicillin and two new neurological medications. He could not provide any additional info at this time. Follow up on 11/17/2003: "From additional information received on 11/10/2003 from the initial reporter, it was reported that the patient died at a university medical center on 11/03/2003 at 8:38AM. A copy of the death certificate was provided and the causes of death are listed as toxic epidermal necrolysis and Stevens-Johnson Syndrome. The approximate interval between the onset of symptoms and death was noted to be one week. No autopsy was performed. The vaccine administrator and responsible physician''s information were also provided, as well as the attending physician''s name and contanct information from the hospital where the patient was treated. The patient received the influenza vaccine on 10/22/2003 in the left deltoid. E-mail correspondence with the attending physician at the hospital that same day stated that he felt that the physicians who were part of the original attending team admitting the patient to the hospital would best be able to answer requests for additional information. He provided the names of the doctors and stated that the forwarded the request from AP, Inc. to these same physicians. No other information was provided." Follow up on 05/18/04 states: "Despite several attempts to obtain follow up information, no additional information was provided. This case is considered closed."


VAERS ID: 212882 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2003-10-30
Onset:0000-00-00
Submitted: 2003-11-24
Entered: 2003-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765955 / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aneurysm, Anorexia, Fatigue, Malaise, Thinking abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None known
Current Illness: Per patient, denied any illness at the time of administration of Flu vaccine.
Preexisting Conditions: Patient denied any allergy to eggs or Thimerisol. No other medical information available.
Allergies:
Diagnostic Lab Data: none known
CDC Split Type:

Write-up: Patient expired on 11/18/03 due to ruptured Aorta. Presented at ER 11/14/03 after "not feeling well", for a few days, complaining of tiredness and loss of appetite. Discharge Summary received on 12/01/2003 states change in mental status.


VAERS ID: 215842 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: California  
Vaccinated:2004-01-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2004-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR V1134BA / 1 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Chills, Coma, Cough, Cyanosis, Dyspnoea, Fatigue, Hyperhidrosis, Malaise, Pallor, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Hypertension, diabetes, Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: A 22 year old received her flu shot between 0600 and 0800 hrs on Friday, 1/9/04. Pt worked 4 hrs following the shot then, because she wasn''t feeling well and had a fever, went home. She saw her to the doctor on Monday, 1/12/04, as she wasn''t feeling well. Pt died on Wednesday, 1/21/04. The pt''s husband, relayed that his wife was being treated for hypertension and diabetes. He added that when she saw her doctor on 1/12, that he was concerned about her blood pressure. The husband also said that she was coughing and had a hard time breathing when she was laying down. The ER record received on 3/8/04 states cyanosis and pale. Chills, sweats, fatigue, unresponsive. Nurse follow up on 06/18/04 states: "Add: Acute Bronchial Pneumonia."


VAERS ID: 222203 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2003-10-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2004-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arteriosclerosis, Asthenia, Back pain, Bone neoplasm, Cardiac arrest, Cholecystitis, Colitis, Coronary artery disease, Cough, Dyspnoea, Dysuria, Faecal incontinence, Gait disturbance, Gastrointestinal disorder, Hepatic neoplasm, Laboratory test abnormal, Lung neoplasm malignant, Lymphoedema, Myocardial infarction, Thrombosis, Vascular anomaly, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Liver tumours of unspecified malignancy (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-05-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject received dose 1 of RSV vaccine or Placebo and Influenza vaccine on 10/11/02. Additional information received 05/25/04. Hypertension, chronic ischemic heart disease, CHF, MI 1994, CABG 1004, Arthritis, Hypercholesterolemia, Angina
Allergies:
Diagnostic Lab Data: Chest CT on 04/09/04-Left upper lobe lung mass most likely primary lung neoplasm with metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. Right L3 core biopsy on 04/16/04-Netastatic adenocarcinoma.
CDC Split Type: 200401445

Write-up: This subject is a 86 year old male who was admitted to the hospital due to increasing back pain over the past several weeks and increasing SOB over the last week while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine versus an RSV Vaccine Adjuvanted with Aluminum Phosphate when Administered Concomitantly with a Licensed Influenza Vaccine in High Risk Adults $g or = 65 years of age. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/22/03. The subject developed increased back pain and shortness of breath, and was admitted to hospital 169 days post immunization on 4/8/04. Treatment and discharged date were not reported. The subject''s outcome was unknown at the time of this report. The increasing back pain over the past several weeks and increasing SOB over the last week were reported by the investigator as unrelated to the study vaccine. Additional information received on 5/25/04. Subject was admitted to the hospital for increasing back pain, difficulty urinating and difficulty ambulating for several weeks. Shortness of breath and wheezing for 1 week. Subject was diagnosed with primary lung cancer with metastasis to the bone 170 days post immunization. Investigations included a chest CT on 4/9/04 which revealed a left upper lobe lung mass most likely primary lung neoplasm with metastasis. Abdomen CT on 4/9/04 revealed metastasis to caudate lobe of liver, left adrenal mass, multiple kidney lesions and multiple metastases to vertebrae. A right L3 core biopsy on 4/16/04 showed metastatic adenocarcinoma. Subject underwent several days of radiation and was maintained on normal routine medications. Subject has not recovered and was discharged to hospice 11 days later on 4/19/04. Subject discontinued the study on 4/23/04. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Additional information received 5/26/04. Notified by spouse that while at home on hospice, subject died on 5/13/04, 204 days post immunization. The subject''s death was reported by the investigator as unrelated to the study vaccine. Additional documents available with source files: Pathology and Laboratory report - Right L3 Transverse Process Core Biopsy; CT Abdomen with and without contrast; CT Chest with and without contrast; Concomitant medications. Nurse follow up on 06/14/04 states: "bowel incontinence; thrombosis; diverticulitis; GERD; Lymphedema; Arthrosclerosis; Cholecystitis; Aortic aneurism; Weakness; Cough." 6/25/04 Death certificate received which revealed COD to be cardiac arrest, Myocardial infarction, coronary artery disease & metastatic lung cancer.


VAERS ID: 228231 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Female  
Location: Maryland  
Vaccinated:2004-10-08
Onset:0000-00-00
Submitted: 2004-10-25
Entered: 2004-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1489AA / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Cerebral infarction, Circulatory collapse, Gait disturbance, Hyperlipidaemia, Hypertension, Lung disorder, Myasthenic syndrome, Myelitis transverse, Pain, Paraesthesia, Pulmonary oedema, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Dyslipidaemia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Lipodystrophy (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: Sciatica, HTN
Allergies:
Diagnostic Lab Data: unknown to me at this time
CDC Split Type:

Write-up: unknown to me at this time. Nurse follow up on 10/29/04 states: "multiple lacunar infarcts in the thalami, (L) caudate head & periventricular white matter; transverse myelitis; hypertension; hyperlipidemia; pain & numbness; weakness of lower extrem; difficulty walking." Autopsy Report received on 12/07/2004 states severe acute CHF, bilateral acute ischemic renal infarcts, severe pulmonary congestion and edema, severe congestion, liver and spleen, and circulatory collapse. 11/18/04 Lab reports received. No new evidence found.


VAERS ID: 228345 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-14
Onset:0000-00-00
Submitted: 2004-10-27
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Bacterial infection, Blood pressure decreased, Cerebrovascular accident, Chromaturia, Coma, Hypertension, Medication error, Pallor, Pulse absent, Urine analysis abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bumetanide; Celebrex; Docusate sodium; Flomax; Potassium CL; Meclizine; Prevacid
Current Illness:
Preexisting Conditions: History of colon cancer; arthritis; vertigo; hypertension; benign prostatic; hypokalemia; diverticular disease; obesity.
Allergies:
Diagnostic Lab Data: 10/20/04: Urine analysis and culture positive for Proteus mirabilis.
CDC Split Type:

Write-up: 80 year old nursing home resident, no acute illness. 10/18/04, dark, cloudy urine noted; UA ordered (10/24 lab report: numerous proteus mirabilis). On 10/22/04 at13:10 patient observed unresponsive and pale; no pulses, no respiration, no BP. CPR initiated, but unsuccessful. Note: Order written for 1cc flu vaccine; documented administration same, though facility says patient actually received 0.5cc. Nurse follow up on 11/01/04 states: "UTI." Death Certificate received on 11/16/2004 states causes of death are hypertension and CVA.


VAERS ID: 228895 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-13
Onset:0000-00-00
Submitted: 2004-11-02
Entered: 2004-11-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK LA / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0062P / UNK RA / -

Administered by: Private       Purchased by: Private
Symptoms: Arteriosclerosis, Cardiac disorder, Chest pain, Malaise
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chest pain; Malaise
Preexisting Conditions: myocardial infarction, HBP, and nocturia.
Allergies:
Diagnostic Lab Data: Chest pain; Malaise
CDC Split Type:

Write-up: First visit to physician. Normal EKG. Received ER medical records. Death Certificate received on 12/01/2004 states pt experienced arteriosclerotic heart disease.


VAERS ID: 232070 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-01-06
Entered: 2005-01-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Hypoglycaemia, Myocardial fibrosis, Myocardial ischaemia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Respiratory failure (broad), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s pre-existing medical conditions include Type I Diabetes. Reportedly, the patient is non-compliant.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200500058

Write-up: From initial information received on 1/4/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male patient in his 50''s received a dose of FLUZONE administered on an unspecified date. The lot number, route and site of administration were not reported. Four hours later, the patient experienced a severe hypoglycemic attack. Per the reporter, he refused to be transferred to the hospital. Twelve hours later, the patient had a cardiac arrest and was found dead. Reportedly, the patient had Type I Diabetes, but was non-compliant. Discharge Summary received on 1/20/2005 states past ischemic injury and myocardial fibrosis.


VAERS ID: 266012 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2006-10-05
Onset:0000-00-00
Submitted: 2006-11-04
Entered: 2006-11-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2240AA / 1 LA / -

Administered by: Other       Purchased by: Private
Symptoms: Respiratory disorder, Respiratory tract infection
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient''s father came in; said patient felt ill, went to emergency room, got hospitalized for respiratory problem/infection and died day(?) shortly afterward. 11/20/06 Received medical records from hospital which indicate patient seen 10/13/06 with altered mental status, SOB, nausea, vomiting. Seen in local clinic & dx w/HTN. Patient coded outside ER where he had been brought by his parents. Code/intubation were successful. NGT revealed coffee ground gastric contents. LABS: WBC 41,800, H/H 9.3/26.3, plts 119,000. Na 110, K5.5, BUN/creat 108/3.9, cl 76. Troponin 0.16. Calcium 5.7. Beta natriuretic peptide 1570. ABG showed metabolic acidosis. CXR revealed cardiomegaly w/pulmonary congestion consistent w/CHF & RLL pneumonia. Patient expired 10/23/06 when he coded again while on his way to OR for trach. No autopsy was done. DX: cardiopulmonary arrest s/p successful resuscitation; Gram neg septic shock, acute renal failure; metabolic acidosis; hypocalcemia; ARDS; multi system organ failure; & UGI bleeding. 12/1/06 Received death certificate which reveals COD as acute cardiopulmonary arrest, septic shock & hypertension.


VAERS ID: 267624 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-11-17
Entered: 2006-11-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Autonomic nervous system imbalance, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood urea increased, CSF test abnormal, Colitis, Demyelination, Dysphonia, Gamma-glutamyltransferase increased, Guillain-Barre syndrome, Inflammation, Polyneuropathy, Quadriplegia, Renal failure, Sepsis, Shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FK506, Prednisone.
Current Illness:
Preexisting Conditions: The pt had a history of hypertension and alcoholic liver cirrhosis, for which he underwent orthotopic liver transplantation six months prior to admission. He denied any precedent episodes of diarrhea, nausea, vomiting, or other gastrointestinal or upper respiratory illness.
Allergies:
Diagnostic Lab Data: Electrodiagnostic studies showed prolonged distal latencies and absence of late responses in all extremities. The component muscle action potentials were reduced throughout with absence of component muscle action potential in the proximal tibial and peroneal nerves bilaterally. The conduction velocities were reduced in demyelination range in the median nerves bilaterally. There was a conduction block in median nerves bilaterally, in right ulnar and in right tibial nerves. These findings were consistent with acute inflammatory demyelination polyneuropathy. Due to size limitation of the lab comments field, the complete reported lab findings are entered in the single case comments field.
CDC Split Type: 200603086

Write-up: Initial information was received on 11/13/06 from the aforementioned literature citation. A 62 year old male pt, with a past medical history of hypertension and alcoholic liver cirrhosis, for which he underwent orthotopic liver transplantation, received an influenza vaccination on an unspecified date. The trade name, manufacturer or lot number were not reported. Two weeks after receiving the vaccine, the pt developed progressive generalized weakness and was diagnosed with Guillain [[name]]e Syndrome. He was seen in a hospital one week after the onset of symptoms, where he was found to have an elevated FK506 level (18.1 ng/ml, and the dose of FK506 was adjusted. His weakness worsened, and he was admitted to another hospital two weeks after th onset of the symptoms. The pts liver transplantation as six months prior to admission. Since then, he had been on FK506 and a low dose of prednisone without any complications. He denied any precedent episodes of diarrhea, nausea, vomiting, or other gastrointestinal or upper respiratory illness. Neurological examination on admission revealed normal mental status, bilateral facial weakness, dysphagia, hypophonia, quadriplegia ( 1-2/5 by Medical research council scale), throughout, and absence of muscle stretch reflexes in all extremities. Blood chemistry showed blood urea nitrogen 34 mg/dl, creatinine 0.9 g/dl, albumin 4.5 g/dl, aspartate aminotransferase 78 u/l, alanine aminotransferase 189 u/l, gamma glutamyl transpepitadase 160 u/l, alkaline phosphatase 146 mg/dl, total bilirubin 1.8 mg/dl, direct bilirubin 0.5 mg/dl, ammonia 47 ul/l, international normalized ration 0.91, and blood FK5506 level 7ng/ml. Serum immunoglobulin G was positive against herpes simplex virus 1, Epstein [[name]] virus and cytomeglaovirus, but neg against herpes simplex virus 2. Immunoglobulin M was neg against Epstein [[name]] virus and CMV in serum. The testing for Campylobacter Jejuni was not performed. Lumbar puncture revealed that the cerebrospinal fluid looked xanthochromic with red blood corpuscles 0/11^3, while blood cells 1/mm3, protein 358 mg/dl, glucose 88 mg/dl, lactic acid 2.7 mEq/l, and opening pressure of 25 cm cerebrospinal fluid. Cerebrospinal fluid venereal disease research lab slide test, gram stain, cyptococcal antigen, and cytology were neg. Herpes simplex virus, CMV, and Epstein [[name]] virus DNA were not detected by polymerase chain reaction test. Electrodiagnostic studies showed prolonged distal latencies and absence of late responses in all extremities. The component muscle action potential were reduced throughout with absence of component muscle action potential in the proximal tibial and peroneal nerves bilaterally. The conduction velocities were reduced in demyelination range in the median nerves bilaterally. There was a conduction block in median nerves bilaterally, in right ulnar and in right tibial nerves. These findings were consistent with acute inflammatory demyelination polyneuropathy. Shortly after admission, the pt was Intubated for airway protection and started on IV immunoglobulin 0.4 g/kg/[[name]] for three [[name]]s without significant improvement. Plasma exchange was not considered because of the pts hemodynamic status. His hospitalization course was complicated by the development of ischemic colitis secondary to dysautonomia, for which he under went subtotal colectomy. The pt expired three weeks after admission from septic shock and acute renal failure. The authors note although the temporal relationship between GBS and influenza vaccination is suggestive of causal relationship, it does not fully prove it.


VAERS ID: 268477 (history)  
Form: Version 1.0  
Age: 89.0  
Sex: Male  
Location: Ohio  
Vaccinated:2006-11-07
Onset:0000-00-00
Submitted: 2006-12-03
Entered: 2006-12-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2250AA / UNK RA / -

Administered by: Public       Purchased by: Private
Symptoms: Back pain, Guillain-Barre syndrome, Laboratory test abnormal, Pain, Pyrexia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-11-29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: As of 5/1/06 over
Current Illness: Spinal stenosis, lubo sacral neuritis.
Preexisting Conditions: Spinal stenosis, lubo sacral neuritis, CHF, Aortic stenosis, Gilberts syndrome, aortic regurgitation, BPH, osteoarthritis, anemia, renal insuffiency.
Allergies:
Diagnostic Lab Data: EMG and Spinal tap confirmed DX according to MD.
CDC Split Type:

Write-up: Reported death due to Guillain Barre Syndrome. Transferred to Hospital on 11/18/06 with severe pain to spinal stenosis, low grade fever, and possible Guillian Barre Syndrome. Dies at hospital. 1/8/07 Received medical records from hospital which reveal patient admitted 11/18/06-11/29/06 for LE pain with ascending paralysis & studies positive for GBS. Treated with IVIG x 4 days. on 11/25, had PEA & coded. Responded well initially then coded several additional times before expiring on 11/29. Consults of pulmonology & neurology included. D/C summary indicates COD as secondary to GBS, causing severe autonomic dysfunction & cardiac arrhythmias. PMH: CHF LABS: EMG/NCS 11/20/06, c/w GBS; CT of head 11/18, showed mild atrophy; fluoroscopic LP on 11/18, revealed elevated protein, normal WBC & RBC. FINAL Dx: Guillain Barre Syndrome; CHF w/ejection fraction of 35%; aspiration pneumonia; BPH; anemia; & CAD. 1/9/07 Received copy of Death Certificate from family which reveals COD as GBS with contributing factors of CAD & spinal stenosis.


VAERS ID: 278371 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-05-11
Entered: 2007-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: The subject''s medical history, concurrent conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0650661A

Write-up: This case was reported by a nurse, and described the occurrence of influenza in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine for prophylaxis. The subject''s medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received unspecified dose of Flu vaccine (unknown). The reporting nurse did not have the name of the Flu vaccine that was administered. At an unspecified time after vaccination with Flu vaccine, the subject experienced influenza and lack of efficacy. It was reported that the subject "died from the flu, however, it was unknown which strain of flu the subject died from". It was unknown whether an autopsy was performed. No further information was provided at the time of reporting.


VAERS ID: 291391 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2007-09-26
Entered: 2007-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Influenza like illness, Intensive care, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-12-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: PMH: mood disorder & depression.
Allergies:
Diagnostic Lab Data: UNK MD office LABS: EKG sinus tachycardia. pulse ox unable to register. Hospital LABS: Blood cultures (+) for fungemia.
CDC Split Type: A0683361A

Write-up: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of Stevens Johnson syndrome in a female subject aged between 20 and 29 years old who was vaccinated with Flu vaccine, manufacturer unspecified) for prophylaxis. Co-suspect medication included Lamotrigine (Lamictal). On an unspecified date the subject received unspecified dose of Flu vaccine (unknown). In 2006, at an unspecified time after vaccination with Flu vaccine, the subject experienced Stevens Johnson syndrome, organ failure, flu-like symptoms, and fever. The subject was hospitalized. The subject died from Stevens Johnson syndrome. An autopsy was performed. The patient developed flu-like symptoms but had just been given the flu vaccine. She then spiked a fever of 106 degrees and was hospitalized. Lamictal was not discontinued because the providers were originally associating the events with the flu vaccine. The patient went into organ failure and was placed in the intensive care unit and then died. The autopsy results indicated that the patient died of Stevens Johnson syndrome which might have been caused by Lamictal use. 10/2/07 Received patient demographics from FDA. 10/5/07 Reviewed MD medical records which reveal patient made emergency visit on 11/30/2006 3 days s/p flu shot at unknown facility. Day after flu shot, developed severely high fever, shaking & chills follwed by SOB, chest discomfort & decreased urine output over past couple of days. Had started Lamictal 14 days prior. Temp in office 107 via ear by MD. Face & chest were red & patient considered extremely toxic w/shaking chills, cracked dry lips, dry mucous membranes. MD called ambulance & sent to ER. Also called pts psychiatrist. MD FINAL DX: malignant hyperthermia, unclear etiology. possible reaction to flu vaccine, possible drug reaction to Lamictal or possible Stevens Johnson syndrome. possible reaction to psychiatric medication. 10/19/07 Received autopsy report which states COD as complication of probable drug hypersensitivity syndrome due to Lamictal therapy for treatment of bipolar disorder & manner of death as therapeutic complication. Final Dx: I. Probable drug hypersensitivity syndrome. A. recent initiation (approx 7-10 days prior to clinical presentation) of Lamictal therapy for treatment of bipolar disorder. B. hospital admission 11/30/06 in acute distress, febrile w/generalized rash & facial & lip swelling. C. progressive deterioration w/multi-organ system failure. D. S/P attempted resuscitation. E. scattered petechiae of head, torso & extremities F. diffuse alveolar damage of lungs G. centrizonal hepatic nectosis H. multifocal infarcts of spleen. I. autolysis of stomach & pancreas. J. focal ischemic changes of small & large intestine. II. Cardiac enlargement. 12/14/07 Reviewed hospital medical records which reveal patient experienced fever, chills & facial rash. Tx empirically for UTI w/IV antibiotics. DX: anticonvulsant hypersensitivity syndrome, renal failure & progressive ARDS. To ICU on vent. Continued fever spikes, DIC & generalized body rash. Tx w/antihistamine & steroids w/some rash improvement. Pulmonary failure progressed & developed bilat pleural effusions. Emergent bronchoscopy done & bilat chest tubes placed. Continued to deteriorate w/progressive acidosis, cardiomyopathy & ischemic bowel. Coded & expired. FINAL HOSPITAL DX: anticonvulsant hypersensitivity reaciton; DIC; ischemic bowel; cardiomyopathy; renal failure; ARDS; fungemia; pulmonary failure; hx of bipolar disease.


VAERS ID: 292942 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:2007-10-05
Onset:0000-00-00
Submitted: 2007-10-12
Entered: 2007-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA302BA / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray normal, Cyanosis neonatal, Death, Dehydration, Infantile apnoeic attack, Jaundice neonatal, Lethargy, Sepsis, Wrong drug administered
SMQs:, Congenital, familial, neonatal and genetic disorders of the liver (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (narrow), Congenital biliary disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-10-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: As in narrative.
Current Illness: newborn, rule out sepsis.
Preexisting Conditions: Birth Hx: 35 wk, c-section due to maternal pain. Nuchal cord at birth & vacuum extraction. Apgar scores were 3/6/8 at 1/5/10 minutes. Patient cyanotic & lethargic at birth.
Allergies:
Diagnostic Lab Data: 10/8 CXR negative LABS: echocardiogram. EKG revealed SVT. Troponin 36.8.Liver enzymes (H). Bilirubin 12.2. H/H 9.7/27.8. D-dimer (+). Transfused w/PRBCs & FFP.
CDC Split Type:

Write-up: This is a newborn (10/3/07) WF by emergency C-section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5 instead of Engerix B (the syringes look alike). The error was discovered on 10/9. The patient was treated with IV genatmicin and ampicillin from days one through three to rule out sepsis. Blood cultures were negative and the patient was discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis. She was given fluids and electrolytes and transferred to Children''s Medical Center. The patient expired on 10/10/07. The initial impression is enteral viral sepsis without a definitive cause at this point. Cause from the flu vaccine is doubtful but unknown. 10/16/07 T/C to reporter who provided patient demographics. 10/18 Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed which reveal lot number correct as reported. D/C to home 10/6 with f/u scheduled for 10/8. 11/13/07 Received hospital medical records which reveal patient experienced poor feeding & apnea/cyanosis events at home. Lethargic w/multiple apneic events at pcp office on 10/8/07. WBC 16.8, platelets 20,000 in pcp poffice. Pcp placed on O2 & called EMS. Blood c/s done & IV antibiotics given. Admitted 10/8-10/10/2007. Admit exam revealed overriding sutures, irritable with minimal suck & response to pain. Had multiple apneic & bradycardic episodes & was intubated. Unable to convert SVT, blood pressure dropped, expired. 11/13/07 Received autopsy report with hospital records which states COD as myocarditis; massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral pneumonia & pleural effusions.


VAERS ID: 329267 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-21
Entered: 2008-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Children with high risk condition (asthma, seizure disorder, neuro/vesicular disorder)
Preexisting Conditions: One child without any risk conditions.
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20082210

Write-up: We received the following information from the above mentioned literature article on 06 OCT 2008: During the 2004-2007 influenza seasons, influenza-associated pediatric deaths were analysed. Of 90 children who were recommended for influenza vaccination, only 5 (6%) were fully vaccinated. 18 children were at least partially vaccinated more than or equal 14 days before illness onset per season, respectively. One child who was partially vaccinated did not have either an age related or ACIP defined high-risk condition recommended for vaccination. The reason for death was not reported for individual cases. Influenza-associated pediatric mortality and/or bacterial coinfection were suspected. The author will be contacted for details. Children with high risk condition (asthma, seizure disorder, neuro/vesicular disorder). One child without any risk conditions. Causality not related. Causes of death for individual cases not identifiable, complications of influenza and bacterial coinfections were mentioned. Expectedness assessment according to product information: Partial vaccination is unexpected. Vaccination failure is expected. Bacterial coinfections and influenza complications are unexpected after vaccination with FLUVIRIN, BEGRIVAC, FLUAD and AGRIPPAL. On a case level, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary.


VAERS ID: 340971 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-02-27
Entered: 2009-03-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None.
CDC Split Type: 200900658

Write-up: Initial report received on 20 February 2009 from a newspaper source. Two children, 2 years and younger, had one of the two doses of vaccine recommended for young children (manufacturer and lot number not reported) and have died of influenza. No further information was provided. List of Documents held by Sender: None.


VAERS ID: 344399 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-04-20
Entered: 2009-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cerebral infarction, Computerised tomogram abnormal, Death, Haemorrhage intracranial, International normalised ratio fluctuation, Rectal haemorrhage, Unresponsive to stimuli
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Warfarin
Current Illness: Unknown
Preexisting Conditions: PMH: on warfarin
Allergies:
Diagnostic Lab Data:
CDC Split Type: MA20090925

Write-up: A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient''s rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient''s health were noted. Upon admission, the patient''s international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient''s outcome positively, and he died approximately 17 hours after admission. The patient''s significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary. 4/21/09 Per FDA COD: Intracranial hemorrhage./pc


VAERS ID: 360527 (history)  
Form: Version 1.0  
Age: 47.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2009-09-22
Onset:0000-00-00
Submitted: 2009-10-09
Entered: 2009-10-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR C3202AA / 2 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C3249AA / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-03
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated. 11/30/09 Death Certificate Received. DOD 10/03/2009. Final Cause of Death: Acute Methadone Toxicity. Additional Information - Underlying conditions: Constrictive Atherosclerotic Artery Disease.


VAERS ID: 361585 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Alabama  
Vaccinated:2009-09-11
Onset:0000-00-00
Submitted: 2009-10-19
Entered: 2009-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3191AA / UNK LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Mechanical ventilation
SMQs:, Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Respiratory failure (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-10-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: alcohol abuse, coronary artery disease, peripheral vasular disease, cirrhosis, stroke.
Allergies:
Diagnostic Lab Data: LABS and DIAGNOSTICS: POINT OF CARE - Na 152 mMol/L (H) K 3.1 mMol/L (L) Glu 242 mg/dL (H) Ca 102 mMol/L (L) HGB 8.8 g/dL (L) HCT 26% (L). AST 115 U/L (H) ALT 286 U/L (H) Creatinine Kinase U/L 1536 (H) CK MB ng/mL 14.5 (H). Urinalysis - Bacteria many, Amorph many, yeast moderate. Urine Culture - Staph coag neg (+) Enterococcus faecalis (+) Yeast (+). Broch Wash Culture / Tracheal aspirate - Serratia marcescens (+). CSF - Albumin Ser 2140 mg/dL (L) Albumin CSF 16.6 mg/dL WNL, CSF IgG 7.63 mg/dL (H). CBC - WBC 18.41 10^3/cmm (H) RBC 2.33 10^6/cmm (L) Platelets 102.3 10^3/cmm (L) RDW 19.7% (H) Neutrophils 87% (H) Lymphocytes 3% (L) Monocytes 16% (H). COAG - PT 28.4 sec (H) PTT 41 sec (H) Fibrinogen 75 mg/dL (L) D-Dimer 7580 (H). IMMONOLOGY - CH50 146 u/mL (H) IgA 679 mg/dL (H). Chest X-ray - Abnormal. Alveolar edema and left pleural effusion,sludge gallbladder. Abdominal Ultrasound - Abnormal, acites, cirrhotic liver, portal vein thrombosis. MRI Brain - Abnormal, old infarct. Ultrasound chest - pleural effusion. Nerve Conduction Study - Abnormal. Echocardiogram - Abnormal. ECG - Abnormal.
CDC Split Type:

Write-up: Pt reported to be at hospital on vent since Oct 2 2009 with Guillain-Barre syndrome. 10/21/09 Hospital records DC summary received service dates 10/2/09 to 10/20/09. Assessment: Death due to sepsis, respiratory failure, disseminated intravasular coagulopathy, acute renal failure, cirrhosis. Patient presented with hx of lower extremity weakness progressing to all four extremities. Was admitted to another facility where he became short of breath and hypoxic, intubated and developed ARDS. Neurological exam - areflexia severe axonal senserimotor polyneuropathy.Tranferred to MSU service for plasma exchange. Multiple infections including ventilator aquired pneumonia. DIC. Bloody stools. Metabolic acidosis, DNR, death.


VAERS ID: 365416 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Michigan  
Vaccinated:2009-09-07
Onset:0000-00-00
Submitted: 2009-11-05
Entered: 2009-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 05849111A / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abasia, Aphasia, Asthenia, Death, Dysstasia, General physical health deterioration, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-10-17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol #3, Namenda, Aspirin 81mg, Ranitidine
Current Illness:
Preexisting Conditions: Patient had Alzheimers, high functioning. History of hip replacements in past 15 years.11/9/09: Medical records and discharge summary received for dates of service 10/8/09 to 10/13/09. PMH: Alzheimers dimentia, HTN, arthritis, hypothyroidism, scoliosis, sundowners.
Allergies:
Diagnostic Lab Data: 11/9/09: Medical records and discharge summary received for dates of service 10/8/09 to 10/13/09. Labs and Diagnostics: Blood cultures, Urinalysis, urine culture, CXR- all normal.
CDC Split Type:

Write-up: Patient showed a marked decline in functioning starting about 12 hours after the vaccine was administered. Pt was shaky, weak, could not put words together. Pt''s doctor was contacted on Sept 8, ruled out UTI. Seen by doctor on Sept 24. Pt was unable to stand or use legs, so she was taken to the hospital on Oct 8. Pt was admitted to hospital Oct 8 at Hospital, admitted to hospice on Oct. 13, and passed away Oct 17. 11/9/09: Medical records and discharge summary received for dates of service 10/8/09 to 10/13/09. Dx: End stage Alzheimers Dimentia, dysphagia, HTN, arthritis, hypothyroidism, scoliosis, and sundowners. Assessment: Presented unable to ambulate that morning, not able to communicate. Pts. baseline is to ambulate using walker, toilet and converse but over past 3-4 weeks she has steady decline and is no longer lucid and has no insight. Urine, blood work and CXR all used to rule out infectious process. Patient unable to improve in any way, palliative care discussed and hospice home decided on by family for comfort care measures only.


VAERS ID: 371498 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: Nevada  
Vaccinated:2009-10-28
Onset:0000-00-00
Submitted: 2009-11-12
Entered: 2009-12-04
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UP005AA / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Death, Diabetes mellitus, Myocardial infarction
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-09
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unk
Current Illness: Unk
Preexisting Conditions: Diabetic; had a pacemaker; other but unk
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unk. Pt. deceased unattended. 11/23/09 Sheriff officer said her doctor ruled heart attack and diabetes as cause of death. 12/10/09 Coroner''s report received. Pronounced dead 11/09/09. Died of Natural Causes related to diabetes, irregular heart rate - had pacemaker, COPD - asthma, high blood pressure, thyroid disease, reflux disease, arthritis. 12/16/09 Death Certificate received. DOD 11/09/09. Cause of Death: Cardiopulmonary Arrest, Chronic Obstructive Pulmonary Disease, Hypertension, Diabetes.


VAERS ID: 373122 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Texas  
Vaccinated:2009-11-25
Onset:0000-00-00
Submitted: 2009-12-14
Entered: 2009-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500829P / 1 NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-12-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Smoking; Cardiac condition
Preexisting Conditions: Per patient''s co-worker, patient has hx of smoking and cardiac condition. 12/16/09 PCP medical records received. Service dates 3/8/08 to 11/18/08. Cough, shortness of breath, low back pain, dizziness, essential hypertension, atherosclerosis, anxiety. Alcohol dependence, alcoholic gastritis, chronic insomnia, depression, erectile dysfunction, hip pain, loss of weight.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: Notified by patient''s co-worker that patient had passed away. 12/15/09 Death Certificate received. DOD 12/08/2009. Cause of Death: Myocardial Infaction. Atherosclerotic Coronary Vascular Disease.


VAERS ID: 373347 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-12-15
Entered: 2009-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Blood product transfusion, Cerebral haemorrhage, Condition aggravated, Death, Diarrhoea haemorrhagic, Glomerulonephritis, Lung neoplasm, Purpura, Skin ulcer, Vasculitis cerebral
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cyclophosphamide; MEPREDNISONE; azathioprine; methotrexate; corticosteroid; gusperimus
Current Illness: Glomerulonephritis; vasculitis; WEGENER''S Granulomatosis
Preexisting Conditions: Crescentic glomerulonephritis; hematuria; proteinuria
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0607925A

Write-up: This case was reported in a literature article and described the occurrence of fatal exacerbation of glomerulonephritis in an adult male subject who was vaccinated with influenza virus vaccine (manufacturer unspecified). At the age of 12 years, the subject was diagnosed with PR3-ANCA-associated glomerulonephritis due to Wegener''s granulomatosis. He was treated with CYCLOPHOSPHAMIDE, METHYLPREDNISONE and AZATHIOPRINE. During the follow-up from 1999 to 2004, the subject suffered from several relapses that were treated with CYCLOPHOSPHAMIDE or METHOTREXATE in combination with CORTICOSTEROIDS. In 2004, the subject developed a biopsy-proven renal relapse. DEOXYSPERIGUALIN, an antiproliferative drug with effects on lymphocytes and macrophage function and neutrophil production, was started in combination with high doses of steroids. During the 1st three cycles, a partial remission was induced. Because hematuria and proteinuria persisted, the kidney was re-biopsied and showed persistently active glomerulonephritis with new necrotizing and and crescentic lesions. The 4th and 5th cycles went uncomplicated. In the 6th cycle, the subject received unspecified dose of Influenza virus vaccine (unknown route and injection site), lot number not provided. Shortly after vaccination, a severe relapse occurred with purpura, arthralgias, new nodular lung lesions and active glomerulonephritis. DEOXYSPERGUALIN was stopped and MYCOPHENOLATE MOFETIL in combination with high-dose CORTICOSTEROIDS and plasma exchange was given. Despite this therapy, the subject developed a severe ulceration of the legs, abdominal pain with bloody diarrhea and intercerebral haemorrhage due to cerebral vasculitis, resulting in death. The vaccination was done while the subject had an active glomerulonephritis suggestion that activation of the vasculitic process after influenza vaccination was caused by so-called bystander activation in which the vaccination resulted in activation of antigen presenting cells expressing the autoantigen proteinase 3. The author considered the events were possibly related to vaccination with Influenza virus vaccine. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed.


VAERS ID: 376388 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2009-10-21
Onset:0000-00-00
Submitted: 2010-01-07
Entered: 2010-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500756P / UNK NS / IN

Administered by: Public       Purchased by: Unknown
Symptoms: Death, Fatigue, Influenza like illness, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Iron pills; Prenatal vitamins; Lisinopril
Current Illness: INFLUENZA
Preexisting Conditions: Iron deficiency anemia; Dysfunctional uterine bleeding; Hypertension.
Allergies:
Diagnostic Lab Data: No autopsy performed, apparently no recent influenza tests performed.
CDC Split Type:

Write-up: Seen in clinic 10/21/09 with cough, congestion, and "feels hot". Prescribed TAMIFLU on 10/21/09 and given intranasal H1N1 vaccine on 10/21. Subsequently apparently had flu-like symptoms and tiredness for unspecified period of time and apparently found unresponsive in home. Resuscitation unsuccessful.


VAERS ID: 397525 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2010-09-02
Entered: 2010-09-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201004682

Write-up: Initial report was retrieved from scientific literature on 31 August 2010; with additional information received on 02 September 2010 from online news report. According to the two literature citations previously noted the objective was to report the occurrence and characteristics of Guillain-Barre syndrome (GBS) after administration of H1N1 vaccine in 2009. The method used the data from the Vaccine Adverse Event Reporting System supplemented by additional data from the center for biologics and research under the Freedom of Information Act. All data was reviewed by a neurologist certified in neuromuscular diseases to confirm the diagnosis of GBS. The data excluded GBS cases that occurred within two days after vaccination. The results were as follows: Thirty five cases (mean age 36.6 +/- 22.5 years; 14 were men) of GBS were reported after administration of H1N1 influenza vaccination, with an estimated occurrence of 3.5 per 10 million vaccinations. All cases of GBS except one were reported within six weeks of vaccination, with 23 cases reported within the first two weeks after vaccine administration. Twenty three of the GBS cases (65.7%) were reported in the first two weeks after vaccination with maximum occurrence in the second week. One report of death and one of disability were reported in the 33 patients who were hospitalized. In 2009, 57 patients were diagnosed with GBS after vaccination with the seasonal influenza vaccine with an estimated occurrence of 7.3 per 10 million vaccinations. The time period of occurrence was similar to that reported for GBS cases after H1N1 influenza vaccination. Documents held by sender: None.


VAERS ID: 404478 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: Utah  
Vaccinated:2009-10-19
Onset:0000-00-00
Submitted: 2010-10-20
Entered: 2010-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500779P / 1 NS / IN

Administered by: Public       Purchased by: Private
Symptoms: Death, Fatigue, Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-11-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Medical examiner said client died of myocarditis. Attributed to a recent viral infection. Patient had not had any known infections prior.
CDC Split Type:

Write-up: A couple weeks after receiving the H1N1 Flumist, client complained of being tired and felt tired "all the time".


VAERS ID: 418362 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: South Carolina  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2011-02-25
Entered: 2011-03-10
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Influenza
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions: Patient presumed to be an active employee.
Allergies:
Diagnostic Lab Data: Endemic H1N1 isolated from the bronchioles
CDC Split Type: MEDI0012732

Write-up: A serious spontaneous report of INFLUENZA has been received from a non-healthcare professional concerning a male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient was presumed to be an active employee. On an unknown date, the patient received FLUMIST. Five weeks after receiving FLUMIST, the patient developed symptoms of INFLUENZA. On an unknown date, the patient died. An autopsy was performed. Endemic H1N1 was isolated from the bronchioles. The cause of death was reported as INFLUENZA. The outcome of the event of INFLUENZA was fatal.


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