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From the 4/30/2021 release of VAERS data:

Found 1,936 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: 246632 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Vermont  
Vaccinated:2005-10-29
Onset:2005-10-30
   Days after vaccination:1
Submitted: 2005-11-02
   Days after onset:3
Entered: 2005-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1823AA / 3 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diabetes mellitus, Hyperglycaemia, Hypoglycaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Hypoglycaemia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin: Lentis 33 U BF Humulog B, L, D sliding scale
Current Illness: NONE
Preexisting Conditions: type 1 diabetes onset 7/03
Allergies:
Diagnostic Lab Data: Autopsy being performed
CDC Split Type: VT200510302005

Write-up: Patient vaccinated between 10am-1 Pm on October 30, 2005. Found dead in bed next morning at home by parents. Pt had type 1 diabetes with AC1 of 7.0 but having hypoglycemic episodes 1-2 times per week and not wanting to treat the symptoms per endocrinlogist. Term of DM removed from symtom list as per autopsy report rec''d 12/28/2005/sr This is tag-2 report.


VAERS ID: 250504 (history)  
Form: Version 1.0  
Age: 1.02  
Sex: Male  
Location: Virginia  
Vaccinated:2005-10-25
Onset:2005-10-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2006-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1762AA / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0935P / UNK LL / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0195P / UNK RL / -

Administered by: Private       Purchased by: Other
Symptoms: Irritability, Pyrexia, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child reportedly fussy, irritable and with mild fever during interval between vaccines and death. 2/27/06 Received autopsy report which reveals patient''s COD was Sudden Unexpected Death in Childhood/ss No new information found in medical records from PCP.


VAERS ID: 249916 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: New York  
Vaccinated:2005-10-26
Onset:2005-10-27
   Days after vaccination:1
Submitted: 2005-11-10
   Days after onset:14
Entered: 2005-12-29
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1819AA / UNK LA / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dorzolamide 2%/TIMOLOL 0.5% SOLN,OPH; Potassium Chloride (K-DUR) 20MED 3A Tab; Trinexyphenidil HCL 2mg Tab;Metoprolol Tartrate 25mg Tab;Aspirin 325mg Tab,Enteric Coated;Carbidopa 10/Levodopa 100mg Tab; Finasteride 5mg Tab;Ferrous Sulfate 32
Current Illness:
Preexisting Conditions: Advanced Parkinson''s Disease, Shy Dragger Syndrome, Atrial Fibrillation. No cause and effect relationship has been established for this event. The event may have been related to an underlying condition or may have occurred by chance after a vaccine was administered.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No cause/effect established; patient died in his sleep.


VAERS ID: 258294 (history)  
Form: Version 1.0  
Age: 1.92  
Sex: Male  
Location: California  
Vaccinated:2005-10-13
Onset:2005-10-26
   Days after vaccination:13
Submitted: 2006-06-12
   Days after onset:229
Entered: 2006-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1765CA / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Diarrhoea, Encephalopathy, Irritability, Lip ulceration, Pneumonitis, Pyrexia, Stomatitis, Viral infection
SMQs:, Severe cutaneous adverse reactions (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (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: 2005-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: viral stomatitis
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Final autopsy report just received. Cause of death "complications of viral infection." All cultures negative. Pathology of brain showed "focal perivascular chronic inflammation consistent with viral encephalopathy, slight brain swelling." Lung path showed "minimal edema and minimal acute and chronic inflammation (mostly lymphocytes and macrophages with occasional neutrophils and rare plasma cells)."
CDC Split Type:

Write-up: Death on 10/26/2005 (found deceased in bedroom), flu vaccination given 10/13/05. Patient also seen at that time for low-grade fever, crankiness, diarrhea, diagnosed with viral stomatitis given finding of ulcers inside lower lip. 6/20/06 Received medical records from PCP which reveal that on day of vax patient had fever, crankiness, sleep difficulties, diarrhea, decreased oral intake & cold sores of lower lip. Dx: viral illness & stomatitis. 6/21/06 Received autopsy report which revealed COD as complications of viral infection. Histology of lungs showed atypical interstitial pneumonitis & brain showed perivascular inflammation consistent with viral infection. Bacterial & viral cultures were neg. Neuropath exam revealed focal privascular chronic inflammation consistent with viral encephalopathy./ss


VAERS ID: 248227 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-21
Onset:2005-10-23
   Days after vaccination:2
Submitted: 2005-11-22
   Days after onset:30
Entered: 2005-11-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER 95381 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bendrofluazide
Current Illness: Ventricular extrasystoles
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0401063A

Write-up: This case was reported by a regulatory authority and described the occurrence of death in a 74 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. Concurrent medical conditions included ventricular extrasystoles. Concurrent medications included bendrofluazide (Bendroflumethiazide). On Oct 21 2005 the subject received unspecified dose of influenza vaccine .5 ml intramuscular. On Oct 23 2005, 2 days after vaccination with influenza vaccine, the subject died, cause of death was not reported. An autopsy was not performed. Verbatim text received. Found dead in bed. Reports to coroner as unexpected. The reporter considered the reaction to be serious for the following reason patient died.


VAERS ID: 249915 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: New York  
Vaccinated:2005-10-20
Onset:2005-10-22
   Days after vaccination:2
Submitted: 2005-11-09
   Days after onset:18
Entered: 2005-12-29
   Days after submission:50
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1983AA / UNK LA / IM

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-10-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diltiazem (INVOB) 240mg SA Cap;Omeprazole (Prilosec) 20mg Cap, SA;Nephrocaps Cap; Simvastatin 20mg TAB;Warfarin (Coumadin) NA 2mg tab;Lisinopril 5mg Tab;Aspirin 81mg Tab,Enteric Coated;Albuterol 90mcg 20- IMHL,Oral;Nicotine 14MG/24HR transd
Current Illness:
Preexisting Conditions: Chronic renal failure, on peritoneal dialysis, Anemia of CRF, Arteriosclerotic Heart Disease and atrial fibrillation, COPD, hypertension, no cause and effect relationship has been established for this event.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death, No cause/effect established.


VAERS ID: 246080 (history)  
Form: Version 1.0  
Age: 1.23  
Sex: Female  
Location: Tennessee  
Vaccinated:2005-10-17
Onset:2005-10-19
   Days after vaccination:2
Submitted: 2005-10-19
   Days after onset:0
Entered: 2005-10-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1765EA / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Abnormal sleep-related event, Bronchitis, 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: 2005-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Upper respiratory infection
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unknown Pt died in her sleep morning of 10/19, she did have low grade, subjective fever 10/17 and 10/18. No additional information in discharge summary rec''d 11/9/05/sr Additional information added from Autopsy report rec''d 01/11/2006: Preexisting condition -- chronic bronchitis. Patient''s sibling was hospitalized for flu & fever & had full recovery & sibling''s admission medical record included. Post mortem viral c/s were neg./sr


VAERS ID: 245502 (history)  
Form: Version 1.0  
Age: 1.95  
Sex: Male  
Location: Florida  
Vaccinated:2005-10-14
Onset:2005-10-15
   Days after vaccination:1
Submitted: 2005-10-17
   Days after onset:2
Entered: 2005-10-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1775AA / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event, Upper respiratory tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None other than Children''s Advil given after immunization
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None available yet
CDC Split Type:

Write-up: Received flu vaccine in his doctor''s office on 10/14/2005. No adverse effects described that evening. Found dead in bed the following morning. Autopsy was performed; results are pending. 3/30/06 Autopsy Report received which stated COD as undetermined.


VAERS ID: 246600 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-14
Onset:2005-10-14
   Days after vaccination:0
Submitted: 2005-11-01
   Days after onset:18
Entered: 2005-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Isosorbide; Metoprolol; Lansoprazole; Clopidogrel; Prochlorperazine; Domperidone; Lisinopril; Aspirin; Meloxicam; Bisoprolol; Atorvastatin calcium; Co-amilofruse;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0398395A

Write-up: This case was reported by a regulatory authority and described the occurrence of death NOS in a 74 year old female subject who was vaccinated with pneumococcal vaccine, unspecified (Pneumovax II), influenza virus vaccine (Influenza vaccine) for prophylaxis. Concurrent medications included isosorbide, metoprolol, lansoprazole, clopidogrel, prochlorperazine, domperidone, lisinopril, aspirin, meloxicam, bisoprolol, atorvastatin calcium (Atorvastatin) and co amilofruse. On Oct 14 2005 the subject received unspecified dose of Pneumovax II .5 ml, intramuscular unknown, unspecified dose of influenza vaccine .5 ml intramuscular, unknown. Three hours after vaccination with Influenza vaccine and Pneumovax II, the subject collapsed and died. The subject died on Oct 14 2005, cause of death was not reported. An autopsy was not performed.


VAERS ID: 247333 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-10-14
Onset:2005-10-14
   Days after vaccination:0
Submitted: 2005-11-08
   Days after onset:25
Entered: 2005-11-14
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clopidogrel bisulfate, domperidone, isosorbide, lansoprazole, lisinopril, meloxicam, metoprolol, prochlorperazine
Current Illness:
Preexisting Conditions: Angina pectoris;Dyspepsia;Nausea;Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0511USA00541

Write-up: Information has been received from a health authority concerning a 74 year old female with angina pectoris, dyspepsia, nausea and hypertension who on 14-Oct-2005 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot number not reported). The patient also was vaccinated intramuscularly with a 0.5 ml dose of influenza virus vaccine (batch number not reported). At the time of the vaccination, concomitant therapy included isosorbide for angina pectoris 10mg BD po since 01-Oct-2005, metoprolol for angina pectoris 25 mg TDS po since 01-Oct-2005, lansoprazole for dyspepsia 30mg OD po since 06-Sep-2005, clopidogrel bisulfate 75mg OD po since 01-Oct-2005, prochlorperazine 10 mg TDS po since 06-Sept-2005, domperidone for nausea 10mg TDS 01-Sep-2005, lisinopril for hypertension 10mg OM since 18-Oct-2005, aspirin for angina pectoris 75mg OD since 30-Apr-2005, meloxicam 7.5mg OD since 07-Jul-2004, bisoprolol 5mg OD since 15-Oct-2003, atorvastatin calcium for angina pectoris 10mg OD since 09-Mar-2004, and amiloride/furosemide 5/40 since 09-Mar-2004. Three hours post vaccination, on 14-Oct-2005, the patient collapsed and died. The cause of death was unknown. No PM was performed. The patient''s death was not considered to be a sudden death. Both the authority and the reporter considered this event to be serious. Other business partner numbers included E2005-04391 and ADROIT497693. No further information is available. The case is closed.


VAERS ID: 245659 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: New York  
Vaccinated:2005-10-10
Onset:2005-10-11
   Days after vaccination:1
Submitted: 2005-10-19
   Days after onset:8
Entered: 2005-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER AFLUA120AA / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-14
   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: Celexa 40mg daily, Senna 2 tabs qHS, Losartan 100mg daily, amlodipine 10mg daily, colchicine 0.6mg daily, Miacalcin, aspirin 325mg daily, sinemet 25/100 TID, prednisone 5mg daily, meclizine.
Current Illness:
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: Recent potassium 6.5 - hemolyzed (date not indicated)
CDC Split Type:

Write-up: IM Flu vaccine (lot#AFLUA120AA) given on 10/10/2005. Between 10/11 to 10/13 the patient experienced nausea and vomiting. On 10/13 the patient experienced coffee-ground emesis. On 10/14 the patient expired. Cause of death pending medical examiner report.


VAERS ID: 249268 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: California  
Vaccinated:2005-10-05
Onset:2005-10-06
   Days after vaccination:1
Submitted: 2005-12-11
   Days after onset:66
Entered: 2005-12-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1808AA / UNK RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Angioneurotic oedema, Blood creatinine increased, Cardiac failure congestive, Cough, Drug toxicity, Glomerulonephritis, Headache, Malaise, Multi-organ failure, Nephritis, Oliguria, Renal failure, Renal failure chronic, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (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), Drug abuse and dependence (broad), Oropharyngeal allergic conditions (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Kidney biopsy showed necrotizing glomerulonephritis.
CDC Split Type:

Write-up: Patient received a flu vaccine on 10/08/05. he then developed a cough, malaise and angioedema. He was admitted on 11/07/05 with nephritis. Biopsy on 11/30/05 showed necrotizing glomerulonephritis. Additional terms added from Dischare Summary rec''d 12/28/2005: Headacne, tachy. CHF, kidney failure, dec. urine output, inc. creatinine/sr Discharge summary states drug reaction. msv Per 60 day folow up report-Patient died of end stage renal disease with multi-organ failure.


VAERS ID: 249981 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-06-30
Submitted: 2006-01-03
   Days after onset:187
Entered: 2006-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Influenza like illness, Myocardial infarction, Pyrexia, Rhinorrhoea
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-15
   Days after onset: 15
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: Body temperature June 30 2005 38 deg C
CDC Split Type: B0404722A

Write-up: This case was reported by an unspecified health professional via another manufacturer and described the occurrence of myocardial infarction in a 91 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. Concurrent medical condition and concurrent medication were unknown. Between Oct 16 2004 and Nov 25 2004, the subject received an injection of Influenza vaccine (0.5 ml, batch not available). On June 30 2005, approximately seven months after vaccination with influenza virus vaccine, the subject experienced influenza disease with fever and rhinorrhea. The highest temperature was 38 celsius degrees and occurred on June 30 2005. The subject was treated with oseltamivir. The influenza stain responsible for the infection was the strain A California 7-2004 derived from a New York 55-2004. This strain was not present in the vaccines formulation Northern Hemisphere in 2004-2005. The events resolved on July 4 2005. On July 15 2005, the subject died from myocardial infarction. It was unknown whether an autopsy was performed. The health professionals causality assessment was unspecified. No more information will be available. This case has been closed.


VAERS ID: 237381 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2005-03-03
Onset:2005-03-05
   Days after vaccination:2
Submitted: 2005-05-14
   Days after onset:69
Entered: 2005-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER U1449 / 2 RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Dyspnoea, Hypoxia, Malaise, Melaena, Stupor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), 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), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-03-29
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: She had pnemonea,she had x-rays,and was given 2pack#1...
Preexisting Conditions: My mom had cirosis of the liver she was so sick all the time..
Allergies:
Diagnostic Lab Data: She had x-rays because the doctor thought she had pnemonea, But yet he still gave her a vacine?????????
CDC Split Type:

Write-up: THIS INCOMPOTENT, DOCTOR. NOT ONLY GAVE MY MOM, INFLUENZA. bUT GAVE HER "PNEUMOCOCCAL", AS WELL ! mY MOTHER WAS SO SICK WHEN HE GAVE HER THIS . wE WERE THERE AT THE DOCTOR BECAUSE SHE HAD A SEVERE COLD,SHE HAD TROUBLE BREATHING .hE SENT US FOR CHEST X-RAYS,AND EVEN GAVE HER A VERY STRONG ANTIBIOTIC, called,( 2pack #1).He sent her for x-rays because of the sound in her lungs.He stated she sounds like pneumonia.""I FEEL,HE LITERLY KILLED MY MOTHER ""!!!! HOW ARE YOU GOING TO GIVE SOME ONE NOT ONLY SICK WITH A COLD ,BUT SHE HAD CIRIOUS OF THE LIVER AND WAS VERY SICK WITH THAT AS WELL... pLEASE IF YOU CAN HELP ME ! OR KNOW SOME-ONE WHO CAN .BEFORE HE HAS THE CHANCE TO KILL SOME-ONE ELSE.. PLEASE Thank You! I am the pt''s Daughter,I took care of her for the last 3years. She has had flu shots before but not while she was sick and never 2 vaccines in a row! She was very sick !! Discharge Summary received stated patient experienced cyanosis, unresponsive, hypoxia, respiratory distress and melena.


VAERS ID: 233373 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Male  
Location: Georgia  
Vaccinated:2005-02-01
Onset:2005-02-03
   Days after vaccination:2
Submitted: 2005-02-03
   Days after onset:0
Entered: 2005-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR 41580AA / 2 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0608P / 1 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0765P / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Hypothermia, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (narrow), Accidents and injuries (broad), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-02-03
   Days after onset: 0
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: Upper respiratory infection
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy is pending
CDC Split Type:

Write-up: Patient was found this afternoon cold and not breathing. His resuscitation was not successful. Autopsy report received stated COD was SIDS.


VAERS ID: 232179 (history)  
Form: Version 1.0  
Age: 1.68  
Sex: Male  
Location: New York  
Vaccinated:2005-01-08
Onset:2005-01-09
   Days after vaccination:1
Submitted: 2005-01-12
   Days after onset:3
Entered: 2005-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1411AA / UNK LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Bronchitis treated with Zithromax on 12/28/04.
Allergies:
Diagnostic Lab Data: Autopsy by coroner.
CDC Split Type:

Write-up: Child was found dead early AM about 16-20 hours after the flu vaccine second dose 0.25ml. Child was fine when went to bed. Happy playful and no respiratory difficulty. Autopsy report received on 2/16/2005 states SIDS.


VAERS ID: 488888 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2005-01-01
Submitted: 2013-04-09
   Days after onset:3019
Entered: 2013-04-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Bone loss, Breast pain, Bronchitis, Confusional state, Death, Diarrhoea, Dysphagia, Ear pain, Fall, Fungal infection, Mucous stools, Oesophagitis, Renal cyst, Respiratory distress, Upper limb fracture
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Osteoporosis/osteopenia (narrow), Osteonecrosis (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: BONEFOS; FOSAMAX; FOSAVANCE; Ibuprofen
Current Illness: Unknown
Preexisting Conditions: Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013DE033673

Write-up: Case number PHHY2013DE033673 is an initial spontaneous report from the foreign Health Authority (reference number: DE-PEI-PEI2013018868) received on 05 Apr 2013. This report refers to a 83-year-old female patient. Her medical history included osteoporosis. Concomitant medications included BONEFOS, FOSAMAX, FOSAVANCE and ibuprofen. She was vaccinated with "first/ second or other dose" of seasonal influenza vaccine INN, (unknown manufacturer, batch number: not reported) in 2004 and with Tetanus vaccine INN, (unknown manufacturer, batch number: not reported) on an unknown date, both doses were given via oral route. It was reported that each time after the last two doses of influenza vaccine, the patient had a fall and was treated in hospital. Due to the fall in 2004, both arms were broken and she was hospitalized for three weeks. During this period the application of FOSAMAX was continued. However instructions for application were not followed and "starting with this severe adverse reactions developed". On 01 Jan 2005, she developed diarrhoea, confusion, bronchitis, esophagitis, fungal infection NOS (not specified), swallowing disorder, respiratory distress, bone loss in jaw, breast pain, ear pain, renal cyst, mucous stool and fall that lasted for 03 years. On an unknown date, the patient died (cause unspecified). The foreign health authority considered diarrhoea, confusion, bronchitis, esophagitis, fungal infection NOS, swallowing disorder, respiratory distress, bone loss in jaw, breast pain, ear pain, renal cyst, mucous stool and fall as adverse events with outcome and seriousness reported as death. The causality of the events were not reported. No further information was available.


VAERS ID: 232210 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Oregon  
Vaccinated:2004-12-30
Onset:2004-12-30
   Days after vaccination:0
Submitted: 2005-01-07
   Days after onset:8
Entered: 2005-01-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Apnoea, Cardiac arrest, Coma, Hyperglycaemia, Hypokalaemia, Leukocytosis, Liver function test abnormal, Myocardial infarction, Oedema peripheral, Pneumonia, Stupor, Tongue oedema, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-04
   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: Enalapril; HCTZ
Current Illness: NONE
Preexisting Conditions: Hypertension; Allergy to penicillin
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cardiac arrest with CPR/cardioversion and ICU care for 5 days. Discharge Summary received on 1/12/2005 states pt experienced ventricular fibrillation and was unresponsive.


VAERS ID: 231664 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Maryland  
Vaccinated:2004-12-15
Onset:2004-12-23
   Days after vaccination:8
Submitted: 2004-12-28
   Days after onset:5
Entered: 2004-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1527AA / UNK RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Laboratory test abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-23
   Days after onset: 0
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 reported
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Urinary antigen positive for Legionella
CDC Split Type:

Write-up: Patient hospitalized with diagnosis on Legionellosis on 12/21/2004. Onset of symptoms 12/16/2004 - patient and family attributed illness to vaccination.


VAERS ID: 231627 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: California  
Vaccinated:2004-12-16
Onset:2004-12-19
   Days after vaccination:3
Submitted: 2004-12-21
   Days after onset:2
Entered: 2004-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1501AA / 4 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Cardiac arrest, Respiratory arrest
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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Pulmicort; Reglan; Zantac
Current Illness: NONE
Preexisting Conditions: Tay Sachs disease; Mental Retardation; GE Reflux; Lung Disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient brought to ED on 12/19/04 in full arrest and could not be resuscitated. That ED notified our hospital that patient had died. Our hospital does not have further details at this time.


VAERS ID: 231269 (history)  
Form: Version 1.0  
Age: 92.0  
Sex: Female  
Location: Oregon  
Vaccinated:2004-12-09
Onset:2004-12-10
   Days after vaccination:1
Submitted: 2004-12-10
   Days after onset:0
Entered: 2004-12-20
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1556AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Arteriosclerosis, Bradycardia, Coma, Pulse absent, Respiratory rate decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norvasc; Lisinopril; Impur; Cipro; Aspirin;
Current Illness: NONE
Preexisting Conditions: Anemic; CVA
Allergies:
Diagnostic Lab Data:
CDC Split Type: OR200442

Write-up: Resident with toileting. Observed by staff to become nonresponsive, slumped off toilet two times. Body lift and then to bed. Respirations shallow and significant decreased with decreased ausultated lungs followed by pulse drop to 30-40 BPM. Then no BP. Then no pulse and no respiration. Resident deceased. Attempted CPR and oxygen. Death Certificate received on 12/29/2004 states COD is ASHD.


VAERS ID: 266257 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Male  
Location: Maryland  
Vaccinated:2004-12-02
Onset:2004-12-03
   Days after vaccination:1
Submitted: 2006-11-08
   Days after onset:705
Entered: 2006-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RL / IM
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LA / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Bronchiolitis, Cough, Hypotonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synagis
Current Illness: Cold, cough, fever (Doctor''s office said there was no fever, but he had a fever at home prior to appointment.)
Preexisting Conditions: Premature
Allergies:
Diagnostic Lab Data: Autopsy report: I''m still waiting for my copy, which I had to send for in writing. On 12/03/2004, I was told that there would be a police report and an autopsy which is standard procedure in the death of an infant. I told them I was glad, and that I was anxious to find out if the immunizations were the cause of death. Weeks later, I was given verbal results over the phone. After they told me all of the things that did NOT cause his death, they said that they were listing the cause as "unknown natural causes" and later they had to change it to SIDS because they had to put something other than "unknown" When I asked about the results of the test for reaction to vaccines, she said they didn''t test for that. I was shocked and disappointed, because for us, that was the most important test to be given!
CDC Split Type:

Write-up: 12/01/04: Dry cough, fever; seen at Dr''s office. Diagnosed with "bronchiotitis." No medication prescribed. Advised to use humidifier. 12/02/04: Synagis shot given at home by hospise nurse. This was a regular procedure since he was premature. 12/02/04: I called doctor''s office to cancel "well baby" appointment, because he had just been seen the day before for a bad cough. I didn''t think he should keep his appointment for his immunizations when he was this sick. The nurse said that if I didn''t keep the appointment that we would be dropped as a patient and charged for a missed appointment. I said that typically with my other children, doctors don''t want to give immunizations when the child is sick and tell me to reschedule well-baby appointments. I took him in because of her threats. He was seen by the doctor that day. I re-stated my concern about giving him immunizations when he was sick. He convinced me that it would be fine. He was given four more shots that day (listed below) 12/03/2004: My husband and I were up early because he had an early day at work. (4 am) When I checked on him, he seemed to be sleeping in an odd position. When I went to adjust him, his head fell back and he was limp and not breathing. We called 911. While we waited for the ambulance, they told me to breathe softly into his mouth. I did with no response. In the emergency room, they tried to revive him, but he died.


VAERS ID: 250332 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Virginia  
Vaccinated:2004-11-23
Onset:2004-11-30
   Days after vaccination:7
Submitted: 2006-01-13
   Days after onset:409
Entered: 2006-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1501AA / 1 UN / IM
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER AHABA015AA / 2 UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0706 / 1 UN / SC
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER UE122AA / 1 UN / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0781P / 1 UN / SC
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR 01282AA / 1 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Asthma, Chest pain, Cough, Loss of consciousness, Myocarditis, Nasal congestion, Oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), 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: 2005-02-17
   Days after onset: 79
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: Asthma age 5
Allergies:
Diagnostic Lab Data: 18 Feb 05: Cardiac-normal distribution of small patent coronary arteries. The valves appear normal. The myocardium does not show any acute changes. The left ventricle measures 1.4 cm in thickness. The septum measures 1.4 cm in thickness. The aorta has youthful intima. Resp-prominent congestion and mild edema without any discrete lesion. The airways patent. The vasculature free of thromboemboli. Microscopic Exam: Heart the mural sections show rare perivascular mononuclear cells some with plasmacytoid features. The AV node section shows extensive infiltration with mononuclear cells many of which are necrotic. Lung there is edema and congestion with focal mild interstitial chronic inflammation and proliferation of pigmented alveolar macrophages. Brain and live - unremarkable. Kidney a rare Bowman capsule sclerosis is seen in the cortex. Pathologic diagnosis: Chronic myocarditis involving AV node. No lethal injuries.
CDC Split Type:

Write-up: The Department of Health informed the HC in May 05 of the death of a medically discharged patient. The patient enlisted in Nov 04, medically discharged in Jan 05, and died on Feb 17th. The following HPI is an account of the events prior to his death as recalled by his mother during an interview in May 05. The service member a 20 year old male, who received his enlistment vaccines on 23 Nov 04. While speaking with his mom on 30 Nov he mentioned that he had a cough, and some chest pain. She state that she encourage him to seek medical attention. She state that a couple of days later, while he was running he ''passed out'' and when he went to the doctor he was told it was asthma. Mom reported that while he was at home during Christmas, he reported to his family that he was experiencing some chest pain, and did have bumps on his face that cleared in Jan. Mom was unaware of which vaccines her son received but did remember that her son said that the needle was "funny." Mom does not recall if he had a scar on his arm. She state that he was discharged for stress related issues and complaints of chest pain. Mom is unaware of any other details regarding her son''s illness during that time only that the chest pain persisted. When questioned about his past history of asthma, she mentioned that he had it a little in childhood but has not been bothered by it since that time. She did mention that her son felt that his pain was not related to asthma. Mom was also questioned about the waiver for a medical exam upon discharge. She state that he was told that if he requested a workup, it would delay his release and that they may not even discharge him. He received his enlistment vaccines of Hep A-Hep B, Influenza, Meningococcal, MRR, Polio, and Td on 23 Nov 04 and he received his second Hep A-Hep B on 5 Jan 05. Chest pain start 11/30/2004, dyspnea (shortness of breath) start 11/30/2004. 4/3/06 Received Autopsy Report which revealed COD as chronic myocarditis.


VAERS ID: 229978 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Alabama  
Vaccinated:2004-11-16
Onset:2004-11-18
   Days after vaccination:2
Submitted: 2004-11-29
   Days after onset:11
Entered: 2004-12-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1439AA / UNK LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Bronchitis, Cardiac failure congestive, Condition aggravated
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-18
   Days after onset: 0
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: Chest Congestion
Preexisting Conditions: History of CHF. Discharge Summary received on 12/15/2004 states pt has a history of HTN, TIA, Cartoid Stenosis, Hyperlipidemia, Leukemia and Hyponatremia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: AL0427

Write-up: Patient died within 48 hours of being given flu vaccine. Cause of death CHF and bronchitis. Patient sick with chest congestion prior to vaccine per niece. Hospitalized 11/18/04. Previous history of CHF.


VAERS ID: 231755 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Male  
Location: California  
Vaccinated:2004-11-17
Onset:2004-11-18
   Days after vaccination:1
Submitted: 2004-11-30
   Days after onset:12
Entered: 2004-12-30
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1519AB / 1 LA / -

Administered by: Other       Purchased by: Public
Symptoms: Apnoea, Coma, Confusional state, Dyspepsia, Encephalopathy, Hypersensitivity, Malaise, Rash, Viral infection
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Respiratory failure (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: 2004-11-23
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA040096

Write-up: Client complained of "heartburn" like sensation and was sent to medical center. They diagnosed him with "allergic reaction " to flu vaccine. This was on 11/18. Client became unresponsive on Sunday 11/21 and had begun to show "red bumps" on face. He was alert in the morning, ate breakfast then fell ill. He was transferred to another hospital when he fell into a coma and passed away 11/23/04. Discharge Summary revealed patient had confusion and respiratory failure.


VAERS ID: 247946 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Michigan  
Vaccinated:2004-11-09
Onset:2004-11-14
   Days after vaccination:5
Submitted: 2005-11-21
   Days after onset:372
Entered: 2005-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Demyelination, Neuropathy, Serum sickness
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), Hypersensitivity (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-11-20
   Days after onset: 371
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations: N V D~Influenza (Seasonal) (no brand name)~~65.00~In Sibling|~Influenza (Seasonal) (no brand name)~~0.00~In Sibling
Other Medications: Synthroid, Lipitor, Iressa
Current Illness: Lung and stomach cancer
Preexisting Conditions: Allergic to PCN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt and spouse state she had been recovering well after Cancer of lung and stomach and returned to work. 4-5 days after getting Flu shot 11/09/2004 she developed progressive weakness which was later DX as ALS. Death from ALS 11/05. No additional terms added from Discharge Summary rec''d 11/28/2005/sr Serum Sickness added from Med. Record rec''d 12/07/2005


VAERS ID: 235375 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2004-11-02
Onset:2004-11-06
   Days after vaccination:4
Submitted: 2005-03-17
   Days after onset:131
Entered: 2005-03-24
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / -

Administered by: Other       Purchased by: Public
Symptoms: Cough, Influenza like illness, Myocarditis, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Cardiomyopathy (broad), Hypersensitivity (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: 2004-11-06
   Days after onset: 0
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: Possibly with autopsy.
CDC Split Type: AR0502

Write-up: Pt was found dead in bed by mother on 11/06/2004. Mom reports pt c/o feeling like he had the flu on Friday night 11 PM, had a cough x 3 days, and a rash on chest with c/o itching on chest and back. He had worked all night 11/04/2004 painting in a trailer. He went to sleep at approximately 5:00 PM 11/05, snored loudly, unable to awaken. 3/30/05 Received Autopsy Report which revealed COD as myocarditis.


VAERS ID: 427909 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Delaware  
Vaccinated:2004-11-04
Onset:2004-11-05
   Days after vaccination:1
Submitted: 2011-07-10
   Days after onset:2437
Entered: 2011-07-22
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER U1516AA / UNK RA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0513P / UNK LA / UN

Administered by: Private       Purchased by: Military
Symptoms: Coma, Dyspnoea, Myocardial infarction, Renal impairment, Speech disorder, Sudden death, Thirst
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-08-03
   Days after onset: 270
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: In records
Current Illness: None
Preexisting Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Coma, Sudden death. Shortness of breath, thirsty, strange conversation, heart attack. Thereafter his medical records have all information. Kidneys were at 13%. That''s why public health said to request this form to see what went on. This adversity was never reported.


VAERS ID: 228894 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Michigan  
Vaccinated:2004-10-27
Onset:2004-10-28
   Days after vaccination:1
Submitted: 2004-11-02
   Days after onset:5
Entered: 2004-11-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK LA / -

Administered by: Private       Purchased by: Private
Symptoms: Anaemia, Cardiac arrest, Dysuria, Lung disorder, Multiple myeloma, Myocardial ischaemia, Renal failure, Respiratory arrest, Respiratory failure, Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Haematopoietic erythropenia (broad), Arrhythmia related investigations, signs and symptoms (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 (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 (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UTI
Preexisting Conditions: COPD; Respiratory Failure; Multiple Myeloma; Anemia; pneumonia, chronic renal failure, encephalopathy, HBP, arrhythmias, hypercholesterolemia, seizure disorder, degenerative joint disease, osteoporosis, quadriparesis, and ischemic heart disease; renal insufficiency
Allergies:
Diagnostic Lab Data: UTI; COPD; Respiratory failure; Multiple Myeloma
CDC Split Type:

Write-up: UTI. Nurse follow up on 11/15/04 states: "dysuria; acute cardiopulmonary arrest; Death Certificate received which revealed COD as acute cardiopulmonary arrest, ischemic heart disease & COPD, all with chronic anemia and renal insufficiency as contributing factors.


VAERS ID: 231831 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2004-10-13
Onset:2004-10-26
   Days after vaccination:13
Submitted: 2004-12-24
   Days after onset:59
Entered: 2005-01-03
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Confusional state, Demyelination, Encephalitis, Erythema, Pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Hypersensitivity (broad), 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: 2004-11-22
   Days after onset: 27
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:
CDC Split Type: E200404797

Write-up: It was reported that an 84 year old female patient was vaccinated with influenza vaccine on 10/13 or 10/14/2004. Soon after the vaccination the patient complained about diffusive pain in thigh, sudden confusion and redness. The patient was hospitalized on 10/26/04. The results of MR scanning showed diffusive changes in white matter of the brain and acute dessiminated demyelinized encephalomyelitis. Investigations of spinal fluid showed normal oligoclonal band. ANA and ANCA were negative. Herpes simplex and varicella zoster were excluded. The patient died on 11/22/04. Further information is required.


VAERS ID: 233034 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Illinois  
Vaccinated:2004-10-11
Onset:2004-10-25
   Days after vaccination:14
Submitted: 2005-01-26
   Days after onset:93
Entered: 2005-01-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1410BA / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Coordination abnormal, Fatigue, Myelitis transverse, Optic neuritis, Pain, Paralysis, Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular infections (broad), Respiratory failure (narrow), 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: 2005-01-01
   Days after onset: 68
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: Diovan; Glyburide; Cholesterol medications
Current Illness:
Preexisting Conditions: The patient''s pre-existing medical conditions include high blood pressure, elevated cholesterol, and diabetes. She denied any illnesses at the time of vaccination.
Allergies:
Diagnostic Lab Data: Lumbar puncture was negative.
CDC Split Type: 200500215

Write-up: From initial information received on 1/24/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 78 year old female patient received a dose of FLUZONE, lot number U1410BA, administered IM in an unspecified site on 10/11/04. Reportedly, within two weeks, the patient developed fatigue. She was diagnosed with a viral illness and hospitalized. Subsequently, the patient developed thoracic pain, spine pain, optic neuritis, and ataxia. Reportedly, the ataxia had worsened and the patient developed paralysis of bilateral lower extremities. The patient was diagnosed with transverse myelitis and sent for rehabilitation treatment, where she also developed a fever. The patient was once again hospitalized. A lumbar puncture was performed and was negative. The patient''s family then transferred the patient to another facility. The physician''s office was later informed that the patient expired in January of 2005. The patient''s pre-existing medical conditions included high blood pressure, high cholesterol, and diabetes. Concomitant medications include Diovan, Glyburide, and unspecified cholesterol medications at the time of vaccination. Discharge Summary received on 2/17/2005 states apnea.


VAERS ID: 228348 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-14
Onset:2004-10-23
   Days after vaccination:9
Submitted: 2004-10-27
   Days after onset:4
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK - / -

Administered by: Other       Purchased by: Private
Symptoms: Choking, Coma, Convulsion, Cough, Dementia, Emphysema, Hypoxia, Laboratory test abnormal, Nasal congestion
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Dementia (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Depakote; Dilantin; Aspirin; Colace; Lexapro; Multivitamin; Zantac; Vitamin B1; Megace; Oystcal; Nicotrol cartride inhaler; Tylenol; Morphine sulfate; Roxanol
Current Illness:
Preexisting Conditions: Dementia; Nicotine addiction; Emphysema; Seizure disorder; Anxiety; Acute delirium; Bipolar disorder; No known allergies.
Allergies:
Diagnostic Lab Data: 10/14/04 WBC 12.2, MCV 101, MCH 33.4, Neutrophils 26 (decreased), Lymphocytes 60 (increased); Mono 14 (increased). Smear suggestive of viral infection. (labs ordered 10/11/04).
CDC Split Type:

Write-up: *Note: resident exhibiting cough 9/20/04. 10/7/04 choking and cough with food. 10/14/04 flu vaccine given. 10/20/04 worst cough and lung congestion. Blood oxygen 80-85% O2 at 26. 10/21/04 97.4, 60, 20, 150/80. Blood oxygen 92% with O2. 10/21/04 Hospice ordered. 10/22/04 99, 80, 28, 130/70; O2 saturation 90% with 3LO2. Unresponsive (1100). 10/23/04 0535 expired. Death Certificate received on 11/16/2004 states cause of death is COPD and end-stage dementia. 11/2/04 Nurses notes & med list from nursing home received. Patient also had history of nicotine addition, dementia, emphysema and seizure disorder.


VAERS ID: 237579 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: California  
Vaccinated:2004-10-23
Onset:2004-10-23
   Days after vaccination:0
Submitted: 2005-05-10
   Days after onset:199
Entered: 2005-05-19
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER U1460AA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Bence Jones protein urine present, CSF test abnormal, Central nervous system neoplasm, Cerebrovascular disorder, Condition aggravated, Coordination abnormal, Ear pain, Encephalitis toxic, Facial neuralgia, Gait disturbance, Headache, Hypoaesthesia oral, Nausea, Nervous system disorder, Neuralgia, Neurological symptom, Nuclear magnetic resonance imaging brain abnormal, Ophthalmoplegia, Optic neuritis, Protein bound iodine increased, Skin ulcer, Viral infection, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic 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), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (narrow), Demyelination (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Ocular infections (broad), Ocular motility disorders (narrow), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-13
   Days after onset: 51
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 44 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergies: NKDA; PMH: CAD s/p CABG x 4; HTN, prostate cancer, hyperlipidemia.
Allergies:
Diagnostic Lab Data: 11/01/2004- MRI with multiple brainstem lesions. Lumbar puncture; with high WBC and protein with PMN and monocytes. 04/04/2004- MRI- disease extension to bilateral brainstem. 04/16/2004- New lesions to cerebellum with some resolution of brainstem lesions. PET Scan r/o lymphoma.
CDC Split Type:

Write-up: 10/23/2004: Pt received influenza vaccine, 10/24/2004- unsteady gait, left facial/ lip numbness, and numbness, and left ear pain. 10/29/2004- To ER with ataxia, Ophthalmoplegia, nausea and vomiting, hallucinations;declined neuro admit. DDX: Acute disseminating encephalomyelitis vs. paraneoplastic syndromes with CNS neoplasm. 11/01/2004-return to ER with worseninging of symptoms and admitted to neuro for presumed acute disseminenated encephalitis. Pt had multiple MRI''s, treated with high dose of corticosteroids and IVIG ??, complicated by panytopenia and MRSA/pseudomonas bacteria. The pt expired on 12/13/2004. 6/7/05 Received hospital D/C summary which states admit DX: presumed ADEM (acute disseminated encephalomyelitis). D/C DX: neuropathy of unknown origin, pancytopenia & MRSA/pseudamonas bacteremia. PMH: HTN, CAD, s/p CABG 2003, prostate ca 2000. MRI done 11/1 showed multiple lesions on the brainstem. LP w/high WBC & protein. By 11/4 MRI showed extension of the disease to involve most of the brainstem bilaterally. Tx with high dose steroids & antibiotics. Periods of intubation/extubation & developed aspiration pneumonia. MRI on 11/12 showed new lesions extending to the cerebellum with some improvement in the brainstem lesions. Developed low platelet counts which prevented PEG & tracheostomy. Tx w/IVIG, steroids & antibiotics. HIT antibody tes was + on 11/27 & started argatroban. Stopped that when developed pancytopenia. Became septic & blood c/s + for both MRSA & pseudamonas, acutely decompensated & expired.


VAERS ID: 229288 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2004-10-18
Onset:2004-10-20
   Days after vaccination:2
Submitted: 2004-11-15
   Days after onset:26
Entered: 2004-11-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1427AA / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Chills, Cyst, Nausea, Pain, Pyrexia, Sudden death, Viral infection
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-27
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA; Trazodone; Niacin; Zantac
Current Illness: NONE
Preexisting Conditions: Obesity; Kidney stones; Depression; High Cholesterol; Sleep apnea; Hernia repair; Chronic pain.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received a influenza shot 10/18/04, Fluzone U1427AA, .05ml, IM. Patient nausea, low grade fever and chills and seen 10/25/04. She had sudden death 10/27/04. Medical Record received on 11/22/2004 states pt experienced viral syndrome, Baker''s Cyst, and calf pain.


VAERS ID: 228204 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2004-10-18
Onset:2004-10-19
   Days after vaccination:1
Submitted: 2004-10-25
   Days after onset:6
Entered: 2004-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1503AA / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-19
   Days after onset: 0
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: NONE
CDC Split Type: TN04052

Write-up: Local hospital reported that pt had no prior cardiac history. 10/26/04 Spoke the reporter/provider for this death. The only information their clinic has on the decedent''s prior medical hx is that she did not check off any of the items listed under medical history on the vax permission sheet including those asking about cardiac problems. She did not list any current meds. This woman was the aunt of one of the other health dept. nurses and this nurse has apparently stated that she is unaware of any health problems for her aunt. They are not aware of the name of her PMD. The reporter states that an autopsy was not done. We have requested the hospital records. 10/27/04 Copies of the ER report and the code blue record and death summary are received and sent for scanning. She arrived at the ER at 8:50 AM and expired at 10:48 AM in the CATH lab. The attending physician''s summary notes COD most likely an inferior posterior acute myocardial infarction based on ECHO and presenting sxs. Family was apparently advised that she was in cardiogenic shock w/ a small chance for survival without therapy. A temp pacemeaker, intra-aortic balloon pump and possibly salvage angioplasty were planned. In between insertion of the pacemaker and beginning of the angioplasty, she was found to have no pulse by palpation and confirmed on EKG and prolonged code was unsuccessful. Please refer to the scanned records for details. 10/27/04 Call to funeral director to request copy of Death Certificate. This record is received and notes Myocardial Infarction as the COD. Neither the hospital record, the original VAERS reporter nor the hospital attending who signed the Death Certificate know who the PMD was for this woman. I placed a call to the son today. There was no answer and no VM. Died of a massive MI on Tuesday morning 10/19/04 while in store.


VAERS ID: 228205 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2004-10-18
Onset:2004-10-19
   Days after vaccination:1
Submitted: 2004-10-25
   Days after onset:6
Entered: 2004-10-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1419AA / UNK LA / -

Administered by: Public       Purchased by: Public
Symptoms: Cerebrovascular accident, Haemorrhage, Haemorrhage intracranial
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: 2004-10-19
   Days after onset: 0
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: NONE
CDC Split Type: TN04053

Write-up: Local hospital reported patient had no prior cardiac history. Patient was found in her bed around noon on Tuesday, 10/19. They believed she had died from a hemorrhagic stroke early Tuesday morning. Nurse follow up on 10/27/04 states: "intracranial hemorrhage."


VAERS ID: 228361 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-14
Onset:2004-10-19
   Days after vaccination:5
Submitted: 2004-10-27
   Days after onset:8
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK RA / -

Administered by: Other       Purchased by: Private
Symptoms: Anorexia, Cardiac failure congestive, Cough, Dehydration, Hyperventilation, Hypoventilation, Hypoxia, Oral intake reduced, Pyrexia, Rales, Somnolence
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (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:
Other Medications: Vitamin B12; Prevacid; Lasix; Bumex; Zithromax; Lumigan; Plavix; Synthroid; Terazosin
Current Illness: Hypothyroid; Incontinence; Depression
Preexisting Conditions: Hypothyroid; Chronic Pain; Depression; Partial Gastrectomy; Stroke
Allergies:
Diagnostic Lab Data: Medical Record received on 11/23/2004 states O2 stats depressed.
CDC Split Type:

Write-up: 10/19 Raled left lung; temp 97.4. 10/20 Mild congestive heart failure seen on x-ray, noisy breathing; started antibiotics. 10/21 Temp 99.5. 10/24 Temp 98.8. 10/25 Pale, rochi/crackles, decreased appetite, decreased voiding, slept all day. 10/26 Refused food, dehydration, water given, shallow breathing, O2 saturation 79%. Care refused by prior request. Medical Record received on 11/23/2004 states pt experienced rales and cough. Follow up 01/19/05, Recovery status unknown, patient expired in October.


VAERS ID: 228504 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: New York  
Vaccinated:2004-10-18
Onset:2004-10-19
   Days after vaccination:1
Submitted: 2004-10-26
   Days after onset:7
Entered: 2004-11-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 622A2 / 3 LL / -
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1407AA / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1038 / 3 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74404 / 3 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Irritability, Liver disorder, Nasal congestion, Nervous system disorder, Pulmonary congestion, Sudden infant death syndrome, Unevaluable event
SMQs:, Cardiac failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-19
   Days after onset: 0
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: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt was found dead in her crib on the morning of 19OCT2004 Follow up: congestion of the lungs, liver and brain. Pending investigation and toxicology examination. Follow up: Coroner states that father of baby mentioned the bay was slightly more fidgety than usual the evening before this death. - Review of well-baby progress note on 11/8/04 indicates baby was apparently healthy at time of immunizations. No additional symptoms. - - 03/23/2005 autopsy report rec''d. COD was SIDS.


VAERS ID: 228987 (history)  
Form: Version 1.0  
Age: 0.82  
Sex: Male  
Location: Ohio  
Vaccinated:2004-10-18
Onset:2004-10-19
   Days after vaccination:1
Submitted: 2004-11-01
   Days after onset:13
Entered: 2004-11-09
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1489AA / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Convulsion, Diarrhoea, Dwarfism, Dyspnoea, Gastroenteritis, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-10-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zithromax suspension
Current Illness: Otitis Media.
Preexisting Conditions: Micro-cephalic osteodyplastic primoidal dwarfism Type I (lethal genetic disease).
Allergies:
Diagnostic Lab Data: Stool for C diff toxin sent 10/22 (negative).
CDC Split Type:

Write-up: Patient had micro-cephalic osteodysplastic primoidal dwarfism type I, a lethal genetic disorder with DNR/DNI status. Per parent request, vaccine given 10/18. Fever developed 10/19 PM. Other symptoms began 10/22, including vomiting, diarrhea, rash and continued fever. Seizure one time in afternoon. Dyspnea developed about 12 AM. 10/23 Patient transported to hospital; patient died about 0830 on 10/23. Medical record received on 11/22/2004 states pt experienced gastroenteritis and respiratory failure. Death Summary & ER Record received on 12/01/2004 states pt experienced Beach Disease and respiratory failure. Death Certificate received on 12/02/2004 states pt experienced respiratory failure, Majewski''s micro-Cephalic osteodysplastic Dwarfism Type 1.


VAERS ID: 228347 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Michigan  
Vaccinated:2004-10-14
Onset:2004-10-18
   Days after vaccination:4
Submitted: 2004-10-27
   Days after onset:9
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dementia, Hypoxia, Pyrexia, Respiratory distress, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-10-25
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Docusate Na; Miacalcin; Celebrex; Ostcal; Act Fears; Tylenol; O2 by nasal cannula.
Current Illness:
Preexisting Conditions: Dementia; Agitation; Depression; Cancer. dysphagia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Last physical 9/17/04. Nasal O2, alert. Last PRRS, S2, no murmur. 10/15 temporary episode of respiratory distress. 10/18 Fever 100.5; no coughing. 10/23 Fever 100.5, responsive, given O2; fever broke late morning. 10/24 Fever 102.2. 10/23 fever 102.4, rapid breathing; on O2, no respiratory distress. Died at 21:00. Death Certificate received on 11/16/2004 states cause of death is end-stage dementia. 11/2/04 Received medical records from PCP which revealed patient with multiple complex medical problems including late stage Alzheimers.


VAERS ID: 231628 (history)  
Form: Version 1.0  
Age: 85.0  
Sex: Male  
Location: California  
Vaccinated:2004-10-15
Onset:2004-10-18
   Days after vaccination:3
Submitted: 2004-12-01
   Days after onset:44
Entered: 2004-12-28
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1394BA / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Caromra, ASA, Pedol, Pravadoe, Parcept, Flexout, Lisinopril, Lasix, Tablol
Current Illness: CAD; DSD; HTN; DMI; CHF
Preexisting Conditions: CAD; DSD; HTN; DMI; CHF
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: S/P Flu vaccine 3 days earlier. Found expired in morning.


VAERS ID: 228346 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Michigan  
Vaccinated:2004-10-14
Onset:2004-10-16
   Days after vaccination:2
Submitted: 2004-10-27
   Days after onset:11
Entered: 2004-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1478AA / UNK - / -

Administered by: Other       Purchased by: Private
Symptoms: Body temperature decreased, Cardiac failure, Cellulitis, Coronary artery disease, Dry skin, Fatigue, Laboratory test abnormal, Oral intake reduced, Pallor, Skin warm, Stomach discomfort
SMQs:, Cardiac failure (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Humulin; Zomig; Ferrous sulfate; Lopressor; Lopid; Senokot; Microk; Metamucil; Lexapro; Cardizem; Bumex; Aranes; Protonix; Allopurinol; Nitro patch; Coumadin; Clindamycin; ASA; Glucophage; Oscal.
Current Illness: Resolving of cellulitis.
Preexisting Conditions: Diabetes Mellitus; Hypercholesterolemia; Hyperlipidemia; Anemia; Depression; Coronary artery disease; Atrial Fib; CHF; Lymph edema; Renal insufficiency; hematuria. Allergies to PCN and Ether.
Allergies:
Diagnostic Lab Data: 10/12: CBC: WBC 17.4, RBC 2.85, Hgb 8.2, HCT 25.4, MCV 89, MCH 28.8, MCHC 32.3, Platelet count 310, Lymphocyte 8; Pro time 25.0, INR 2.1.
CDC Split Type:

Write-up: Flu vaccine given 10/14/04; unknown time (none charted). Flu vaccine 1cc with route not documented. 10/15/04 VS: 126/70, temp 97.7, 72, 20. No noted problems. 10/16/04 03:20, VS 140/50, 96.6, 64, 24; with time 97.3, 64, 24, 140/50. Complaints of feeling tired. 10/16/04 13:00 refused lunch (upset stomach); ate liquid diet. Skin W/D and pale. 14:25 while being assisted to bathroom, resident slumped. Nurse follow up on 11/01/04 states: "bilateral cellulitis of legs." Death Certificate received on 11/16/2004 states cause of death is CHF and coronary artery disease.


VAERS ID: 232753 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Female  
Location: New York  
Vaccinated:2004-10-12
Onset:2004-10-14
   Days after vaccination:2
Submitted: 2005-01-24
   Days after onset:102
Entered: 2005-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1442AA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Lung disorder, Malaise, Pneumonia, Pyrexia, Respiratory distress, Sepsis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-12-24
   Days after onset: 71
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 66 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Levaquin
Current Illness: Bronchitis Allergies
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PT Received Vaccination on Tues October 12th, On Saturday Oct 16 PT complained of feeling sick, Pt was admitted on Monday. PT was diagnosed with Pneumonia, and Septic Shock. Pt was in ARDS and never recovered. Pt was under other doctors care for bronchitis. PT deceased on 12/24/2004. Discharge summary from hospital received which revealed pt had multiple respiratory allergies, heavy smoker had SOB, fever, back & chest pain. CXR consistent w/multilobar pneumonia & COPD.


VAERS ID: 228896 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2004-10-13
Onset:2004-10-13
   Days after vaccination:0
Submitted: 2004-11-04
   Days after onset:22
Entered: 2004-11-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR Y9552 / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1336N / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; Perindopril; Pravastatin Na; Rabeprazole sodium
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0410USA04392

Write-up: Information has been received from a health authority concerning an 80 year old male patient who on 10/13/04 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot # 648713/1336N; batch # HV24410). Secondary concomitant therapy on 10/13/04 included an IM dose of influenza virus split virion 3v vaccine inactivated (batch # Y9552-1). Concomitant therapy included perindopril, zopiclone, pravastatin Na, aspirin and rabeprazole sodium. On 10/13/04 the patient died a sudden, unexplain death. A post mortem had not been performed and a cause of death had not been established. No further infromation expected. Case is closed. Other business partner numbers include E200403681.


VAERS ID: 231830 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2004-10-11
Onset:2004-10-11
   Days after vaccination:0
Submitted: 2004-12-22
   Days after onset:72
Entered: 2005-01-03
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / 7+ - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Pneumonia, Renal failure, Respiratory failure, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-13
   Days after onset: 63
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 63 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lipitor; Pindol; Synthyroid; Koracon; Prednisone; Hydrochlorazide
Current Illness:
Preexisting Conditions: The patient''s past medical history is significant for hypertension, high cholesterol and arthritis. She did not have any illnesses at the time of vaccination. Her vaccination history includes 10 doses of influenza vaccine on unspecified dates. At the time of vaccination, the patient was also taking the following medications: Lipitor, Pindol, Hydrochlorazide; Synthyroid, Kloracon, and Prednisone.
Allergies:
Diagnostic Lab Data: EKG; CT scan of the head; X-ray of the head; Chest X-ray, an EEG and blood work were performed, however the results were not provided. An autopsy was not performed.
CDC Split Type: 200404004

Write-up: From initial information received on 12/21/04 from the patient''s niece regarding an adverse event occurring in the USA, it was reported that an 89 year old female patient received a dose of FLUZONE at 11:00 AM on 10/11/2004. The lot number, site and route of administration were not provided. Eight hours later, on 10/11/04 at 7:00 PM, the patient complained of dizziness and her hands were shaking. She was seen in an emergency room, was diagnosed with kidney failure and was admitted to the hospital on 10/11/04. The patient was seen by renal specialists, critical care physicians, neurologists and infectious disease. The patient was hospitalized until she died on 12/13/04. No autopsy was performed. Medical Records received on 1/07/2005 states pneumonia and respiratory failure.


VAERS ID: 233743 (history)  
Form: Version 1.0  
Age: 97.0  
Sex: Female  
Location: Arizona  
Vaccinated:2004-10-06
Onset:2004-10-11
   Days after vaccination:5
Submitted: 2005-02-12
   Days after onset:124
Entered: 2005-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1462AA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Cough, Lung disorder, Nasal congestion, Pneumonia, Pyrexia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-10-15
   Days after onset: 4
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:
Other Medications: eyedrops, baby aspirin
Current Illness: senile dementia
Preexisting Conditions: senile dementia, macular degeneraiton, arteriosclerosis
Allergies:
Diagnostic Lab Data: As prescribed by hospital.
CDC Split Type:

Write-up: Patient was healthy for her age when vaccine was administered on 10/06/04. On 10/11/04, patient was admitted to Hospital for respiratory distress. Later diagnosis was pneumonia of an unknown itology. Her main symptoms were a deep cough, extreme respiratory congestion, chills, high fever, etc. Radiology confirmed presence of fluid on lungs. Patient was given intraveneous antibiotics as well as Lasix to try and improve her condition. She did not respond to antibiotics and expired on 10/15/04. No further information was given on Death Certificate or dischage summary, both rec''d on 03/02/2005.


VAERS ID: 227712 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2004-10-07
Onset:2004-10-07
   Days after vaccination:0
Submitted: 2004-10-11
   Days after onset:4
Entered: 2004-10-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1380AA / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lupron; Atenolol; Imdur; Actos; Digoxin; Aspirin; Norvasc; Furosemide; Lisinopril; Zocor
Current Illness:
Preexisting Conditions: The patient had a history of unspecified cardiac problems and prostate cancer. He had previously received influenza vaccines in 2002 and 2003, and a Pneumovax vaccine in 2003. Nurse follow up on 10/14/04 states: "Diabetes Type II; Myocardial Infarct 2000; aortic stenosis; ischemic cardiomyopathy." From additional information received on 10/21/04, it was reported that the patient had no illnesses at the time of vaccination. He had previously received at least three or more influenza vaccines in the past without experiencing any adverse events. His previous medications had included amlodipine, atorvastatin, atenolol, digoxin, furosemide, nitrates, lisinopril, and metformin. His current medication list was not available at the time of this report, so it is unknown if the patient was taking any of these medications at the time he received the influenza vaccine on 10/7/04. From additional information received on 11/8/04, it was reported the patient''s medical history included coronary artery disease with myocardial infarction in 10/00, triple coronary arter bypass, ischemic cardiomyopathy, aortic stenosis, prostate cancer, cataract extraction with intraocular pressure, total hip arthroplasty in 1993 and adult onset diabetes mellitus. Patient''s previous medications included Imdur, Actos, Atenolol, Digoxin, Aspirin, Norvasc, and Furosemide all taken every morning. Evening medications included Atenolol, Lisinopril and Zocor.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200403324

Write-up: From initial information received from a health care professional on 10/7/04 regarding an adverse event occurring in the USA, it was reported that an 80 year old male patient with a history of cardiac problems and prostate cancer received a FLUZONE vaccination, lot number U1380AA, administered in the right deltoid on 10/7/04. One hour after receiving the vaccine, the patient died in his car in the hospital parking lot. Per the reporter, the coroner''s initial impression was that it may have been a coronary heart attack and he stated that he would check for this. No other information was provided at this time. There was no autopsy done. Nurse follow up on 10/19/04 states: "No new information." Follow up on 10/28/04 states: "From additional information received on 10/21/04, it was reported that the pt had no illnesses at the time of vaccination. He received the FLUZONE SV ''2004-2005 vaccination IM. He had previously received at least 3 or more influenza vaccines in the past without experiencing any adverse events. His previous medicaitons had included amlodipine, atorvastatin, atenolol, digoxin, furosemide, nitrates, lisinopril and metformin. His current medication list was not available at the time of this report, so it is unknown if the pt was taking any of these medications at the time he received the influenza vaccine on 10/07/04."


VAERS ID: 228168 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2004-10-05
Onset:2004-10-07
   Days after vaccination:2
Submitted: 2004-10-22
   Days after onset:15
Entered: 2004-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1394CA / 7+ RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cerebral ischaemia, Chills, Hypertension, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic 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), Acute central respiratory depression (broad), Hypertension (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-10
   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: NONE
Current Illness: NONE
Preexisting Conditions: Diabetes; previous strokes; cerebellar atrophy and bilateral prostatic hypertrophy - BPH.
Allergies:
Diagnostic Lab Data:
CDC Split Type: SC0439

Write-up: Client''s wife called health department and reported that client received his flu shot on Tuesday, October 5, 2004 and was feeling fine. On Thursday, October 7th, client told his wife he didn''t feel well, was having body aches. Wife reported client continued to feel worse and that by Saturday he reported he hurt all over and wanted to stay in bed. Sunday AM, October 10th, client ate a bowl of cereal then returned to bed where he watched a ball game. After the game his wife went to read the paper and came back into the client''s room about 5:15 PM to see what he wanted for supper. He told his wife he still didn''t feel good, was feeling cold and shivering, but would eat a little of whatever she was having. A little later the wife sent their adult daughter to the client''s room to get him for supper and found him dead, still sitting up in bed. Due to client''s work in a local funeral home he had requested no autopsy be done so client was taken directly to the funeral home and buried on Wednesday, October 13th. According to his wife he had suffered several previous strokes and was a diabetic. The wife also reported that a friend who is also a physician stated it sounded like the client had a heart attack. The client has received flu vaccinations through the health department since 1998 with no adverse events. Nurse follow up on 11/01/04 states: "cardiovascular arrest; cerebrovascular ischemic disease; hypertension." -- 10/29/04 Copy of Death Certificate is received and lists COD as: cardiovascular arrest; cerebrovascular ischemic disease and hypertension.


VAERS ID: 228819 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Unknown  
Vaccinated:2004-09-30
Onset:2004-10-01
   Days after vaccination:1
Submitted: 2004-11-04
   Days after onset:34
Entered: 2004-11-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: Omeprazole, Bendroflumethiazide, Enalapril, Salbutamol, Paracetamol.
Current Illness:
Preexisting Conditions: The pt was taking the following concomitant medications: Omeprazole, 20mg per mouth for gastritis since 01/17/00; Bendroflumethiazide, 2.5mg per mouth for essential hypertension since 03/18/03; Enalapril, 2.5mg per mouth for essential hypertension since 03/11/03; Salbutamol, 100mcg inhaler for acute bronchitis NOS between 04/22/03 and 08/11/04 and paracetamol 500mcg per mouth for localized osteoarthritis since 03/17/97.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E200403742

Write-up: This case concerns an 87 year old female pt. The pt received a 0.5ml dose of influenza vaccine, manufacturer unknown, batch # not reported, given IM on 09/30/04. On 10/1/04 the pt died at home during sleep. A post mortem was carried out, the cause of death was established as acute myocardial infarction. The pt was taking the following concomitant medications: Omeprazole, 20mg per mouth for gastritis since 01/17/00; Bendroflumethiazide, 2.5mg per mouth for essential hypertension since 03/18/03; Enalapril, 2.5mg per mouth for essential hypertension since 03/11/03; Salbutamol, 100mcg inhaler for acute bronchitis NOS between 04/22/03 and 08/11/04 and paracetamol 500mcg per mouth for localized osteoarthritis since 03/17/97. No further information is expected, case is closed.


VAERS ID: 227394 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-10-24
Onset:2004-09-23
   Days after vaccination:335
Submitted: 0000-00-00
Entered: 2004-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Deep vein thrombosis, Gastrointestinal necrosis, Gastrointestinal neoplasm, Intestinal obstruction, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal obstruction (narrow), Thrombophlebitis (broad), Ischaemic colitis (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-23
   Days after onset: 0
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: Vitamin C, E, B complex; Testosterone injections; Slo K; Maxide; Lasix; Acupril; Zyloprim; ASA;
Current Illness:
Preexisting Conditions: Received a dose of RSV vaccine or Placebo and Influenza vaccine. Administration date not reported. Blood pressure high; Hypertension; Congestive Heart Failure; Osteoarthritis; wac degenerative; Left orchiectomy in 2002;
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200403234

Write-up: This subject is a 67 year old male who was admitted to the hospital and died while enrolled in a study. The subject received two doses of RSV vaccine or Placebo and Influenza vaccine. The last dose prior to the event was given on 10/23/03. The subject was hospitalized for a stomach mass, date of hospitalization not reported. While in the hospital subject developed a blood clot and died 334 days post immunization on 9/21/04. The subject''s death due to a blood clot was reported by the investigator as unknown in relationship to the study vaccine. Follow up on 10/08/04 states: "There was no autopsy done for this decedent." Nurse follow up on 10/14/04 states: "pulmonary embolism; deep vein thrombosis." Nurse follow up on 10/19/04 states: "small bowel mass." Nurse follow up on 11/11/04 states: "fat necrosis of the mesentery with partial small bowel obstruction."


VAERS ID: 218454 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2003-10-06
Onset:2004-03-17
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2004-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiovascular disorder, Lung disorder, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV/ Placebo, Xaxax, oxygen, Nasonex, lasix.
Current Illness:
Preexisting Conditions: First dose of RSV vaccine or placebo and influenza vaccine administered on 17 October 2002. History of COPD, hypertension, aortic valve sclerosis, hyperlipidemia. History-smoker (45 pack, history) stopped 2000.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200401314

Write-up: This subject is a 72 year old female who died in her home while enrolled in a study. The subject received two doses of the study vaccine. The last dose prior to the death was given on 10/6/03. The subject''s daughter reported that her mom was found dead in her home on 3/17/04, 163 post immunization. Suspected cause of death is a heart attack. No autopsy performed. Subject was not brought to the hospital. The death was reported by the investigator as unrelated to the study vaccine. Nurse follow up on 05/17/04 states: COPD, Hypertensive cardiovascular disease (Lung dis, Cardiovasc dis). The death was reported by the investigator as unrelated to the stud vaccine. Additional information received 7 April 2004. Concomitmant therapies and relevant medical history. Cross reference with 2003-00300 (SAE #2003-0-1056)- Same patient.


VAERS ID: 217869 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Virginia  
Vaccinated:2003-10-22
Onset:2004-02-21
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2004-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Cardiac failure, Cholecystitis, Dyspnoea, Gastric ulcer, Gastrooesophageal reflux disease, Hypotension, Hypothyroidism, Liver function test abnormal, Lung disorder, Neuropathy, Respiratory failure, Sepsis, Shock
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (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), Gastrointestinal ulceration (narrow), Acute central respiratory depression (narrow), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Hypothyroidism (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-05
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RSV/ Placebo
Current Illness:
Preexisting Conditions: Information from follow up 3/10/04: received first dose of RSV or Placebo and Influenza vaccine on 10/31/02. Asthma; CHF
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200400770

Write-up: This subject is a 67 year old female who was admitted to the hospital due to labored breathing while enrolled in a study. The subject received 2 doses of RSV vaccine or Placebo and Influenza vaccine with the last dose administered on 10/22/03. The subject presented with labored breathing on 2/21/04, 122 days post immunization and was admitted to the hospital on the same day. The causality has not been assessed by the investigator. Additional info has been requested. Additional info received on 3/1/04. The laboured breathing was assessed by the investigator as unrelated to the study vaccine. Outcome is unknown at this time. Additional info received 3/9/04. Subject was admitted to hospital on 2/21/04 with acute cholecystitis, septic shock, CHF, respiratory failure, labored breathing. Subject was on a respirator. Subject died on 3/5/04, 13 days after admission and 135 days post immunization. Additional info received 3/10/04. Subject received first dose of RSV or Placebo and Influenza vaccine on 10/31/02. Additional info received on 3/11/04. The acute cholecystitis, septic shock, CHF, respiratory failure were reported by the investigator as unrelated to the study vaccine. The death certificate received on 3/22/04 states COPD. The medical record received on 3/22/04 states neuropathy, GERD, ulcers and hypothyroidism. The hospital discharge summary received on 3/23/04 states hypotension, SOB, decreased po intake and elevated liver enzymes. Follow up on 03/24/04: "Copy of death certificate: Cause of death: Sepsis syndrome-cholecystitic. Other significant conditions contributing in death but not resulting in the underlying cause of death is advanced COPD."


VAERS ID: 217552 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Female  
Location: New York  
Vaccinated:2003-10-29
Onset:2004-01-30
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2004-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Condition aggravated, Cough, Dyspnoea, Lung disorder, Productive cough, Pyrexia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-02-17
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Verapamil; Tamoxifen; Albuterol; Atrovent; Pulmicort; Advair; Foradil; Bactroban; Xanax; Verelan SR
Current Illness:
Preexisting Conditions: COPD; Hypertension; Atrial fib; History of breast cancer; History of basal cell carcinoma; Question of dysrhythmia; No known drug allergies; First dose of RSV or placebo and influenza vaccine administered on 10/17/02.
Allergies:
Diagnostic Lab Data: Negative urinalysis with a white blood cell count of 15.1 with normal hematocrit and platelet count. A troponin is negative on admission. Coags are within normal limits. The SMA-7 is normal except for a bicarb of 34. The initial gas was 7.22/83/132 and the latest gas on BiPAP is 7.34/58/57. Electrocardiogram shows no ischemic changes with sinus tachycardia at a rate of about 105. There is a normal axis. Chest x-ray shows chronic obstructive pulmonary disease, no evidence of pneumonia. FVC of approximately 0.5 liter.
CDC Split Type: 200400418

Write-up: This subject is a 76 year old female who was admitted to the hospital with respiratory failure and COPD exacerbation while enrolled in a comparative randomized study of safety and immunogenocity of a non-adjuvanted respiratory syncytial virus 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 10/29/03. The first dose was 10/17/02. Subject developed increasing shortness of breath over the last month and purulent sputum, fever, chills and cough over the last 2 weeks. Subject was taken to emergency by ambulance 93 days post immunization on 1/30/04 and admitted the same day with respiratory failure. Subject was placed on BiPAP, and treated with nebulizer treatments, Rocephin 1gm, Zithromax 500mg, Decadron 6mg IV, Prednisone 40mg BID, Vantin 200mg BID. A chest x-ray on 1/30/04 showed COPD and no pneumonia. EKG is normal. There is no history of chest pain. Subject had mild improvement, however her disease is severe with an FVC of approximately 0.5 liter. Seen in consultation with pulmonary and agreed that she is in end stage. Subject declined any further BiPAP and was discharge from the hospital to hospice 4 days later, 3 February 2004. Subject discontinued the study on 2/3/04. The respiratory failure and COPD exacerbation was reported by the investigator as not related to the study vaccine. Additional information received on 3/5/04: Subject was discharged from the hospital on 2/3/4 to hospice. Subject died in hospice on 2/17/04, 111 days post immunization. The death due to respiratory failure and COPD exacerbation was reported by the investigator as unrelated to the study vaccine. Follow up on 03/24/04: "Additional information received 03/18/04. Copy of death certificate: Cause of death: Advanced Chronic Obstructive Lung Disease. No autopsy performed."


VAERS ID: 215914 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-10-27
Onset:2004-01-26
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2004-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Fall, Myocardial infarction
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV/Placebo; Zocor; Zesteril; Aspirin; Toprol; Allopurinol; Norvasec; Plavix
Current Illness:
Preexisting Conditions: HTN; LVH; Heart murmur; Unsteady gait; CHF; Cardiomyopathy; Aortic stenosis; Hypercholesteremia; Venous stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200400390

Write-up: The subject is a 79 year old male who was found unresponsive by his wife while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted RSV Vaccine Versus An RSV Vaccine Adjuvanted Wtih Aluminum Phosphate When Administered Concomitantly With A Licensed Influenza Vaccine In High-Risk Adults $g or = 65 Years Of Age, Protocol Number RSV11. The subject has received RSV vaccine or Placebo and Influenza vaccine twice with the last dose on 10/27/03. Date of first dose date was not reported. The subject was found unresponsive on 1/26/04 by his wife, 91 days post immunization. As per subject''s wife, it appears that the subject went out to retrieve the mail, slipped on ice and fell. She found him unresponsive. Paramedics were unsuccessful in reviving him. He was transported to the hospital where treatment was continued but unsuccessful. Subject died on 1/26/04. The event was reported by the investigator as not related to the study vaccine. Myocardial infarction.


VAERS ID: 217992 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: California  
Vaccinated:2003-10-24
Onset:2004-01-26
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2004-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aortic valve stenosis, Asthma, Atrial fibrillation, Blood glucose increased, Blood sodium decreased, Cardiac asthma, Cardiac failure, Cardiomegaly, Cardiovascular disorder, Disorientation, Dysphagia, Dyspnoea, Hyperglycaemia, Hypertrophy, Hypoxia, Pulmonary hypertension, Pulmonary oedema, Respiratory distress, Sepsis, Speech disorder
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-03-12
   Days after onset: 46
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 46 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RSV/ Placebo; Azmacort, Verapamil, Fosamax, Uniphyl, Nasacort, Ventolin, Diovan HCT, Accolate, Premarin, baby aspirin, Zocor, Vioxx, Xopenex, Duratuss, Darvocet-N, Forodil, Valtrex, Cipro, Fluconazole, KCL, sodium chloride flush, multivitam
Current Illness:
Preexisting Conditions: COPD, emphysema, interstitial lung fibrosis. Allergies: ampicillin, fresh paint, air freshener, cleansers with strong odor, perfume, aeromed
Allergies:
Diagnostic Lab Data: Sodium 106. Information from f/u received 3/9/04-elevated blood sugars
CDC Split Type: 200400471

Write-up: This subject is a 75 year old female who was admitted to the hospital due congestive heart failure while enrolled in a study. The subject has received two doses of RSV vaccine or Placebo. Administration dates not reported. The subject developed moderate congestion with fluid build up in her lungs and was admitted to the ICU with a diagnosis of congestive heart failure on 2/8/04. Subject''s sodium was also low at 106. The congestive heart failure was reported by the investigator as life threatening and not related to the study vaccine. Additional info received on 2/13/04. Subject received two doses of RSV vaccine or Placebo and Influenza vaccine with the last dose on 10/24/03. Dates of first dose 10/31/02. Subject developed congestive heart failure 94 days post immunization and was admitted to the hospital on 1/26/04, was transferred to the ICU on 2/8/04. Subject remains in ICU. On 1/12/04 breathing tube and feeding tube were removed. She is breathing well on her own. X-rays are being done daily and she is still on IV antibiotics. Seriousness not reported. Subject is recovering and will continue in the study. Additional info 2/20/04. The congestive heart failure was reported by the investigator as life threatening and not related to the study vaccine. Additional info received on 2/20/04. Subject was released from ICU and returned to the regular medical floor. She complained of dysphagia and difficulty with speech since feeding tube and breathing tube were removed and is mildly disoriented (responsive to commands). The subject is recovering and will continue with the study. Additional info received 2/27/04. Diagnosis: A-fibrillation, severe aortic stenosis, severe cardiac and bronchial asthma with congestive heart failure. Echo report on 2/9/04: Impression 1. Calcified degenerative aortic valve disease with moderate aortic valve stenosis with estimated aortic valve area of 0.9 cm squared and mean gradient of 24MMhg. 2. Mild bi-atrial enlargement, normal left ventricular size with hyperdynamic left ventricular hypertrophy.3. There is evidence of left ventricular diastolic dysfunction, moderate aortic valve stenosis, aortic valve of 0.9cm squared. Mild mitral and tricuspid valve insufficiency and mild pulmonary hypertension by doppler. Subject''s breathing is extremely poor and is scheduled to have a tracheotomy and feeding tube inserted. She has been non verbal for the past 2 1/2 weeks, but seems to hear and comprehend better now. Mucus is being flushed from her lungs every 24 hrs. Resistant to massive doses of corticosteroids. Additional info received on 3/1/04. Tracheotomy was performed on 2/27/04. A gastric feeding tube was also scheduled to be inserted however she is on Coumadin and her bleeding time was too high to have procedure done. It will be performed once her bleeding time is controlled. Investigator has assessed the event as life threatening, unrelated to the study vaccine. Additional info received on 3/9/04. Gastric feeding tube placed, date of procedure unknown. Subject was extubated and receives breathing treatments every 4 hrs. She remains nonverbal and can now swallow. Antibiotic therapy continues. Subject has started antidepressants as well as Coumadin. Subject''s blood sugars have been elevated and Insulin is being administered prn. Subject''s recovery is ongoing and has been discharged to a long term acute care hospital (exact date not reported). Additional info received 3/15/04. Subject expired on 3/12/04, 140 days post immunization while in the acute care hospital. Diagnosis: Congestive heart failure. Awaiting death certificate. The subject''s death due to congestive heart failure was assessed by the investigator as unrelated to the study vaccine. Additional information received Mar 29, 2004. Discharge summary from Jan 30, 2004 to Feb 7, 2004 Discharge Diagnosis: The patient status post L2 through L 5 laminectomy and decompression performed. 1.The patient is mediclaly and surgicaly stable postop. 2. Patient with evidence of atrial fibrillation as well as signifant pulmonary deficits at the time, transferred to the acute medical service for stabilization. Patient also noted to have hyponatremia at the time. Hospital course: The patient was begun on intensive physical and occupational therapies as well as utilizing speech and nursing services for all of her deficits. During the hospitalization, the patient made good progress in her rehabilitation. The patient however did have low sodium level which at its lowest point was at 108. She also had evidence of some mild respiratory distress on the 7th of February. The patient was evaluated by the medical service and subsequently was tranferred to the medical service secondary to atrial fibrillation as well as some respiratory distress and significant hypoatremia was noted. Disposition: The patient ws transferred to the acute service on the 7th of February. Additional ifnromation received 7 April 2004. Jan 26, 2004: Admitted to hospital for elective spinal surgery. Feb 7, 2004: Discharge from rehab to ICU. Feb 17, 2004: Discharge from ICU to acute care (hospital floor). March 5. 2004: Discharge from hospital and transferred to acute care facility. March 12, 2004: Subject expired at acute care facility. 8 April 2004- Upon internal review from information received on 29 March and 7 April the subject''s hospitalization for spinal surgery due to antero-spondylalisthesis and lumbar spinal stenosis will be combines into report 2004-00471. The subject was admitted to the hospital for elective surgery on 26 January 2004, 94 days post immunization. Subject had an MRI (date not reported) of the lumbar spine which showed severe spinal stenosis at the L4-5 level, with evidence of severe ligamentum hypertrophy at the lumbar spine resulting in lateral recess and neuro foraminal stenosis. She underwent a bilateral L2, L3, L4, L5 laminectomy with exploration/decompression L2-3, L3-4, L4-5, L5-5 neuro foramen. Additional information received on 4/14/04: Follow up report and Death Certificate. Subject wa originally diagnosed with Congestive Heart Failure however developed Pneumonia which led to Sepsis. Sepsis was the final cause of death which was secondary to Pneumonia, organism unspecified CU. Additional information received 4/29/04 Discharge summary report for admission to ICT on 2/7/04 and discharged from ICU to Acute care facility 3/5/04. Discharge Diagnosis: 1) Lumbar laminectomy post-operative day 40. 2) Severe hyponatremia, which has resolved. 3) Ventilator-dependent respiratory failure. 4) Severe chronic obstructive pulmonary disease, FEV 1.0 L, which is 50% of predicted, FVC 1.93, 70% of predicted. 5) Atrial fibrillation. 6) Moderate to severe aortic stenosis. 7) Myopathic neuropathy syndrome. 8) Hyperlipidemia. 9) Hypertension. 10) Osteoporosis. 11) ALBUTEROL allergy and possibly AMPICILLIN allergy. 12) Obstructive sleep apnea syndrome. 13) Anemai. 14) Thrombocytopenia. 15) Candida-albicans in sputum. 16) Mild hyperglycemia/diabetes mellitus 2. 17) Tracheostomy post-operative day 6 and percutaneous endoscopy gastrostomy tube post operative day 1. Discharge medications: Diflucan, Verapamil, Zovirax, Prevacid, Xopenex, Solu-Medrol, Atrovent, Free water, Bacitracin ointmen, Trach collar 30% as tolerated, Ventilator, Tylenol, Regular Insulin sliding scale. Subject was aformentioned diagnosis 40 days ago was seen when she had change in mental status and respiratory insufficienty. She was transferred urgently for these complaints to the intensive care unit, and she was found with a sodium of 109. She was intubated and treated agressively. Her sodium was gently repleted to the normal levels. SHe has had difficulty with her cardiopulmonary status, particularly respiratory failure requiring Bi-PAP. Tracheostomy was performed six days ago and a PEG-tube was placed for nutrition. Patient had slight atelectasis in the left lower lobe which was likely due to the fact that she has been breathing spontaneously on Trach collar, but not taking deep breaths. Treated with a ventilator at night per the aforementioned settings. Subsequent medical care under the supervision of doctor. The family has been informed of diagnosis and prognosis. Details of the case has been discussed with the patient''s son. A cardiology consultation should be obtained to optimize cardiopulmonary status, management of aortic stenosis and atrial fibrillation. Coumadin anticoagulation should be re-initiated.


VAERS ID: 218850 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2003-11-07
Onset:2004-01-26
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2004-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Bacterial infection, Cardiac failure, Cerebrovascular accident, Coma, Condition aggravated, Convulsion, Diabetes mellitus, Embolism, Gastrointestinal disorder, Gastrointestinal haemorrhage, Hypertension, Hyperventilation, Muscle twitching, Paralysis, Pneumonia, Renal failure, Respiratory failure, Sepsis, Skin disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (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), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-04-02
   Days after onset: 67
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:
Current Illness:
Preexisting Conditions: Insulin dependent diabetes, hypertension
Allergies:
Diagnostic Lab Data: Blood samples were obtained. Pulse oximetry: No 01/29/04 98% on 2 liters. On 02/19/03 97% on 2 liters.
CDC Split Type: 200400397

Write-up: This subject is a 69 year old female who was admitted to a progressive care unit due to seizure while enrolled in a Comparative Randomized Study of Safety and Immunogenicity of a Non-Adjuvanted Respiratory Syncytial Virus 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 the second dose of RSV vaccine or Placebo and Influenza vaccine on 11/7/03. The first dose not reported. The subject experienced a seizure 80 days post immunization and was taken to the ER on 1/26/04. Subject had sonorous respirations and was unresponsive with persistent facial twitching. Treatment included Ativan, Dilantin, and oxygen. Subject was transferred to Progressive Care Unit/Telemetry. Clinical impression was epileptic seizure, cerebrovascular accident, postictal state, uncontrolled insulin dependent diabetes, hypertension. The seizure, cerebrovascular accident and uncontrolled insulin dependent diabetes were reported by the investigator as unrelated to the study vaccine. Additional information received 4/2/04. Subject was admitted to hospital on 1/26/04 for seizure and respiratory failure and was then transferred to a burn center for a skin problem associated with the epileptic medicine that she was receiving. Treatment for seizures included Dilantin. Subject expired at the burn center on 2/4/04, 9 days after admission and 89 days post immunization. Medical records not received by investigator as of yet. The respiratory failure and death were assessed by the investigator as unrelated to the study vaccine. Additional information received 4/6/04. Onset date of respiratory failure is 1/26/04. Additional information received 4/8/04: Date of death confirmed as 4/3/04. Exact cause of death and death certificate to follow. Nurse follow up on 05/27/04 states: "ADD: Anemia, Renal failure, GI bleed, Embolism, Pneumonia, CHF, Septic shock, Hemiplegia, GERD, Infect Bacterial (ANEMIA, KIDNEY FAIL, HEM GI, EMB, PNEUMONIA, HEART FAIL RIGHT, SEPSIS, PARALYSIS, GI DIS, INFECT BACT)" Follow up on 07/12/04 states: "Main diagnosis is Seizures. Pt was admitted to the hospital on 01/26/04 after family witnessed Grand Mal Seizure. MD verbally noted respiratory failure upon admission also. Pt was discharged from hospital 02/19/04 to a nursing home and then to a burn center for skin problems associated with epileptic medication reaction. Pt expired at the burn center on 04/04/04." Follow up on 08/06/04 states: "Subject expired at the burn center on 04/02/04, 67 days after admission and 147 days post immunization. Onset date for respiratory failure is 01/26/04. Date of death confirmed as 04/02/04. Exact cause of death and death certificate to follow. Main diagnosis is seizures. Pt was admitted to the hospital on 01/26/04 after family witnessed Grand Mal Seizure. MD verbally noted respiratory failure upon admission also. Pt was discharged from hospital 02/19/04 to a nursing home and then to a burn center for skin problems associated with epileptic medication reaction. Pt expired at the burn center on 04/02/04 (corrected). Discharge summary: Admission date 01/26/04, Discharged date 02/19/04. The 69 year old subject had a grand mal seizure lasting for 10 minutes and was brought to the ER and treated with Dilantin and Ativan. Subject had a constricted pupil, peripheral pulses decreased. CNS-drowsy, responded to tactile stimuli. Left sided weakness noted. Detailed exam could not be performed due to sedation by Ativan. Tests performed included an Ultrasound of Kidney-unremarkable, CT of the head without contrast-mild atrophy-VQ scan-probability of pulmonary embolism considered quite low, chest x ray, one view on 01/26/04 poor inspiration, patchy infiltrates versus alveolar edema in the upper lobes. Left lower extremity venous Doppler-DVT, left common femoral vein and proximal superficial femoral vein. CT of the brain-no acute abnormalities. Electrocardiogram showed no acute process. Echocardiogram had no obvious RWMAs at rest. Probable C LVH. Trivial degenerative changes, aortic and mitral valves. Technically difficult to perform study. Hospital course: admission orders in addition to routine PCU orders included neuro checks, seizure precautions, IV fluids, nothing by mouth, Foley catheter, O2 protocol, sliding scale Humulin R insulin coverage SC, IV Lopressor and additional Regular Insulin and also Zofran IV prn nausea. Consult from neurology with his impression of breakthrough seizure most likely secondary to metabolic abnormalities, elevated glucose, history of seizure disorder secondary to old CVA, residual left hemiparesis. A PICC line by interventional radiology which was carried out. The pt was confused/disoriented. Had no localized neurologic signs. Th ept was cultured and put on IV Rocephin. She had increased temperature of 104.5. She was found to have a DVT, left leg. An infections disease consult was obtained with impression of fever most likely secondary to aspiration pneumonia after seizure disorder. Recommended Ceftriaxone addition to Clindamycin. The pt was alert but nonverbal. Did not follow commands. Blood sugars were over 300. Dilantin level was 8.4, she was given extra dose of Cerenex. House physician was called to see the pt the am of 01/29 for hypertension with SBP in the 180s. She was also hyperglycemic at 380. She was given Lopressor. He felt she might benefit from a spinal tap. Recommended repeat of Ct of the head and follow up with neurology. En route from CT scanner her nurses reported the pt became apneic. Pulse oximetry dropped to 78. Code Blue was called when the pt returned to the room. Upon arrival of house physician she was stable. Pulse oximetry was 98%. She was transferred to ICU for closer monitoring with consideration for possible need for intubation for airway protection. A VQ scan showed low probablity for pulmonary embolism. ECG with QT prolongation which he felt probably related to metabolic disturbance specifically hypokalemia, associated drug effect an/or CNS effect. He recommended repleting K and magnesium, additional diagnostic studies, adjustment of blood pressure medication. CT scan showed no change from study of 01/26/04. No acute lesion. Temperature was 103.8, white count 10.1. Doctor felt we should presume meningitis. Ampicillin was added. Clindamycin was discontinued. LP was recommended. Urologic consult was obtained re hematuria on anticoagulation therapy for DVT. Recommended holding of heparin until urine cleared and then attempt to restart. If recurrent hematuria, then consideration to renal ultrasound. A nephrology consultation was obtained, his impression of seizure disorder, fever, fuled out aspiration pneumonia, diabetes poorly controlled, labile hypertension, on Cardene; mild hypoartremia. He recommended no free water and IV fluids, change of all IV medication to normal saline and if sodium dropped further, then consideration to discontinuation of Paxil. He also recommended daily BMP. The pt was more alert and smiling, verbalizing; temperature was 102.8. Cardiology recommended a Greenfield filter. K was low and being repleted. IVC filter was place on 01/30/04 without complications. Hypoatremia was improving. K was being repleted. Creatinine was 1.5. Sugars were over 300. She again had hematuria on heparin. Urology recommended discontinuation of anticoagulation since Greenfield filter was placed. The pt''s husband and daughter refused a lumbar puncture. They wanted to wait until the following week. The pt was much more awake and alert, oriented, followed commands with no further seizures. Dilantin level was therapeutic. Doctor felt there was no urgent need for lumbar puncture. Cardiology recommended start of PO fluids, assessing swallowing function, continuation of beta blocker and ACE inhibitor, resumptoin of low-dose anticoagulation and transfer out of ICU. The pt had no complaints. Was awake. Had no diarrhea. Urine was clear. Ultrasound of the kidney was a limited study; kidneys appeared normal. Outpt cystoscopy was recommended. Medication was adjusted. Creatinine was stable. She had no further hematuria. Cysto in office was recommended and discussed with pt husband. She had no cardiac symptoms, Coumadin was resumed. Wound care consult had been requested. She also had presumptive C.difficile colitis for which she had been treated with Metronidazole and Flucanazole for fungal dermatitis had also been administered, both of which were discontinued. Pt had no further breakthrough of seizures. Wound care was being carried out for bilateral buttock maceration, stage II ulcer at base of spine. Medications were adjusting for hypertension. The pt was stable for discharge to the nursing home on 02/19/04. Discharge Diagnosis: Breakthrough seizures, aspiration pneumonitis, suspected meningitis, suspected C.difficile colitis, fungal dermatitis, Subtherapeutic dilantin level, old cerebrovascular accident with left hemiparesis and known seizure disorder, decubitus ulcer, deep venous thrombosis, left lower extremity, greenfield filter placed, hypertension/hypertensive heart disease, diabetes mellitus type 2 non insulin dependant, obesity, coronary artery disease, status post myocardial infarction, sleep apnea, history of gstroesophageal reflux, chronic obstructive pulmonary disease, hypoatremia mild, hematuria on anticoagulation, QT prolongation secondary to metabolic disturbance specifically hypokalemia, allergy to E-Mycin and Tetracycline. Complementary information form: SAE respiratory failure start date 01/26/04, stop date 02/19/04. The following events are all pre-existing and are not SAEs (part of history): cerebrovascular accident, uncontrolled insulin dependent diabetes, hypertension. Death certificate will be sent when available. 07/30/04: Upon internal review, correction to the date of death in the narrative was made to 04/02/04. Cross reference with cases F20030006, 2004-00009.


VAERS ID: 314404 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2003-12-08
Onset:2004-01-20
   Days after vaccination:43
Submitted: 2008-06-01
   Days after onset:1593
Entered: 2008-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1088AA / 1 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Death
SMQs:, Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2008-02-17
   Days after onset: 1489
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE. PMH: typanostomy tubes, phimosis, GERD,. Allergy to sulfa.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: EMG/NCS 1/24/08 showed widespread sensory motor neuropathy significantly worsened since 2004. Swallow study shows mild/moderate aspiration risk. Genetic testing showed several sequence variations of unknown significance. CSF culture (-). CSF glucose 61. CSF protein 47. CSF lactic Acid 1.5. (N). CSF Pyruvic Acid 0.18 (N). ESR 22. Thymidine phosphorylase activity normal.
CDC Split Type:

Write-up: DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY 2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy. 06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2'' DX: Tachycardia. Respiratory Distress. Pt most recently presented to another facility in December 2007 with GI issues and increasing lower extremity weakness. Pt was discharged and was transferred for further evaluation due to progressive upper extremity weakness and dyspnea, as well as new onset urinary and fecal incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially developed limb weakness and paresthesias 4 years ago. Testing showed widespread sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating Polyneuropathy. Course has been slowly progressing over the years and has had multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the years without response. Pt now with autonomic dysfunction. BIPAP improved overall energy level. Pt unable to return to rehab facility given questionable prognosis so pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP, Recent Gastroenteritis.)


VAERS ID: 217132 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Florida  
Vaccinated:2003-10-21
Onset:2004-01-13
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2004-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV/ Placebo
Current Illness:
Preexisting Conditions: COPD, hematemesis, blood in stool, abdominal pain, thrombocytopathy, breast CA
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2004006821

Write-up: This subject is a 79 year old female who died while enrolled in a Comparative Randomized Study of Safety and Immunogenicity Of A Non-Adjuvanted RSV Vaccine VS. 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 RSV vaccine or Placebo and Influenza vaccine on 10/21/03. The subject died on 1/13/04, 84 days post immunization. The investigator has not reported the causality. Additional info to follow when available. Additional information received 27Feb2004. The death was reported by the Investigator as not related to the study vaccine. Additional information received 10March2004. Copy of Death certificate received. Cause of death is not legible, no autopsy was performed. Additional information received by phone on 12Mar04. Verbal report from study coordinator that the cause of death was non-small cell lung cancer. Written following report requested. Additional information received 12Mar04. Written report: Diagnosis: Subject died on January 13, 2004. Manner of death-natural-Immediate cause-non-small cell lung Carcinoma.


VAERS ID: 215624 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2004-01-10
Submitted: 2004-01-13
   Days after onset:3
Entered: 2004-01-27
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-10
   Days after onset: 0
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:

Write-up: Heart attack at home, called 911, taken to hospital, couldn''t revive. County coroner called because sudden death. Family thinks death is a result of flu shot received about 2 weeks ago.


VAERS ID: 214911 (history)  
Form: Version 1.0  
Age: 1.8  
Sex: Female  
Location: Foreign  
Vaccinated:2003-11-30
Onset:2003-12-30
   Days after vaccination:30
Submitted: 2004-01-13
   Days after onset:14
Entered: 2004-01-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Convulsion, Encephalitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (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: 2003-12-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200400038

Write-up: It was reported from a news article on 1/6/04 that a 22 month old female child died after receiving a dose of Influenza vaccine on an unspecified date in late November, 2003. The pt developed a high fever, suffered multiple seizures and subsequently experienced severe brain swelling consistent with the condition acute disseminated enceplahomyelitis on 12/30/04, approximately one month post immunization. The child was placed on life support and died on Sunday night after her parents consented to unhook life support. No other info was provided at this time. Additional information received January 19, 2004: stated that subject''s death was unrelated to the flu vaccine. This child developed fever 30days after flu vaccination and died 36 days after her flu vaccination. No further information was provided.


VAERS ID: 214418 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2003-12-11
Onset:2003-12-19
   Days after vaccination:8
Submitted: 2003-12-23
   Days after onset:4
Entered: 2003-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765880 / 2 LA / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1497L / 2 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Congenital brain damage, Encephalitis, Headache, Hemiparesis, Hypoaesthesia, Hypotension, Laboratory test abnormal, Mental impairment, Mydriasis, Nausea, Pain, Paralysis, Pyrexia, Tachycardia, Viral infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-22
   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: None
Current Illness: None
Preexisting Conditions: No allergies History of meningococcemia at age 2, which required multiple skin grafts and bilateral knee and hip replacements. History of cervical dysplasia
Allergies:
Diagnostic Lab Data: Lumbar puncture w/ cerebrospinal fluid cultures, which were negative. Herpes PCR pending. Blood cultures negative. Serial CT scans- cerebral edema w/ a mid-line shift and effacement of the sulci and compression of the 4th ventricle MRI- white matter changes suggestive of acute disseminated encephalomyelitis
CDC Split Type:

Write-up: The patient presented at the clinic on 12/19 with complaints of headache, nausea, neck ache, mild left arm numbness and fever. Was diagnosed with a viral syndrome and sent home with symptomatic management. She then presented to the ER on 12/20 with a left-sided hemiparesis and mental status changes. She was admitted and started on antibiotics as well as acyclovir. She was subsequently started on steroids after an MRI showed findings that suggested acute disseminated encephalomyelitis (ADEM). During the course of the day on 12/20, the patient''s status deteriorated as she developed unequal pupils and later required intubation for compromised respiratory status. She then was put on an esmolol drip for tachycardia, but that was stopped when pt became hypotensive on the morning of 12/21. She was then started on dopamine. During this time course, her neurologic status also declined, and on the morning of 12/21, her pupils were fixed and dilated, and patient presented evidence of brain death with no spontaneous respirations and negative cold calorics. Brain death was pronounced on 12/22 after repeat evaluation, and life support was withdrawn. Medical Record received on 1/08/2004 states chills.


VAERS ID: 214640 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2002-09-30
Onset:2003-12-18
   Days after vaccination:444
Submitted: 2003-12-26
   Days after onset:8
Entered: 2004-01-06
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U11374A / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Asthenia, Chest pain, Dyspnoea, Haemoptysis, Hypokinesia, Hypoxia, Lung neoplasm malignant, Pain, Skin disorder
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV/Placebo
Current Illness:
Preexisting Conditions: Lung mass, dyspnea, pleural effusion, + smoker, asthma, COPD.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200303616

Write-up: This subject is a 74 year old female, who died while enrolled in a comparative randomized study of safety and immunogenicity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with Aluminum Phosphate when administered concomitantly with a Licensed Influenza vaccine in High-Risk $g or = 65 years of age. The subject received a dose of RSV vaccine or placebo and influenza vaccine on 9/30/02. The subject died, 444 days post-immunization. The cause of death was not reported. The patient''s has a history of lung mass, dyspnea, pleural effusion, smoking, asthma, and COPD. The death was reported by the investigator as unrelated to the study vaccine. THe death certificate received on 2/3/04 states metastatic lung CA. The medical record received on 2/9/04 states pain, anorexia, blood oxygen decreased, decreased mobility, respiratory distress, weakness, hemoptysis, and chest pain. Additional information received January 12, 2004 death certificate cause of death: metastic lung cancer.


VAERS ID: 232509 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Minnesota  
Vaccinated:2003-12-10
Onset:2003-12-17
   Days after vaccination:7
Submitted: 2005-01-04
   Days after onset:384
Entered: 2005-01-19
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 622B2 / 3 LL / -
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1128AA / 1 RL / -

Administered by: Public       Purchased by: Private
Symptoms: Blindness, Convulsion, Delirium, Developmental delay, Gene mutation identification test positive, Growth retardation, Hypokinesia, Hypotonia, Irritability, Neutropenia, Oral intake reduced, Pyrexia
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-10-12
   Days after onset: 664
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 40 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Cefzil for possible left ear infection.
Current Illness: Left ear slightly pink, possible ear infection Information from medical records state otitis media.
Preexisting Conditions: NONE PMH: leukodystrophy, seizures, leukoencephalopathy, neutropenia.
Allergies:
Diagnostic Lab Data: She has had genetic testing for all known Leukodystrophies multiple times - results negative. Has been tested for any/all diseases and disorders that can cause damage to white matter of the brain - all negative. Information from medical records state neutropeni. 2/5/07 Received labs from ME office which reveal: 8/15/04 unremarkable RBCs; vacuolated monocytes; unremarkable plts. 3/23/05 absolute neutropenia, marked; absolute monocytosis, mild; & apparently normal RBC & plts.
CDC Split Type:

Write-up: Low grade fever and very cranky immediately after vaccination that lasted 7 days. 7 days after vaccination, she started having seizures and was hospitalized. 14 days after vaccination, MRI of head showed diffuse white matter abnormalities. Since then, she has lost all physical abilities. She can not hold her head up, does not eat by mouth (has G-tube), does not smile, lost her sight and has hypotonia. She has been tested for numerous diseases but all test results are negative thus far. White matter of brain is continually decreasing. Information from medical records state developmental delay. Per follow up report-Patient passed away 10-12-05. Gene mutations were found that caused the disease vanishing white matter disease. This disease was triggered by the onset of Influenza within a few days after getting the Influenza vaccine. Although patient would have presented with the symptoms of this disease eventually it is believed that getting the flu vaccine is what triggered the symptoms earlier. 8/10/07 Received Death Certificate which reveals COD as Vanishing White Matter Disease.


VAERS ID: 299262 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: California  
Vaccinated:2003-12-03
Onset:2003-12-06
   Days after vaccination:3
Submitted: 2007-12-11
   Days after onset:1466
Entered: 2007-12-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Asthenia, Chest X-ray abnormal, Death, Haemorrhage, Lethargy, Pain, Pulmonary congestion, Stomach discomfort, Surgery, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-12
   Days after onset: 6
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:
Other Medications:
Current Illness: Diabetes, Arthritis, TIA,Hypertension records received 12/26/07-Reportedly fell two days ago and struck her head.
Preexisting Conditions: Diabetes Mellitus, Arthritis. TIA, Hypertension records received 12/26/07-HX of diabetes, cerebrovascular accident, atrial fibrillation.
Allergies:
Diagnostic Lab Data: The emergency room doctors took x-rays of her lungs and found bleeding areason one side of the lung. It was uncontrollable and they attempted to suction it off first, then called a surgeon in to operate. The surgery was unsuccessfull and she never regained consciousness. records received 12/26/07-INR of 9. CT of head no acute intracranial hemorrhage detected. Pumonary hemorrahge noted on CT.
CDC Split Type:

Write-up: On 12/2 at 10:00am, patient attended an appt w/ Dr. as a follow-up for previous stroke monitoring. The doctor administered a mini-check up and with a series of cognitive exercises. They ended their appt and planned for another follow-up appt. in January or February of 2004. The next day, patient was taken to an 1:30 afternoon appt at her regular physician. She saw him for a brief 10 minutes as he administered a flu innoculation in her upper left arm. On Saturday, 12/6/03, patient started experiencing chest congestion, but was alert and keeping to her normal holiday schedule. On Tuesday, 12/9/03, pateint started experiencing stomache upset, throwing-up, lethargy and aches and pains. She took to her bed. On wednesday eve, 12/10,after not being able to retain any food, soup of liquids, her children got her ready to take to the hospital. On Thursday morn, patientwas alert, coherent, but very weak and her family made attempts to drive her quickly to Emegency Room for treatment. She went downhill and expired the following morning. 12/26/07-records received for DOS 12/11-12/12/03-Final diagnosis:massive hematemesis and or hemoptysis secondary to coumadin. Presented to ED with increased shortness of breath, nausea and hemoptysis. Since then had progressive loss of energy. Increasing confusion and agitation. Nonproductive cough. Intubated and sent to ICU. Unsuccessful bronchoscopy. Upper GI bleeding secondary to coumadin and shocked liver. Massive pulmonary hemorrhage with multiple organ damage and coma. Pupils fixed and dilated, unreactive to light. No babinski. Acute oliguric renal failure most likely secondary to hypoxia. Severe metabolic acidosis with increased anion gap most likely seconary to lactic acidosis, hypokalemia. DOD 12/12/03 at 4:10 p.m. 2/19/08-record received-final cause of death pneumonia. Diabetes Mellitus


VAERS ID: 216434 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: New York  
Vaccinated:2003-10-21
Onset:2003-12-02
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2004-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Angina pectoris, Apnoea, Chest pain, Dyspnoea, Oedema peripheral, Renal failure, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), 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: 2004-02-09
   Days after onset: 69
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: Warfarin, Lasix, Avandia, Monopril, Synthroid, Quinine Sulfate, Valium, Zocor, Vioxx, Toprol, Exelon, Zetia, Norvasc
Current Illness:
Preexisting Conditions: COPD, CHF, CAD, Atrial fibrillation, HTN, Diabetes, Osteoarthritis, hypothyroidism
Allergies:
Diagnostic Lab Data: Cardiac catheterization 10/Dec/2003; Placement hemodialysis - 15/Dec/2003
CDC Split Type: 200303306

Write-up: Initial SAE report received on 08/Dec/2003. Additional information received on 16/Dec/2003. This subject is a 77 year old male, who was admitted to the hospital due to SOB and peripheral edema while enrolled in a study. The subject received a dose of RSV or placebo and flu vaccine on 21/Oct/2003. The subject developed increased SOB and peripheral edema, 42 days post immunization. A CXR confirmed CHF and subject was admitted to ICU the same day, 2/Dec/2003. Subject was transferred to the floor and continued to have burning substernal chest pain and unstable angina. Treatment included a cardiac catheterazation on 10/Dec/2003. Subject developed acute renal failure possible secondary to the dye. A hemodialysis catheter was inserted on 15/Dec/2003 and dialysis was started. The subject''s outcome is ongoing. It is unknown if they continued in the trial. The SOB and peripheral edema was reported by the investigator as unrelated to the study vaccine. Additional information received on 10/Feb/2004. The subject''s spouse informed the investigator that her husband died while in the hospital on 8/Feb/2004. Subject died 68 days after admission to the hospital and 110 days post immunization. Cause of death is unknown at present. Information will be forward when available. The death was reported by the investigator as unrelated to the study vaccine. The hospital discharge summary received on 2/26/04 states respiratory failure and septicema.


VAERS ID: 213214 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Male  
Location: Iowa  
Vaccinated:2003-11-30
Onset:2003-11-30
   Days after vaccination:0
Submitted: 2003-12-01
   Days after onset:1
Entered: 2003-12-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765705 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anaphylactic reaction, Apnoea, Cyanosis, Dyspnoea, Hypotonia, Shock
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Toprol XL
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Anaphylactic reaction and subsequent shock. ACLS Protocol: Epi, Benadryl, Solu-cortef, Atropine, Sod. Bicarb, Cricothyrotomy. The hospital discharge summary received on 1/28/04 states cyanotic, dyspnea, apneic and limpness.


VAERS ID: 214136 (history)  
Form: Version 1.0  
Age: 1.68  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2003-11-24
Onset:2003-11-29
   Days after vaccination:5
Submitted: 2003-12-02
   Days after onset:3
Entered: 2003-12-18
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1088AA / 2 - / -

Administered by: Private       Purchased by: Public
Symptoms: Aspiration, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac; Reglan; Miralax; Omnicef;
Current Illness: Otitis Media; Upper respiratory infection;
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy-report pending, preliminary finding with aspiration
CDC Split Type:

Write-up: Pt discovered dead in bed with vomitus. Autopsy reveal aspiration of formula. Full autopsy report pending. Pt was the product of a preterm 25 week gestation with a birth weight of 1lb 6oz. Her neonatal course was prolonged and complicated by ligation of a patent ductus arteriosus, Broncopulmonary Dysplasia, Gastro-Esophageal Reflux Disorder, Retinopathy of Prematurity status post laser surgery, and a grade 4 intraventricular hemorrhage with severe developmental delay and cerebral palsy. Neonatal hospitalization discharge date = 07/15/2002. Her latest MRI showed a porencephalic cyst. During her NICU course she also lost the tips of her left fingers 2,3,4 and 5 secondary to a PIC line complication. Her developmental issues, constipation and poor weight gain were her most active problems. Her weight gain had improved after starting supplemental Pediasure at 17 months of age. She was seen in our office 11/24/03 for a weight check and incidentally found to have a upper respiratory tract infection and bilateral otitis media. She was afebrile and nontoxic appearing with no wheezing or other adventitious chest sounds at that time. For her otitis media she was prescribed Omnicef. Because she looked well, she also received her second dose of influenza vaccine. She had received her first dose of influenza vaccine on 10/23/2003 w/out incident or adverse reaction.


VAERS ID: 213215 (history)  
Form: Version 1.0  
Age: 0.56  
Sex: Male  
Location: Michigan  
Vaccinated:2003-11-26
Onset:2003-11-27
   Days after vaccination:1
Submitted: 2003-12-01
   Days after onset:4
Entered: 2003-12-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 9610A2 / 3 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1089AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1440 / 3 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493265 / 3 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: 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 (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-27
   Days after onset: 0
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: Joubert Syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: DOA 11/27/03. The autopsy states cardiorespiratory arrest.


VAERS ID: 213221 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Florida  
Vaccinated:2003-11-18
Onset:2003-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2003-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765180 / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: 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 (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Allergy to Iodine; Diabetes Melitus Type 2; Colon Cancer 1998; Early Alzheimer''s
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: An 84 year old male with a past history of diabetes but no other medical problems, no lipid abnormalities and no prior cardiac history. He had a documented allergy to Iodine. This pt had received flu shots in my office every year since 1997. He received his Fluvirin dose this year on 1/18/03. He was found dead at home of a presumed sudden cardiac death on 11/20/03. The death certificate received on 12/3/03 states sudden cardiac death.


VAERS ID: 218510 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Unknown  
Vaccinated:2003-11-16
Onset:2003-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2004-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765855 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cough, Pharyngolaryngeal pain, Pneumonia, Pyrexia, Renal failure acute, Rhinorrhoea, Shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (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: Levaquin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: X-ray: left lower lobe infiltrate
CDC Split Type: PJP200301127

Write-up: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter''s causality assessment. Update 3/22/04: A follow up report was received from a health care professional indicating that the vaccinee experienced a fever of 101.5 degrees F and productive cough one day after receiving Fluvirin on 11/16/03. An x-ray taken on an unspecified date revealed a left lower lob infiltrate. The vaccinee died on 11/26/03. Concomitant medication taken included levofloxacin. Follow up pending. Discharge summary for 04/30/04 states: respiratory failure, pneumonia, acute renal failure, Rhabdomyolysis, shock, sepsis.


VAERS ID: 213643 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Male  
Location: Unknown  
Vaccinated:2003-11-09
Onset:2003-11-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2003-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765855 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Diarrhoea, Dyspnoea, Hypoxia, Nasal congestion, Pharyngolaryngeal pain, Pyrexia, Respiratory rate increased, Rhinorrhoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (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 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-11-18
   Days after onset: 2
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: Ativan, Trazodone, seroquel, atenolol, Lasix, Zantac, Hytrin, Zestril, Asavalproic acid, sinemet 10/100
Current Illness:
Preexisting Conditions: Alzheimers disease; Congestive heart failure; Hypertension; History of ethanol abuse; MI; Dementia with psychosis; Insomnia; Arteriosclerotic heart disease; Anxiety; Respiratory distress (before 31Dec1998)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP200301129

Write-up: A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, sore throat, and was hospitalized and died 8 days after receiving Fluvirin on 11/9/03. On an unspecified date, 2 to 3 days after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. The vaccinee was treated with antibiotics on commencing on 11/13/03. The vaccinee was transferred to hospital on 11/15/03 and subsequently intubated. The vaccinee died on 11/17/03. The cause of death was not reported. There was insufficient information to determine the reporter''s causality assessment. Follow up pending. Follow up on 12/10/2003: "Update 1, 11/26/03: A follow up report was received from a health care professional indicating that an 84 year old male vaccinee experienced respiratory failure 8 days after, with mild cough, vomiting, fever of 100 degrees F, occurring 4 days after receiving Fluvirin, and diarrhea occuring an unspecified length of time after vaccination. The vaccinee has a history of respiratory distress, Alzheimer''s disease, congestive heart failure, hypertension, alcohol abuse and dementia with psychosis since 12/31/1998. The vaccinee also has a history of MI, arteriosclerotic heart disease, anxiety and insomnia from an unspecified date. Concomitant medication taken included lorazepam, trazodone, quetiapine, atenolol, furosemide, and ranitidine hydrochloride. On 11/13/03 the vaccinee experienced a mild cough with congestion, vomiting and a fever of 100 degrees F. The vaccinee also experienced diarrhea on an unspecified date. The vaccinee was treated with levofloxacin on 11/31/03. At this point the vaccinee''s respiration was rapid. The vaccinee was admitted to hospital on 11/15/03 and on an unknown date was placed on a ventilator. On 11/17/03 the vaccinee died due to respiratory failure. A post mortem report is not available. "Update 2, 18February2004": A follow up report was received from a healthcare professional indicating that the vaccinee had received Fluvirin on 10 November 2003 and not on 9 November 2003 as previously reported. The vaccinee received Influenza vaccine (brand unspecified) previously on 25 November 2002. Additional concomitant medication included terazosin hydrochloride and lisinopril. The reporter indicated that the vaccinee had a history of respiratory distress, congestive heart failure, hypertension, myocardial infarction, moderate pulmonary hypertension and bi-ventricular failure prior to 31 December 1998. In addition to the events reported previously the reporter indicated that the vaccinee was also feeling week and lethargic on 13 November 2003. The reporter also indicated that the vaccinee died from respiratory collapse on 18 November 2003 and not on 17 November 2003 as previously reported. "Update 3, 27 April 2004": A follow up report was received from a health care professional indicating that the vaccinee had received Fluvirin on 9 November 2003 as initially reported. The vaccinee had received a prior influenza vaccination on an unspecified date in November 2002. Additional concomitant medications reported included acetylonlicylic acid, valproic acid and levodopa in combination with carbidopa. The vaccinee also has a history of severe tricupsid regurgitation before 31 December 1998, and Parkinson''s disease. The reporter indicated that the vaccinee was treated with levofloxacin and quoifenesin after 3 days with no improvement. The vaccinee was also treated with paracetonol for fever. The vaccinee''s level of consciousness began to decrease and the vaccinee was experiencing shortness of breath. The vaccinee was treated with oxygen. The vaccinee was admitted to the hospital on 15 November 2003, where he was on a ventilator which was removed 2 days later. The vaccinee died on 18 November 1003. No follow up pending, all information received. Cross reference with: PJP-2003-01118, PJP-2003-01119, PJP-2003-01120, PJP-2003-01121, PJP-2003-01122, PJP-2003-01123, PJP-2003-01124, PJP-2003-01125, PJP-2003-01126, PJP-2003-01127, PJP-2003-01128, PJP-2003-01117."


VAERS ID: 212767 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2003-10-22
Onset:2003-11-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2003-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Circulatory collapse, Laboratory test abnormal
SMQs:, Anaphylactic reaction (narrow), 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), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bumez; Zaroxolyn; Coreg; Zocor; Zestril; Bufferin; Salsalate; Doxycycline; Milk of Magnesia; Dimetapp; Albuterol, Atrovent; Zocor; Lasix; Lanoxin; K-lor; Colace; ASA; Toprol; Amoxicillin; Antivert; Hydrodiuril; Lortab; Quinine; Pepcid; Ativ
Current Illness:
Preexisting Conditions: CHF, bronchitis, COPD, leg cramps, gout, acute renal failure. Information from previous hospital admissions. Admission February 19-23/2003. Subject was admitted for bilateral knee replacement 96 days post-immunization. Reported labs were as follows: postop day one-PCV 35.9, INR 1.27, BUN 50 and creatinine 1.7. Day two INR was 2.41. Day three urine output was 550cc in 8 hrs, BUN 54, creatinine 1.8, PCV 34.8 and INR 2.55. He also had 1+ pitting pedal edema. Post operative day four room air sat was 93% and INR was 2.22. Treatment post surgery included infusion of two units packed red blood cells. The subject recovered and was discharged on 2/23/03 and continued in the trial. The event of bilateral knee replacement surgery was reported by the investigator as unrelated to the study vaccine. Past medical history includes use of quad cane for ambulation, arthritis, leg cramps, gout, COPD, renal insufficiency, HTN, CHF with cardiomyopathy, hyper cholesterolemia, obesity, rotator cuff tear, back surgery and chronic bronchitis. Past radiography demonstrated advanced arthritis in both knees. Concurrent medications include Bufferin, SAlmalate, Doxycycline, milk of Magnesia, Dimetapp, Albuterol, Atrovent, Zocor, Lasix, Zestril, Lanoxin, K-Lor, Colace, ASA, Toprol, Amoxicillin, Antivert, Hydrodiuril, Lortab, Quinine, Pepcid, Ativan, Colchicine, vitamin E, One a day multi vitamin, Selenium, Lorazepam and Bextra. Admission 6/25-27-2003. Over the last two months the subject experienced intermittent severe dyspnea, peripheral edema and paroxysmal nocturnal dyspnea which became progressively worse and on 3/25/03, 223 days post immunization he was admitted to the hospital. Subject underwent a right heart catheterization on the day of admission and was found to have a right atrial pressure of 16 and a wedge pressure of 25. Subject was aggrressively diuresed with IV Lasix with symptomatic improvement and was discharged from hospital 2 days later on 6/27/03. The event was assessed by the investigator as unrelated to the study vaccine. Previous history: Diagnosed with dialated cardiomyopathy in 1992. In 1995, the ejection fraction was 15% to 25%. He underwent cardiac catheterization in February 1999, and was found to have an ejection fraction of 20% and no significant coronary disease. Over the last two years, he had intermittent severe dyspnea and peripheral edema. Admission 7/10-13/03. Subject was admitted 238 days post immunization for congestive heart failure and acute renal insufficiency. This subject had been admitted approximately two weeks prior secondary to volume overload, was diuresed and sent home on Bumex and Zaroxolyn of which the pt took both q.d. Despite previous advised to take Zaroxolyn on a prn basis per his weight. During this time he had also been on escalated doses of Neurontin for his peripheral neuropathy. Just prior to be being admitted his dose was 3600mg q.d. He presented at the clinic for evaluation with a one week history of increasing fatigue, sleepiness, increasing tremor and shakiness, difficulty walking, swelling in his feet bilaterally. It was felt he had Neurontin toxocity. Subject had his Neurontin held and neurological symptoms improved. Routine labs demonstrated that his initial creatinine was 4.0 with a BUN of 137 and a potassium of 5.4 indicating acute renal insufficiency likely secondary to volume depletion and he had become toxic on his Neurontin doses. A renal ultrasound was obtained which was normal. Post multiple 500cc fluid boluses, his renal function returned to his baseline. At the time of discharge he was reinstituted on his ACE inhabitor and beta-blocker, continued on Digoxin, Zocor and his diuretic was changed to Bumex 3mg p.d. without Zaroxolyn. He was placed on fluid restriction for his peripheral neuropathy, which he continued to complain about. He was started on Elavil at 25mg p.o q.d. Medications Bumex 2mg p.o. q.d., potassium chloride 30mEq p.o. q.d., Zestril 5mg p.o. bid, Lanoxin 0.25mg p.o. q.d., Metoprolol extended release 50mg p.o. q.d., sublingual Nitroglycerin prn., Zocor 4mg p.o. q.d., Enteric coated aspirin 325mg p.o. q.d., Pepcid 20mg p.o. bid, vitamin E and C q.d., Elavil 25mg p.o. q.d. Albuterol and Atrovent metered-dose inhalers. Subject was discharged 3 days later on 7/13/03. The event was assessed by the investigator as unrelated to the study vaccine.
Allergies:
Diagnostic Lab Data: Admission: 2/19-23/2003. Reported labs were as follows: postop day one-PCV 35.9, INR 1.27, BUN 50 and creatinine 1.7. Day two INR was 2.41. Day 2: BUN 54, creatinine 1.8, PCV 34.8 and INR 2.55. Post operative day four room air sat was 93% and INR was 2.22. Admission on July 10-13/2003. Creatinine 4.0 BUN 137, potassium 5.4. Post treatment: creatinine 1.2, BUN 71.
CDC Split Type: 200302974

Write-up: This subject is a 66 year old male who was taken to the emergency dept after collapsing in his home while enrolled in RSV11 study. The subject received his second dose of RSV vaccine or Placebo and influenza vaccine on 10/22/03. Subject collapsed at home on 11/12, 21 days post immunization. Subject''s wife and stepson attempted CPR. An ambulance was called and subject was taken to the emergency dept. There was little EKG activity on arrival and subject died in the ER on 11/12/03. Cause of death was not reported. The death was reported by the investigator as not related to the study vaccine. Follow up on 12/16/2003: "Additonal information received 12/01/2003, CIF and ER report. CIF: Cause of death-cardiac arrest w/secondary underlying cardiac disease. Additional information received 12/03/2003. Subject attempted to get out chair at home in the AM of 11/12/2003, and collapsed, hit a wall and landed on the cough. EMS notified and responded. Subject in asystole, CPR was started, IV fluids, intubated and sent to ER for further management, but remained asystole. Cause of death, cardiac arrest with secondary underlying cardiac disease. The cardiac arrest with secondary underlying cardiac disease was assessed by the investigator as unrelated to the study vaccine. Additonal information available with source documents. ER report


VAERS ID: 212170 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Indiana  
Vaccinated:2003-11-07
Onset:2003-11-08
   Days after vaccination:1
Submitted: 2003-11-11
   Days after onset:3
Entered: 2003-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765797 / 4 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coronary artery atherosclerosis
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Insulin Oral diabetic agents Calcium Channel blocker?
Current Illness: None reported
Preexisting Conditions: Diabetes Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient expired 11/9/03 Cause of death following autopsy: Fatal Heart Disease (Athero- sclerotic heart disease) Fatal Arrythmia Diabetic Related


VAERS ID: 214073 (history)  
Form: Version 1.0  
Age: 65.0  
Sex: Female  
Location: New York  
Vaccinated:2003-10-28
Onset:2003-11-08
   Days after vaccination:11
Submitted: 2003-12-14
   Days after onset:36
Entered: 2003-12-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1124AA / UNK RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chills, Depressed level of consciousness, Dyspnoea, Erythema, Hypoxia, Peripheral vascular disorder, Pyrexia, Sepsis
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (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), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-09
   Days after onset: 1
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:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Cardiomegaly; Obesity
Allergies:
Diagnostic Lab Data: LP, CSF culture; Blood culture; Urine culture; Blood culture grew gram positive cocci in pairs and chains. Diagnosis - TSS. Cause of death - Sepsis.
CDC Split Type:

Write-up: Patient admitted to hospital on 11/8/03 (8:39 PM). Patient presented with fever (105), generalized erythema, chills, SOB, semi-conscious state. Patient also hypoxic and had ischemia on fingers. Patient was intubated.


VAERS ID: 218724 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2003-11-03
Onset:2003-11-06
   Days after vaccination:3
Submitted: 2004-04-06
   Days after onset:151
Entered: 2004-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLU-IMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Public       Purchased by: Unknown
Symptoms: Asthenia, Cardiac failure congestive, Myocardial infarction, Pain
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: BRONCHITIS
Preexisting Conditions: MECHANICAL HEART VALVES DUE TO RHUEMATIC FEVER AS A CHILD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: FLU VACINE GIVEN ON NOV.6, 2003. PATIENT HAD TWO MECHANICAL HEART VALVES. WAS ON AN ANTIBIOTIC AT THE TIME THE VACCINE WAS GIVEN. FOUR DAYS LATER WENT INTO CONGESTIVE HEART FAILURE. HOSPITALIZED FOR 4 DAYS. CONTINUED TO GET WEAKER OVER THE LAST THREE MONTHS. LEG PAINS, WEAKNESS. PATIENT PAST AWAY MARCH 16TH 2004. SEEMED TO BE IN GOOD HEALTH UNTIL THE VACCINE. CARDIOLOGIST FEELS ONE OF THE VALVES FAILED. I BELIEVE THE FLU VACCINE IS WHAT THE PROBLEM WAS. Per death certificate, cause of death was acute MI valvular disorder.


VAERS ID: 211550 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: New York  
Vaccinated:2003-10-15
Onset:2003-10-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2003-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1137HA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Herpes zoster
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Norflex, Aspirin, Diltiazem, Zocor, Vioxx, folic acid, Actonel, Prednisone, Nystatin
Current Illness:
Preexisting Conditions: COPD, pulmonary fibrosis-end stage-diagnosed 6/2003. Angioplasty and stent 2001.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302804

Write-up: This subject is a 72 year old male who died while enrolled in the RSV11 study. Subject received RSV vaccine or Placebo and influenza vaccine on 10/15/2003. The subject developed shingles 10/19/03, 4 days post immunization and 7 days later, on 10/26/03 he had increasing shortness of breath and died while on the way to the hospital. The death was reported by the investigator as possibly related to the study vaccine. Follow up on 12/10/03: "Additional info received 12/01/03. Death cert received with the date of death being 10/28/03 not 10/26/03 as stated in the initial report . Cause of death was CHF w/approximate interval of 2 weeks between onset and death. Due to or as a consequence of CAD w/appropriate interval of years between onset and death. Due to or as a consequence of Idiopathic Pulmonary Fibrosis w/approximate interval of months between onset and death." Follow up on 02/09/04: "The causality has been changed by the investigator from possible relationship to "unrelated"."


VAERS ID: 216653 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2002-10-17
Onset:2003-10-26
   Days after vaccination:374
Submitted: 0000-00-00
Entered: 2004-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration, Bursitis, Cardiac arrest, Cellulitis, Choking, Hypoxia, Lung disorder, Respiratory arrest, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paxil; Klonopin; Risperdal; Glyburide; K-Dur; Prinivil; Norvasc; Pepcid; Imdur; Lasix; Glucophage; Lanoxin; Uniphyl; Albuterol
Current Illness:
Preexisting Conditions: Emphysema; COPD; Chronic Ischemic Heart Disease; Hypertension; Diabetes. Information from the patient''s previous SAE and hospitalizations. On November 7, 2002, the subject noticed a lump in her right breast 21 days post immunization and 96 days later was diagnosed with breast cancer. Subject had a mammogram and ultrasound. Pathology results showed infiltrating ductal carcinoma, class 4. There is no family history of breast cancer. Patient was not hospitalized. Event was assessed as life threatening. History- on home oxygen. Past surgical history: Hysterectomy, tonsillectomy and appendectomy. Allergies: Penicillin. First hospitalization occured 163 days post immunization on March 28, 2003. She had a right sentinel node axillary dissection and lumpectomy. On postoperative day #1, she complained of shortness of breath. Pulmonary was consulted. Her dressing were clean and dry. Her hemoglobin was stable. On postoperative day #2, her vital signs remained stable. Jackson-Pratt drains had minimal drainage. She was seen by the doctor and placed on Decadron. Post op complications included acuter exaberation COPD, bronchitis and metabolic encephalopathy. Subject recovered with residual effects and was discharged 7 days later on April 4, 2003. Second hospitalization occured 358 days post immunization on October 10, 2003 for cellulitis of her elbow and was discharged 6 days later on October 16, 2003.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302775

Write-up: This is a 71 year old female died after a respiratory arrest secondary to aspiration while enrolled in RSV 11 vaccine study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/17/02. The subject died 374 days post immunization on 10/26/03 after choking on some food and aspirating. She was intubated, but did not recover. The aspiration and respiratory arrest were reported by the investigator as unrelated to the study vaccine. Additional information received on 2/13/04. After several attempts, the investigator is unable to obtain a death certificate. The ER record received on 2/26/04 states syncope and cardiac arrest. The discharge summary received on 2/26/04 states cellulitis of R elbow, infected bursitis, and severe COPD.


VAERS ID: 211692 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Female  
Location: Missouri  
Vaccinated:2003-10-14
Onset:2003-10-23
   Days after vaccination:9
Submitted: 2003-11-04
   Days after onset:12
Entered: 2003-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1255AA / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-31
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Type 2 Diabetes, COPD, Hypertension, Hyperlipidemia, Peripheral Vascular Disease, TIA, osteoarthritis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Guillain-Barre Syndrome. The hospital discharge summary received on 12/15/03 states apnea/respiratory failure.


VAERS ID: 211721 (history)  
Form: Version 1.0  
Age: 1.28  
Sex: Female  
Location: Missouri  
Vaccinated:2003-10-21
Onset:2003-10-22
   Days after vaccination:1
Submitted: 2003-11-04
   Days after onset:13
Entered: 2003-11-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 616A2 / 4 LL / IM
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4020017 / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 494759 / 4 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Bacterial infection, Cholangitis, Grunting, Laboratory test abnormal, Pyrexia, Sepsis, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Infectious biliary disorders (narrow), Biliary tract disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-10-23
   Days after onset: 1
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:
Other Medications: Norvase; Vasotec; Lasix
Current Illness:
Preexisting Conditions: Polycystic Kidney Disease; Hypertension; Previous E. Coli bacteremia
Allergies:
Diagnostic Lab Data: Blood cultures; Autopsy report; Pseudomonas sepsis (possible infected liver cyst).
CDC Split Type:

Write-up: Fever day after immunization. Gone that night, but then developed moaning and grunting. Went to ER; looked shocky and then arrested. Died several hours later despite repeated resuscitation efforts. The autopsy received on 11/11/03 states pseudomomas sepsis. The autopsy report received on 2/4/04 states shock and cholangitis.


VAERS ID: 216741 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Iowa  
Vaccinated:2003-10-22
Onset:2003-10-22
   Days after vaccination:0
Submitted: 2004-02-12
   Days after onset:113
Entered: 2004-02-24
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1079AA / UNK RA / -

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Cardiac arrest, Respiratory arrest
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), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-22
   Days after onset: 0
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: COPD, HTN, ASHD
Allergies:
Diagnostic Lab Data:
CDC Split Type: IA03016

Write-up: Pt received a yearly influenza vaccination. Pt received this years flu shot at the pharmacy. Pt was taken to ER by ambulance. Death certificate states "anaphylaxis, respiratory and cardiac arrest, influenza vaccination." Body released to funeral home no autopsy.


VAERS ID: 213220 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Florida  
Vaccinated:2003-10-02
Onset:2003-10-20
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2003-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765180 / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Arrhythmia, 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 (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HCTZ; KCL
Current Illness: NONE
Preexisting Conditions: Hypertension; Hypercholesterolemia; Allergy to PCN
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: A 68 year old female with a past history of hypertension and hypercholesterolemia but no prior cardiac history. She had a documented allergy to PCN. She had also received flu vaccine in my office in 2001 and in 2002. She received her Fluvirin dose on 10/02/03. The pt was found dead at home of a presumed sudden cardiac death on 10/20/03. The death certificate received on 12/3/03 states cardiac arrhythmia and cardiac arrest.


VAERS ID: 211044 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: California  
Vaccinated:2003-10-17
Onset:2003-10-19
   Days after vaccination:2
Submitted: 2003-10-23
   Days after onset:4
Entered: 2003-10-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1260AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-19
   Days after onset: 0
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: Hypertension, hyperlipidemia, osteoarthritis, spinal stenosis, acromegaly and Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302675

Write-up: From initial info received on 10/22/03, from a health care professional, regarding a death occurring, it was reported that a 79 year old female pt died of a "heart attack" on 10/19/03, two days after receiving a dose of Fluzone SV ''2003-''2004, lot number U1260AA, given IM in the left deltoid on 10/17/03. The reporter stated that the case of death indicated on the death certificate was cardiac arrest. A 15-day follow up report received 11/04/2003 adds: From additional info obtained on 10/27/2003, from a telephone conversation with the reporter, it was stated that the responsible physician is waiting for follow-up documents. The reporter also stated that she was not sure if there will be an autopsy report and that they had not yet received any hospital records or test results. The correct spelling of the responsible physician''s last name was also provided. A 15-day follow up report received 11/13/2003 adds: From additional info received on 11/06/2003 from faxed correspondence from the reporter, it was reported that the pt had pre-existing conditions of hypertension, hyperlipidemia, osteoarthritis, spinal stenosis, acromegaly and Parkinson''s disease. The pt received the influenza vaccine on 10/17/2003 and expired on 10/19/2003 at 9:31 AM. Per the reporter, the pt''s death was not caused by the vaccine. The death certificate was also provided and the "immediate cause" of death was listed as cardiac arrest . Both hypertension and hyperlipidemia were listed as "underlying cause". No other info was reported. Case is closed.


VAERS ID: 211829 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2002-10-31
Onset:2003-10-19
   Days after vaccination:353
Submitted: 0000-00-00
Entered: 2003-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Choking, Dyspnoea, Pulse absent
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Imdur; Buspar; Mobic; ASA; Protonix; Pulmicort; Norvasc; Astelin; Atrovent; Advair; Cardura
Current Illness:
Preexisting Conditions: Angina; Asthma; GERD; Anxiety; BPH; HTN: Arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302580

Write-up: This subject is a 82 year old male who died from a choking episode while enrolled in RSV 11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/31/2002. The subject died 353 days post immunization on 10/19/03. The subject choked on some food and 911 was called. Subject was taken to the hospital and pronounced dead on arrival. The subject''s death was reported by the Investigator as unrelated to the study vaccine. A 15-day follow up report received 11/13/2003 adds: Additional info received on 11/3/03: Diagnosis: Cardiac arrest. According to discharge summary, pt was gasping for air more than choking. When intubated by the paramedics they did not see any food obstructing his airway. Resuscitation attempted in ER, but arrived there pulseless and remained pulseless. Family reported pt complained of intermittent chest pain over the past week. Etiology suspected arrythmia related. Cause of death: Cardiac arrest/pulseless electrical activity/idioventricular rhythm. Additional documents available with source file: ER note: 10/19/2003.


VAERS ID: 213824 (history)  
Form: Version 1.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2003-10-13
Onset:2003-10-18
   Days after vaccination:5
Submitted: 2003-12-04
   Days after onset:47
Entered: 2003-12-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-16
   Days after onset: 2
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: Cyanocobalamin; Folic acid
Current Illness:
Preexisting Conditions: Folate deficiency; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0311USA02895

Write-up: Information has been received from a health authority concerning a 97 year old male with a folate and Vitamin B12 deficiency who on 10/13/03 was vaccinated IM with a dose of pneumococcal 23v polysacchardie vaccine. On 10/13/03 the patient was also vaccinated IM with a dose of influenza virus sAg 3v vaccine inactivated. Concomitant therapy included IV cyanocobalamin for his Vitamin B12 deficiency and oral folic acid for his folate deficiency. On 10/16/03 the patient was seen by his physician with proximal progressive muscle weakness. The patient was hospitalized and diagnosed with GBS. On 10/18/03 the patient died. The probable cause of death was reported as GBS. A post-mortem had not been performed. Additional information is not expected. The case is considered to be closed.


VAERS ID: 211535 (history)  
Form: Version 1.0  
Age: 59.0  
Sex: Male  
Location: New York  
Vaccinated:2003-10-15
Onset:2003-10-15
   Days after vaccination:0
Submitted: 2003-10-29
   Days after onset:14
Entered: 2003-11-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765874 / UNK LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1212M / UNK RA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1001AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory arrest, Coronary artery disease
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 (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hyzaar, Advair
Current Illness: NONE
Preexisting Conditions: HTN, probable emphysema
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Death approx 6 to 7 hrs after vaccine administration. The death certificate state cardiopulmonary arrest and CAD.


VAERS ID: 213219 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: Florida  
Vaccinated:2003-10-10
Onset:2003-10-15
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2003-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765180 / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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 (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bextra; Glucotrol; Metformin; Zesteretic; Felodipine
Current Illness: NONE
Preexisting Conditions: Hypertension; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: An 82 year old male with past history of hypertension and diabetes but no prior cardiac history. He had no previous documented allergies. He had previously received flu vaccine in my office in 2001 and in 2002. He received the Fluvirin on 10/10/03. He was found at home expired with a presumed sudden cardiac death on 10/15/03. The death certificate received on 12/3/03 states cardiac arrhythmia and myocardial infarction.


VAERS ID: 237654 (history)  
Form: Version 1.0  
Age: 38.0  
Sex: Female  
Location: Ohio  
Vaccinated:2003-10-01
Onset:2003-10-15
   Days after vaccination:14
Submitted: 2005-05-17
   Days after onset:580
Entered: 2005-05-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1081AA / UNK LA / -

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Condition aggravated, Convulsion, Encephalopathy, Guillain-Barre syndrome, Hypokinesia, Laboratory test abnormal, Neuropathy, Pulmonary embolism, Urinary tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (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: 2003-11-21
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 25 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Seizure disorder: UTI
Preexisting Conditions: NKDA, MR , seizure disorder, obesity
Allergies:
Diagnostic Lab Data: Albumin 33.6% 1.78g/dL; Alpha 1 9.6% 0.51g/dl; Alpha 2 14.9% 0.79g/dL; Beta 11.9% 0.63g/dl; Gamma 30.0% 1.59g/dl. Subacute progressive axonal neuropathy, Guillain Barre
CDC Split Type:

Write-up: 10/05/2003 admitted for UTI, 10/7/03 home (not related). 10/15/03 admitted loss of mobility, 10/23/03 home. 10/28/03 ER UTI, vomiting, home. 11/6/03 Vomiting, weakness admit, died 11/21/03.


VAERS ID: 210423 (history)  
Form: Version 1.0  
Age: 58.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2003-10-08
Onset:2003-10-09
   Days after vaccination:1
Submitted: 2003-10-14
   Days after onset:5
Entered: 2003-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 765705 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiovascular disorder, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: lisinopril
Current Illness: none
Preexisting Conditions: hypertension h/o pneumonia diet controlled diabetes smoker
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: patient came into clinic 10/8 for follow up of hypertension, diabetes. No symptoms reported. Agreed to take influenza vaccine. Medical resident who saw her was call by the medical examiner the next day. she was found dead in bed by family. Apparently c/o soreness at injection site; no other symptoms. Medical examiner signed case out as hypertensive cardiovascular disease, but only did external exam, not full autopsy. The autopsy states hypertensive cardiovascular dx.


VAERS ID: 210764 (history)  
Form: Version 1.0  
Age: 0.78  
Sex: Female  
Location: California  
Vaccinated:2003-10-07
Onset:2003-10-08
   Days after vaccination:1
Submitted: 2003-10-20
   Days after onset:12
Entered: 2003-10-22
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UI078AA / 1 RL / IM

Administered by: Private       Purchased by: Other
Symptoms: Cardiac arrest, Lung disorder, 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 (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), 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: 2003-10-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Lasix; Pulmicort; KCL; Iron
Current Illness: NONE
Preexisting Conditions: Chronic lung disease; Recurrent pneumonia; Microcephaly; Developmental delay
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received influenza .25cc on 10/7/03 and also received Synagis same day. No illness/fever reported. Patient put to bed; last checked at 3AM 10/08. Found dead in crib on 10/8 about 9 AM. No autopsy done. Hospital discharge summary received on 11/21/03 states cardiopulmonary arrest. Death Certificate received on 10/29/2003 states pneumonia and chronic lung disease.


VAERS ID: 212685 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Texas  
Vaccinated:2003-09-30
Onset:2003-10-08
   Days after vaccination:8
Submitted: 2004-03-05
   Days after onset:149
Entered: 2003-11-20
   Days after submission:106
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / 1 - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 5452460029N / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Abscess, Apnoea, Cardiac valve disease, Chills, Confusional state, Cough, Cyanosis, Diarrhoea, Endocarditis, Hyperhidrosis, Neck pain, Pharyngolaryngeal pain, Pneumonia, Pyrexia, Renal failure, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-10-09
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Coumadin Lipito aspirin acetaminophen
Current Illness:
Preexisting Conditions: Coronary bypass surgery; Aortic valve replacement; Lumbar vertebral fracture; Aortic aneurysm; Cardiac murmur; Haemorrhoids; Smoker; Iodine allergy; Hyperlipidaemia; social alcohol drinker; hearing loss
Allergies:
Diagnostic Lab Data: Blood pressure 10/8/03, little low, Blood pressure, 10/9/03, 91 7:37AM, Blood pressure, 10/9/03, 101 8:25AM, Diagnostic laboratory, 10/8/03 normal, Chest x-ray 10/8/03 normal, Blood pressure 10/09/03, 80 10:41AM. Body temp 10/8/03 fever, Complete blood cell 10/8/03 unknown. INR, 06/23/03, 2.3 Prothrombin time, 06/23/03, 24.4 seonds 12.2-14.8 High Serum alanine, 05/12/03, 42U/L, 21-72 SCPT Serum creatinine, 05/12/03, 1.0mg/dL, 0.5-1.5 Serum cholesterol/HDL-C, 05/12/2003, 2.9, 1.7-6.7 Low Serum cholesterol, 5/12/03, 150mg/dL, 120-200 Serum chloride, 05/12/03, 103mmol, 98-110 Serum calcium, 05/12/03, 9.4mg/dL, 8.4-10.2 Serum blood urea, 05/12/03, 15mg/dL, 9-20 Serum aspartate, 05/12/03, 37U/L, 15-46, GOT Serum alkaline, 05/12/03, 92U/L, 38-126 Serum albumin, 05/12/03, 3.7g/dL, 3.6-5.0 Total serum protein, 05/12/02, 7.2g/dL, 6.3-8.2 Total serum carbon, 05/12/03, 30mmol, 22-32 Total serum bilirubin, 05/12/03, 0.8mg/dL, 0.2-1.3 Temperature measurement, 10/9/03, 96, 7:37AM Serum VLDL-C, 05/12/03, 11mg/dL, 5-51 Serum triglyceride, 05/12/03, 55mg/dL, 40-160 Serum sodium, 05/12/03, 137mmol, 137-145 Serum prostate specific, 05/12/03, 1.66ng/mL, 0.0-4.0 Serum potassium, 05/12/03, 4.4mmol, 3.5-5.3 Serum LDL-C calculated, 05/12,03, 87mg/dL, 0-135 Serum HDL-C, 05/12/03, 52mg/dL, 30-90 Serum glucose, 05/12/03, 85mg/dL, 75-115 Serum glucose, 05/12/03, 85mg/dL, 75-110 PT control, 06/23/2003, 13.5 second Serum direct bilirubin, 05/12/03, 0.1mg/dL, 0.0-0.5 Body temp, 10/08/2003, afebrile; normal Body temp, 10/07/03, 103 Blood drug screen, 10/02/03, 3.3, Coumadin level Body temp, 10/08/03, fever Blood glucose, 10/08/03, 104
CDC Split Type: WAES0311USA00578

Write-up: Information has been received from a health professional and a physician concerning a 61 year old male with a history of coronary bypass surgery who on 9/30/03 was vaccinated with a dose of penumococcal 23v polysaccharide vaccine (645246/0029N). Concomitant therapy included influenza virus vaccine and Coumadin. For several days after the vaccine the pt had a fever and chills. On 10/8/03 the pt was brought to the ER with chills, sweats and a fever. The report indicated that they "did tests." It was also reported that he had a chest x-ray and CBC and was given an injection of Rocephin and Phenergan. He was diagnosed with mild renal failure. He was discharged with a prescription for Keflex and went home. The next day, on 10/9/03, the pt died of pneumonia. The reporter expressed a concern with the lot. There was no product quality complaint involved. Pneumonia was considered to be immediately life-threatening and disabling. Additional info has been requested. The autopsy report states septic endocarditis. Follow up on 12/04/03: "The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information from a physician and medical records indicated that the pt had open heart surgery on 23Dec2002 which consisted of one by-pass and a valve replacement. It was reported that the operation went well and the pt had a remarkable recovery. He first had a heart murmur which felt to be benign. He followed up with his primary who ordered an echodardiogram and the problem with his heart valve was discovered. He was sent for a cardiac cathaterization and they recommended immediate replacement of his aortic valve together with a repair of the aneurysm. On 30Sep2003 the pt was seen by a physician and reported to be in good health, and would probably live to be 100. His physical exam was negative at that time. That day he received te pneumococcal 23v polysaccharide vaccine and the influenza virus vaccine. On 02Oct2003 the pt had his monthly labwork done for a a warfarin sodium level. The result was 3.3 and he was instructed to stay on the same dose. On 04Oct2003 the pt was feeling a bit under a the weather, was coughing and did not act up to par. On 05Oct2003 the pt felt the same way, but he had a slight cough and was hoarse. By 07Oct2003 the pt began to run a temperature of 103 and was having uncontrollable chills, sweating, vomiting and diarrhea. The symptoms were only temporary and he took acetaminophen which broke the fever. He had a good appetite and was eating three meals a day. On 08Oct2003 the pt felt good, but had a bout with uncontrollable chills and reported that he was so cold he couldn''t get warm. He took two acetaminophen and felt better, but later had the sweating, vomiting and diarrhea. At 8:30PM he was again having uncontrollable chills and the lobes of his ears looked blue. He was not running a temperature. He was seen in the ER and was told he had symptoms of pneumonia. His temperature was normal and his blood pressure was a little low. He was told by a physician that this was because he was sick. A chest x-ray and bloodwork were done and were reported to be normal, however his blood sugar was 184. He was told that this may make him a little confused. His wife reported that he was confused after taking it. It was reported that the doctor also ordered an injection of something for nausea and an injection of an antibiotic. The pt''s wife was assured by the nurse that these medications would not interact with anything the pt was currently taking. He was given IV to replace body fluids since his blood presure was low. While he was on the IV he had to go to the bathroom with diarrhea and vomiting. It was reported that he was very weak and almost fell off the commode. The pt was released from the ER with a diagnosis of a viral infection and was given prescriptions for dicyclomin hydrochloride 10mg capsule, cephalexia 500mg capsule and diphen/atrop 2.5mg tablet. It was reported that he rested well that night, but did a lot of night sweating. He felt better than the day before, but was still experiencing diarrhea and vomiting. ON 09Oct03 at 7:37AM the pt''s blood pressure was 91-56-117 and his temperature was 96. He tried to eat and drink and his blood pressure at 8:25 was up to 101-54-112. The pt indicated that he would be ok so his wife left the house. She found him at 10:30AM sitting on the floor. He had gotten up to go to the bathroom, but felt sick so he sat there to vomit in the trash can. His wife put him in bed, he took his medications and drank some water and reported that his throat burned. At 10:41AM his blood pressure was 80-44-68 and his nails were blue so the pt''s wife called 911. The pt reported that his neck hurt, so his wife removed pillows and the pt turned his head and stopped breathing. The wife started CPR. With no reponse after a few minutes, she ran out and screamed to a neighbor. The neighbors gave CPR until the ambulence arrived. The pt was taken to the ER where the family was told the pt passed away. An autopsy was performed and the cause of death was listed as septic paravalvular leak due to dehiscence of prosthetic aortic valve due to prosthetic valve endocarditis with ring abscess. The death was reported as natural. Pneumonia, sepsis, endocarditis, abscess and leakage were considered to be immediately life-threatening and disabling. Additional information is not expected."


VAERS ID: 210048 (history)  
Form: Version 1.0  
Age: 56.0  
Sex: Male  
Location: Washington  
Vaccinated:2003-10-02
Onset:2003-10-02
   Days after vaccination:0
Submitted: 2003-10-06
   Days after onset:4
Entered: 2003-10-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1093AA / UNK RA / -

Administered by: Private       Purchased by: Public
Symptoms: Difficulty in walking, Dizziness, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-05
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Site redness~Influenza (Seasonal) (Fluzone)~~54.00~In Patient
Other Medications: Tegretol; Cough medicine; Phenobarbital; Dilantin
Current Illness: NONE
Preexisting Conditions: Severe mental handicap; Obesity; Seizure disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10/02 vaccine administered. 10/02 Evening: patient began running fever. 10/03 Patient unable to walk due to dizziness; dyspnea on and off since 10/02. 10/05 Mother thought bloated; gave suppository and he died.


VAERS ID: 210188 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2003-10-02
Onset:2003-10-02
   Days after vaccination:0
Submitted: 2003-10-03
   Days after onset:1
Entered: 2003-10-08
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1271AA / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Nausea, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-04
   Days after onset: 2
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: cancer, severe anemia
Preexisting Conditions: see 18
Allergies:
Diagnostic Lab Data: na
CDC Split Type: MS 03 077

Write-up: Wife called clinic 10/03/03. Reports 2 and half hours after flu vaccine patient c/o, n/v, bpv. Symptoms not improved next day, instructed patient to see PMD ASAP. Patient went to hospital from residence 10/4/03 via ambulence, expired that night.


VAERS ID: 211160 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Washington  
Vaccinated:2002-10-22
Onset:2003-09-29
   Days after vaccination:342
Submitted: 0000-00-00
Entered: 2003-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Coma, Condition aggravated, Deep vein thrombosis, Fluid overload, Mental impairment, Pulse absent
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RSV/Placebo, Allopurinol, Atenolol, Furosemide, Simvastatin, ASA, insulin, Mirtazapine, Doss, Loperamide, Simethicone
Current Illness:
Preexisting Conditions: DM, CHF, CAD, PVD, gout, UTI (recurrent). Above the knee amputation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302676

Write-up: This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject died 342 days post immunization on 10/01/2003. Subject was admitted on 9/29/03. He was transferred from ICU post AKA for decrease MS and possible CHF exacerbation. He was volume overloaded on admission and IV diuresis was started. Pt showed bilateral DVT''s and was placed on Heparin and then Lovenox the same day. He remained stable until October 1, 2003 in the evening when he was found unresponsive and pulseless. Subject expired more than 30 minutes of unsuccessful resuscitation. Diagnosis: DVT with presumed PE, cardiopulmonary failure secondary to DVT, CHF exacerbation, DM, GRI, and altered MS. The death was reported by the investigator as not related to the study vaccine. Follow up on 11/26/03: "Initial SAE report received on 10/22/03. This subject is a 69 year old male who died while enrolled in RSV11 S & I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/22/02. The subject died 342 days post immunization on 10/01/2003. Subject was admitted on 09/29/03. He was transferred from ICU post AKA for decreased MS and possible CHF exacerbation. He was volume overloaded on admission and IV diuresis was started. Patient showed bilateral DVT''s and was placed on Heparin and then Lovenox the same day. He remained stable until 10/01/03 in the evening when he was found unresponsive and pulseless. Subject expired after more than 30 minutes of unsuccessful resuscitation. Diagnosis: 1) DVT with presumed PE. 2) Cardiopulmonary failure secondary to #1. 3) CHF exacerbation. 4) DM. 5) GRI. 6) Altered MS. The death was reported by the Investigator was not related to the study vaccine. Additional information received 11/18/03. Death certificate: Cause of death: Pulmonary Embolism due to deep vein thrombosis due to congestive heart failure. The pulmonary embolism secondary to deep vein thrombosis secondary to congestive heart failure was reported by the investigator as not related to the study vaccine."


VAERS ID: 213876 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: California  
Vaccinated:2002-10-22
Onset:2003-09-23
   Days after vaccination:336
Submitted: 0000-00-00
Entered: 2003-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Atrial fibrillation, Bacterial infection, Deep vein thrombosis, Infection, Leukopenia, Muscular weakness, Neutropenia, Pneumonia, Pulmonary haemorrhage, Renal failure, Respiratory failure, Thrombocytopenia, Vasculitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (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), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-10-08
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 15 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RSV/Placebo; tRinalin; Seravent; Aeobid; Glucophage; Glucotrol; Lipitor; Digoxin; Zestril; Aldacton; Lasix;
Current Illness:
Preexisting Conditions: Emphysema, asthma, CHF, HTN, COPD, chronic bronchitis; Endstate renal failure, Vaculitis;
Allergies:
Diagnostic Lab Data: Aspergillus infection; thrombocytopenia and leukopenia
CDC Split Type: 200303297

Write-up: The subject is a 78 year old male who was admitted to the hospital due to respiratory failure, lower extremity weakness and died while enrolled in RSV11 study. The study received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject developed lower extremity weakness with SOB 336 days post immunization and was admitted to the hospital on 9/23/03. He was found to have a large syrinx (syringomyelia) in the thoracic spinal cord probably secondary to chronic ischemia which had progressed to the point where there was compromise of his lower extremity innervation causing his weakness. Pneumonia was found on his chest x-ray which accounted for his respiratory failure; he was treated with antibiotics. He developed thrombocytopenia and leukopenia secondary to his immunosuppressive therapy and was treated with granulocyte colony-stimulation factor. His counts improved. He was maintained on hemodialysis. He developed further respiratory failure secondary to mucous plugging and required intubation for deep suctioning. He developed a subsequent left upper lobe infiltrate which was felt to be secondary to Aspergillus. Deep venous thrombosis was discovered and he was treated with Heparin. There was a long discussion undertaken with wife and the family requested comfort care only and to extubate the pt. Subject was extubated, given IV morphine for comfort and expired 15 days after admission on 10/8/03, 351 days post immunization. Discharge summary: 9/23/03-10/8/03. Admission diagnosis: respiratory failure, lower extremity weakness. Discharge diagnosis: Respiratory failure secondary to pneumonia exacerbating chronic obstructive pulmonary disease. Large thoracic spine syrinx probably ischemic in origin. neutropenia secondary to Cytoxan. ANCA positive vasculitis with secondary glomerulonephritis and end-stage renal disease, hemodialysis-dependent. Alveolar, ar hemorrhage syndrome secondary to ANCA positive vasculitis. Paroxysmal atrial fibrillation. Mucous plugging of the bronchial tubes with further respiratory failure. Deep venous thrombosis. Aspergillus pneumonia. The respiratory failure, large thoracic spine syrinx, neutropenia, ANCA positive vasculitis, alveolar hemorrhage, paroxysmal A. fib, mucous plugging on bronchial tubes, deep vein thrombosis, and Aspergillus pneumonia were reported by the investigator as not related to the study vaccine. The death certificate received on 1/2/04 states renal failure and vasculitis.


VAERS ID: 209988 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Georgia  
Vaccinated:2002-11-01
Onset:2003-09-13
   Days after vaccination:316
Submitted: 0000-00-00
Entered: 2003-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arteriosclerosis, Cardiovascular disorder
SMQs:, Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Digoxin; Simethicone; Simvastatin; Polyvinyl alcohol; Spironolactone; Losartan; Pyridoxine HCL; Folic Acid; Cyanocobalamin; Insulin Glargine; Isosorbide Dinitrate; Torsemide; Insulin Glargine; Rabeprazole
Current Illness:
Preexisting Conditions: Patient has history of myocardial infarction, valvular heart disease, congestive heart disease, hypertensive heart disease and diabetes mellitus. On 12/10/02 the patient was admitted to the hospital for chest pain that worsened on ambulation. The patient was diagnosed with angina pectoris (atypical), unknown etiology and was discharged the following day 12/11/02. Patient recovered as of 12/22/02.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302207

Write-up: This subject is a 67 year old male who died at home from Ateriosclerotic Cardiovascular Disease while enrolled in the RSV 11 study with RSV vaccine. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 11/1/02. The subject died from Arteriosclerotic Cardiovascular Disease on 9/13/03, 316 days post immunization. Death Certificate 9/17/03: The cause of death was Arteriosclerotic Cardiovascular Disease. No autopsy was performed. The death was reported by the investigator as unrelated to the study vaccine. A 15-day follow up report received 10/22/2003 adds: Additional info received 10/09/2003. Pt, 67 year old male seen 08/12/2003 in cardio clinic reporting doing well overall, blood sugars were stable, CHF stable with medications. Echocardiography performed on 09/03/2003 revealing marked concentric LVH, marked left atrial enlargement, mild mitral regurgitation, mild tricuspid regurgitation with normal pulmonary pressure. No other info is available as pt died at home and no autopsy performed. Diagnosis: Arteriosclerotic Cardiovascular disease. List of additional info received and available with source file: Death certificate: 9/22/2003. Medication Record: 10/16/2002-08/12/2003. Doctors notes: 08/12/2003. Echocardiography report: 09/03/2003. A 15-day follow up report received 10/23/2003 adds no new info.


VAERS ID: 211046 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Male  
Location: Arizona  
Vaccinated:2002-10-21
Onset:2003-08-21
   Days after vaccination:304
Submitted: 0000-00-00
Entered: 2003-10-28
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, Renal failure acute
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (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), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RSV/Placebo, Celexa, Aspirin, Prevacid, Nephrocap, Amiodarone, Coreg, Metoclopramide, Miralax, Alphagan, Lumigan, Flonase
Current Illness:
Preexisting Conditions: Information received October 17, 2003 regarding previous hospitalizations: Discharge Summary: 5/29/03-6/4-03. The subject developed respiratory distress and wheezing 220 days post immunization and was admitted to the hospital on 5/29/03. He was diagnosed with possible pneumonia or bronchitis along with reactive airways disease and also volume overload state. The pt received dialysis with fluid removal as tolerated. he was hypotensive on dialysis and received dialysis several days in a row. The pt was treated with IV antibiotics along with oral Biaxin and has been maintained on oral Biaxin. Also, the pt has received supplemental oxygen and small volume nebulizer bronchodilator therapy. His respiration status has improved significantly throughout the hospitalization. Repeat chest x-ray showed interval decreases in the bilateral perihilar opacities, with a small pleural effusion. Dialysis will be continued 3 times a week. Subject''s condition is ongoing and he was discharged from hospital to a nursing facility 7 days later on 4/6/03. The event was reported by the investigator as not related to the study vaccine. Admission/ Discharge Summary 7/22/03-7/25/03. The subject developed increased shortness of breath over the last five days and was admitted 274 post immunization on 7/22/03 with SOB, CHF, fluid overload and pleural effusion. Treatment underwent a thoracenteses of the right pleural effision. The fluid studies were consistent with a transudative effusion likely secondary to fluid overload with this end-stage renal disease and congestive heart failure. He continued on hemodialysis during the hospital course and his fluid status improved as well as his respiratory status. After undergoing hemodialysis the pt experienced some episodes of hypotension but remained asymptomatic without any chest pain, shortness of breath, lightheadedness or dizziness. He was started on Proamatine 2.5mg po bid to be increased as needed. Pt also experienced some diarrhea. A c. diff stool study done on the 6/25/03 was noted to be positive for C. diff. He was started on Flagyl 500mg po tid for 10 days. Pt was discharged to a nursing home 3 days later on July 25. He was comfortable at rest and ambulated with oxygen 2 liters nasal cannula. The pt will continue on hemodialysis on a three times a week basis and will continue on his medications including Coreg and Amiodarone. Labs include a white count of 10.3, hemoglobin of 11.7, platelets of 230,000, sodium 136, potassium 3.9, chloride 98, bicarb 28, BUN 43, creatinine 4.5, glucose 123, calcium 8.9, total bilirubin 1, AST 37, ALT 47, Alk phos 135, CK 34, Troponin 0.07, chest x-ray shows a right-side pleural effusion as well as bilateral perihilar consistent with CHF. The EKG shows sinus rhythm with ST depression findings in the lateral leads and inferior leads. C. diff stool study done on the 6/25/03 was noted to be positive for C. diff. The event was reported by the investigator as not related to the study vaccine. Admission/ discharge 8/4/03. Hx-CHF, pneumonia, pleurisy, pleural effusion, RAD, ESRD, prostate surgery, quit smoking 20 years ago. The subject developed SOB and a productive cough 287 days post immunization and was admitted to the hospital on 8/4/03. Pt apparently had been having similar problems which had cleared up after a course of treatment, however symptoms resumed over the next couple of days. Treatment included oxygen, SVN and IV antibiotics and he was placed on IV Invanz. Chest x-ray revealed diffuse infiltrates and bilateral pleural effusions. Cocci serology report is pending. CPK 27l, sodium 136, potassium 4.5, chloride 99, CO2 29, glucose 137, BUN 23, creatinine 4.4, SGOT 83, SGPT 124, alkaline phosphatase 208, Troponin negative, white count 7.5, hemoglobin 12.3, platelets 531. No manual differential available. EKG shows sinus rhythm without any acute ischemic changes. The subject''s condition is ongoing and he was discharged the same day. The event was reported by the investigator as not related to the study vaccine. Admission/ Discharge 8/11-8/15-03. The subject developed SOB 294 days post immunization and was admitted to the hospital on 8/11/03 with chronic obstructive pulmonary disease exacerbation. He was started on Solu-Medrol 120mg IV, then 60mg IV q. 12H, SVN. Treatments of Albuterol and Atrovent were started q. 4h. while awake. Pulmonary consultation was arranged. He was started on his home medication as well as Flagyl 500mg one po tid x 5 days which had been started prior to admission. He was seen in consultation and assessment was respiratory insufficiency, mental status change, right pleural effusion and COPD. At this point his medications were continued as previously ordered. He was seen by a Nephrologist for continued dialysis. On the 13th he remained stable. Speech evaluation is ordered for evaluation of his swallowing. CT scan of his chest was noted to show possible right upper lobe mass. CT scan of head show atrophy, with nothing acute. At this point there are no further plans for further evaluation of the mass. On the 15th Dr. did discuss the mass at length with the family and they decided on a hospice evaluation. The subject''s condition is ongoing and he was discharged with hospice to the nursing home 4 days later on 8/15/03 to hospice. Lab: sodium 138, potassium 5.0, chloride 101, CO2 30, glucose 147, BUN 27, creatinine 4.8, albumin 2.5, alkaline phosphatase 125, white count 6.6, hemoglobin 11.6, platelet count 362,000, blood gases 7.46/43/76 four liters. The event was reported by the investigator as unrelated to the study vaccine.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302461

Write-up: This is a 83 year old male who died on August 21, 2003 while enrolled in RSV S and I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/21/02. The subject died 304 days post immunization while in hospice care. The event was reported by the investigator as not related to the study vaccine. A 15-day follow up report received 10/31/2003 adds: The subject died 305 (corrected) days post immunization while in hospice care. Additional info received 10/24/2003: Date of death is 08/22/2003, changed from 08/21/2003. Diagnosis: Pt died at hospice on 08/22/2003 from CHF and ESRD.


VAERS ID: 209178 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Male  
Location: D.C.  
Vaccinated:2002-10-31
Onset:2003-08-13
   Days after vaccination:286
Submitted: 0000-00-00
Entered: 2003-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Atrial fibrillation, Cardiac failure congestive, Coronary artery embolism, Intestinal gangrene, Nausea, Pain, Pleural effusion, Vomiting, White blood cell count increased
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-15
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Coumadin, Restoril, Remeron, Protonix, Lasix, Lisinopril, Coymadin
Current Illness:
Preexisting Conditions: Surgery a few years ago for a small bowel obstruction, chrome atrial fibrillation , CHF, recurrent pleural effusions, open cholecystectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200301863

Write-up: This subject is an 82 year old male who was admitted to the hospital on 8/13/03 and died 2 days later on 8/15/03 while enrolled in RSV 11 study, with RSV vaccine or Placebo and Influenza vaccine. The subject received study vaccine on 10/31/02. Subject developed nausea, vomiting, abdominal distention and pain 286 days post immunization and was admitted to the hospital 286 days later on 8/13/02. Subject was diagnosed with gangrene of small bowel, congestive heart failure, chronic atrial fibrillation, embolus of the superior mesenteric artery. Treatment included the medication, Restoril, Remeron, Protonix, Lasix, Lisinopril and IV antibiotics. Subject died 2 days later on 8/15/03. The causality has not been assessed by the investigator as of yet, additional information has been requested. On examination, he was mentally alert. He was complaining of quite a bit of pain. His abdomen was distended. At first, bowel sounds were absent. Note, he gave a history of passing flatus on the day prior to admission and having a bowel movement, but none on the day of admission. The patient was given IV fluids. He was not given antibiotics at first. His Coumadin was discontinued. His other medications continued were appropriate. On the morning of 8/14/03, the patient had had nasogastric suction overnight, which was fairly profuse. He was still complaining of abdominal pain but stated that he had passed some flatus during the night. His white count became elevated. He was therefore placed on broad spectrum antibiotics. We discussed the possibility of proceeding with surgery with him. He said he wanted to avoid this if at all possible. A CT of the abdomen was obtained, and this suggested proximally dilated bowel and collapsed distal bowel. Our impression at this time was on of an incomplete small bowel obstruction, particularly in view of the fact that he recently passed flatus, and there was a considerable amount of gas in the colon. The patient was treated overnight. On the morning of 8/15/03, however, his white count had dropped only minimally. He was still complaining of pain. His abdominal distention had not decreased. His nasogastric suction was quite profuse. We recommended surgery. He discussed this with his daughter in some detail and considered not giving permission but finally relented. He was aware that he was at high risk and that even offered his comment that he thought he would not survive the surgery. He was taken to the surgical area where an A line and a Swan-Ganz catheter was placed. He already had a Foley catheter in situ. He was taken to surgery. At the time of surgery, ischemia of the entire bowel was found in the distribution of the superior mesenteric artery. The bowel was clearly not viable. The abdomen was therefore closed. The patient returned to recovery room where he was kept on large doses of vasopressors but was maintaining inadequate blood pressure. He was kept on a ventilator. Later, after discussion with his daughter and on our advice, we discontinued the vasopressor, and within just a few minutes, he developed cardiac asystole. He was pronounced dead as 2:30 pm on 8/15/03. An autopsy was declined by the family. A 15-day follow up report received 09/30/2003 adds: Final Diagnosis: 1. Gangrene of the small bowel. 2. Probable embolus of the superior mesenteric artery. 3. Chronic atrial fibrillation. 4. Congestive heart failure. 5. Recurrent pleural effusions.


VAERS ID: 209989 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Georgia  
Vaccinated:2002-10-31
Onset:2003-08-08
   Days after vaccination:281
Submitted: 0000-00-00
Entered: 2003-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ascites, Neoplasm malignant, Pleural effusion
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Clopidogrel; Aspirin Enteric Coated; Carvedilol; Furosemide; Nitroglycerin; Amlodipine; Albuterol Inhalor; Enalapril Maleate; Spironolactone; Megestrol Acetate; Ipratropium Bromide.
Current Illness:
Preexisting Conditions: Other significant conditions of COPD, anorexia/malnutrition. History of myocardial infarction, CHF, and HTN. Relevant history from previous hospitalizations: On 1/5/03 patient was admitted with dyspnea and chest discomfort associated with CHF 66 days after vaccination. He recovered and was discharged one day later.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200302206

Write-up: This subject is a 76 year old male, who died at home of carcinoma of unknown primary origin while enrolled in RSV11 study with RSV vaccine. The subject received RSV vaccine or placebo and Influenza vaccine on 10/31/02. The subject died of carcinoma of unknown primary origin on 8/8/03, 281 days post immunization. Death Certificate 8/17/03: The cause of death was carcinoma of unknown primary with ascites and pleural effusion. Approximately interval between onset and death: 5 months. Other significant conditions were COPD, anorexia/malnutrition. The death was reported by the investigator as unrelated to the study vaccine. Further information has been requested. A 15-day follow report received 10/23/2003 adds: Additional info received 10/09/2003. Death occurred at home. Upon researching recent history, 4 additional hospitalizations, SAE''s found unreported to site with some medical history and relevance to this will be forthcoming. Reference hospitalization SAE of 7/17-7/23/03 as last medical info available. Pt released in stable condition in care of hospice on 7/23/03. No further data available other than Discharge Summary of 7/23/03. Diagnosis: Carcinoma of UNK primary with ascites and pleural effusion. Cross Reference SAE hospitalization for CHF symptoms 01/05/2003. Hospital Discharge Summary: 07/17-07/23/2003. The pt presented to the Emergency Dept with mental status changes after taking 0.5 mg of Ativan also with a concomitant increase in his Duragesic patch to 50 micrograms. He was admitted for evaluation and continued treatment of his mental status changes and also due to some increase in his shortness of breath and dysphagia type symptoms. A therapeutic paracentesis was performed x2. Due to his dysphagia, speech therapy was consulted for a swallowing evaluation. A barium swallow showed a normal swallowing mechanism. Computed tomographic scan showed air in the esophagus, which was consistent with some sort of mass lesion in the mediastinum, although this was not apparent on the computed tomographic scan done previously. An esophagogastroduodenoscopy was consistent with mild esophagitis, otherwise was WNL without strictures or other obstructions seen. The pt continued to be at his baseline during his hospital stay with no definite etiology of the globus sensation, his dysphagia and swallowing difficulties that the pt was having. He was given no apparent etiology from an esophagogastroduodenoscopy, barium swallow or computed tomographic scan. After discussing the risks and benefits of total parental nutrition and ventral line, the pt declined that therapy at this time. The pt''s medications were changed to add Megace, Morphine Sulfate as needed and the pt was instructed to call his Primary Care Provider if his symptoms returned for a repeat therapeutic paracentesis as well as other interventions as needed. Additional info received and available in source file: Medication Record: 10/29/2002-07/24/2003. Death Certificate: 08/17/2003. Discharge Summary: 07/17-07/23/2003.


VAERS ID: 211326 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Washington  
Vaccinated:2002-10-17
Onset:2003-07-28
   Days after vaccination:284
Submitted: 0000-00-00
Entered: 2003-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiomyopathy, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-10
   Days after onset: 13
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:
Other Medications:
Current Illness:
Preexisting Conditions: Trachy Brady Syndrome; A-fib; CAD; CHF; COPD; Sprain; Actinic Keratosis; Gastroesophageal Reflux Disorder; Colonic Polyps; Iron Deficiency Anemia; Obstructive Lung Disease; Hypertension; Glaucoma; Cataract; Hypothyroidism; Renal insufficiency; Anticoagulation assoc bleeding; Allergy;
Allergies:
Diagnostic Lab Data: Information received from previous hospitalization 11/25/02-11/28/02: The subject developed back and shoulder pain, 36 days post-immunization and 3 days prior to admission into hospital. The pain increased and became associated with chest pressure and radiation of pain down his left arm. NTG did not relieve the pain. Subject did not want to go to the hospital until the evening of 11/25/02 when pain became very severe with associated nausea. He was admitted to hospital on 11/25/02 and started on NTG gtt, morphine and b-blocker and when stabilized was transferred to another hospital. At transfer subject was pain free, enzymes were essentially negative and EKG had no new changes. He was unable to tolerate a nuclear stress test secondary to claustrophobia. Physical exam was within normal limits except for decreased breath sounds at lung bases. Renal U/S showed no hydronephrosis or renal calculi w/in either kidney with mild parenchymal thinning. Initial troponin was 0.1. ECG showed RBBB with ST seg depression in V1 and V2, left axis deviation and sinus tachycardia. Chest x-ray showed cardomegaly with no infiltrates. Reported labs were HCT 31.8, platelets 203, creatinine 3.2, BUN 43, CPK 101, CKMB 4.6, and troponin 0.15. Creatinine increased from 3.2 to 3.5. Urine protein/creatinine ratio and renal U/S were both obtained and were normal. Subject was started on ASA and continued on digoxin, dilitiazem and started low dose of carvedilol and continued on outpt inhalers for severe COPD based on PFT''s. UTI was diagnosed by U/A with $g30 WBC HPF and treated w/ Levofloxacin. A sudden onset of pain and swelling on the lateral left ankle was treated with Tylenol. He was discharged home w/diagnosis of atypical chest pain in setting of known CAD on ASA and b-blocker. Symptoms/Diagnosis: Chest pain, intermittent A-fib, CHR class II-III, Acute Renal Failure, UTI. The subject recovered. He has a follow up appointment with cardiology in 1-2 months. Information received from previous hospitalization 05/05-08/03. Subject was hospitalized 200 days post immunization for diaphoresis, with chest pressure, palpitations, nausea, diaphoresis, tachycardia. He has had difficulty with variable heart rates in a fib/flutter/jxnal since 04/03. On digoxin/carvedilol for a fib rate control and heart failure. Developed bradycardia with apparent accelerated jxnal rhythm when seen in clinic by doctor on 04/10/03. He has been off and on his digoxin and carvedilol since, with alternating episodes of tachycardia and bradycardia. Stopped Digoxin 04/27/03. Continued on carvedilol 3.125 mg bid. Plan for OP permanent pacer to treat bradycardia assoc with tx of atrial tachycardia. EKG-aflutter, rate about 150, extreme LAD, RBBB, info Q, Q V3-4 after 10 mg Diltiazem-rate 102, freq PVC''s o/w unchanged. CxR 05/05-Although the left lung base was excluded in the image, there may by opacity obscuring left hemidiaphragm possibly atelectasis or pneumonia. Cardiomegaly unchanged w/out sign of interstitial edema. 05/06-Cardiomegaly and pulmonary vascular engorgement w/out overt failure. New cardiac pacer in satisfactory position. 05/07-PA/LAT-continued satisfactorypostoperative appearance following single-lead left transvenous pacemaker placement, w/pacemaker components in customary position. No pneumothorax of other complication is seen, and no change observed from yesterday''s film Moderate to severe cardiomegaly is again noted, w/out evidence of CHF. Hospital course: 1) Tachy/Brady Syndrome: patient admitted to tele for monitoring and rate control. Diltiazem boluses brought rate from 140s to 90s readily. Initially increased long acting Diltiazem to 240mg qd from 180mg qd in rsponse. Also increased Carvedilol from 3.125 mg bid to 6.125 mg bid. However, patient became relatively hypotensive on these med increases with SBP 80s-90s on hosp day #2. Thus decreased back to OP doses of Carvedilol and Diltiazem and restarted Digoxin with IV load as rate had been in 40s as OP on this regimen. Subject received pacemaker on 05/06/03 w/out complication. Pacing appropriately below rates of 70. 2) NSTEMI-patient admitted with CP assoc w/tachycardia. Had small bump in troponin to 0.43 from baseline of 0.18 or so. Experienced no further CP in house. Thought that small NSTEMI was rate related. Patient was continued on CAD risk modification meds, including ASA, Carvedilol, Losartan. Patient rqstd to PharmD on d/c that ASA be discontinued. 3) Ischemic Cardiomyopathy-EF 35-40% 04/01. No signs of volume overload on CxR or exam and osygenation fine, thus diuresis was not pursued. CO likely worsened by tachycardia, causing worsening renal function and acidosis, but improved with rate control. Continued Losartan, Carvedilol, ASA, Lasix 40mg qd restarted on d/c. 4) Renal failure-Experienced worsening of Cr from recent baseline of 2.8-2.9 to 3.7 recently, likely due to tachycardia resulting in worsened cardiac output. Decreased to and stabilized at 3.1 on discharge. Following with Renal as outpatient to determine when and whether to start dialysis. Continued on Losartan. 5) Gap metabolic acidosis-subject presented with bicarb of 18 and AG 16, resolved over hospital stay. Presumed due to decreased CO and lactic acidosis and better now that rate is better controlled Bicarb 24 on d/c.
CDC Split Type: 200302677

Write-up: This subject is an 81 year old male who according to his wife was admitted to the hospital due to an acute myocardial infarct while enrolled in the RSV 11 study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/17/02. Subject was admitted to the hospital 284 days post immunization and died 13 days later. Investigator has requested a discharge summary. The myocardial infarction was reported by the investigators as not related to the study vaccine. The death certificate received on 11/20/03 states cardiomyopathy. Follow up on 11/26/03: " Additional information received 11/18/03. Death Certificate: Date of death: 08/10/03. Cause of death: PEA arrest due to Global Dilated Cardiomyopathy. The PEA arrest secondary to Global Dilated Cardiomyoptahy was reported by the Investigator as not related to the study vaccine."


VAERS ID: 210190 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Arizona  
Vaccinated:2002-10-22
Onset:2003-07-25
   Days after vaccination:276
Submitted: 0000-00-00
Entered: 2003-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Dehydration, Hyponatraemia, Laboratory test abnormal, Oral intake reduced, Pyrexia, Renal failure, Urine output decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-28
   Days after onset: 65
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: Potassium Hydralazine; Ranitidine; Isosorbide mononitrate; Macrobid; Atenolol; Quinine sulfate; Sinemet; Lasix; Insulin; Imdur; ASA; Synthroid
Current Illness:
Preexisting Conditions: Patient has a history of congestive heart failure, hypertension, angina, coronary heart disease, stent placement and angioplasty, left ventricular dysfunction, hyperlipidemia, diabetes type II, chronic renal failure, mild anemia, degenerative joint disease, hypothyroidism. Allergies: Penicillin, Sulfa.
Allergies:
Diagnostic Lab Data: Glucose 245, BUN 27, Sodium 127, Potassium 3.8, Chloride 93, Bicarbonate 26, Creatinine 1.8. The rest of the comprehensive metabolic profile is within normal range. Complete blood count revealed white blood cell count 11.2, Hemoglobin 10.9, Hematocrit 32.2, MCV 94, and Platelets 243,000. Urinalysis with micro is normal. Basic metabolic profile on discharge, glucose 151, blood urea nitrogen 21, sodium 134, potassium 4.0, chloride 104, total bicarbonate 26, creatinine 0.3, calcium 8.0, and magnesium 1.6. Prior to her discharge, the subject on 2g of magnesium sulfate IV infusion). CBC: WBC 11.2, hemoglobin 10.9, hematocrit 33.2, mean corpuscular volume 94, platelet 243. Cardiac enzymes were negative. Urinalysis, protein +2 and nitrates and leukocyte esterase are negative. White blood cell is only 224.
CDC Split Type: 200302227

Write-up: This subject is an 83 year old female, who was admitted to hospital due to acute renal failure while enrolled in RSV11 study. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 10/22/02. The subject developed generalized weakness, low grade fevers, low intake and decreased urinary output for 24 hours and was brought to the emergency room by the family on 7/25/03, and was admitted to hospital on 7/25/03, 276 days post immunization. She was diagnosed with renal failure which was thought to be superimposed on an underlying chronic renal failure. Treatment included IV fluid with infusion of normal saline and put on oral fluid restriction to one liter per day and Lasix was hold. The subject''s hyponatremia recovered and dehydration was resolve with IV infusion. During her admission it was suspected that she had Parkinsonism. She was started on a low dose Sinemet to be followed up by the primary care physician. Discharge diagnosis: Hyponatremia recovering, Suspicion of Parkinsonism, History of coronary artery disease, stable, Acute renal failure secondary to dehydration superimposed on chronic renal failure, Dehydration, resolved, Diabetes Mellitus, on insulin, Hypertension controlled, Mild chronic anemia of chronic disease. After subject was stable she was discharged home for hospice home care visits. While at home she got a severe upper respiratory infection. Subject and family only wanted good comfort interventions. The subject expired on 9/28/03 at home. The event was reported by the Investigator as unrelated to the study vaccine. Additional information received and available in the source file: History and Physical for admission 7/25/03, Discharge Summary for 7/25 to 7/27/03, Summary of Lab tests from 5/31/02 to 7/27/03, Chest X-ray 7/25/03, Hospital Discharge Notification, Hospice Plan of Care 9/1/03, Hospice Physician Admission Orders 9/1/03. A 15-day follow up report received 10/22/2003 adds no new info. A 15-day follow up report received 10/23/2003 adds: Additional info received 10/07/2003. Subject was a hospice pt. No autopsy was done. Confiemed that pt wasn''t hospitalized on 09/08/2003. 10/17/2003: No further info is anticipated, case is closed.


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