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VAERS ID: 213825 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Michigan  
Vaccinated:2003-05-22
Onset:2003-06-05
   Days after vaccination:14
Submitted: 2003-12-04
   Days after onset:182
Entered: 2003-12-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1012M / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491169 / 3 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0865M / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Bacterial infection, Brain oedema, Bronchitis, Pneumonia
SMQs:, Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-05
   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:
CDC Split Type:

Write-up: Child died suddenly at day care on or about 6/5/03. No other specifics known. Autopsy report report received on 12/16/2003 states COD was bacterial pneumonia, bronchitis, and cerebral edema.


VAERS ID: 213872 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Unknown  
Vaccinated:2003-04-17
Onset:2003-08-09
   Days after vaccination:114
Submitted: 2003-12-11
   Days after onset:124
Entered: 2003-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV075 / 3 - / -

Administered by: Military       Purchased by: Military
Symptoms: Cardiovascular disorder, Coronary artery atherosclerosis, Depressed level of consciousness, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-09
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood and urine negative for ethanol. Liver negative for prescription or illicit drugs.
CDC Split Type:

Write-up: Patient could not be aroused from his cot by others. In presence of dependent lividity, his core body temperature was 108oF. Temperatures in the area at the time were at or above 120oF. Wet-bulb globe temperatures were "pegged" (at max recordable temp), but were typically at least 92oF. Final autopsy report: Cause of death--heat-related death. Autopsy diagnoses: Micro pulmonary findings suggestive of heat injury. Mild right ventricular hypertrophy. Mild coronary atherosclerosis.


VAERS ID: 213876 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Unknown  
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: 213877 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Unknown  
Vaccinated:2003-04-03
Onset:2003-11-03
   Days after vaccination:214
Submitted: 2003-12-08
   Days after onset:35
Entered: 2003-12-12
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0738M / 2 - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Brain oedema, Diabetes insipidus, Drug ineffective, Hernia, Hyponatraemia, Meningitis
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-09
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Pneumonia; Urinary tract infection; Fever; Hospitalization; Weight gain poor; Infection
Allergies:
Diagnostic Lab Data: Autopsy 11/?/03 results requested. CSF red blood cells 11/03?/03 880. CSF white blood cells 11/03?/03 12880.
CDC Split Type: WAES0312USA00014

Write-up: Information has been received from a physician concerning a 12 month old pt with a history of multiple hospitalizations for pneumonia, urinary tract infection and fever. It was noted that the pt was not immunocompromised and had no allergies to food or medications. On 4/3/03 the pt was vaccinated with a second dose of Comvax (543655/0738M). It was noted that the pt had not received the third dose of Comvax. On 11/3/03 the pt began symptoms and was later diagnosed with invasive haemophilus influenzae. Concomitant therapy included "other childhood immunizations." On 11/10/03 the pt died. The cause of death was invasive haemophilus influenzae. It was noted that an autopsy was performed and the results were unknown at the time of the report. Additional info has been requested. The hospital discharge summary received on 12/16/03 states cerebral edema, diabetes insipidus and cerebral salt-wasting. Follow up information from the same physician indicated that the patient had a history of recurrent infections including pneumonia x 4, poor weight gain and UTI, but there was no immune compromise. On 03-Nov-2003 the child experienced "invasive HIB disease meningitis". Reported labs inlcuded CSF WBC of 12800 and WBC''s of 880. The child died on 09-Nov-2003, rather than 10-Nov-2003 as previously reported. the causes of death were reported in the follow up as Hib meningitis, cerebral edema and herniation. Additional information, including autopsy findings, has been requested.


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: 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: 214195 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Texas  
Vaccinated:2003-12-02
Onset:2003-12-14
   Days after vaccination:12
Submitted: 2003-12-17
   Days after onset:3
Entered: 2003-12-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1006AA / 1 LL / -
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0987M / 2 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA861AA / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W11562 / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-14
   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: NONE
Current Illness: NONE
Preexisting Conditions: History of Prematurity
Allergies:
Diagnostic Lab Data: Autopsy 12/15/03 results: findings consistent with Sudden Infant Death Syndrome
CDC Split Type: TX03154

Write-up: Infant death, diagnosed as Sudden Infant Death Syndrome 02/04/2004 Autopsy report rec''d -- COD was SIDS.


VAERS ID: 214220 (history)  
Form: Version 1.0  
Age: 32.0  
Sex: Female  
Location: Unknown  
Vaccinated:2003-01-15
Onset:2003-02-18
   Days after vaccination:34
Submitted: 2003-12-03
   Days after onset:288
Entered: 2003-12-22
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020017 / 2 - / -

Administered by: Military       Purchased by: Other
Symptoms: Leukaemia, Lymphadenopathy, Shoulder pain
SMQs:, Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-09-22
   Days after onset: 215
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Birth Control Pill
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine given on 01/15/2003. Pt was in good health prior to receiving vaccine. Approximately 2 weeks after vaccine, swollen lymph nodes. Lymph nodes remained swollen but pt began having left shoulder pain after exercising on 02/18. On 02/19 seen by provider and diagnosed with Leukemia.


VAERS ID: 214221 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2000-11-03
Onset:0000-00-00
Submitted: 2003-12-18
Entered: 2003-12-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5100A2 / UNK RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: The pt''s medical history, concurrent conditions and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0443072A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. On 11/03/2000, the pt received Engerix-B vaccine (lot ENG5100A2). On 12/10/2003, the pt''s attorney alleged that "the thimerosal contained in the vaccines administered to the children (child) contributed to and/or caused their death." No further info regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214222 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-18
Entered: 2003-12-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS ENG1607A9 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: The pt''s medical history, concurrent conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443083A

Write-up: This report describes the occurrence of death in child of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Engerix B) injection for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. On unspecified dates, the pt received a dose of Engerix-B (lot ENG 1944A and lot ENG1607A9). Los number ENG1944A is not a complete lot number for Engerix-B. On 12/10/2003, the pt''s attorney alleged that "the thimerosal contained in the vaccines administered to the children (child) contributed to and/or caused their deaths." No further info regarding the specifics of the claim was available at this time. The cause of death is unknown at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214223 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-18
Entered: 2003-12-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 2597A2 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: The pt''s medical history, concurrent conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443084A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The pt received a dose of Engerix-B (lot ENG2597A2) on an unspecified date. On 12/10/2003, the pt''s attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further info regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214224 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-19
Entered: 2003-12-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 2167A2 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: The pt''s medical history, concurrent conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443085A

Write-up: This report describes the occurrence of death in child of unspecified age who received Hepatitis B vaccine recombitant (Engerix-B) injection. The report was received as part of litigation proceeding and has not been verified by a physician or other health care professional. On unspecified dates, the pt received doses of Engerix-B (lot ENG225A2 and lot ENG2167A2. Lot number #ENG225A2 is not a valid lot number for Engerix-B. On 12/10/2003, the pt''s attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further info regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214225 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-18
Entered: 2003-12-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 2392A2 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: The pt''s medical history, concurrent conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0443086A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The pt received a dose of Engerix-B vaccine (lot ENG239A2) on an unknown date. On 12/10/2003, the pt''s attorney alleged that the "thimerosal contained in the vaccines administered to the children (child) contributed to and/or caused their deaths." No further info regarding the specifics of the claim was available at this time. The cause of death is unknown at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214322 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2001-03-27
Onset:0000-00-00
Submitted: 2003-12-22
Entered: 2003-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0328BA / UNK - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 3329A2 / 1 - / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR R1434 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443080A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The pt received the first injection of Engerix-B vaccine (Lot # ENG3329A2) on 03/27/2001. He also received injections of DTAP (Tripedia, AP); inactivated IPV (IPOL, AP); and HIB (Hib-Titer, Lederle Labs) on 03/27/2001. On 12/10/03, the pt''s attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further information regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214323 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-22
Entered: 2003-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443081A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. On 12/10/03, the pt''s attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further information regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214324 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-22
Entered: 2003-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443082A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. On an unspecified date, the pt received either Engerix-B vaccine (lot number unknown) or Infanrix vaccien (Lot # DTPA958A2 or lot # DTPA524A2). On 12/10/03, the pt''s attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further information regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214325 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-22
Entered: 2003-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443087A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. On an unspecified date, the pt received either Engerix-B vaccine (lot number unknown) or Infanrix vaccine (Lot # DTPA958A2 or lot # DTPA524A2). On 12/10/03, the pt''s attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further information regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214326 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-22
Entered: 2003-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443088A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. On an unspecified date, the pt received either Engerix-B vaccine (lot number unknown) or Infanrix vaccine (Lot # DTPA958A2 or lot # DTPA524A2). On 12/10/03, the pt''s attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further information regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


VAERS ID: 214327 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-22
Entered: 2003-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0443089A

Write-up: This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection. The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. On an unspecified date, the pt received either Engerix-B vaccine (lot number unknown) or Infanrix vaccine (Lot # DTPA958A2 or lot # DTPA524A2). On 12/10/03, the pt''s attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths." No further information regarding the specifics of their claims is available at this time. It is unknown whether an autopsy was performed.


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: 214346 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-02-02
Entered: 2003-12-24
   Days after submission:40
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bradycardia, Bronchitis, Cardiac arrest, Hypotension, Meningitis, Pneumonia, Pulmonary oedema, Viral infection
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (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 (broad), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prednisone
Current Illness:
Preexisting Conditions: Cystic fibrosis; Lung Transplant; Immunosuppression
Allergies:
Diagnostic Lab Data: VZV Strain: "wild-type VZV infection"
CDC Split Type: WAES0312USA01394

Write-up: Information has been received from a physician concerning a 18 year old female with cystic fibrosis who, in 2003, developed extensive disseminated varicella zoster virus (VZV) infection while immunosupressed post-lung transplantation (time frame not known) and eventually died from the VZV infection. The physician also reported that the pt had also developed meningitis and pneumonia. The pt was noted ot be on high dose prednisone and had not been vaccinated with varicella virus vaccine live. The physician did not know how the pt could have been exposed since she had been in the hospital. The physician noted that the hospital did have an isolate that had grown VZV. The physician was interested in confirming the strain of VZV in case of pt had been exposed to someone who was vaccinated with varicella virus vaccine live. Upon internal review, meningitis was considered to be an other important medical event (OMIC). Additional info has been requested. The autopsy report received on 2/18/04 states hypotension, bradycardia, cardiac arrest, pulmonary edema and bronchitis. Results of PCR testing revealed that the patient had wild-type VZV infection. The physician also reported that another patient developed herpes zoster after being vaccinated with varicella virus vaccine live (WAES #0312USA01103). Additional information has been requested. No further information is available.


VAERS ID: 214424 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2003-12-17
Entered: 2003-12-29
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 4 - / -

Administered by: Military       Purchased by: Military
Symptoms: Completed suicide
SMQs:, Suicide/self-injury (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: 03AV0042

Write-up: A serviceman hung himself the day after he was given his fourth AVA dose.


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: 214677 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Alaska  
Vaccinated:2003-12-18
Onset:2003-12-22
   Days after vaccination:4
Submitted: 2003-12-30
   Days after onset:8
Entered: 2004-01-07
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 616A2 / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0451N / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1619 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493268 / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Umbilical hernia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby present D.O.A. to ER 4 days after vaccine admin. Was healthy and behaving normal several hours prior to death. The autopsy report received on 1/14/04 states SIDS.


VAERS ID: 214713 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:1998-11-16
Onset:0000-00-00
Submitted: 2004-01-02
Entered: 2004-01-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1015H / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Medication error, Unevaluable event
SMQs:, Medication errors (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:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0312USA02392

Write-up: Information has been received from an attorney indicating that on an 11/16/98 a pt was vaccinated with a dose of hep B virus vaccine. It was also reported that, on 11/16/98, the pt was vaccinated with a dose of hep B virus vaccine and Hib conj vaccine (622469/1015H). Subsequently the pt experienced death. The cause of death was not reported. Additional info will be provided as it becomes available.


VAERS ID: 214715 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:1998-06-02
Onset:0000-00-00
Submitted: 2004-01-02
Entered: 2004-01-08
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0238E / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0312USA02390

Write-up: Information has been received from an attorney concerning a pt who on 6/2/98 was vaccinated with a dose of hep B virus vaccine. Other reported vaccinations included a dose of MMR II (620003/0238E). Subsequently the pt experienced death. The cause of death was death unexplained. Additional info will be provided as it becomes available.


VAERS ID: 214944 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Florida  
Vaccinated:2002-11-06
Onset:2003-03-09
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2004-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0921DA / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-03-09
   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: Cozaar; Celebrex; Digoxin; Neurontin
Current Illness:
Preexisting Conditions: HTN; CHF; Back pain - laminectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200300660

Write-up: A male (unknown age) received RSV vaccine or Placebo and Influenza vaccine on 11/6/02 and later died (unknown date). The subject was lost to follow up. The phone was disconnected and certified letter returned with deceased 11/3/03 written on the envelope unopened. Will try and get information from PCP and follow up. Patient has a history of Hypertension, CHF, and back pain. Information from 5/15/03 telephone conversation with the Investigation. A 67 year old male, no family, has tried calling patient''s family physician who is not available. The subject was called for follow up, found phone disconnected, then a certified letter was sent which was returned with deceased marked on it. Further information is expected. Follow up information received on 6/5/03. Investigator spoke to subjects doctor on 5/20/03, stated that he did not know his patient had passed away. Doctor does not know what happened or which hospital patient went to. No other information available. Additional information received on 1/12/04. Death certificate. DOB 4/22/35. Subject died on 3/9/03, 123 days post immunization. The state does not release cause of death information. Follow up on 01/21/04 : "The death was reported by the investigator as not related to the study vaccine. Subject died 03/09/03. Cause of death is unknown. Symptoms and treatment related to the serious adverse events are unknown. Subject had a history of hypertension and congestive heart failure. No further information is available."


VAERS ID: 215228 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Oklahoma  
Vaccinated:2003-09-25
Onset:2003-10-13
   Days after vaccination:18
Submitted: 2004-01-16
   Days after onset:95
Entered: 2004-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 596C9 / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA876AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0869 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493262 / 2 RL / 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: 2003-10-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient finished last dosage of Zithromax on the morning of 9/25/2003.
Current Illness: Allergies
Preexisting Conditions: Patient was diagnosed with seasonal allergies 1 week prior to vaccination.
Allergies:
Diagnostic Lab Data: Autopsy-SIDS.
CDC Split Type:

Write-up: She received her vaccinations on 9/25/03 and passed away on 10/13/03. The autopsy report received on 1/29/04 states SIDS.


VAERS ID: 215585 (history)  
Form: Version 1.0  
Age: 90.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2003-12-26
Onset:2003-12-26
   Days after vaccination:0
Submitted: 2004-01-23
   Days after onset:28
Entered: 2004-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0925N / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Convulsion, Dehydration, Dyspnoea, Respiratory failure, Restlessness, Tachycardia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Convulsions (narrow), Akathisia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-27
   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: Recephin, Zithromax, Vasotec, Furosemide, Protonix, Norvasc, Plavix, ASA, NTG patch, KCl, Dulcolax, Dilantin
Current Illness: Pneumonia
Preexisting Conditions: Nausea, vomiting, wheezing, chronic renal failure, CHF, depression, HTN, breaast CA, ovarian CA, mitral valve insufficiency, Cardiomyopathy, Kidney failure.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shortness of breath, had to increase to non-rebreather mask. Restlessness and 2 seizures. The hospital discharge summary received on 2/3/04 states seizure, tachycardia, respiratory failure, and dehydration.


VAERS ID: 215541 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Minnesota  
Vaccinated:1981-01-15
Onset:1981-01-15
   Days after vaccination:0
Submitted: 2004-01-19
   Days after onset:8404
Entered: 2004-01-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Public       Purchased by: Other
Symptoms: Brain oedema
SMQs:, Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1981-01-15
   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:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was pronounced dead 3 1/2 hrs after his DPT shot. He was mis-diagnosed a SIDS death and then amended to cerebral edema-probable cause-DPT.


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: 215731 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Unknown  
Vaccinated:2000-07-27
Onset:2000-11-06
   Days after vaccination:102
Submitted: 2004-01-27
   Days after onset:1177
Entered: 2004-01-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 956A2 / 3 LL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0494K / 3 RL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 591403A / 3 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472542 / 2 RL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anorexia, Apnoea, Cerebrovascular disorder, Coma, Cyanosis, Pulmonary congestion, Pulmonary oedema, Salivary hypersecretion, Somnolence, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-06
   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:
Current Illness:
Preexisting Conditions: Drug Hypersensitivity
Allergies:
Diagnostic Lab Data: Toxicology test negative blood toxicology screen
CDC Split Type: HQ9439613DEC2001

Write-up: This report of SIDS is being submitted in an expedited time frame was requested by the FDA. Follow up information received from the investigator provided the autopsy results and coroner''s report. Information regarding Prevnar was received from an investigator regarding a 9 month old male participant in a Prevnar Post-Marketing Safety Surveillance Trial. At 6 months of age, the participant received the second dose of Prevnar on 7/27/00. The patient''s concurrent illness includes drug hypersensitivity. The infant had not been eating and was sluggish for a few days prior to his death. Indication for Prevnar was immunization. Product was administered on 7/27/00. Dose regimen was 1 dose. Concomitant therapy included Hib-TITER, Infanrix, and Recombivax-HB. On 11/6/00, the infant was found unresponsive by his mother about twenty minutes after he was put down for a nap. He was blue, and not breathing. The coroner''s report stated that there was foam coming out of his nose and mouth. Emergency services were called and resuscitation was attempted. He was seen an emergency room where resuscitation efforts continued unsuccessfully. The infant was pronounced dead on 11/6/00 at 4:10 PM. The autopsy report indicated the infant had pulmonary edema and congestion, visceral organ congestion, and cerebral flattening. The infant had no congenital anomalies. The autopsy report stated that the cause of death was unexpected sudden death in a 9 month old infant. The coroner''s report indicated that the pathologist reported the cause of death as sudden infant death. Toxicology test (results: negative blood toxicology screen) was done on 11/7/00. The investigator and medical monitor considered sudden infant death syndrome (expected as per US package insert) was not related to study vaccine administration.


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

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

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

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


VAERS ID: 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: 215919 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Missouri  
Vaccinated:2003-12-09
Onset:2003-12-11
   Days after vaccination:2
Submitted: 2004-01-29
   Days after onset:49
Entered: 2004-02-04
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA859AA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0100N / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493264 / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0544N / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-11
   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: Allergic to PCN
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: None. Had diarrhea 2 weeks before.


VAERS ID: 215994 (history)  
Form: Version 1.0  
Age: 0.76  
Sex: Female  
Location: Michigan  
Vaccinated:2004-01-26
Onset:2004-02-03
   Days after vaccination:8
Submitted: 2004-02-04
   Days after onset:1
Entered: 2004-02-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0467N / 3 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0367 / 3 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Asphyxia, Hypoxia
SMQs:, Asthma/bronchospasm (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-03
   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: Cefzil
Current Illness: Right otitis media
Preexisting Conditions: Jaundice as newborn
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Per EMS, found face down in crib not breathing. CPR initiated. Patient intubated and received O2, epinephrine 2 times, Atropine 1 time per ER record. Autopsy Report received on 4/27/2004 states COD was suffocation.


VAERS ID: 216188 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Washington  
Vaccinated:2003-12-29
Onset:2003-12-30
   Days after vaccination:1
Submitted: 2004-02-03
   Days after onset:35
Entered: 2004-02-09
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1526AA / 2 - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UE02AA / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Candidiasis, Ear disorder, Rash, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Neonatal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: Synagis
Current Illness: Mild URI 1 week prior.
Preexisting Conditions: 36 weeks gestation at birth; Apnea as neonate
Allergies:
Diagnostic Lab Data: Autopsy status is unknown.
CDC Split Type: 200400416

Write-up: It was reported that a four-month-old male pt received Daptacel, C1526AA; Hib vaccine, UE02AA; and Synagis, TA5370B administered on 12/29/03. The next morning, the pt was found dead in bed with the mother. She had taken the child to bed with her at 7:30 am that morning and found him lifeless at 10:30 am. The autopsy status is unknown. The autopsy report received on 3/23/04 states SIDS. Oral thrush, diaper rash, plugged ear duct. From additional information received from another manufacturer, their reference number WAES0402USA00439, was provided. No new medical information was reported. From additional information received on 14/Apr/2004 from a health care professional, the patient''s birth weight, number of siblings, place of vaccination and how the vaccine was purchased were reported. No now medical information was provided.


VAERS ID: 216343 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Female  
Location: Unknown  
Vaccinated:2002-05-20
Onset:2003-04-10
   Days after vaccination:325
Submitted: 2004-02-10
   Days after onset:306
Entered: 2004-02-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5248A2 / 3 RL / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5295A2 / 3 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA646AA / 3 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484198 / 3 LL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Neoplasm, Nervous system disorder, Pulmonary congestion, Pulmonary oedema, Unevaluable event
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-04-10
   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:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Toxicologic test negative: was done on 10APR2003. An x-ray performed during autopsy revealed a large cellous formation with catzo-chondroid formation, fibrous tissue proliferation and calcification of osteioid.
CDC Split Type: HQWYE851206FEB04

Write-up: Information regarding Prevnar was received from an investigator regarding a 16 month old female participant in the Prevnar Post-Marketing Safety Surveillance Trial, "Post-Marketing Evaluation of Prevnar Pneumococcal 7-Valent Conjugate vaccine: Safety of Prevnar Administered Concurrently with Routine Infant Vaccinations at 2, 4, 6, and 12 to 15 Months of Age," who died as a result of SIDS-like syndrome. The child received the third dose on 5/20/02, at 6 months of age. On 4/10/03, the pt experienced SIDS-like syndrome. The reporter indicated that the "coroner''s report (pending paperwork) states the cause of death is not explainable due to findings; too old for SIDS." No additional info was available at the time of this report. Both the investigator and the medical monitor assessed the SIDS as "not related" to the study vaccine. No additional info was available at the date of this report. Follow Up: On 10APR2003, at approximatley 1530 hours to 1545 hours, the child was found unresponsive by a day care worker. The 911 system was activated and the paramedics responded. The child was taken to an emergency room; efforts to resuscitate her failed. At 1642, she was pronounced dead. The coronoer''s reported cause of death was "not explainable due to findings; too old for SIDS." On 11Apr2003, at approximately 1530 hours to 1545 hours, the child was found unresponsive by a day care worker. The 911 system was activated and the paramedics responded. The child was taken to an emergency room; efforts to resuscitate her failed. At 1642, she was pronounced dead. The coroner''s reported cause of death was "not explainable due to findings; too old for SIDS." On 11APR2003, an autopsy was performed; the results revealed a clinical hisotry of listlessness and tirednes. The autopsy anatomical diagnoses included "cerebral flattening, pulmonary edema and congestion, no congenital anomalies, and a healing fracture of right clavicle." The coroner''s autopsy reported cause of death was reported as "anatomic and toxicologic findings insufficient to explain death in a child with a healing fracture of right clavicle." The investigator indicated that the cause of death was "SIDS-like syndrome."


VAERS ID: 216344 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Unknown  
Vaccinated:2000-11-28
Onset:2000-12-01
   Days after vaccination:3
Submitted: 2004-02-10
   Days after onset:1166
Entered: 2004-02-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 77042 / 1 LL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1376K / 1 LL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 473006 / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0118 / 1 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 471226 / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-01
   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: Medical history: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Toxicologic test 04 Dec 2000 negative for ethanol, opiates (morphine/ codeine), cocaine and/or metabolite, phenocyclidine, amd methamphetamine. No common alcohols, ketonen, barbiturates, meprobamate, glutuethimide, phenytoin, acetaminophen, salicylates, diatepan, nordiazepam, methaqualone, or chlordiazepoxide were recovered.
CDC Split Type: HQWYE863209FEB04

Write-up: This report of SIDS is being submitted in an expedited time frame as requested by the FDA. Information regarding Prevnar was received from an investigator regarding a 2 month old female participant in a post marketing evaluation of Prevnar. The child received the first dose on 11/28/00, at 2 months of age. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 11/28/00. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Infanrix vaccine, IPOL, vaccine, and Recombivax HB vaccine. On 12/1/00, four days post immunization, the patient experienced SIDS. According to the coroner''s office, the cause of death was reported as SIDS. Both the investigator and the medical monitor assessed the SIDS as remotely possibly related to the study vaccine. On 2/2/04, additional documentation regarding this event has been requested by the investigator. Additional information received on 11-Feb-2004 provide autopysy results. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm 197 protein) Injection) was received from an investigator regarding a 2 month old female participant in a surveillance trial. Safter of Prevnar administered concurrently with routing infant vaccinations at 2, 4, 6 and 12 to 15 months of age who died as a result of an unexpected sudden death. The child received the first dose on 28-Nov-2003, at 2 months of age.


VAERS ID: 216345 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Unknown  
Vaccinated:2003-02-03
Onset:2003-02-07
   Days after vaccination:4
Submitted: 2004-02-10
   Days after onset:368
Entered: 2004-02-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (TRIHIBIT) / SANOFI PASTEUR - / 2 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491176 / 2 RL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coma, Pathological fracture, Petechiae, Sudden infant death syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Osteoporosis/osteopenia (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-02-07
   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:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: On 2/10/03, an autopsy was performed and revealed petechiae of the thymus. The autopsy reported the cause of death as SIDS. Toxicologic test results revealed no common acidic, neutral or basic drugs were detected; no blood ethyl alcohol or other alcohols or acetone were detected; and no analgesics or barbiturates were detected by specific drug assay.
CDC Split Type: HQWYE853106FEB04

Write-up: this report of SIDS is being submitted in an expedited time frame as requested by the FDA. Information regarding Prevnar was received from an investigator regarding a 4 month old female participant in a post-marketing safety surveillance trial who died as a result of SIDS. The child received the second dose on 2/3/03. The baby had no medical history. The mother reported her child had been sick recently with diarrhea and vomiting. Indication for Prevnar was immunization. Product was administered on 2/3/03. Dose regimen was 1 dose. Concomitant therapy included Pentacel. On 2/7/03, 4 days post immunization, at approximately 0920 hours, the child was found unresponsive. Emergency services was called and emergency personnel responded and started life saving measures. The child was transported to a hospital and life saving measures were continued. The child was pronounced dead on 2/7/03 at approximately 0945 hours. On 2/10/03, an autopsy was performed and revealed petechiae on the thymus. The autopsy reported the cause of death as SIDS. On 2/10/03, toxicologic test results revealed no common acidic, neutral or basic drugs were detected; no blood ethyl alcohol or other alcohols or acetone were detected; and no analgesics or barbiturates were detected by specific drug assay. The cause of death was reported as provisional SIDS and the autopsy cause of death was sudden infant death syndrome. Both the investigator and the medical monitor assessed the SIDS as remotely possibly related to the study vaccine. No additional information was available at the date of this report. The autopsy report received on 2/26/04 states healing fx of clavicle.


VAERS ID: 216430 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Indiana  
Vaccinated:2003-11-19
Onset:2003-11-20
   Days after vaccination:1
Submitted: 2004-02-11
   Days after onset:83
Entered: 2004-02-16
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0986N / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardiac failure congestive, Cellulitis, Dyspnoea, Injection site erythema, Injection site swelling, Injection site vesicles, Pyrexia, Stupor, Viral infection
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (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), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-01
   Days after onset: 42
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, anemia, Hypothyroidism
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0312USA01440

Write-up: Information has been received from al licensed practical nurse concerning 5 female patient''s, all over 60 years old with some 70 to 80 years old, all with medical history, who in 2003 were each vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). All of the patients had concomitant medications. At least two of the patient''s received a prior dose of pneumococcal 23v polysaccharide vaccine. Subsequently in 2003, the patient''s developed injection site reactions the size of a saucer that were red and inflamed. Unspecified medical attention was sought. Subsequently, all of the patients fully recovered. A product quality complaint was not involved. The reporter stated the doctor was concerned because all patients received the same lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. One of the female patients had a larger injection site reaction that also included blisters. This patient was treated with sulfamethoxazole (+) trimethoprim bid for seven days. Follow up information received from the licensed practical nurse concerning the female patient treated with sulfamethoxazole (+) trimethoprim. The patient was an 86 year old Caucasian female patient with COPD, HTN, anemia, hypothyroidism and PVD who on 11/19/03 at 13:00 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). There was no illness at the time of vaccination. On 11/20/03 at 15:45, the patient developed red, swollen, cellulitis and was treated with sulfamethoxazole (+) trimethoprim. On 1/1/04, the patient died from congested heart failure. Cellulitis was considered to be an other important medical event (OMIC). One of the other female patients was treated with cephalexin. Another one of the female patient received no treatment. The remaining two female patients were treated with diphenhydramine hydrochloride and cold packs. Additional information is not expected. The hospital discharge summary received on 2/18/04 states influenza, fever, respiraotry distress, and altered mental status.


VAERS ID: 216433 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2002-01-01
Onset:2002-03-01
   Days after vaccination:59
Submitted: 2004-02-12
   Days after onset:713
Entered: 2004-02-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Dyspnoea, Lung neoplasm malignant, Pericardial effusion, Pleural effusion
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (narrow), 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: 2003-01-27
   Days after onset: 332
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: Mesothelioma
CDC Split Type: HQWYE845405FEB04

Write-up: Information regarding Orimune Vaccine (poliovirus vaccine live oral trivalent solution) (manufacturer unknown) was received from an attorney regarding a male patient who experienced mesothelioma. The patient received a dose on an unspecified date sometime during 1959 or in the early 1960''s. Relevant medical history was not provided. Indication for Orimune vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. On or about 3/02, the decedent was reportedly diagnosed with mesothelioma. The decedent''s history included exposure to asbestos and asbestos-containing products. The legal complaint states that the decedent''s exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. On 1/27/03, he died. The death certificate received on 2/19/04 states respiraotry failure, pleural effusion and pericardial effusion.


VAERS ID: 216434 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Unknown  
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: 216435 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Virginia  
Vaccinated:2004-02-02
Onset:2004-02-05
   Days after vaccination:3
Submitted: 2004-02-06
   Days after onset:1
Entered: 2004-02-16
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 616A2 / 1 - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA874AA / 1 - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1440 / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493472 / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-05
   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: GERD and mild eczema
Allergies:
Diagnostic Lab Data: 1/20 viral respiratory infection - RSV negative
CDC Split Type:

Write-up: The autopsy report received on 3/30/04 states SIDS.


VAERS ID: 216476 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Kentucky  
Vaccinated:2004-02-05
Onset:0000-00-00
Submitted: 2004-02-12
Entered: 2004-02-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 602A2 / 3 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495161 / 3 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none known
Preexisting Conditions: Tx with antibiotic through private MD
Allergies:
Diagnostic Lab Data: Coroner informed me of SIDS death
CDC Split Type: KY2004010

Write-up: No adverse event form immunizations, but baby died with report of SIDS


VAERS ID: 216572 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Colorado  
Vaccinated:2003-11-04
Onset:2003-11-05
   Days after vaccination:1
Submitted: 2004-01-03
   Days after onset:59
Entered: 2004-02-17
   Days after submission:45
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21912AZ / 1 RL / SC
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0663N / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493266 / 1 LL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-05
   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: recovering URI
Preexisting Conditions: prematurity, twin infant
Allergies:
Diagnostic Lab Data: Autopsy: "cause undetermined"
CDC Split Type: C0030044

Write-up: Pt. given first set of immunizations. Found dead at 8am the next morning. Autopsy shows cause "undetermined".


VAERS ID: 216479 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Florida  
Vaccinated:2004-02-11
Onset:2004-02-15
   Days after vaccination:4
Submitted: 2004-02-15
   Days after onset:0
Entered: 2004-02-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U10060A / 1 RL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0367N / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0626 / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-15
   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:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Presumed SIDS 2/15/04 hospital ER. 3/30/05 Autopsy report received which revealed COD as probable SIDS.


VAERS ID: 216583 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: California  
Vaccinated:2004-02-13
Onset:2004-02-14
   Days after vaccination:1
Submitted: 2004-02-17
   Days after onset:3
Entered: 2004-02-19
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495207 / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Coma, Feeling hot, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-14
   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: NONE
Current Illness: Mild nasal congestion
Preexisting Conditions: Recent treatment for otitis media
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Infant found lifeless at 08-830 2/15/04 by pm. Infant fed at around 230 am. Reported to be doing fine except feel warm that afternoon after shot. Autopsy report received on 6/14/2004 states COD was SIDS.


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: 216654 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Female  
Location: Connecticut  
Vaccinated:2004-01-09
Onset:2004-01-13
   Days after vaccination:4
Submitted: 2004-02-19
   Days after onset:37
Entered: 2004-02-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21895A2 / 1 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE096AA / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493377 / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Atelectasis, Autopsy, Blood caffeine, Cardiac arrest, Cyanosis, Peripheral coldness, Pulse absent, Respiratory arrest, Resuscitation, Sudden infant death syndrome, Tracheal haemorrhage, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE No concurrent medication
Current Illness: NONE Unknown
Preexisting Conditions: NONE No relevant medical history. One sibling.
Allergies:
Diagnostic Lab Data: Autopsy report: Autopsy showed patchy anterior livor of inguinal region, a band of livor across the bridge of the nose. No petechial hemorrhages of thymus, pericardia, or pleura noted. An abundant amount of prevertebral fascial hemorrhage was noted. There was no evidence of fracture. Lung sections revealed diffuse atelectasis and alveolocapillary congestion. Cross-section of trachea revealed hemorrhage laterally and posteriorly within the soft tissues around the esophagus. Gas chromatography of brain tissue revealed the presence of caffeine. Cause of death determined to be Sudden Infant Death syndrome.
CDC Split Type: CT200403

Write-up: Child was laughing and playing; nothing abnormal. Went down to nap and approximately 1.5 hours later he was found unresponsive in his crib. Was taken to ER and pronounced dead. Autopsy report on 04/28/04 states: SIDS. This report was received from the Centers for Disease Control (CDC) in response to a Freedom-of-Information request by GSK. This case was reported by the Centers for Disease Control and described the occurrence of sudden death infant death syndrome in a 3-month-old female patient who had received PEDIARIX. The Centers for Disease received the report from the Department of Health (Ref. No. CT 2004-03). There was no relevant medical history. On 09 January 2004, the patient received the first dose of PEDIARIX (GlaxoSmithKline lot number 21895A2). Co-administered vaccinations on that dat included ACTHIB (Aventis Pasteur) and PREVNAR (Lederle Laboratories). On 13 January 2004, four days after vaccination, the child was laughing and playing. Nothing abnormal was noticed. The child was put down for a nap. One and one-half hours later, the child was found unresponsive in the crib. The child was taken to the emergency room and upon arrival she was cold, cyanotic, pulseless, and asystolic. She was not breathing. Despite resuscitation attempts (cardiopulmonary resuscitation, advanced cardiac life support, bilateral needle thoracotomy), she was pronounced dead at 1746. Causality was not reported. An autopsy report stated there was no evidence of trauma or significant natural disease processes. Gas chromatography of brain tissue revealed the presence of caffeine. The report identified Sudden Infant Death syndrome as the cause of death.


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: 216742 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: North Carolina  
Vaccinated:2004-02-17
Onset:2004-02-18
   Days after vaccination:1
Submitted: 2004-02-19
   Days after onset:1
Entered: 2004-02-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1028AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0465N / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE027AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0146 / 1 RL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-18
   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:
Current Illness: NONE
Preexisting Conditions: Respiratory distress, hypoalbuminuria, anemia, hypokalemia-resolved
Allergies:
Diagnostic Lab Data: Preliminary autopsy results-SIDS.
CDC Split Type:

Write-up: None stated. Autopsy report on 05/05/04 states: SIDS.


VAERS ID: 217129 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Male  
Location: California  
Vaccinated:2004-02-26
Onset:2004-02-26
   Days after vaccination:0
Submitted: 2004-03-02
   Days after onset:5
Entered: 2004-03-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21893B9 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0915N / 2 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0178N / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493505 / 2 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0196N / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Adrenal haemorrhage, Bacterial infection, Crying, Heart disease congenital, Pyrexia, Sepsis, Shock, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Congenital, familial and genetic disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: 2004-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin 1/2 tab per day (baby Aspirin)
Current Illness: NONE
Preexisting Conditions: Cardiac heterotaxy; Dextrocardia; Complete AV Septal defect; Pulmonary Atresia
Allergies:
Diagnostic Lab Data: blood culture (+) for streptococcus pneumoniae;
CDC Split Type:

Write-up: According to family, 3 hours after immunizations given, patient had vomiting and temperature of 103. Arrived in ER 2/26/04 at 21:15; temp was 106 rectally. C/C to ER; was crying, fever, vomiting. Died 2/26/04 at 23:58. The hospital discharge summary received on 3/23/04 states meningococcaemia/ sepsis and congenital heart dx. Nurse follow up on 09/21/04 states: "septic shock, adrenal hemorrhage."


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: 217542 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Kentucky  
Vaccinated:2004-02-24
Onset:2004-02-28
   Days after vaccination:4
Submitted: 2004-03-01
   Days after onset:2
Entered: 2004-03-08
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21918D2 / 1 RL / ID
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495161 / 1 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Coma, Sudden infant death syndrome
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-28
   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: n/a
Preexisting Conditions: none-reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY2004015

Write-up: Baby found by mother in am, nonresponsive. Nurse follow up on 05/18/04 states: SIDS.


VAERS ID: 217543 (history)  
Form: Version 1.0  
Age: 0.0  
Sex: Male  
Location: Florida  
Vaccinated:2000-07-19
Onset:2000-08-02
   Days after vaccination:14
Submitted: 2004-03-08
   Days after onset:1314
Entered: 2004-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (DITANRIX) / GLAXOSMITHKLINE BIOLOGICALS 956A2 / 2 RL / IM
HBPV: HIB POLYSACCHARIDE (HIBIMUNE) / PFIZER/WYETH 468487 / 2 LL / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3198A2 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 1433 / 2 RL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Convulsion, Injury, Irritability, Pyrexia, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-08-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: sinus infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 14 days child had fussiness,fever,vomiting ,Seizures, respiratory arrest. Child passed on August 10,2000.Caregiver charged with infants death. Case being appealed. Per autopsy report, cause of death was shaken baby syndrome.


VAERS ID: 217395 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-03-05
Entered: 2004-03-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Dyspnoea, Lung disorder, Neoplasm malignant
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 (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-25
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: Reported cause of death: mesothelioma, cardio-respiratory arrest.
CDC Split Type: HQWYE347125FEB04

Write-up: Information regarding poliovirus vaccine live oral trivalent solution was received from an attorney regarding a male pt who experienced mesothelioma and cardiopulmonary arrest. The pt received a dose of polio vaccine in the "1980s." On or about December 1997, the decedent was diagnosed with mesothelioma. The decedent''s history includes exposure to asbestos and asbestos-containing products. The legal complaint states that the "descendent''s exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the descendent including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage." On 3/25/01, he died. The death certificate indicates mesothelioma and cardiopulmonary arrest as the cause of death.


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: 217666 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2002-11-02
Onset:2002-11-03
   Days after vaccination:1
Submitted: 2004-03-11
   Days after onset:494
Entered: 2004-03-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR V0929AA / UNK RA / -

Administered by: Private       Purchased by: Other
Symptoms: Cerebrovascular accident, Chills, Diarrhoea, Erythema, Headache, Myocardial infarction, Paralysis, Peripheral coldness, Pneumonia, Pyrexia, Urinary tract infection, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-08-04
   Days after onset: 273
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: Cholesterol; Blood pressure; Blood thinner; Water pill
Current Illness: NONE
Preexisting Conditions: HBP; Retroperiteneal fibrosis; High cholesterol; Swelling of the leg
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection was given Saturday morning, 11/2/02. Sunday night around 11 or so, started throwing up, fever diarrhea, chills, headache. He continued getting up, going to the restroom with the vomiting and diarrhea until about 10am Monday morning 11/4/02. He told my mom sometime later that he could not move his legs. I went to their house around 2:30 PM. Upon entering his room, he was laying in bed on top of the covers. I felt his foot and ankle, they were cool to the touch. I felt his back when he was trying to sit up and it was burning hot. His face was red. He was speaking. He wanted my son and I to help him get up. We were unable to lift him. I called a nurse friend of mine at 2:55 PM to have her stop by and take his blood pressure and kind of check him over. While I was on the phone with her, my mom yelled for me to call an ambulance. It took the ambulance about 5-10 minutes to get to their home. Dad was speaking to the paramedics, telling them what all was going on. They loaded him into the ambulance and he was still alert and speaking. Somewhere in the 2-3 minute trip to the emergency room, my dad died. Upon entering the emergency room, they had made it a code blue call and continued working on him. The ER doctor worked on dad until 6:00 PM when he was life flighted to another hospital. He was taken to ICU where we were told by the doctors they did not know if he would make it through the night. He was in ICU for 7 days. The doctors ran several tests. During this time, we learned that he had become paralyzed from the waist down, he had a spinal stroke, a head stroke and they were not sure if any damage had been done when he actually died (lack of oxygen to the brain). After 2 weeks in the hospital, dad was moved to a rehab center, from there to a skilled nursing facility and from there, home. Over the next 8.5 months, dad was in and out of the hospital. The longest time between hospital stays was 35 days. On 7/1/03, dad was taken to the hospital for fever. He had a UTI. He was in the hospital for about 10 days and they could not figure out why he kept running a fever at night. He was transferred to another hospital. He was given an injection and it reacted with the medication they had him on, he went into rigors, had a massive heart attack and died on 8/4/03. The death certificate received on 3/23/04 states pontine stroke and pneumonia.


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: 217870 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-03-12
Entered: 2004-03-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Ascites, Drug ineffective, Glomerulonephritis, Hepatic necrosis, Hepatitis, Hypertension, Laboratory test abnormal, Myocardial infarction, Myocardial ischaemia, Pleural effusion, Pneumonia, Pulmonary oedema, Renal failure, Sepsis, Shock, Skin ulcer, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Steroids
Current Illness:
Preexisting Conditions: Chronic renal disease
Allergies:
Diagnostic Lab Data: Autopsy-liver had intra nuclear inclusion bodies in the hepatic cells. VZV strain-identified in liver and kidneys. Diagnostic lab (01/08/04): DFA-negative for VZV and HSV; Epstein-Barr virus (12/13/03): positive; VZV strain: VZV identified in liver and kidneys;
CDC Split Type: WAES0403USA00348

Write-up: Information has been received from a physician concerning a 9 year old female who in approximately 1998 at the approximate age of 12-15 months was vaccinated with a dose of varicella virus vaccine live. It was noted that the child had been healthy until about two to three years ago (approximately 2001 to 2002) when she developed chronic glomerulonephritis. It was also noted that she had chronic renal insufficiency. Her condition was relatively stable, however, "shortly after Christmas in early January," she had an exacerbation of her glomerulonephritis. Her physician was concerned about her decreasing renal function adn treated her with a bolus of steroids (also reported as "was placed on very high dose of steroids"). About one week prior to receiving the steroids, she had been exposed to a child who had chickenpox. Subsequently, the pt developed severe varicella, although clinically had few skin lesions (also reported as a case of breakthrough chickenpox). About one week after receiving the steroids, the child was hospitalized with a rapidly progressive severe hepatitis that progressed to hepatic necrosis. It was also reported that the pt developed pneumonia. In approximately February 2004, "about a month ago," the pt died of a disseminated varicella infection with the primary mode of death being from the hepatitis (hepatic necrosis). Post mortum evaluation revealed that the liver had intra nuclear inclusion bodies in the hepatic cells. A VZV virus was identified in her liver and kidneys. Upon internal medical review chronic renal insufficiency, chronic glomerulonephritis, hepatic necrosis and pneumonia were considered to be other important medical events (OMIC). Additional info has been requested. Follow-up from physician on 6/22/04: "There is no documentation of varicella immunization and therefore no reasonable evidence that a vaccine failure has occurred." Follow up on 07/19/04 states: "Follow-up information from the physician indicated that the pt died at the hospital on 01/12/04 following an acute, severe illness characterized by a progressive papulovesicular rash that first appeared on 01/05/04, hepatitic failure and diffuse coagulopathy. The pt had an underlying ANA positive glomerulonephritis that was first diagnosed in Feb 2002 and had been maintained in good control with low doses of immunosuppressive therapy. On 12/25/03 she developed an acute exacerbation characterized by gross hematuria, periorbital edema and rising creatinine. She had been generally well prior to this time except for a history of a persistent cough for about two months and a recent febrile illness diagnosed as mononucleosis on the basis of a positive monospot test on 12/13/03. She received a brief course of prednisone in a dose of 60mg/day for 4 days as treatment for mononucleosis. Subsequently she had significant indoor exposure to chickenpox on 12/22/03. On 12/28/08 she was admitted to the hospital and started on a three day course of IV methylprednisolone sodium soccunate (solu-medrol) at a dose of 500mg per day. Despite a rocky course requiring admission to the PICU for management of hypertension, electrolyte abnormalities, and a diminishing renal function, she slowly improved and was discharged on 01/04/04. She remained relatively stable at home until readmitted on 01/08/04 with her terminal illness. The DFA stain obtained on 01/08/04 from one of the vesicular lesions was negative for VZV and HSV antigen. However her progressive illness was characteristic of disseminated varicella and this diagnosis was confirmed postmortem by demonstration of VZV DNA in the kidney and other tissues. Throughout her chart is was recorded by several physicians that her immunizations were "up to date" and it was noted that she had receoved varicella vaccine at some point in the past. The pt''s primary care physican indicated that she did not receive the varicella vaccine at his practice where she was a pt a since birth. Her hospital medical record contains an immunization record with no enteries. The pt''s father and mother thought that the pt received the chickenpox vaccine but they could not recall which provider or what medical institution and they did not have an immunization record at home. Follow-up from physician states: "There is no documentation of varicella immunization and therefore no reasonable evidence that a vaccine failure has occurred."Additional follow up information indicated that neither the physician nor the parents were interested in pursuing any additional specimen analysis. The physician reported that the pt had a known exposure to wild type varicella and that most certainly this was a case of wild type varicella in a child who had not been vaccinated. No further information is expected." 7/7/05 Autopsy report received which revealed COD to be glomerulonephritis, varicalla infection, septic shock, DIC, pulmonary edema & effusions, LV ischemia & infarct, ascites, HTN and cardiac hypertrophy.


VAERS ID: 217975 (history)  
Form: Version 1.0  
Age: 0.0  
Sex: Female  
Location: Ohio  
Vaccinated:2002-01-17
Onset:2002-01-17
   Days after vaccination:0
Submitted: 2004-03-18
   Days after onset:791
Entered: 2004-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1067L / 1 LL / IM

Administered by: Military       Purchased by: Unknown
Symptoms: Apnoea, Atelectasis, Jaundice, Lethargy, Nasal congestion, Petechiae, Sepsis
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), 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: 2002-01-18
   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: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Autopsy report Cause of Death Extensive periportal Inflammatory Infiltrate in Liver Consistent with possible sepsis with an onset of hours. Petechiae of the thymus, pulmonary Ateletisis and congestion, Icterus.
CDC Split Type:

Write-up: Patient began snorting and flaring her nostrils while breathing about 1 1/2 hours after vaccine, nurses assured us it was normal. Jaundice and lethargy began to set in around the same time and again we were told it was common and to have her checked by the peds the next day if it was worse. We were discharged to home where she continued to display above symptoms. around 3:45 am on 01/18/2002 she stopped breathing, CPR was performed by her father and then the paramedics arrived, she was taken by ambulance to hospital ER where she was pronounced dead at 4:31 a.m.


VAERS ID: 217979 (history)  
Form: Version 1.0  
Age: 42.0  
Sex: Male  
Location: Unknown  
Vaccinated:2004-03-12
Onset:2004-03-15
   Days after vaccination:3
Submitted: 2004-03-18
   Days after onset:3
Entered: 2004-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 3 - / -

Administered by: Military       Purchased by: Military
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? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown at this time
Current Illness: Unknown at this time
Preexisting Conditions: Unknown at this time
Allergies:
Diagnostic Lab Data: None available at this time`
CDC Split Type:

Write-up: 42 y/o male was brought into Aide Station in full cardiac arrest after physical training. Expired ~72 hours after receiving anthrax #3. Nurse follow up on 05/27/04 states: "Complete."


VAERS ID: 217931 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-03-31
Entered: 2004-03-19
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Cough, Drug ineffective, Haemolytic uraemic syndrome, Pneumonia, Pyrexia, Wheezing
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Renovascular disorders (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: Hemoglobin 0.6 g/dL; platelet count 20,000; white blood cell count 18,000 (20% neutrophils, 38% bands). Bacterial antigen positive: urine pneumococcal antigen positive. CT confirmed pneumonia. Mediastinoscopy results not provided. Ultrasound chest confirmed pneumonia. X-ray right lung pneumonia. The autopsy reported cause of death was hemolytic-uremic syndrome.
CDC Split Type: HQWYE774312MAR04

Write-up: Information regarding Prevnar was received from a physician regarding a 15 month old female who received a dose of Prevnar and subsequently developed hemolytic-uremic syndrome and pneumococcal pneumonia. The patient''s concurrent illness includes a history of mild asthma. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose (IM). Concomitant medications were not reported. Four days before admission, a 15 month old infant was seen by her pediatrician for cough, fever, and wheezing. She was treated with inhaled steroids. The following day, she was again evaluated by the pediatrician who ordered a chest x-ray with the results of right lung pneumonia. She was then admitted. A chest computerized tomogram and ultrasound were performed and confirmed pneumonia. A urine latex AG was performed and the results indicated urine pneumococcal antigen positive. Day 2 of hospitalization, video-assisted thoracoscopic surgery was performed; results were not provided. The reporter indicated that there were no complications of surgery. Treatment consisted of cefuroxime, azithromycin, methylprednisolone and ampicillin sodium/sulbactam. Day 3 of hospitalization brought sudden death. Laboratory tests performed at resuscitation were: hemoglobin, 0.6 g/dL; platelet count, 20,000; white blood cell count 18,000. The autopsy reported cause of death was hemolytic-uremic syndrome. The reporter indicated that this was related to likely pneumococcal infection. No additional information was available at the time of this report.


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), 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: 218169 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Unknown  
Vaccinated:1987-06-29
Onset:1987-08-07
   Days after vaccination:39
Submitted: 2004-03-22
   Days after onset:6072
Entered: 2004-03-26
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Drug ineffective, Infection, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), 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: 2000-09-19
   Days after onset: 4792
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Idiopathic thrombocytopenic purpura, splenectomy
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0403USA01533

Write-up: Information has been received regarding a case in litigation concerning an approximately 3 year old male patient with idiopathic thrombocytopenic purpura who on 6/29/87 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 8/7/87, the patient''s spleen was removed to address his idiopathic thrombocytopenic purpura condition. Despite seeing several doctors for various reasons in subsequent years, including while at times febrile, the patient did not receive any follow up or revaccination, either with his family practice provider or the local hospital. On 9/19/00 at the age of 16 years, the patient died from fulminate pneumococcal infection. Upon internal review, worsening of idiopathic thrombocytopenic purpura was considered to be an other important medical event (OMIC).


VAERS ID: 218414 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Illinois  
Vaccinated:2004-03-18
Onset:2004-03-30
   Days after vaccination:12
Submitted: 2004-03-30
   Days after onset:0
Entered: 2004-04-01
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1679AA / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1290N / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0707 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494376 / 2 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: 2004-03-30
   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: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Patient found dead in crib on 3/30/04. Other correspondence on 05/05/04 states: file complete. Autopsy Report received on 6/17/2004 states COD was SIDS.


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: 218561 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Georgia  
Vaccinated:2003-12-05
Onset:0000-00-00
Submitted: 2004-03-10
Entered: 2004-04-02
   Days after submission:23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21883B2 / 1 LL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0340N / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493266 / 1 RL / -

Administered by: Public       Purchased by: Public
Symptoms: Pyrexia, Restlessness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carbofed DM, Oral Motrin
Current Illness: cold
Preexisting Conditions: Alpha Thalassemia Trait (Bart''s)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GA04014

Write-up: Elevated temperature--103 degrees Farenheit 24 hours after. Increased restlessness.


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: 218568 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Virginia  
Vaccinated:2004-01-27
Onset:2004-02-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2004-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1625AA / UNK LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR VE096AA / UNK LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0367 / UNK RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495159 / UNK RL / -

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Encephalitis
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: 2004-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~~0.30~In Sibling
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy performed.
CDC Split Type:

Write-up: Patient died 2 weeks after receiving his 4 months immunizations. The medical examiner diagnosed him with encephalitis. He died as a result of a seizure. Prior to this, he showed no signs of distress. Nurse follow up on 05/14/04 states: Complete.


VAERS ID: 218569 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Female  
Location: Arizona  
Vaccinated:2003-12-10
Onset:0000-00-00
Submitted: 2004-03-30
Entered: 2004-04-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asphyxia
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-12-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None reported. Autopsy Report received on 4/08/2004 states COD was asphyxia.


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: 218631 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Male  
Location: California  
Vaccinated:2004-03-24
Onset:2004-03-26
   Days after vaccination:2
Submitted: 2004-03-31
   Days after onset:5
Entered: 2004-04-07
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE118AA / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495203 / 1 LL / -

Administered by: Private       Purchased by: Private
Symptoms: Acidosis, Apnoea, Cardiac arrest, Hypoxia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-28
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Iron
Current Illness: Static severe hypoxic ischemic encephalopathy
Preexisting Conditions: Severe reflux; GI Feeds
Allergies:
Diagnostic Lab Data: CBC; CH50; C3 and C4 normal
CDC Split Type:

Write-up: Death. Unsure if related to vaccine administration. Apnea and full arrest. Nurse follow up on 07/30/04 states: "hypoxia; Metabolic acidosis." Discharge Summary received on 8/02/2004 states cardiovascular arrest.


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: 218872 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Kentucky  
Vaccinated:2004-03-26
Onset:2004-03-29
   Days after vaccination:3
Submitted: 2004-04-05
   Days after onset:6
Entered: 2004-04-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21931A2 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1249N / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495227 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Bronchiolitis, Lung disorder, Pyrexia, Respiratory syncytial virus infection, Viral infection
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-02
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Kepra; Phenobarbitol
Current Illness: NONE
Preexisting Conditions: Long chain fatty acid oxidation defect; Seizure disorder; Developmental delay
Allergies:
Diagnostic Lab Data: RSV +
CDC Split Type:

Write-up: Was hospitalized on 3/29/04 for RSV Bronchiolitis. Was still in hospital when event occurred. Event not due to vaccines. Discharge summary on 04/28/04 states: fever, RSV, Bronchoplumonary dysplysia.


VAERS ID: 218903 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Kentucky  
Vaccinated:2004-03-26
Onset:2004-03-27
   Days after vaccination:1
Submitted: 2004-03-31
   Days after onset:4
Entered: 2004-04-12
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21931AZ / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1249N / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495227 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-27
   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: none
Current Illness: see #7
Preexisting Conditions: see #7
Allergies:
Diagnostic Lab Data: unknown at time of death
CDC Split Type: KY2004021

Write-up: Patient presented to an ER with Bradycardia, resuscitation was unsuccessful. I''m uncertain if this event was due to any immunizations. Pt had microcepitally and decreased tone. Also suspect abnormal male chromosome. Discharge summary on 04/28/04 states: Cardiac arrest, apnea.


VAERS ID: 219330 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Georgia  
Vaccinated:2004-04-05
Onset:0000-00-00
Submitted: 2004-04-13
Entered: 2004-04-21
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21893A9 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0340N / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494303 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-07
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:
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Infant found dead in bed 4/7/04. Autopsy investigation not complete.


VAERS ID: 219489 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Massachusetts  
Vaccinated:2004-04-16
Onset:0000-00-00
Submitted: 2004-04-20
Entered: 2004-04-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1272BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE086AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0368 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494333 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-18
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:
CDC Split Type:

Write-up: Found dead in crib after being put for nap. 4/18/04 afternoon. Autopsy results pending.


VAERS ID: 219639 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-04-27
Entered: 2004-04-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure, Cardio-respiratory arrest, Dyspnoea, Lung disorder, Lung neoplasm malignant, Neoplasm malignant, Respiratory disorder, Respiratory failure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Non-haematological malignant tumours (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-23
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: Mesothelioma; Cardiopulmonary failure; Mesotheliom acute cardiorespiratory insufficiency.
CDC Split Type: HQWYE474215APR04

Write-up: Information regarding a polio vaccine was received from an attorney regarding a male patient who received a dose of unspecified date sometime in the 1950''s. The patient was reportedly exposed to asbestos and asbestos containing products. Indication for the polio vaccine was immunization. Product was administered on an unspecified date sometime in the 1950''s. Dose regimen was 1 dose. Concomitant medications were not reported. According to the legal complaint, the patient was diagnosed with mesothelioma on or about March 2002. Reportedly, the patient received a polio vaccination that was contaminated with the SV 40 virus which was a substantial factor in the decedent''s contraction of mesothelioma. The legal complaint states that the decedent''s exposure to asbestos, asbestos-containing products, and the SV 40 virus caused severe and permanent injury to the decedent, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. On 6/23/03, the patient died. The cause of death stated in the legal complaint was acute cardio respiratory insufficiency and mesthelioma. No additional information was available at the time of this report.


VAERS ID: 219786 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Male  
Location: Idaho  
Vaccinated:2004-04-30
Onset:2004-05-01
   Days after vaccination:1
Submitted: 2004-05-01
   Days after onset:0
Entered: 2004-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 630B2 / 4 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0678N / 1 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1350N / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Coma, Cyanosis, Dyspnoea, Irritability, Mydriasis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic 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), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-05-01
   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 1/4 tab daily
Current Illness: tx for sinusitis on 4/21 with Amoxicillin, was seen 4/30, in normal state of health
Preexisting Conditions: Tetrology of Fallot with severe PS, VSD & Hypertrophied R ventricle, Double Outlet R, vent, Imperforate anus, VATER syndrome, s/p colostomy,
Allergies:
Diagnostic Lab Data: Unknown from hospital where pt coded.
CDC Split Type:

Write-up: After vaccination, pt irritable and emesis 1-2 x. No fever. Acting better by morning. Mom gave pt bottle at ~4:30 am. Pt developed respiratory difficulty at ~5-5:30 am. Dad initiated CPR and ambulance called. Pt received CPR to local hospital. Coded there for 30-45 min (not at my facility). Pronounced dead at ~6:30 am. Nurse follow up on 05/14/04 states: Unresponsive, cyanosis, pupils fixed, apneic, asystold (stupor, cyanosis, mydriasis, apnea, heart arrest).


VAERS ID: 219791 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Louisiana  
Vaccinated:2004-04-05
Onset:2004-04-06
   Days after vaccination:1
Submitted: 2004-04-16
   Days after onset:10
Entered: 2004-05-03
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21923A2 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0722N / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494331 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Lung disorder, Pulmonary oedema, Unevaluable event
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-06
   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: Nystatin Oral Suspension; Pediacare infant drops.
Current Illness: Thrush; Rhinitis; Foreskin adhesion.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Administered immunizations 4/5/04. Received call from coroner''s office stating child expired 4/6/04. No other information available. Nurse follow up on 06/14/04 states: "acute pulmonary congestion; acute pulmonary edema."


VAERS ID: 219792 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Colorado  
Vaccinated:2004-04-19
Onset:2004-04-22
   Days after vaccination:3
Submitted: 2004-04-26
   Days after onset:4
Entered: 2004-05-03
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0702 / UNK RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 494381 / UNK LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-22
   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: Oxygen per nasal cannula
Current Illness:
Preexisting Conditions: Pre-term; Hypertonia; Hypotonia; Mild developmental delays.
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Sudden infant death approximately 72 hours following receipt of vaccines. Nurse follow up on 06/18/04 states: "Add: Chronic lung dx."


VAERS ID: 219922 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Arkansas  
Vaccinated:2004-04-09
Onset:2004-04-12
   Days after vaccination:3
Submitted: 2004-05-04
   Days after onset:22
Entered: 2004-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21899C9 / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0025P / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495133 / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-12
   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: tylenol earlier in week
Current Illness: resolving viral type illness, better times 4 days
Preexisting Conditions: colic, viral syndrome, possibly coxsackie viral type illness,thrush, marked increase in crying, constipation, formula intolerance, GE Reflux on reglan and zantac, milk of magnesia
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Patient seen in prior week for viral type illness, had unremarkable CBCs, recovering fairly well, seen on 4/9/04, assessed as stable enough for shots, given standard Pediarix, Hib and Prevnar. No history known to me about weekend, taken to day care, respiratory arrest described. Taken to ER, seen by MD, resusitation unsuccessful.


VAERS ID: 219933 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: California  
Vaccinated:2003-12-26
Onset:2003-12-27
   Days after vaccination:1
Submitted: 2004-04-29
   Days after onset:123
Entered: 2004-05-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Influenza like illness, Pyrexia, Rhinitis
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: 2003-12-29
   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: UNK
Current Illness: Cough
Preexisting Conditions: URI;
Allergies:
Diagnostic Lab Data: Autopsy. Coroner''s case # 03-9897
CDC Split Type:

Write-up: Received five vaccines IM on 12/26 then developed flu-like symptoms the following day. Expired on the AM 12/29 at home. Nurse follow up on 06/21/04 states: "Fever, URI, Rhinitis."


VAERS ID: 220015 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-05-05
Entered: 2004-05-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Brain neoplasm, Brain neoplasm malignant
SMQs:, Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-03
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: Relevant cause of death brain neoplasm malignant.
CDC Split Type: HQWYE670503MAY04

Write-up: Information regarding poliovirus vaccine (manufacturer unknown) was received from an attorney regarding a female patient who experienced malignant brain tumor. The patient received vaccine. Medical History: Relevant medical history was not provided. Product Details: Indication for poliovirus vaccine was immunization. Product was administered "during the 1960''s." dose regiment was not provided. Concomitant therapy: Concomitant medications were not reported. Event Details: The attorney alleges that the polio vaccine received by the decedent contained a harmful prohibited animal virus known as Simian Virus 40 (SV 40). The Simian Virus 40 contained within the polio vaccine product was the cause of the malignant brain tumor (brain neoplasm malignant) that caused the death of the decendent. The decendent died on 03-Dec-2001. No additional information was available at the time of this report.


VAERS ID: 220185 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-05-10
Entered: 2004-05-12
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Brain neoplasm malignant, Malaise, Neoplasm malignant, Viral infection
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-26
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: Brain neoplasm malignant; Malignant brain tumor.
CDC Split Type: HQWYE670303MAY04

Write-up: Information regarding poliovirus vaccine live oral trivalent solution was received from an attorney regarding a deceased female who received a dose on an unspecified date. Relevant medical history was not provided. Indication for Orimune vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. An attorney alleges that the polio vaccine received by the decedent contained a harmful prohibited animal virus known as Simian Virus 40 (SV40). The attorney also alleges that the decedent became ill with Simian Virus 40 -related disease, including malignant brain cancer, and subsequently died on 1/26/02. No additional information was available at the time of this report.


VAERS ID: 220268 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2004-05-11
Entered: 2004-05-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Brain neoplasm malignant, Viral infection
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-18
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: Brain neoplasm malignant, malignant brain tumor
CDC Split Type: HQWYE710105MAY04

Write-up: Information regarding poliovirus vaccine live oral trivalent solution was received from an attorney regarding a deceased male who received a dose on an unspecified date. Relevant medical history was not provided. Indication for Orimune vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. An attorney alleges that the polio vaccine received by the decedent contained a harmful prohibited animal virus known as Simian Virus 40 (SV40). The attorney also alleges that the decedent became ill with Simian Virus 40-related disease, including malignant brain cancer, and subsequently died on 2/18/01 at 10:00 PM. No additional information was available at the time of this report.


VAERS ID: 220407 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: New York  
Vaccinated:2004-02-10
Onset:2004-02-11
   Days after vaccination:1
Submitted: 2004-05-12
   Days after onset:90
Entered: 2004-05-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1612AA / 1 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR W1391 / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0367 / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-02-11
   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: Autopsy performed - results pending.
CDC Split Type: 200401855

Write-up: From initial information received on 5/11/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a two month old female patient received her first dose of ActHIB, lot number UE096AA, administered in the left thigh, her first dose of Daptacel, lot number C1612AA, administered in the left thigh and her first dose of IPOL, administered in the right thigh on 2/10/04. At approximately 5:00 AM the next morning the patient was found dead. An autopsy was performed, the physician''s office is sending a certified letter requesting results. The physician''s office will forward a copy to the manufacturer once it''s received. Reportedly, the local sherriff''s office quarantined the sharps container and the vaccine lots involved. Follow up on 11/01/04 states: "From additional information received on 11/01/04 from the initial reporter, it was reported, "Reviewed, no additional information at this time." From additional information redceived on 11/8/04 from the initial reporter, the information has reportedly been reviewed on 11/4/04 and additional information is availale at this time.


VAERS ID: 221869 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Virginia  
Vaccinated:2003-12-24
Onset:2003-12-28
   Days after vaccination:4
Submitted: 2004-05-19
   Days after onset:142
Entered: 2004-05-26
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5338D9 / 3 LA / -

Administered by: Public       Purchased by: Private
Symptoms: Agitation, Anorexia, Asthenia, Chills, Discomfort, Haemoptysis, Hypoxia, Nervousness, Pulmonary haemorrhage, Pyrexia, Respiratory failure, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-18
   Days after onset: 21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: 4 days of hospital tests; Autopsy;
CDC Split Type:

Write-up: Joint pain last week of December 2003. Fever, chills, loss of appetite, generalized weakness and discomfort. Syncope episode 1/12/04. Coughed up blood 1/13/04. Hospitalized 1/14 for respiratory failure. Vent 15th. Died on 1/18/04. Death certificate reads intractable pulmonary hemorrhage. Discharge Summary received on 6/14/2004 states agitation, restlessness, hypoxia, and tachycardia.


VAERS ID: 222119 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: California  
Vaccinated:2002-12-30
Onset:0000-00-00
Submitted: 2004-05-24
Entered: 2004-05-28
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0812AA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Fracture, Murder, Neurological symptom, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Osteoporosis/osteopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-26
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: 200401989

Write-up: This subject is a ten month old who died due to child abuse/homicide while enrolled in a Comparative post-marketing study of DAPTACEL administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received one dose of the study vaccine on 12/30/02. The subject received a DAPTACEL vaccination, lot number C0812AA (route and site not reported) on 12/30/02. On 9/7/03, the subject suffered acute neurologic deterioration association with occipital skull fracture, cerebral edema and subarachnoid hemorrhage. On 1/26/04, the patient died from injuries secondary to child abuse. Per the coroner''s office the cause of death was blunt force trauma. This case is considered a homicide and is still under investigation. An autopsy was performed but not obtained. The death was reported by the investigator as unrelated to the study vaccine.


VAERS ID: 222120 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: California  
Vaccinated:2004-01-22
Onset:2004-02-04
   Days after vaccination:13
Submitted: 2004-05-25
   Days after onset:110
Entered: 2004-05-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1245AA / 3 - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5401A2 / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE078AB / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W1233 / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495212 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Respiratory arrest
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), 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: 2004-02-04
   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: Infant suffered from Walker-Warburg Syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200401993

Write-up: This subject is a seven month old female, who died while enrolled in Comparative post-marketing safety study of DAPTACEL administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received two doses of the study vaccine. The last dose prior to the event was given on 1/22/04. On 2/4/04 the subject died. The subject suffered from Walker-Warburg Syndrome and expired due to respiratory arrest and cardiac failure. No autopsy was performed. The death was reported by the investigator as unrelated to the study vaccine.


VAERS ID: 222121 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: New Jersey  
Vaccinated:2004-01-07
Onset:2004-01-09
   Days after vaccination:2
Submitted: 2004-04-29
   Days after onset:110
Entered: 2004-05-28
   Days after submission:29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR 60A / 1 - / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 785N / 1 - / -

Administered by: Private       Purchased by: Other
Symptoms: Agitation, Crying, Irritability, Oral intake reduced, Screaming, Sleep disorder, Sudden infant death syndrome
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-25
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Congestion
Preexisting Conditions: Jaundice
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Screaming, inconsolable crying for 2 days, fussy, wasn''t feeding or sleeping as usual. Nurse follow up on 07/28/04 states: "SIDS."


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

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

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

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


VAERS ID: 222263 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Louisiana  
Vaccinated:2004-01-09
Onset:2004-01-26
   Days after vaccination:17
Submitted: 2004-01-27
   Days after onset:1
Entered: 2004-06-03
   Days after submission:127
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 601A2 / 4 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495248 / 3 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Brain oedema, Dehydration, Delirium, Encephalitis, Viral infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-01-27
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unexpected death shortly after administration of 3rd DTaP and 2nd Prevnar. 18 month old admitted to hospital for dehydration secondary to Rota virus on 1/25/04. Died 1/27/04 after being pronounced brain dead. Autopsy diagnosis was encephalitis with cerebral edema and uncal. herniation.


VAERS ID: 222269 (history)  
Form: Version 1.0  
Age: 1.05  
Sex: Male  
Location: Unknown  
Vaccinated:2004-03-31
Onset:2004-04-26
   Days after vaccination:26
Submitted: 2004-08-10
   Days after onset:106
Entered: 2004-06-03
   Days after submission:68
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21924A2 / UNK RL / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 6467050823N / 1 LL / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 6477101248N / 1 LL / -

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Anorexia, Cardiac failure, Drug ineffective, Haematemesis, Immune system disorder, Pneumonitis, Rash papular, Respiratory distress, Skin ulcer, Somnolence, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: DiGeorge''s Syndrome
Preexisting Conditions: Medical history: Surgery; Fallot''s tetralogy; Ventricular septal defect repair. Concurrent condition: DiGeorge''s syndrome.
Allergies:
Diagnostic Lab Data: Chest x-ray: diffuse pulmonary opacities; Tracheal aspirate positive for measles virus; 2 urines were PCR positive for measles; Blood CD4 count 320; VZV pending - lesion type papule, VZV positive, vaccine type, bronchial washings
CDC Split Type: WAES0405USA01493

Write-up: Information has been received from a physician via the VZV identification program concerning a 13 month old male with DiGeorge''s syndrome status post central shunt (March 2003) and Rastelli repair for tetralogy of Fallot (26-Jan-2004) who on 31-Mar-2004 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot number 646705/0823N) and a first dose of varicella virus vaccine live (lot number 637710/1248N) in the left leg. The patient was concomitantly vaccinated on 31-Mar-2004 with a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid) (lot 21924A2) in the right leg. It was reported that the patient did not developed a rash at the injection site post vaccination. On approximately 26-Apr-2004, the patient developed diffuse bilateral pneumonitis possibly due to heart failure. The patient was afebrile. On 03-May-2004, the patient was admitted to the hospital with severe amenia, congestive heart failure, and bloody emesis. Patient had decreased po intake lethargy, and retching for 1 week prior to admission. On 13-May-2004, the patient''s pneumonitis worsened. The patient developed an increased requirement for pressor support, worsening respiratory distress requiring intubation and had diffuse pulmonary opacities on CXR. Therapy with caspofungin was stated on 13-May-2004. On 20-May-2004, therapy with ribavirin, vancomycin, and piperacillin was started. On 21-May-2004, the patient developed a papular rash with 5 lesions scattered on the trunk. On 21-May-2004, therapy with acyclovir was started. A culture/PCR from tracheal aspirate for varicella and measles was performed on 19-May-2004 and 21-May-2004, and a papule specimen was taken 21-May-2004. Preliminary reports from the CDC revealed that the culture from tracheal aspirate taken 21-May-2004 and 2 urines were PCR positive for measles virus (Strain ID to follow). The PCRs were being repeated to verify the result. The physician reported that the patient had originally been seen by an infectious disease physician and placed on sufamethoxazole/trimethropim (Bactim) for a low CD4 count (320). The infectious disease (ID) physician advised that the patient should not be vaccinated with any live vaccines. It was reported that the patient did not have any recent exposure to shingles and exposure to chicken pox was unknown. Vaccination history included on 11-Jun-2003, the patient was vaccinated with a dose of diptheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid) (lot 21882C2) in the right leg, Hib conj vaccine (OMPC) (PedvaxHIB) (lot 1307L) in the left leg, and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (lot 491589) in the left leg. Additional information has been requested. Follow up on 06/08/04 states: "Follow up information indicated that the vesicle and bronchial washings samples obtained on 05/17/04 were VZV positive and the VZV strain that was identified was vaccine-type. Follow up information was received from the physician who reported that the child''s pulmonary disease was not secondary to the vaccinations he received. The physician indicated that he could not share additional findings at this time. Follow up information indicated that the patient died. PCR testing from autopsy samples on the lungs and lymph node were negative or VZV. Additional information has been requested."


VAERS ID: 222397 (history)  
Form: Version 1.0  
Age: 0.83  
Sex: Male  
Location: Unknown  
Vaccinated:2001-06-11
Onset:2001-09-14
   Days after vaccination:95
Submitted: 2004-06-03
   Days after onset:993
Entered: 2004-06-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 998A2 / 3 LL / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5189A2 / 3 RL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 478392 / 3 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 3 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 471226 / 3 RL / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Laboratory test abnormal, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-14
   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:
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Toxicologic test: (results: heart blood: ethanol, 0: opiates (morphine/codine), non detected; cocaine and/or metabolite, none detected; phencyclidine, non detected; methamphetamin, non detected.) was done on 17Sep2001. Histology (results: lungs, congestion, edema, colonies of bacteria) was done on 19SEP2001. The cause of death was reported as sudden infant death syndrome and the autopsy cause of death was sudden infant death syndroe. The investigator(s) and medical monitor (s) considered sudden infant death syndrome (expected per package insert) not related to the receipt of vaccine. No additional information is available at the time of this report.
CDC Split Type: HQWYE117126MAY04

Write-up: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from an investigator in a post marketing surveillance study regarding a 10 month old male participant in a study entitled "ongoing Surveillance of Invasive Pneumococcal Disease in Original Efficacy Population and in NCKP<5 Years of Age." On 11-JUN-2001, at 6 months of age, the participant received the third dose of Prevnar, along with third doses of Hib-TITER, Infanrix, Engerix B, and IPOL. The patient experienced sudden infant death syndrome on 14-Sep-2001. The coroner''s office reported that the patient expired due to sudden infant death syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA. The investigator(s) and medical monitor(s) considered SIDS not related to the study product. No additional information was available at the time of this report. Follow up information received from the investigator provided the autopsy findings. Information regarding Prevnar was received from an investigator in a post marketing surveillance study regarding a 10 month old male participant in a study entitled "Ongoing Surveillance of Invasive Pneumococcal Disease in Original Efficacy Population and in NCKP <5 Years of Age." On 11JUn2001, at 6 months of age, the participant received the third dose of Prevnar, along with third doses of HiB Titer, INfanrix, Engerix and IPOL. The infant was fed oat meal about 1000 hours. At about 1100 hours, he was laid down for his noontime nap with a bottle of formula. At about 1145 hours, the infant was discovered blue in color and unresponsive. Paramedics responded to the call and initiated advanced cardiac life support measures. They then transported him to the emergency room where ACLS was continued for about 20 minutes but all efforts were to no avail. The coroner''s office reported that the patient expired on 14SEP2001 due to sudden infant death syndrome. The autopsy cause of death was reported as sudden infant death syndrome. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA. Follow up on 06/10/04 states: "Complete."


VAERS ID: 222616 (history)  
Form: Version 1.0  
Age: 0.0  
Sex: Male  
Location: Ohio  
Vaccinated:2004-06-10
Onset:2004-06-10
   Days after vaccination:0
Submitted: 2004-06-11
   Days after onset:1
Entered: 2004-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5518AZ / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Arrhythmia, Cardio-respiratory arrest, Cardiomegaly, Dyspnoea, Grunting, Heart disease congenital, Livedo reticularis, Mydriasis, Pallor, Peripheral coldness, Pulse absent, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-06-10
   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: iLOTYCIN GIVEN 19:32 ON 06/09/2004 AQUA MEPHYTON 19:31 ON 06/09/2004
Current Illness: NONE
Preexisting Conditions: POSSIBLE CONGENTIAL HEART DISEASE (AUTOPSY NOT BACK YET)
Allergies:
Diagnostic Lab Data: abrupt cardiopulmonary arrest, possible congential heart disease.
CDC Split Type:

Write-up: shot give 1600 06/10/2004 06/10/04 2020 infant grunting, color grey, mottled hr 120, no murmur noted 06/10/04 unable to get temp , extremities cold (infant in warmer) pupils dialted no HR - on strip shows skipping heart beat CXR:cardiomegaly 6/10/04 22:10 newborn died Nurse follow up on 06/18/04 states: "unresponsive, tachycardia, respiratory distress, regurgitation." Nurse follow up on 08/02/04 states: "Hypoplastic left heart complex."


VAERS ID: 222637 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Michigan  
Vaccinated:2004-04-05
Onset:2004-04-15
   Days after vaccination:10
Submitted: 2004-06-09
   Days after onset:55
Entered: 2004-06-15
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 546A2 / 4 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Hyperthermia, Otitis media
SMQs:, Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-04-15
   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: UNK
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Learned of child''s death from mother. It was 10 days after Hepatitis B immunization. Death certificate: otitis media and hyperthermia. Nurse follow up on 06/18/04 states: "complete."


VAERS ID: 223187 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2002-07-23
Onset:2002-07-23
   Days after vaccination:0
Submitted: 2003-02-21
   Days after onset:213
Entered: 2004-06-23
   Days after submission:487
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 546A2 / UNK - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0937L / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0937L / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR V0422 / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 479791 / UNK - / -

Administered by: Public       Purchased by: Private
Symptoms: Child maltreatment syndrome, Coma, Diarrhoea, Injury, Lethargy, Retinal haemorrhage, Tachycardia, Upper respiratory tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Retinal disorders (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-09-02
   Days after onset: 41
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Infant Tylenol
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lethargic. Developed an upper respiratory infection, diarrhea, vomiting. Nurse follow up on 06/30/04 states: "ADD: shaken baby syndrome, retinal hemorrhage, tachycardia, unresponsive." Nurse follow up on 07/27/04 states: "manner of death was Homicide." Nurse follow up on 07/30/04 states: "Complete."


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