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VAERS ID: 248143 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Male  
Location: New Hampshire  
Vaccinated:2005-05-01
Onset:2005-05-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2005-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVA064AA / 1 LL / -

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: 2005-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0511

Write-up: SIDS, ? Mom rolled over on baby but not confirmed according to MD. Autopsy report received 11/30/2006 confirms SIDS/sr


VAERS ID: 248477 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Colorado  
Vaccinated:2005-10-20
Onset:2005-11-12
   Days after vaccination:23
Submitted: 2005-11-30
   Days after onset:18
Entered: 2005-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1396AB / 1 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0643K / 1 - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0496 / 1 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08637H / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Prematurity (35 weeks); No medical problems
Allergies:
Diagnostic Lab Data: Coroner ruled death due to SIDS. No additional terms found in Autopsy report rec''d 12/21/2005/sr
CDC Split Type:

Write-up: SIDS per autopsy report.


VAERS ID: 248538 (history)  
Form: Version 1.0  
Age: 1.07  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2005-11-22
Onset:2005-11-23
   Days after vaccination:1
Submitted: 2005-11-25
   Days after onset:2
Entered: 2005-12-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1787DA / 1 - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1072P / 1 - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0418R / 1 - / -

Administered by: Unknown       Purchased by: Public
Symptoms: Apnoea, Malaise, Upper respiratory tract infection
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-24
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient became ill within 24 hours of vaccine administration with URI symptoms, He was then discovered by parents to have stopped breathing.


VAERS ID: 248624 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Massachusetts  
Vaccinated:2005-11-28
Onset:2005-11-29
   Days after vaccination:1
Submitted: 2005-12-02
   Days after onset:3
Entered: 2005-12-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC216027AA / 1 - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE692AA / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A85856F / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-29
   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: Amoxicillin 125mgm 1 tsp PO every day
Current Illness:
Preexisting Conditions: Bilateral renal pelvical rectors, murmur resolved.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Well appearing 2 month old infant given immunization at wellness visit. Apparently expired during sleep about 24 hours later.


VAERS ID: 249020 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Florida  
Vaccinated:2005-12-07
Onset:2005-12-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2005-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B015DA / 1 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE686AA / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A56117D / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-09
   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: MCD
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None Stated Received autopsy report which revealed COD as undetermined. Patient was cosleeping w/adult.


VAERS ID: 249021 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Male  
Location: New Jersey  
Vaccinated:2005-11-03
Onset:2005-11-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2005-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1904AA / UNK RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0347R / UNK LA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A25962H / UNK RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Cardiac failure, Irritability, Myocarditis
SMQs:, Cardiac failure (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-10
   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: Pulmicort, Zantac, Singulair, Albuterol, AccuNeb
Current Illness: History of RAD
Preexisting Conditions: Premie, asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received vaccine 11/03/2005, admitted in heart failure, myocarditis 11/10/2005, Died 11/10/2005. Increasingly cranky for 2 days procedding admission to hospital.


VAERS ID: 249112 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Ohio  
Vaccinated:2005-11-03
Onset:0000-00-00
Submitted: 2005-12-08
Entered: 2005-12-12
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1396BA / 2 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0265 / 2 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A56116K / 2 LL / -

Administered by: Public       Purchased by: Public
Symptoms: Anoxia, Diabetes mellitus, Ecchymosis, Fracture, Pyrexia, Retinal haemorrhage, Subarachnoid haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Retinal disorders (narrow), Osteoporosis/osteopenia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HBOC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Questionable beaten. Fever, Vomit aded from med rec rec''d 12/22/2005/sr Terms added from Discharge summary rec''d 01/20/2006: subarachnoid hemorrhage, anoxia, DM, retinal Hemorrhage, contusions, fractures./sr No additional terms added from Autopsy report rec''d 12/30/2005.


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

Administered by: Other       Purchased by: Private
Symptoms: Angioneurotic oedema, Blood creatinine increased, Cardiac failure congestive, Cough, Drug toxicity, Glomerulonephritis, Headache, Malaise, Multi-organ failure, Nephritis, Oliguria, Renal failure, Renal failure chronic, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug abuse and dependence (broad), Oropharyngeal allergic conditions (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Kidney biopsy showed necrotizing glomerulonephritis.
CDC Split Type:

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


VAERS ID: 249312 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2005-11-02
Onset:2005-11-04
   Days after vaccination:2
Submitted: 2005-12-15
   Days after onset:41
Entered: 2005-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1802FA / 7+ LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Arrhythmia, Blood pressure increased, Bronchiolitis, Cardiomegaly, Cough, Dyspnoea, Hyperglycaemia, Hypoxia, Ileus, Laboratory test abnormal, Leukocytosis, Pneumonia, Pneumothorax, Respiratory failure
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Interstitial lung disease (narrow), Neuroleptic malignant 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), Gastrointestinal obstruction (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-02
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 27 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: synthroid 75 mcg qd; lopressor 200 mg BID; lasix 40 mg daily; norvasc 5 mg daily; pulmicort inhaler BID
Current Illness: non-productive cough, nasal drainage, afebrile
Preexisting Conditions: HPD, hypothyroidism, anxiety, reflux disease, S/P laryngeal cancer
Allergies:
Diagnostic Lab Data: ABG, CBC, chemistry, lung biopsy
CDC Split Type:

Write-up: Developed marked dyspnea on exertion with SOB at rest and occasional cough productive of red sputum. Condition deteriorated despite intervention. Additional terms added from Discharge Summaries rec''d 12/28/2005: Hypoxia, lab test abnorm, leukocytosis, Inc. BP, Hyperglycemia, atrial fib, anemia, dyrhythmia, resp failure, cardiomegaly, pneumothorax, ileus, broncholitis, pneumonia/sr


VAERS ID: 249499 (history)  
Form: Version 1.0  
Age: 1.62  
Sex: Female  
Location: Florida  
Vaccinated:2004-02-19
Onset:2004-02-21
   Days after vaccination:2
Submitted: 2005-12-19
   Days after onset:667
Entered: 2005-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1679AA / 4 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Convulsion, Otitis media, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-04
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omnicef
Current Illness: Bilateral ear infection
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: DTAP administered 2/19/04, 2/21/04 ER visit for convulsions and temperature 105.6, Pediatric follow up 2/22/04 & 3/4/04 resulting in death 3/4/04 No new information from Med Record rec''d 01/11/2006/sr Autopsy report received which revealed COD as H. influenza infection, otitis media & febrile seizures.


VAERS ID: 249598 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-12-16
Entered: 2005-12-21
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / 2 UN / -

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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0512USA01522

Write-up: Information has been received from a consumer concerning a patient who was vaccinated with the second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. The consumer reported that she "heard of a patient who died after the second MMR shot." No further information is available.


VAERS ID: 249821 (history)  
Form: Version 1.0  
Age: 1.61  
Sex: Female  
Location: Illinois  
Vaccinated:2005-12-06
Onset:2005-12-12
   Days after vaccination:6
Submitted: 2005-12-28
   Days after onset:16
Entered: 2005-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1788FA / 2 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Pneumonia
SMQs:, 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: 2005-12-12
   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: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None Stated Autopsy Report received 3/16/06 revealed COD as bronchopneumonia.


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

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

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

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


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

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

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

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


VAERS ID: 250218 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Male  
Location: Florida  
Vaccinated:2005-07-05
Onset:2005-07-15
   Days after vaccination:10
Submitted: 2006-01-04
   Days after onset:173
Entered: 2006-01-10
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2183AA / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. UE548AA / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardiac disorder, Irritability, Liver disorder, Nasal congestion, Pulmonary haemorrhage
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Moderate club foot (right).
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Exhibited fussiness at bedtime, was found deceased after 7am next morning. Med examiner report states cause undetermined and lists focal congestion and hemorrhage of liver, lungs, and heart. No additional terms added from autopsy report rec''d 01/18/2006/sr


VAERS ID: 250255 (history)  
Form: Version 1.0  
Age: 0.31  
Sex: Female  
Location: Texas  
Vaccinated:2005-12-29
Onset:2005-12-30
   Days after vaccination:1
Submitted: 2005-12-30
   Days after onset:0
Entered: 2006-01-10
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B001CA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE772AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A94456A / 1 GM / IM

Administered by: Private       Purchased by: Public
Symptoms: Congenital anomaly, Upper respiratory tract infection
SMQs:, Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-30
   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: Lovenox; Bactrim; Ditropan; Nitrofurantoin; Prilosec; Pediatex
Current Illness: Mild URI symptoms.
Preexisting Conditions: Arnold Chiari malformation with myelomeningocele, In utero Dx of myelomeningocele, ventriculomegaly, lemon sign, and Talipes. Mom treated for HIV (Combivir). Hx of non compliance in past pregnancy. Mom Hx HPV and grand mal seizure.
Allergies:
Diagnostic Lab Data:
CDC Split Type: TX06001

Write-up: Pt was found dead in crib at 6am. Mild URI symptoms x 1-22 days. had been started on Pediatex (antihistamine only) on 12/29/2005 and was given 1st set of shots.3/20/06 Received autopsy report which revealed COD as complications from multiple congenital anomalies & abnormalities/ss


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

Administered by: Military       Purchased by: Military
Symptoms: Asthma, Chest pain, Cough, Loss of consciousness, Myocarditis, Nasal congestion, Oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-02-17
   Days after onset: 79
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma age 5
Allergies:
Diagnostic Lab Data: 18 Feb 05: Cardiac-normal distribution of small patent coronary arteries. The valves appear normal. The myocardium does not show any acute changes. The left ventricle measures 1.4 cm in thickness. The septum measures 1.4 cm in thickness. The aorta has youthful intima. Resp-prominent congestion and mild edema without any discrete lesion. The airways patent. The vasculature free of thromboemboli. Microscopic Exam: Heart the mural sections show rare perivascular mononuclear cells some with plasmacytoid features. The AV node section shows extensive infiltration with mononuclear cells many of which are necrotic. Lung there is edema and congestion with focal mild interstitial chronic inflammation and proliferation of pigmented alveolar macrophages. Brain and live - unremarkable. Kidney a rare Bowman capsule sclerosis is seen in the cortex. Pathologic diagnosis: Chronic myocarditis involving AV node. No lethal injuries.
CDC Split Type:

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


VAERS ID: 250398 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Male  
Location: Georgia  
Vaccinated:2005-11-14
Onset:2005-11-23
   Days after vaccination:9
Submitted: 2006-01-13
   Days after onset:51
Entered: 2006-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B002AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0807P / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0707 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67180E / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Nasal congestion, Otitis media, Tracheobronchitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: unknown
Preexisting Conditions: none documented
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child seen 11/14/05 at health department and 2 month shots given. 9 days later (11/23/05) child found dead in his crib by his mother. Child had some congestion prior to death. 8/4/06 Received autopsy report which revealed COD as acute tracheobronchitis with otitis media/ss


VAERS ID: 250407 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2005-12-20
Onset:2005-12-20
   Days after vaccination:0
Submitted: 2005-12-21
   Days after onset:1
Entered: 2006-01-16
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB171AA / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Arteriosclerosis, Atherosclerosis, Cardiac arrest, Cardio-respiratory arrest, Cardiovascular disorder, Coronary artery disease, Hypertension
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: Allergies - Dopsone
Allergies:
Diagnostic Lab Data: "Death due to cardiac arrest;severe sed to arteriosclerosis
CDC Split Type:

Write-up: Employee arrived for routine Hep B inj #2. Denies previous reaction to inj #1. Inj give without incident, no signs or symptoms of reaction. Patient had fallen on knee prior to injection. Medical Records received from Alegent ER stated patient experienced cardiopulmonary arrest. Final autopsy report received on 1/24/06 revealed COD severe arteriosclerosis, hypertensive cardiovascular disease and coronary artery disease.


VAERS ID: 250430 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Colorado  
Vaccinated:2005-12-22
Onset:2006-01-03
   Days after vaccination:12
Submitted: 2006-01-09
   Days after onset:6
Entered: 2006-01-17
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2277AA / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0643R / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0496 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A25964H / 1 RL / -

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: 2006-01-03
   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: Polytrim;Eye drops 12/27 for 7 days
Current Illness:
Preexisting Conditions: Had corneal abrasion 12/27 on eye resolved 12/29
Allergies:
Diagnostic Lab Data: SIDS per autopsy
CDC Split Type:

Write-up: SIDS per autopsy 1/3/06. No added information from autopsy report rec''d 01/18/2006/sr


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

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

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

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


VAERS ID: 250769 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Utah  
Vaccinated:2005-11-03
Onset:2005-11-03
   Days after vaccination:0
Submitted: 2006-01-23
   Days after onset:81
Entered: 2006-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2253AA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0343R / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0459 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A56077K / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration, 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: 2005-11-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none. Received a dose of tylenol prior to vaccine administration (80mg)
Current Illness: Mild GER.
Preexisting Conditions: 1)Born at 37 ega 2)Had neonatal pneumonia, which required mechanical ventilation for one day and supplemental oxygen for another 2 days. No persistent problems form this. 3)Mild gastroesphageal reflux. No clinical signs of GERD or discomfort. Good growth.
Allergies:
Diagnostic Lab Data: Autopsy performed with no findings of significant disease process, trauma or congenital anomaly and certified the death as a sudden unexpected death in infancy.
CDC Split Type:

Write-up: Patient is a 4 month old male with a history of neonatal pneumonia (resolved) and mild GER. Seen in clinic on 11/3/5 for his four month well child check. Patient was vigorous and healthy. Received his vaccinations. Per his mother, he acted fine the rest of the day. That night, he was found unresponsive in a bassinet shortly after having been placed there by his sitter, with the ensueing interval of approximately 5 minutes. CPR was performed by the sitter and paramedics, but the patient was declared dead shortly thereafter. Autopsy declared the cause of death to be SIDS after finding no significant disease process, trauma or congenital anomaly. Autopsy also revealed aspiration & obstruction of both main bronchi & alveoli by aspirated material due to gastric outlet restriction. No new terms found in medical records from PCP.


VAERS ID: 251124 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Unknown  
Vaccinated:2005-12-19
Onset:2006-01-09
   Days after vaccination:21
Submitted: 2006-01-17
   Days after onset:8
Entered: 2006-02-01
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Candidiasis, Hepatitis, Hepatosplenomegaly, Laboratory test abnormal, Lymphadenopathy, Pneumonia, Respiratory rate increased, Sepsis, Urinary tract infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bactrim (20 days);Oral Mycostatin drops (20 days,Daktarin oral gel (7 days), Vidaylin syrup (27 days), Ferro drops (27 days)
Current Illness:
Preexisting Conditions: Past medical history is significant for right eye mild conjunctivitis (12/10/2005-12/25/2005), mild oral thrush (12/17/2005), and Escherichia coli urinary tract infections (12/19/2005). The subject was HIV positive. He was not taking HIV medication. The subject had no tuberculosis contact. The mother''s rapid plasma reagin test was negative. This subject was also enrolled in the delayed antiretroviral therapy treatment arm of protocol CIPRA SA 002 "A Phase III, Randomized, Open-label Trial to Evaluate Strategies for Providing Antiretroviral Therapy to Infants Shortly after Primary Infection in a Resource Poor Setting."
Allergies:
Diagnostic Lab Data: 12/12/2005 viral load 9300 copies/ml;CD4 2075 x 10^s/l (normal 500-2010). 12/19/2005 CD4 1747 x 10^6/l (normal 500-2010);urine dipstick;3+ leucocytes esterase;nitrite positive 1+ protein 3+blood. 12/21/2005 urine microscopic exam;leucocytes 550,000 per ml (normal <4000 per ml);Escherichia calf $g100,000 cfu/ml. 01/03/2006 Urine dipstick 1+ ketones. Chest x-ray: prominent hilum, possible hilar nodes, bilateral reticular pattern, hyperinflated, normal heat, patent main bronchi.
CDC Split Type:

Write-up: This is a 67 day old, HIV positive, male infant enrolled in protocols CIPRA SA 004, "Evaluation of quantitative and qualitative antibody response to streptococcus pneumoniae and haemophilus influenzae type B conjugate vaccines amongst HIV-1 exposed infected children that are receiving vs those not receiving antiretroviral therapy, as well as among HIV-1-exposed-uninfected children and HIV-1 unexposed-uninfected children," on 12/15/2005 who died of an unknown cause. The subject was also enrolled in the delayed antiretroviral therapy treatment arm of protocol CIPRA SA 002 "A Phase III, randomized, open-label trial to evaluate strategies for providing antiretroviral therapy to infants shortly after primary infection in a resource poor setting." The subject was born by vaginal breech delivery at 37 weeks gestation. Mother had apgar scores of 2 and 4 with no prenatal problems. The mother received zidovudine for an estimated 3 weeks prior to delivery and nevirapine at delivery. The subject received one dose of nevirapine at birth 7 days of zidovudine after birth. The subject has been solely formula fed since birth. The subject received one dose of Prevnar on 12/19/2005. He was evaluated on 01/03/2006 and his weight was in the 5th percentile, length just below 6th percentile, head circumference in the 10th percentile and his weight for height 1-score was 0.20. The subject had generalized lymphadenopathy (size 0-0 5cm), mild oral thrush, hepatosplenomegaly (4cm live span, 2cm palpable spleen), and no signs of respiratory distress. He was sent home on Vidaylin syrup, Ferro, drops, Bactrim, oral Mycostatin drops, and oral Daktarin gel. The mother reported no cough, no diarrhea or vomiting, no fever and no other complaints prior to 01/09/2006. At 18:00 on 01/09/2006 the mother noticed that the subject was breathing fast and at 22:00 the subject looked pale. The mother took the subject to the local hospital at 23:00. The subject was dead on arrival at 23:30 on 01/09/2006. Differential diagnoses of sepsis or pneumonia have been made. A post-mortem exam was performed on 01/17/2006 and results are pending. This site investigator believes this event is not related to study agent. The DAIDS medical officer believes this event is probably not related, but cannot rule out a relationship to study agent. 3/2/06 Received medical records which revealed UTI, oral thrush, hepatomegaly & splenomegaly. Received Autopsy Report 3/6/06 which revealed COD as pneumocystis carinii pneumonia & granulomatous hepatitis.


VAERS ID: 251163 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-01-30
Entered: 2006-02-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activated partial thromboplastin time prolonged, Anorexia, Antinuclear antibody positive, Bacterial infection, Candidiasis, Coombs indirect test positive, Coombs positive haemolytic anaemia, Drug ineffective, Fatigue, Fungal infection, Immunoglobulins decreased, Jaundice, Laboratory test abnormal, Multi-organ failure, Oesophageal ulcer, Oesophagitis, Otitis media, Pericardial effusion, Pleural effusion, Pneumonia, Systemic lupus erythematosus
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal ulceration (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific inflammation (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Failure to thrive, Pneumonia, Transplant, Serositis, candidiasis, Otitis media chronic, chronic mucocutaneous candidiasis.
Allergies:
Diagnostic Lab Data: Chest x ray showed pleural pericardial effusions, diagnostic lab positive anticardiolipin antibodies, poor antibody response to pneumococcal polysaccharide antigen, depressed chemotactic response to FMLP, Low T cell (CD3+560 /ul, CD4+310/ul, CD8+170/ul,) and NK cell CD 16+56+:30/ul) counts were found, low IgG2 and C4 levels detected. APTT prolonged, indirect Coombs positive Serum ANA 1:320 positive serum immunoglobulin A low, deoxyribonucleic acid 1:20 double stranded.
CDC Split Type: WAES0601USA02809

Write-up: It was reported in a published article, title as stated above and presented at the 2005 annual meeting of the American college of allergy, asthma and immunology, Nov 3-9 2005 concerning a 23 year old female with chronic mucocutaneous candidiasis who began to suffer from persistent thrush, failure to thrive, recurrent otitis media (staph aureus) and pneumonia (staph aureus and pseudomonas aeruginosa) since 6 weeks of age, who was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown), (dose, duration and indication not reported). At age 4, she was noted to have poor antibody response to pneumococcal polysaccharide antigen, but normal to diphtheria and tetanus. Pneumonia episodes decreased with intravenous immunoglobulin IVIG at age 6. At 11 years of age, she developed persistent times capitis and severe Coombs positive hemolytic anemia. Four months later, she was noted to be very fatigued, slightly jaundiced and chest x ray showed pleural pericardial effusions. At 12 years of age, she developed severe Candida esophagitis and ulcerations. She had 2 times PBMN stem cell transplantation from HLA identical brother at 17 years of age without any reconstitution. At age 17 years she had depressed chemotactic response to FMLP low IgA, IgG2, and C4 levels. Low T cell (CD3+560 /ul, CD4+310/ul, CD8+170/ul,) and NK cell CD 16+56+:30/ul) counts were found at age 18. Candida albicans was isolated several times in KOH preparations and cultures from skin, mouth tongue in addition to her severe Candida esophagitis. At 18 years of age, she was diagnosed to have systemic lupus erythematous SLE on the basis of Coombs + hemolytic anemia, double stranded, deoxyribonucleic acid analysis (dsDNA) (1:20) serum antinuclear antibodies test ANA positivity (1:320) serositis (pericardial) and prolonged activated partial thromboplastin time PPT with positive anticardiolipin antibodies besides clinical findings. At age 23, she was admitted to the hospital due to Coombs + hemolytic anemia second time and died due to multiple organ failure. The authors state that chronic mucocutaneous candidiasis CMC is a heterogeneous group of diseases characterized by persistent yeast infection usually with Candida albicans and described for the first time, a patient with CMC that was diagnosed with SLE, with clinical as well as lab findings. Additional information is not expected. A copy of the published article is attached as further documentation of the patients experience.


VAERS ID: 251239 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Hawaii  
Vaccinated:2006-01-05
Onset:2006-01-22
   Days after vaccination:17
Submitted: 2006-01-23
   Days after onset:1
Entered: 2006-02-06
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR 14B005AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0944P / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 736AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0425 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 94456H / 1 RL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Sudden infant death syndrome, Upper respiratory tract infection
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-22
   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:
Allergies:
Diagnostic Lab Data: Had URI symptoms few days
CDC Split Type: HI0601

Write-up: Probable SIDS. 3/9/06 Received autopsy report which revealed patient experienced cold s/s with COD Sudden Infant Death Syndrome/ss


VAERS ID: 251263 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: North Carolina  
Vaccinated:2005-10-27
Onset:2005-10-27
   Days after vaccination:0
Submitted: 2006-01-13
   Days after onset:78
Entered: 2006-02-06
   Days after submission:24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM AC14B002AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0644P / 2 LL / IM
HIBV: HIB (PROHIBIT) / SANOFI PASTEUR UE142AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 298 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A85856K / UNK LL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Bronchitis, Irritability, Pneumonia, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (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: 2005-10-30
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of "Spitting up"
Allergies:
Diagnostic Lab Data: Death certificate;Autopsy indicates bronchial pneumonia
CDC Split Type: NC06005

Write-up: Patient received 5 shots at routine well child visit on 10/27/05. She was fussy the rest of the day and slept all day on the 25th awakening only to eat, The mother treated the child with Tylenol cold drops for infants. 2/23/06 Received medical records from PCP. 2/23/06 Received Autopsy Report which states COD is Acute bronchopneumonia./ss


VAERS ID: 251477 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Arizona  
Vaccinated:2005-12-29
Onset:2006-01-01
   Days after vaccination:3
Submitted: 2006-02-13
   Days after onset:43
Entered: 2006-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B011BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE760AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A85856C / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardio-respiratory arrest, Sudden infant death syndrome
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), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-01
   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: Nystatin Oral Susp, Gentian Violet.
Current Illness: NONE, oral thrush noted.
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death 3 days later. Received medical records from ER which indicate patient arrived at ER in full arrest & was unable to be resuscitated. 2/17/06 Autopsy report received which revealed COD as SIDS./ss


VAERS ID: 251493 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: Louisiana  
Vaccinated:2005-11-21
Onset:2005-11-22
   Days after vaccination:1
Submitted: 2005-12-22
   Days after onset:30
Entered: 2006-02-14
   Days after submission:54
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B01DAA / 2 LL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0186R / 2 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A94451H / 2 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: 2005-11-22
   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: Jaundice at birth, Failure to thrive
Allergies:
Diagnostic Lab Data:
CDC Split Type: LA060201

Write-up: No complaints on the day vaccines were given 11/21/05. 2/17/06 Death Certificate received which revealed COD as SIDS./ss 2/28/06Autopsy Report received which revealed COD as SIDS/ss


VAERS ID: 251569 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Female  
Location: Oregon  
Vaccinated:2006-02-10
Onset:2006-02-11
   Days after vaccination:1
Submitted: 2006-02-16
   Days after onset:5
Entered: 2006-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0741R / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arteriosclerosis, Coronary artery disease, Diabetes mellitus, Gastrooesophageal reflux disease, Hyperlipidaemia, Hypertension, Hypothyroidism, Obesity, Osteoporosis
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Hypertension (narrow), Hypothyroidism (narrow), Other ischaemic heart disease (narrow), Lipodystrophy (broad), Osteoporosis/osteopenia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-02-11
   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: metformin, avandia, lipitor, hctz, cozaar, synthroid, omeprazole, asa
Current Illness: None
Preexisting Conditions: NKDA or birth defects. Diabetes, HTN, hyperlipidemia, obesity hypothyroidism, GERD, cataracts
Allergies:
Diagnostic Lab Data: Autopsy not performed. Coroner ruled it probable myocardial infarction (many risk factors for that). 3/2/06 Death certificate received which revealed COD as ASHD w/diabetes as contributing cause./ss
CDC Split Type:

Write-up: Patient died in her sleep the night after receiving the vaccine. 2/21/06 Received medical records from PCP/ss 2/23/06 Received medical records from new PCP who provided vaccine/ss


VAERS ID: 252076 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Unknown  
Vaccinated:2004-11-03
Onset:2004-11-28
   Days after vaccination:25
Submitted: 2006-01-12
   Days after onset:410
Entered: 2006-02-28
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1527AA / UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE237AA / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0181N / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399C / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Congenital anomaly, Convulsion, Encephalopathy, Ventricular arrhythmia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-28
   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:
Preexisting Conditions: The subject''s past medical history included central hypoventilation syndrome. The subject had received a first dose of DAPTACEL, lot number not available, on 15 September 2003; a second dose of DAPTACEL, lot number C1245AA on 04 December 2003 and a third dose of DAPTACEL, lot number C1354AA, on 05 March 2004.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200500887

Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss


VAERS ID: 252077 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Unknown  
Vaccinated:2004-03-04
Onset:0000-00-00
Submitted: 2006-01-12
Entered: 2006-02-28
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1354AA / UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE210AA / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Congenital anomaly, Dyspnoea, Hypotonia, Nervous system disorder, Neurodevelopmental disorder, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-03-29
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: 200500888

Write-up: This subject is a female with the date of birth of 11/4/2003, who expired while enrolled in a comparative post marketing safety study of Daptacel (Diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) administered with other recommended vaccines according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received two dosed of the study vaccine. The last dose prior to the event was given on 3/4/2004. Other vaccines administered on that day included a dose of ActHib lot number UE210AA (manufacturer lot number X0411-3). this subject, with a congenital anomaly, suffered from Lissencephaly and hypotonia and required g tube feedings. She expired 25 days post immunization. Autopsy was not requested. The event of a congenital anomaly was reported by the investigator as unrelated to the study vaccine. no additional information is pending at this time. Death Summary received which revealed lissencephaly, failure to thrive, Pierre-Robin syndrome and global hypotonia w/recent URI & dyspnea.


VAERS ID: 252078 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Female  
Location: Unknown  
Vaccinated:2003-11-14
Onset:2004-09-28
   Days after vaccination:319
Submitted: 2006-01-12
   Days after onset:471
Entered: 2006-02-28
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1245AA / UNK UN / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA873AA / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0131M / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 493505 / UNK UN / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0344N / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200500900

Write-up: This subject is a two year old female, who expired due to asphyxiation while enrolled in a comparative post marketing safety study of Daptacel (Diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) administered with other recommended vaccines according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dosed of the study vaccine. The last dose prior to the event was given on 11/14/2003. Other vaccines administered on that day included a dose of ACTHIB, lot number W1452 (manufacturer lot number UA873AA), a dose of MMR lot number 0131N, a dose of Prevenar lot number 493505, a dose of VZV lot number 0344N. The routes and sites of administration were not provided. The subject presented to the ER in full code for probable aspiration of food. The subject subsequently deteriorated and resuscitation was unsuccessful. The subject expired due to asphyxiation 319 days post immunization. The coroners office determined that the cause of death was a bean in the subjects trachea. Autopsy results were not been requested. The event of asphyxiation was reported by the investigator as unrelated to the study vaccine. Further information is not anticipated, this case is considered closed. 3/7/06 Autopsy report received which states COD as asphyxia secondary to bean lodged in mid trachea./ss


VAERS ID: 252079 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Unknown  
Vaccinated:2003-05-13
Onset:0000-00-00
Submitted: 2006-01-12
Entered: 2006-02-28
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C0947AA / UNK UN / -
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0498N / UNK UN / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR W0197 / UNK UN / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0858M / UNK UN / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0485N / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Neoplasm, 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: 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: The subject had a history of renal failure and pancytopenia. The subject received the following vaccines in addition to vaccines listed in the product section. 1/8/2001 first dose of Infanrix, lot number 970A2, 3/8/2001 second dose of Infanrix, lot number 979A2, 9/20/2001 third dose of Infanrix lot number 506A2.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200500901

Write-up: The subject is a female with the date of birth of 10/18/2000, who expired due to cancer while enrolled in a comparative post marketing safety study of Daptacel (Diphtheria and Tetanus toxoids and Acellular pertussis vaccine absorbed) administered with other recommended vaccines according to standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received the study vaccine on 5/13/2003. Other vaccines administered on that day included a dose of IPOL, lot number W01972, a dose of hepatitis A vaccine, lot number 0498N, a dose of MMR/measles, mumps and rubella vaccine, lot number 0858M, and a dose of VZV, lot number 0485N, manufacturer unknown. The routes and sited of administration were not provided. The subject suffered from a germ cell tumor. The tumor was resected and radiotherapy and chemotherapy were started. The subject was in palliative care when she expired 398 days post immunization. The subject did have a history of renal failure and pancytopenia. Autopsy information is pending. The event of cancer was reported by the investigator as unrelated to the study vaccine. 3/7/06 Multiple d/c summaries received which state patient had abdominal teratoma w/metastasis/ss


VAERS ID: 252294 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Georgia  
Vaccinated:2006-01-06
Onset:2006-01-27
   Days after vaccination:21
Submitted: 2006-02-06
   Days after onset:10
Entered: 2006-03-03
   Days after submission:25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B002AA / 2 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1013P / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0325 / 2 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A56077P / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Epiglottitis, Laboratory test abnormal, Sudden infant death syndrome, Tracheitis
SMQs:, Oropharyngeal infections (narrow), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Drug screen detected: pweudoephedrine, norpseudoephedrine, chlorpheniramine, brompheniramine & methorpan/ss
CDC Split Type: GA06007

Write-up: Mom reported no problems after immunizations. Infant stopped breathing at daycare while sleeping. Autopsy pending. 8/9/06 Received autopsy report which revealed COD as Sudden Unexplained Infant Death. Pathologic diagnoses: mild chronic epiglottitis & tracheitis, pulmonary congestion & edema.


VAERS ID: 252686 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Iowa  
Vaccinated:2005-10-31
Onset:2005-11-01
   Days after vaccination:1
Submitted: 2006-03-13
   Days after onset:132
Entered: 2006-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0746D / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Atherosclerosis, Coronary artery disease, Injection site erythema, Injection site swelling, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-15
   Days after onset: 75
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CAPTOPRIL 25MG BID, BENADRYL, SOLUMEDROL, ZYRTEC, PRILOSEC 20MG PRN
Current Illness: NO
Preexisting Conditions: ALLERGIES TO PENICILLIN, SULFA, CEPHALEXIN, ASPIRIN, CODEINE, TYLENOL, ZOCOR, TRICOR, POSSIBLE PREDNISONE ALLERGY
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: VACCINE ADMINISTERED 10/31/2005. PT RETURNED TO CLINIC 11/1/2005 COMPLAINING OF REDNESS AND SWELLING IN ARM WHERE VACCINE WAS ADMINISTERED. SOLUMEDROL 125 MG GIVEN IM. ON 11/8/2005 PT RETURNED TO CLINIC FOR FOLLOW-UP AT WHICH TIME SHE FELT BETTER. PT STATED FEELING "CREEPY, CRAWLY" HAD DIMINISHED. PT WAS TAKING BENADRYL AND AYRTEC AT THAT TIME, BUT HAD STOPPED TAKING PREDNISONE DUE TO HYPERACTIVITY. 3/28/06 Received autopsy report which revealed COD as coronary artery atherosclerosis (years)/ss


VAERS ID: 252693 (history)  
Form: Version 1.0  
Age: 26.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2005-11-18
Onset:2005-11-28
   Days after vaccination:10
Submitted: 2006-03-13
   Days after onset:105
Entered: 2006-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 1 LA / -

Administered by: Military       Purchased by: Military
Symptoms: Fatigue, Injection site pain, Laboratory test abnormal, Myocarditis, Pulmonary oedema, Pyrexia, Shoulder pain, Sleep disorder, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-04
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN 10 MG QD PRN (DISPENSED 12/1/05) MOTRIN 800 MG TID PRN PAIN (DIPSENSED 12/01/05) LIDEX CREME 0.05% (DISPENSED 12/1/05).
Current Illness: NONE
Preexisting Conditions: MEDICAL CONDITIONS: ASTIGMATISM, FLAT FEET NKDA
Allergies:
Diagnostic Lab Data: 1)URINE TOXICOLOGY IS NEGATIVE FOR DRUGS OF ABUSE. 2)AUTOPSY SERUM TOXICOLOGY IS NEGATIVE FOR DRUGS OF ABUSE. 3)CBC IS NEGATIVE FOR SIGNS OF ACUTE BLOOD LOSS WITH A NORMAL HEMOGLOBIN AND HEMATOCRIT.
CDC Split Type:

Write-up: RECEIVED BOTH SMALLPOX AND INACTIVATED INFLUENZA VACCINES ON 11/18/2005. HE PRESENTED TO THE VACCINE HEALTHCARE CENTER ON 12/01/05 FOR EVALUATION OF FATIGUE, FEVERS, POOR SLEEP, LEFT SHOULDER PERSISTENT PAIN, AND CONCERNS REGARDING HIS INOCULATION SITE. THE PATIENT WAS EXAMINED AND FOUND TO HAVE AN ORAL TEMPERATURE OF 99.2F. HE DID APPEAR FATIGUED. HE WAS DIAGNOSED AS HAVING A ROBUST REACTION AND SENT HOME ON CLARITIN, MOTRIN, AND LIDEX CREME. THE PATIENT CONTINUED WITH FATIGUE ON THE FOLLOWING TWO DAYS BUT NEVER COMPLAINED OF CHEST PAIN OR SHORTNESS OF BREATH. THE PATIENT WAS FOUND DECEASED IN HIS BARRACKS BED ON THE MORNING OF 12/04/05. ACLS PROTOCOL WAS INITIATED IN THE FIELD AND CONTINUED IN THE HOSPITAL EMERGENCY ROOM TO NO AVAIL. THE PATIENT WAS PRONOUNCED DEAD AT 0933 HOURS. THE PATIENT''S INITIAL AUTOPSY WAS NEGATIVE FOR ANY SIGNS OF FOUL PLAY, FRACTURE, ACUTE INJURY, TRAUMA, ALCOHOL OR ILLICIT DRUG INTOXICATION OR OVERDOSE. 8/3/06 Received medical records & autopsy report which stated COD as hypersensitivity myocarditis. Final autopsy diagnoses also include sudden death in apparent healthy 26 year old; history of recent smallpox & flu vax; lymphocytic eosinophilic myocarditis, pulmonary edema.


VAERS ID: 252817 (history)  
Form: Version 1.0  
Age: 0.31  
Sex: Female  
Location: Ohio  
Vaccinated:2006-03-01
Onset:2006-03-04
   Days after vaccination:3
Submitted: 2006-03-06
   Days after onset:2
Entered: 2006-03-15
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1350AB / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE589AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0265 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A56116K / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-04
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mother put child in crib for a nap around 3 pm; went in to get her up around 5 pm and found child not breathing. 4/20/06 Received autopsy report which stated COD as undetermined after complete exam/ss


VAERS ID: 253203 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Iowa  
Vaccinated:2005-11-15
Onset:2005-11-17
   Days after vaccination:2
Submitted: 2006-03-20
   Days after onset:123
Entered: 2006-03-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0604R / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Agitation, Infection, Lethargy, Pyrexia, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-12-17
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Avalide 150/12.5 1 po qd; Allopurinol 300 mg 1 po qd
Current Illness: Lymphoma, HTN
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/21/06- WBC 1.3;11/14/06 - WBC 1.90;deceased complications of
CDC Split Type:

Write-up: Family reported temp 101, lethargy, agitation for 2-3 days, starting 2-3 days after immunization. Was seen in office 11/21/2005 - afebrile; family reported "downhill" from there, no cause of fever/infection identified; continued WBC decreased.


VAERS ID: 253367 (history)  
Form: Version 1.0  
Age: 39.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2006-03-17
Onset:2006-03-17
   Days after vaccination:0
Submitted: 2006-03-22
   Days after onset:5
Entered: 2006-03-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 166AB / UNK LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 093AA / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-17
   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:
Current Illness: Gastritis
Preexisting Conditions: HTN, Dilipidemia, obesity (mild), smoking
Allergies:
Diagnostic Lab Data: Autopsy states coronary occlusion left ar art.
CDC Split Type:

Write-up: Cardiac arrest approx 2 hrs post vaccination, could not be resuscitated.


VAERS ID: 253513 (history)  
Form: Version 1.0  
Age: 0.31  
Sex: Male  
Location: Idaho  
Vaccinated:2006-03-23
Onset:2006-03-26
   Days after vaccination:3
Submitted: 2006-03-27
   Days after onset:1
Entered: 2006-03-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B065AA / 2 LL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1189R / 2 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08642D / 2 RL / -

Administered by: Private       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: 2006-03-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS patient presented unresponsive taken to ED by ambulance and pronounced dead. 5/18/06 Received autopsy report which revealed COD as SIDS/ss


VAERS ID: 253690 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-04-03
Entered: 2006-04-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Cardiac disorder, Fatigue, Immune system disorder, Muscular weakness, Nervous system disorder, Respiratory disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: A0599998A

Write-up: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced pain in his joints, fatigue possible autoimmune disease, decreased activities of daily life, possible neurological injuries, respiratory problems, heart problems and muscle weakness. The subject died. The cause of death was not reported. It was unknown whether an autopsy was performed. This information was received via a statement of injuries.


VAERS ID: 253739 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Florida  
Vaccinated:2006-04-04
Onset:2006-04-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2006-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardio-respiratory 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), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-04-05
   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:
Preexisting Conditions: Birth HX: 38 wk twin, c-section w/o complication.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child presented with cardiopulmonary arrest per parents previously health with negative PMH. Found apneic and unresponsive, medics called and child intubated and resuscitation attempted in route. Child apneic and unresponsive upon arrival at ED. Resuscitation was not successful. Per parents child received vaccine, 1 day DTP. 5/8/06 Received ER medical records which indicate patient arrived at ER in full arrest & was unable to be resuscitated. 5/19/08 Autopsy states COD as sudden death associaated with a hypotonic-hyporesponsive episode due to recent vaccinations. Autopsy states patient & twin well on day of vaccination. Then developed fever, vomited & developed severe diarrhea. Became limp with diaper change, caregiver started CPR & was transported to ER.


VAERS ID: 253803 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Female  
Location: Kansas  
Vaccinated:2004-03-03
Onset:2006-03-13
   Days after vaccination:740
Submitted: 2006-04-06
   Days after onset:23
Entered: 2006-04-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 491189 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Dehydration, Dyspnoea, Hypoxia, Multi-organ failure, Respiratory distress, Sepsis, Sinusitis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (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 (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-13
   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: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/13/2006 Blood culture: streptococcus pneumoniae. Pneumococcal sepsis, multi organ failure, overwhelming streptococcus pneumoniae sepsis resulting in multi organ failure.
CDC Split Type: HQWYE612603APR06

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a female patient who on 3/3/2004 at 14 months, received a fourth dose of Prevnar. on 3/8/2006, at 3 years of age, the child developed respiratory syncytial virus and sinusitis. On 3/13/2006, the patient developed overwhelming streptococcus pneumoniae sepsis and subsequently died. No know allergies, no previous drug reactions. Indication for Prevnar was immunization. Product was administered on 3/3/2004. Dose regimen was 0.5ml 1 time per day intramuscular. Concomitant medications were not reported. On 3/3/2004, the patient received a fourth dose of Prevnar. On 3/8/2006, the patient developed respiratory syncytial virus (respiratory syncytial virus infection) and sinusitis. Treatment included breathing treatments. On 3/13/2006, the child was vomiting and the patients conditions worsened. The child was evaluated at the doctors office and a blood culture revealed streptococcus pneumoniae. No serotype testing was performed. On the same day, the patient was hospitalized for pneumoniae sepsis (pneumococcal sepsis) (drug ineffective). The pneumococcal sepsis resulted in multi system organ failure and the patient subsequently died on the same day. The cause of death was reported as overwhelming streptococcus pneumoniae sepsis resulting in multi system organ failure. Blood culture (results streptococcus pneumoniae) was done on 3/13/2006. No additional information was available at the time of this report. 6/19/06 Received hospital medical records which revealed patient experienced overwhelming septic shock from streptococcus pneumoniae causing multisystem organ failure. Hospitalized & expired on 3/13/06. DC summary indicates patient had URI for several days which had gotten progressively worse. 6/19/06 Received medical records from hospital which reveal transferred in on 3/13/06 with a diagnosis of overwhelming septic shock from streptococcus pneumoniae causing multisystem organ failure. Patient had progressively worsening respiratory infection w/dry nonproductive cough for approx 10 days prior to admit. Patient expired 3/13/06 after coding x 2. A CXR showed left pleural effusion vs empyema w/near whiteout of left lung field. Aspiration of the left pleural space revealed approx 30 ml of purulent dark colored fluid. C/S of the pleural fluid revealed strep pneumoniae heavy growth. She was unable to be resuscitated after the second code. 1/25/08 Reviewed death certificate which states COD as multiorgan system failure with septic shock, streptococcal pneumoniae empyema & sepsis & recent RSV infection as contributing causes.


VAERS ID: 253946 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-03-17
Onset:2006-03-18
   Days after vaccination:1
Submitted: 2006-04-06
   Days after onset:18
Entered: 2006-04-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1400CA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0527R / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0535 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A259640 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Pulmonary haemorrhage, Unevaluable event
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-18
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NC06022

Write-up: Pt received vaccines on 3/17/2006. Pt died 3/18/2006. Autopsy pending. 8/3/06 Received autopsy report which revealed COD as undetermined. Pathological diagnoses was intra-alveolar hemorrhage/ss


VAERS ID: 253947 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-03-27
Onset:2006-03-28
   Days after vaccination:1
Submitted: 2006-04-06
   Days after onset:8
Entered: 2006-04-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B056AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0891R / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08642D / 1 RL / IM

Administered by: Public       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Sudden infant death syndrome
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), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-28
   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: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mother of baby came into WIC department today and stated her baby got shots and the next day her baby died. 9/19/06 Received ER medical records which reveal patient was sleeping on couch overnight & was found unresponsive next am with bloody sputum around nares. Arrived to ER in full arrest & resuscitation was unsuccessful. 9/19/06 Received autopsy report which reveals COD as SIDS/ss


VAERS ID: 254142 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Idaho  
Vaccinated:2005-12-20
Onset:2006-01-04
   Days after vaccination:15
Submitted: 2006-03-20
   Days after onset:75
Entered: 2006-04-17
   Days after submission:27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 14B008A / 1 LA / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0568P / 1 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y053R / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A25962A / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-01-04
   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: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ID06013

Write-up: Death. 4/26/06 Received autopsy report which stated COD as SIDS. Patient had been placed face down in playpen w/adult sized blanket folded. Had recent runny nose/ss


VAERS ID: 254315 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-04-19
Entered: 2006-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Cognitive disorder, Dyspnoea, Fatigue, Immune system disorder, Malaise, Rash, Rheumatoid arthritis
SMQs:, Anaphylactic reaction (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: A0601618A

Write-up: This case was reported by a lawyer and described the occurrence of shortness of breath in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unknown time after vaccination with Lymerix, the subject experienced shortness of breath, fatigue, general malaise, rash, rheumatological symptoms, neurological impairment, cognitive impairment and autoimmune disease. The subject died. The cause of death was not reported. It was unknown whether an autopsy was performed. This information was received via a statement of injuries.


VAERS ID: 254375 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Indiana  
Vaccinated:2006-04-18
Onset:2006-04-19
   Days after vaccination:1
Submitted: 2006-04-20
   Days after onset:1
Entered: 2006-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B053BA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0718R / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08653B / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal sleep-related event, Apnoea, Bronchitis chronic, Cardio-respiratory arrest, Sleep apnoea syndrome, Sudden infant death syndrome
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), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unaware of any other medications.
Current Illness: No illness. Was on apnea monitor since birth. Born 1 month premature.
Preexisting Conditions: Apnea monitor - premature infant
Allergies:
Diagnostic Lab Data: Full ER report will be faxed.
CDC Split Type:

Write-up: Child on apnea monitor since birth. Born 1 month premature. Parents awakened by monitor going off. I am unsure of # of episodes throughout night. Parents have not yet returned call. Full ER report will be faxed, which includes all treatment, etc. 4/20/06 Received ER medical records which reveal patient arrived in full arrest w/blood around nares & was unable to be resuscitated. 5/25/06 Received autopsy report which reveal COD as SIDS with cosleeping in child with history of sleep apnea & mild chronic bronchitis/ss


VAERS ID: 254460 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Female  
Location: Minnesota  
Vaccinated:2006-01-25
Onset:2006-02-01
   Days after vaccination:7
Submitted: 2006-04-24
   Days after onset:81
Entered: 2006-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B034AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE723AB / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A25969B / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-02-01
   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: none
Current Illness:
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No signs or symptoms of reaction. Patient died 2-1-06.


VAERS ID: 254832 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Alabama  
Vaccinated:2005-11-03
Onset:2005-11-07
   Days after vaccination:4
Submitted: 2006-04-24
   Days after onset:167
Entered: 2006-05-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1830AA / UNK RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Asthma, Cardiomegaly, Cerebral ischaemia, Encephalopathy, Hepatic necrosis, Hypoxia, Pneumonia, Pyrexia, Status epilepticus, Subdural haematoma
SMQs:, Cardiac failure (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Accidents and injuries (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-08
   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: Flovent; Singulair
Current Illness: Asthma
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: WBC 28,500.
CDC Split Type:

Write-up: Child developed fever early morning of Monday 11/7/06, then status epilepticus. Was brought to ER, was intubated and ventilated. Suffered hypoxic insult. Died 11/8/06. 7/6/06 Received medical records & autopsy report from hospital which reveal COD as status epilepticus with subsequent severe hypoxic/ischemic encephalopathy; cerebral edema with bilateral cerebellar tonsillar herniation; subdural hematoma, small, right lateral cerebellum & asthma (by clinical history). Stated that status epilepticus possibly related to URI (MRSA). Temp max 105.8


VAERS ID: 255021 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Oregon  
Vaccinated:2006-04-20
Onset:2006-04-23
   Days after vaccination:3
Submitted: 2006-04-26
   Days after onset:3
Entered: 2006-05-03
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B063AA / 3 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0656R / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08642C / 3 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Bradycardia, Gastrooesophageal reflux disease, Patent ductus arteriosus, Premature baby, Pulmonary hypertension, Respiratory disorder, Retinopathy
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (narrow), Gastrointestinal nonspecific dysfunction (narrow), Retinal disorders (narrow), Neonatal disorders (narrow), Respiratory failure (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Captopril, Caffeine
Current Illness:
Preexisting Conditions: 26 week preemie, chronic lung disease,
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine admin on 4/20/2006. Death from apnea/bradycardia reportedly on 4/23/2006. I do not have details. 6/1/06 Received medical records from hospital which reveal patient had been readmitted to hospital 3/28/06 after having been transferred to university med center for bronchoscopy & trach placement 3/17/06. Concurrent dx: GERD, retinopathy of preemie, left hydrocele and perianal excoriations, anemia, PDA, pulmonary HTN & hyperbilirubinemia. Patient had continued occasional desaturation spells & occasional chronic lung disease shutdown spells but was felt to be stable overall. D/C from hospital 4/18/06 w/final dx: preemie, chronic lung disease, persistent apnea, subglottic stenosis s/p trach, HTN, retinopathy of preemie, bilateral hydrocele/ss


VAERS ID: 255199 (history)  
Form: Version 1.0  
Age: 0.55  
Sex: Male  
Location: Arizona  
Vaccinated:2006-05-02
Onset:2006-05-04
   Days after vaccination:2
Submitted: 2006-05-08
   Days after onset:4
Entered: 2006-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B028AA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE798AA / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08635E / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Convulsion, Drug abuser, Encephalopathy, Feeding disorder neonatal, Neurodevelopmental disorder, Premature baby
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Drug abuse and dependence (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-04
   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: Phenobarbital 75mg once daily
Current Illness:
Preexisting Conditions: Encephalopathy of UNK etiology, Intrauterine drug exposure, Barbiturates, Methadone.
Allergies:
Diagnostic Lab Data: Extensive w/u done including genetic & metabolic tests which were WNL. MRI was WNL
CDC Split Type:

Write-up: Pt expired during sleep 36 hrs after vaccine. 5/11/06 Received notes from PCP which revealed patient was 34 week preemie w/encephalopathy dx by EEG, intrauterine drug exposure (barbiturates, methadone & TCAs), seizure disorder, severe developmental delays, vascular ring, inguinal hernia & NG feeding tube. PMH: apnea. Unclear whether pateint was deaf & blind. Very poor suckle & continued on tube feeds. Lived with foster parent & because of very poor prognosis was made DNR. 7/25/06 Received Death Certificate which stated COD as encephalopathy/ss


VAERS ID: 255270 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Florida  
Vaccinated:2006-03-06
Onset:2006-03-07
   Days after vaccination:1
Submitted: 2006-05-09
   Days after onset:62
Entered: 2006-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B047BA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0717R / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08639D / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-08
   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:
Current Illness: COLIC
Preexisting Conditions: CEPHALOHEMATOMA R OCCIPITAL-PARIETAL
Allergies:
Diagnostic Lab Data: Pending further studies. No information received at this time from the medical examiner.
CDC Split Type:

Write-up: Infant died 2 days post vaccination. By report had been crying all day and night of 3/7/06. Started vomiting on 3/7/06 also.


VAERS ID: 255327 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-05-08
Entered: 2006-05-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Myelopathy
SMQs:, Peripheral neuropathy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unkown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0605USA00741

Write-up: Information has been received from a lawyer concerning a literature article where a 36 year old patient was vaccinated with a booster dose of RECOMBIVAX HB manufacturer unknown. Subsequently, the patient developed a progressive and ultimately fatal, inflammatory myelopathy polyradiculopathy nine days after the booster dose. It was reported that the patient had no fever or systemic illness and did not respond to extensive immunotherapy. No further information was available at the time of this report. Additional information has been requested. A copy of the published article will be provided, when available, as further documentation of the patients experience.


VAERS ID: 255328 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-05-08
Entered: 2006-05-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0605USA01099

Write-up: Information has been received from a lawyer concerning a male who was vaccinated with RECOMBIVAX HB (manufacturer unknown). The patient suffered a vaccine injury Guillain Barre syndrome as a result of RECOMBIVAX HB. In 2005 the patient died from hypertension. No further information was available at the time of this report. No further information is available.


VAERS ID: 255329 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-03-16
Onset:2006-04-01
   Days after vaccination:16
Submitted: 2006-05-08
   Days after onset:36
Entered: 2006-05-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / -

Administered by: Other       Purchased by: Other
Symptoms: Candidiasis, Cerebral haemorrhage, Chromosome abnormality, Coagulopathy, Dehydration, Hypoxia, Immune system disorder, Laboratory test abnormal, Liver function test abnormal, Lung disorder, Pneumonia, Pulmonary fibrosis, Rash vesicular, Respiratory distress, Sepsis, Viral infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-05-25
   Days after onset: 53
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 41 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Inhaled corticosteroid
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Bronchial irrgation-4/9/06?-(+) for mumps on day 3; Diagnostic lab-4/9/06?-ifa negative for measles Initial WBC 5,400. EEG revealed diffuse cerebral dysfinction. Elevated LFTs & coagulopathy. Severe lymphopenia
CDC Split Type: WAES0604USA03984

Write-up: Information has been received from a physician concerning a 13 month old female who on 3/16/2006 was vaccinated with a dose of Varicella virus vaccine live. Concomitant vaccine administered on the same day included a doe of measles mumps rubella vaccine. Concomitant therapy included an inhaled corticosteroid unspecified. On 4/9/2006 the patient was diagnosed with adenosine deaminase deficiency and the mumps virus had been isolated from her bronchial tract. The patient was hospitalized, was being treated in the critical department, and was on a ventilator. At the time of the report the patient had not recovered. It was noted that there were numerous diagnostic studies, unspecified. Follow up information from a physician indicated that the patient was currently being treated, in April 2006, for disseminated Varicella. The patient was also being treated for lung disease attributed to Varicella, which had shown response to treatment. The patient was still being mechanically ventilated, which required 50% supplemental oxygen. A bronchioalveolar lavage sample was positive for mumps on day three. An immunofluorescence assay was negative for measles. The treatment of the patient has included acyclovir, foscarnet, ribavirin IV, amantadine, and pegylated adenosine deaminase. Current therapy included amantadine, ribavirin and acyclovir. The patients reaction was considered to be immediately life threatening, disabling, and an important medical event by the reporter (OMIC). Additional information has been requested. 6/1/06 Received t/c from reporter with unofficial COD of intracranial hemorrhage which was probably caused by the drug Ecmo. Had also used 2 IND drugs on this patient (ribavirin & VeriZIG) PMH: preexisting pulmonary fibrosis & intermittent thrush since birth. Patient had been hospitalized past fall with extensive pulmonary infection for approx 3 weeks. Patient was on less than 3% percentile mark in physicial development. 6/19/06 Received medical records from prior hospitalization 8/20/05-9/4/05 w/dx: pneumonia, hypoxia & dehydration. PMH: protracted history of colds & ear infections. Birth hx: pregnancy complicated by oligohydramnios, c-section, breech presentation, 6#, length 19 in & head circum 33.5. Blood cultures during hospitalization were neg. Final dx: viral pneumonia. 7/13/06 Received medical records from hospital for admit 4/17/06-5/25/06. Final Dx: disseminated varicalla infection, septic shock & respiratory failure requiring mechanical ventilation. Final dx: ADA deficient SCID, ARDS, septic shock, intracranial hemorrhage. 8/4/06 Received d/c summary from hospital which revealed final dx as respiratory failure.


VAERS ID: 255503 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2005-04-06
Onset:2005-04-06
   Days after vaccination:0
Submitted: 2006-05-11
   Days after onset:400
Entered: 2006-05-16
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A013AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE251AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67188D / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Coma, Irritability, 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), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-07
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby fussy with temperature/fever. At 12:30 PM on 4/07/2005, baby was unresponsive. 9/25/2007 Received Death Certificate which reveals COD as SIDS.


VAERS ID: 255762 (history)  
Form: Version 1.0  
Age: 98.0  
Sex: Male  
Location: New York  
Vaccinated:2004-04-26
Onset:2006-04-26
   Days after vaccination:730
Submitted: 2006-05-15
   Days after onset:19
Entered: 2006-05-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0605USA01866

Write-up: Info has been received from a physician, via a company representative, concerning a 98 year old male who "two years ago", on 4/26/04, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. "Two weeks ago" on 4/26/06, the pt died due to non-pneumococcal cause. It was reported that the pt was hospitalized or had prolonged hospitalization and that the experience was life threatening. The non-pneumococcal cause of death was considered to be immediately life-threatening. Additional info has been requested.


VAERS ID: 257068 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: Florida  
Vaccinated:2006-03-20
Onset:2006-03-22
   Days after vaccination:2
Submitted: 2006-05-30
   Days after onset:68
Entered: 2006-05-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2278AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0231P / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0706 / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Atrial septal defect, Hypoxia, Patent ductus arteriosus, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-22
   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: GER/Slow stomach emptying
Preexisting Conditions: Pyloric stenosis-Surgery at 2 weeks of age.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received vaccine on 3/20/06. Pt expired at home on 3/22/06. 7/10/06 Received autopsy report which revealed COD as persistence of fetal circulation/ss


VAERS ID: 257684 (history)  
Form: Version 1.0  
Age: 1.33  
Sex: Female  
Location: Arkansas  
Vaccinated:2006-05-31
Onset:2006-06-01
   Days after vaccination:1
Submitted: 2006-06-02
   Days after onset:1
Entered: 2006-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1774CA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE795AA / 3 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR YO991 / 2 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0092F / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08653R / 3 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1022R / 1 LL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardio-respiratory arrest, Circulatory collapse, Dehydration, Hypoxia, Neurodevelopmental disorder, Pneumonia, Pyrexia, Respiratory distress
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-06-02
   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: Prevacid, Tabs 15 mg Solutab PO Oxygen at home device Albuterol MDI, Inhaler, 90 mcg, Atrovent nasal Spray (0.03%) Metoclopramide, Syrup 5mg/5ml .8ml Nystatin Powder Was given Augmentin ES-600 susp, for otitis media the day she was in offic
Current Illness: Otitis Media Bi latteral
Preexisting Conditions: Gerd, Scoliosis- Idiopathic, Tracheomalacia,Wheezing, Developemental Delay, Speech Delay, Otitis Media-Chronic Supporative Bilateral
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received immunizations in this office on 5/31/06. She was noted to have an otitis media withoutfever. Mother called the office on 6/1/06 and talked to the nurse because she was running a fever and not acting quite right. She was given standard instruction for post immunization. During the night she became febrile and started having respiratory difficulties with her pulse ox dropping into the 80''s. Mother drove her to the emergency room. In route the child became apneic. By the time she arrived she was asytolic. Rescussitation was unsuccessful. She had a temperature of 107 when she arrived in the ER.This patient had fever and cardiovascular colapse within 48 hours of immunization. I feel this was a major immunization reaction. 7/18/06 Received medical records from ER which reveal patient developed respiratory distress & failure. PMH: tracheomalacia, developmental delay, chronic respiratory deficitis & congenital heart defects. Had trach & PEG in place & was on home O2. Developed decreased LOC prior to hospitalization with cyanosis despite O2. Found to be febrile at 107, apneic & asystolic in ER & resuscitation was unsuccessful. 7/31/06 Received medical records from PCP which did not add new info. 8/9/06 Received Death Certificate which stated COD as pneumonia with dehydration with tracheomalacia as underlying cause./ss


VAERS ID: 257920 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Kentucky  
Vaccinated:2006-05-22
Onset:2006-05-25
   Days after vaccination:3
Submitted: 2006-05-30
   Days after onset:5
Entered: 2006-06-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC218063AA / 1 UN / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0719R / 1 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08639C / 1 UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Asphyxia, Cardio-respiratory arrest, Rhinitis
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), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant taken to ER per ambulance. Pronounced dead in ER. No other current date. Post mortum will be done. 6/8/06 Received medical records from ER which reveal patient arrived in full arrest & was unable to be resuscitated. 6/13/06 Received medical records from PCP which reveal Mom had hx of HSV II & was neg for beta strep at delivery. Apgars were 6 & 9 at 1 & 5 min. All cultures were neg. Developed allergic rhinitis & had frequent cough/cold symptoms. On last visit 10 days prior to vax, note indicates well child visit. 8/3/06 Received autopsy report which stated COD as asphyxia. Patient had been placed face down on baby blanket covering adult size comforter which had been folded. Patient was not on baby blanket when found. Comforter had looe nylon type fabric.ss


VAERS ID: 258226 (history)  
Form: Version 1.0  
Age: 0.56  
Sex: Male  
Location: Arizona  
Vaccinated:2006-05-25
Onset:2006-05-31
   Days after vaccination:6
Submitted: 2006-06-09
   Days after onset:9
Entered: 2006-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2278AA / 2 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 9372806 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1049 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B086354 / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Lymphadenitis, Pneumonia, Premature baby
SMQs:, Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-31
   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: not avalible
CDC Split Type:

Write-up: Office was notified of death of child by Epidemiologist of State on 06-05-2006. Sudden infant death on 05/31/2006 immunizations given on 05/25/2006. 7/31/06 Received autopsy report which stated COD as pneumonia with pathological diagnoses as bilateral acute hemorrhagic pneumonia; small reducible periunbilical hernia; slyphadenitis of mesenteric lymh nodes; & history of prematurity./ss


VAERS ID: 258229 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Female  
Location: West Virginia  
Vaccinated:2006-05-11
Onset:2006-05-14
   Days after vaccination:3
Submitted: 2006-06-10
   Days after onset:27
Entered: 2006-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0946P / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
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: 2006-05-14
   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: none
Allergies:
Diagnostic Lab Data: none: there was a medical examiners referral and no report has been received at this time.
CDC Split Type:

Write-up: HBV was given on a routine WCC on the regular 3 day recommended follow up from the Hospital on 5-11-06. Weight had returned to almost birth weight and the baby was not jaundiced and eating well. Sunday am 5-14-06 while in the hospital I was asked to go to the ED regarding a resusitation attempt on this infant who was found in the bed unresponsive. Resusitation was unsuccessful. 7/7/06 Received ER medical records which reveal patient arrived in full arrest & was unable to be resuscitated. 9/15/06 Received autopsy report which reveal COD as SIDS./ss


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

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Diarrhoea, Encephalopathy, Irritability, Lip ulceration, Pneumonitis, Pyrexia, Stomatitis, Viral infection
SMQs:, Severe cutaneous adverse reactions (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: viral stomatitis
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Final autopsy report just received. Cause of death "complications of viral infection." All cultures negative. Pathology of brain showed "focal perivascular chronic inflammation consistent with viral encephalopathy, slight brain swelling." Lung path showed "minimal edema and minimal acute and chronic inflammation (mostly lymphocytes and macrophages with occasional neutrophils and rare plasma cells)."
CDC Split Type:

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


VAERS ID: 258554 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2006-02-03
Onset:2006-02-19
   Days after vaccination:16
Submitted: 2006-06-08
   Days after onset:108
Entered: 2006-06-19
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB171AB / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Atrial fibrillation, Cardio-respiratory arrest, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-02-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: nka
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY2006024

Write-up: Patient had M.I. No known history of illness. Received records from county health department with no new info. 7/13/06 Received old medical records from prior hospital visits which reveal patient was a smoker & had hx of back pain. Chest pain dx as costochondritis & also intermittent atrial fibrillation. Cardiac enzymes were neg. 8/18/06 Received ER medical records which revealed patient had been found by family member & had been down for approx 45 min prior to arrival in ER. Was in full arrest upon arrival & resuscitation was unsuccessful. 8/18/06 Received Death Certificate which revealed COD as acute MI/ss


VAERS ID: 258786 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Tennessee  
Vaccinated:2006-05-09
Onset:2006-05-10
   Days after vaccination:1
Submitted: 2006-06-08
   Days after onset:29
Entered: 2006-06-26
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B051AA / 2 RL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0891R / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08642D / 2 LL / -

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Apnoea, Cardio-respiratory arrest, Hypoxia, Sudden infant death syndrome, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-10
   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: NONE
Current Illness: URI
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient stopped breathing about 7:00 AM 5/10/2006. CPR began by rescue personnel and continued in ER. Pt intubated and resuscitative effort continued for 45 minutes. Pronounced dead at 8:09 AM 5/10/2006. 6/30/06 Received ER medical records which reveal patient arrived febrile & in full arrest. History of URI for approx 1 mon prior to death & wa co-sleeping with adult. Resuscitation unsuccessful. 6/30/06 Received medical records from PCP with no new info. 7/18/06 Received autopsy report which stated COD as Sudden Death in infant cosleeping with adult/ss


VAERS ID: 259492 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Female  
Location: Mississippi  
Vaccinated:2006-06-27
Onset:2006-07-01
   Days after vaccination:4
Submitted: 2006-07-07
   Days after onset:6
Entered: 2006-07-13
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B056AA / 2 RL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0891R / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B22930A / 2 LL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Apnoea, Autopsy, Cardio-respiratory arrest, Chromosome abnormality, Decreased appetite, Diarrhoea, Infantile spitting up, Irritability, Pathology test, Rhinorrhoea, Sudden infant death syndrome, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-02
   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:
Current Illness: Mild G/enteritis
Preexisting Conditions: No. (Abnormal neonatal organic acid screen, normal confirmatory tests).
Allergies:
Diagnostic Lab Data: Autopsy done. Result not known.
CDC Split Type:

Write-up: Fussiness all night, became apneoic on the way to ER. CP arrest on arrival to ER, died at 13:50 7/2/06. 7/17/06 Received provisional autopsy report which revealed COD as sudden unexplained infant death. Pathologic dx of cardiomegaly. 7/27/06 Received medical records from PCP which reveal patient had normal c-section delivery. Newborn blood screen revealed acylcamitine profile abnormality & was referry to genetists. Had frequent spitting up & runny nose. On day of vax, had diarrhea, diaper rash & continued to spit up. Had been fussy for several days with decreased appetite & episode of emesis. PCP sent patient to ER & arrested on the way. 7/27/06 Arrived at ER in full arrest & resuscitation was unsuccessful. 7/5/07 Received t/c from coroner stating has received final autopsy report & will mail copy to VAERS. States COD as SUDS. Also stated 2nd child in family died approx 2 wks ago from apparent cardiac condition as heart size was approx 2x normal. ALthough suspicious, deaths are probably unrelated. 7/11/07-final autopsy report received-COD-Sudden Unexplained Infant Death Syndrome. Parent stated patient had been irritable all day & had wheezing & difficulty breathing. Parent took to ER where patient was found to be unresponsive. Intubated w/much effort due to very swollen trachea & resuscitation efforts were unsuccessful.


VAERS ID: 259634 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2006-01-25
Onset:2006-01-27
   Days after vaccination:2
Submitted: 2006-07-17
   Days after onset:170
Entered: 2006-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B034AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE500AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08634B / 1 LL / IM

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

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

Write-up: Child reported died 2 days after vaccine given.


VAERS ID: 259715 (history)  
Form: Version 1.0  
Age: 0.84  
Sex: Female  
Location: Missouri  
Vaccinated:2006-05-12
Onset:2006-05-18
   Days after vaccination:6
Submitted: 2006-07-18
   Days after onset:61
Entered: 2006-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1163R / 3 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0381R / 1 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1110R / 1 RL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Febrile convulsion, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-18
   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: unknown
Current Illness: postmortem=pneumonia
Preexisting Conditions: unknown
Allergies:
Diagnostic Lab Data: unknown time vaccine administered is also unknown but filled in a time so could complete form.
CDC Split Type:

Write-up: Infant febrile morning of 5/18/2006 around 5:30 a.m. No other S/S per parent. Parent administered tylenol. Midday infant began seizing, mom called 911, infant transported and later pronounced dead at hospital. 7/19/06 Received death certificate which stated COD as pulmonary edema due to protracted febrile seizure. 7/28/06 Received tag-2 report from PCP. Family had moved to another state. Records accompanying report included vax records, Death Summary from ER & Autopsy Report. COD stated as non-cardiogenic pulmonary edema as the result of febrile seizures/ss


VAERS ID: 259725 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Rhode Island  
Vaccinated:2006-07-11
Onset:2006-07-12
   Days after vaccination:1
Submitted: 2006-07-14
   Days after onset:2
Entered: 2006-07-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B053AA / 3 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08635H / 3 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Cardiac arrest, Pyrexia, Respiratory distress, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (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 (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-13
   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:
Current Illness:
Preexisting Conditions: eczema
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant had routine well child exam on 7/11/06 healthy. 7/12/06 PM 2 episodes of emesis. 7/13/06 fever/acute respiratory distress 911 call asystole when ambulance arrived code ran in field and ER/infant expired.


VAERS ID: 259768 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Florida  
Vaccinated:2006-07-18
Onset:2006-07-18
   Days after vaccination:0
Submitted: 2006-07-19
   Days after onset:1
Entered: 2006-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2627AA / 1 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE730AA / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z000012 / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-19
   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: Oral thrush
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 month old received routine Daptacel, IPOL, ActHIB. No other problems. Baby was found dead during the night.


VAERS ID: 261075 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2006-07-24
Onset:2006-07-28
   Days after vaccination:4
Submitted: 2006-08-03
   Days after onset:6
Entered: 2006-08-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2116AA / UNK LA / -

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Coma, Pulse absent
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-28
   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:
Preexisting Conditions: Allergic to bee stings and sulfa, mild hypercholesteremia PMH: frequent URI, nasal congestion, pharyngitis, mouth ulcers, eczema, rhinorrhea, otitis media, hives, epiglottitis, croup, PE tubes, impetigo, eye laceration w/sutures & infection, forehead laceration w/sutures, contact dermatitis, pneumonia, strep throat multi episodes, bronchitis, adenopathy, local reaction to DPT at 5yo, multi episodes of URI, asthma, fracture right wrist, conjunctivitis, bee sting infection (venom allergy requiring epi pen) requiring allergy consult, , obesity (wt 255 on 2/8/06), anxiety requiring psych eval, borderline prolonged QT requiring cardio consult, Holter monitor WNL, sports injury concussion, elbow tendonitis, sports injury fractured right thumb, multi episodes sinusitis Allergy: sulfa
Allergies:
Diagnostic Lab Data: LABS: 2004 chole 217, HDL 33 reported in notes, no printed lab results included in medical records from PCP office.
CDC Split Type:

Write-up: Reported by MD that 18 year old male received Menactra vaccine on 7/24/2006, on 7/28/2006, Patient was found unresponsive, pulseless and not breathing in bed. Etiology unknown at this time. 12/21/06 Received medical records from PCP which did not include any lab reports. T/C to PCP to check status of request for labs. Office states no labs done since 2005. 4/10/07 Received Autopsy Report which reveals COD as presumed cardiac arrhythmia. No anatomic, histologic or toxicologic cause. Manner of death was natural.


VAERS ID: 261100 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Ohio  
Vaccinated:2005-11-25
Onset:2006-05-19
   Days after vaccination:175
Submitted: 2006-08-04
   Days after onset:77
Entered: 2006-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1047P / 2 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection, Drug ineffective, Hypotension, Mental impairment, Myocardial infarction, Pneumonia, Renal failure acute, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-22
   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: Xanax, Periactin, Synthroid
Current Illness: None
Preexisting Conditions: Allergies to Penicillin and codeine (reaction "jumpy), chronic abdominal pain, diverticulosis, anxiety, back/shoulder pain, dementia, hypothyroid
Allergies:
Diagnostic Lab Data: Blood cultures isolated strep pneumoniae
CDC Split Type:

Write-up: Failed Vaccine 8/7/06 Received death certificate which revealed COD as streptococcal pneumoniae sepsis with underlying cause of streptococcal pneumoniae pneumonia. 8/11/06 Received D/C summary from hospital which reveal patient was hospitalized from 5/19/06-5/22/06 with bilateral pneumonia, hypotension, chronic CHF, acute mental status changes, hx of CAD & pulmonary embolism for which patient had recently d/c Coumadin and chronic abdominal pain. Final dx: bilateral streptococcal pneumoniae pneumonis; sepsis secondary to streptococcus pnaumoniae; acute renal failure; MI on 5/21/06; hypotension;acute mental status change; & chronic abdominal pain. Patient''s clinical status worsened progressively until her death despite antibiotics, IVF & Dopamine & O2 by mask.


VAERS ID: 261277 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: South Carolina  
Vaccinated:2006-08-01
Onset:2006-08-01
   Days after vaccination:0
Submitted: 2006-08-08
   Days after onset:7
Entered: 2006-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U1857BA / 2 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0268F / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0001 / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B086838 / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-08-02
   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:
Current Illness: MILD CONGESTION
Preexisting Conditions: NONE KNOWN
Allergies:
Diagnostic Lab Data: NONE, AUTOPSY WAS PERFORMED
CDC Split Type:

Write-up: cHILD SEEN FOR 4 MONTH WELL EXAM 8/1/2006 NORMAL EXAM RECEIVED ROUTINE IMMUNIZATIONS AND DURING THE NIGHT THE PATIENT EXPIRED


VAERS ID: 261425 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: New Jersey  
Vaccinated:2006-03-07
Onset:2006-03-09
   Days after vaccination:2
Submitted: 2006-08-11
   Days after onset:154
Entered: 2006-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2405AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE855AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0824 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08633B / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Coma, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), 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 (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-03-09
   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:
Current Illness: Patient was seen for a cold on 2/20/06 and 2/24/06. She had no fever, alert, appetite good. Day of vaccination, alert, smiling & happy, eating well, cooing, no fever.
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: As per Emergency Room Report dated 03/09/06: Baby was found unresponsive in her crib by her mother @ 3:15pm. Vomitous around her mouth, last seen alive @ 2:30pm when dad turned patient on back. ALS was done at scene, patient was in asystole and transported to emergency room.


VAERS ID: 261757 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: New Hampshire  
Vaccinated:2006-04-06
Onset:2006-05-07
   Days after vaccination:31
Submitted: 2006-08-17
   Days after onset:102
Entered: 2006-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB134AA / 1 UN / IM

Administered by: Public       Purchased by: Public
Symptoms: Abnormal sleep-related event, Laboratory test abnormal, Monocytosis, Platelet count increased, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-07
   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: NONE
Current Illness: Fever, Stool, Congestion, no appetite, fussy, Gastroenteritis viral.
Preexisting Conditions: Neonatal jaundice, Neonatal acne. Child had been seen by PCP on 4/29/06 for sniffles & on 5/5/06 for fever & flu-like symptoms.
Allergies:
Diagnostic Lab Data: CBC 5/05/2006 12.6 (H) MCV 89 (H), MCHC 34.2 (H), PLT 597 (H), Band 1 (L), MONO 7 (H).
CDC Split Type: NH0603

Write-up: SIDS Category II, undetermined 8/29/06 Received autopsy report which stated COD as Category II SIDS & manner of death as undetermined. Patient was cosleeping with parent in adult bed lying on belly & suffocation caused by overlay could not be excluded.


VAERS ID: 261871 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: Maryland  
Vaccinated:2006-08-18
Onset:2006-08-18
   Days after vaccination:0
Submitted: 2006-08-21
   Days after onset:3
Entered: 2006-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB288AA / 2 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0215F / UNK LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Cardiac arrest, Convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-08-18
   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: NONE KNOWN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received MMR vaccine and Hepatitis B vaccine at 1:45 PM. Brought in to ER at 10:48 PM in full cardiac arrest. Apparently had witnessed seizure prior to arrest.


VAERS ID: 261907 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Female  
Location: New Hampshire  
Vaccinated:2006-04-21
Onset:2006-05-17
   Days after vaccination:26
Submitted: 2006-08-22
   Days after onset:97
Entered: 2006-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 927690B / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Abnormal sleep-related event, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-17
   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: Amoxicillin 4/25/06; prophylaxis for kidney
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0604

Write-up: Undetermined - Category II SIDS 9/15/06 Received autopsy report which reveals COD as Category II SIDS. Patient cosleeping in adult bed between 2 adults & lay over could not be excluded/ss


VAERS ID: 262025 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Mississippi  
Vaccinated:2006-07-14
Onset:2006-07-17
   Days after vaccination:3
Submitted: 2006-08-23
   Days after onset:37
Entered: 2006-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B055AA / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0891R / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08655B / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms:
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-17
   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: ALBUTEROL NEBULIZER PRN PULMICORT RESPULES 0.25 BY NEBS
Current Illness:
Preexisting Conditions: FAILURE TO THRIVE LIMITED HISTORY IN FOSTER CARE
Allergies:
Diagnostic Lab Data: 7/17/2006 5:30 CXR AT SCRMC---(1)PERICARIDAL EFFUSION (2)PROGRESSIVE BILATERAL INFILTRATES
CDC Split Type:

Write-up: PATIENT WENT TO ER ADMISSION, DIED SHORTLY AFTER ADMISSION ABOUT 6:30 P.M. 9/26/06 Received provisional autopsy report which states: COD, pending;underlying COD consolidation of bilateral lungs suggestive of pneumonia; polyp of cecum with ball valve effect & ulceration of cecum; & manner of death pending. Pathologic diagnoses: cocaine baby by hx; respiratory deficiency & fever by hx; renomegaly bilateral; & hepatomegaly w/steatosis of liver. 8/15/08 Received final autopsy report which states COD as changes compatible with viral pneumonitis.


VAERS ID: 262512 (history)  
Form: Version 1.0  
Age: 0.01  
Sex: Female  
Location: New Hampshire  
Vaccinated:2005-07-05
Onset:2005-07-13
   Days after vaccination:8
Submitted: 2006-09-01
   Days after onset:415
Entered: 2006-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBV07499 / 1 - / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Premature baby, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-13
   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: Phytuncame 1mg; Erythromycin 3.5gm
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0606

Write-up: Family lost a baby about 1 year ago D/T accidental asphyxiation (wedging against parent and couch cushion. Undetermined category II SIDS. 9/19/06 Received Autopsy Report which reveals COD as SIDS with hx of cosleeping in adult bed with parent & twin sibling. Patient was preemie due to c-section delivery of twin gestation & PDA./ss


VAERS ID: 262780 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Kansas  
Vaccinated:2006-09-06
Onset:2006-09-08
   Days after vaccination:2
Submitted: 2006-09-09
   Days after onset:1
Entered: 2006-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2649AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0237F / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1031 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08683E / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0578F / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-09-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Infant multivitamin liquid with iron
Current Illness: None
Preexisting Conditions: Prematurity- 32 weeks gestation Twin B Breech vaginal delivery Apnea of prematurity Anemia of prematurity
Allergies:
Diagnostic Lab Data: CBC performed on 08/30/2006 prior to vaccination showed WBC 8.83, Hgb 9.1, Hct 25.4, platelets 321K. Glucose during
CDC Split Type:

Write-up: Child was found apneic in his crib. EMS was contacted. Mother performed CPR. Child was pulseless when EMS arrived. Upon arrival to local hospital, child was asystolic with no response to chemical resuscitation.


VAERS ID: 262857 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: California  
Vaccinated:2005-03-31
Onset:2005-04-05
   Days after vaccination:5
Submitted: 2006-09-02
   Days after onset:515
Entered: 2006-09-12
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-05
   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: AUGMENTIN 400/5cc prescribed 03/31/2005 same day as vaccinations. On 03/10/2005 she was prescribed Amoxicillin for same ear infection. On 03/17 she was again prescribed amoxicillin for same ear infection. On 03/13/2005 she was prescribed
Current Illness: acute ear infection
Preexisting Conditions: AUGMENTIN 400/5cc prescribed 03/31/2005 same day as vaccinations. On 03/10/2005 she was prescribed Amoxicillin for same ear infection. On 03/17 she was again prescribed amoxicillin for same ear infection. On 03/13/2005 she was prescribed AUGMENTIN for the same chronic ear infection and vaccinated.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 4 1/2 month healthy infant died 4/12 days after vaccinations. Autopsy said "SIDS" which mean nothing. I have copy or report if you want copy.


VAERS ID: 263163 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:1994-07-11
Submitted: 2006-09-11
   Days after onset:4445
Entered: 2006-09-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Public       Purchased by: Other
Symptoms: Death, Hepatitis B
SMQs:, Liver infections (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1994-07-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? Yes
Previous Vaccinations: ~Hep B (no brand name)~~54.00~In Patient
Other Medications:
Current Illness: Hepatitis B. Pulmonary emphysema
Preexisting Conditions: liver problems caused by hepatitis B virus
Allergies:
Diagnostic Lab Data: Hepatitis B. Cirrhosisand fatty metamorphosis of liver.
CDC Split Type:

Write-up: Hepatitis B 3/16/07 Received copy of Death Certificate from reporter which states COD as cirrhosis & fatty metamorphosis of liver with pulmonary emphysema as contributing factor. Also noted corrected DOB & DOD. Immediate cause disease or condition resulting in death. Cirrhosis and fatty metomorphsis of liver. Cancer to liver. Pulmonary emphysemo. He die of pulmonary emphysome and the vaccine cause to get worse.


VAERS ID: 263164 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-10
Entered: 2006-09-19
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1994-07-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pertussis Whooping cough
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pertussis
CDC Split Type:

Write-up: Pertussis (Whooping cough). 4/20/07 Received copy of Death Certificate from patients son which reveals COD as advanced metastatic cancer lungs, ribs and vagina and squamous cell carcinoma of cervix.


VAERS ID: 263165 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2006-09-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PER: PERTUSSIS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial infection
SMQs:

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1997-08-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 16 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Pertussis whooping cough
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pertussis (whooping cough)
CDC Split Type:

Write-up: Pertussis (Whooping Cough)


VAERS ID: 263405 (history)  
Form: Version 1.0  
Age: 53.0  
Sex: Male  
Location: Unknown  
Vaccinated:2006-02-10
Onset:2006-04-19
   Days after vaccination:68
Submitted: 2006-08-24
   Days after onset:127
Entered: 2006-09-22
   Days after submission:29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2341A / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Dyspnoea, Hypoxia, Pulmonary oedema, Respiratory distress, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (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 (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject had a history of obesity, type 2 diabetes with peripheral circulatory disorder and neurologic manifestations, peripheral edema, hypertension and stroke (1996).
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200601981

Write-up: Initial report received on 7/19/06 from an investigator participating in the above mentioned trial. A 53 year old male subject with a history of obesity, type 2 diabetes with peripheral circulatory disorder and neurologic manifestations, peripheral edema, hypertension ans stroke (1996), experienced respiratory difficulty 68 days after he had received an injection of Adacel, lot number C2341AA. The following day, the subject presented to an ER with respiratory distress and guppy breathing. On exam, the subject suffered a cardiac arrest. Resuscitative efforts were impaired by airway difficulties (Copious vomitus and difficult intubation). He was treated with IV epinephrine and atropine. Resuscitative efforts were unsuccessful, and the subject died. Per the investigator, the serious adverse event was cardiac arrest due to pulmonary edema. No autopsy was to be performed. This case was not considered a coroners case per the coroners office. According to the investigator, the event was not related to the study vaccine. Documents held by sender Emergency room report.


VAERS ID: 263520 (history)  
Form: Version 1.0  
Age: 0.14  
Sex: Male  
Location: South Carolina  
Vaccinated:2006-08-31
Onset:2006-09-05
   Days after vaccination:5
Submitted: 2006-09-25
   Days after onset:20
Entered: 2006-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B047BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF011AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08655AA / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0139F / 1 MO / PO

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-10-08
   Days after onset: 33
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: Fever of Unknown Origin
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: CBC and lumbar puncture done in office. Cerebral spinal fluid brought to hospital by family. CBC, BMP, and blood cultures ordered when arrival to pediatric unit.
CDC Split Type:

Write-up: Received 2 month shots on 8/31/06: Pediarix, Prevnar, Acthib, and Rotateq. Office visit on 9/5/06 presenting with fever of unknown origin. Family stated fever as high as 102.3 rectally. At time of visit temp was 100.3 rectally post tylenol. LP and CBC performed in office. Admitted to Hospital. 10/13/06 Received D/C Summary from hospital which reveals the primary Dx as meningitis, cardiac arrest & seizures. Patient had neurologic devastation s/p cardiac arrest, family requested palliative care & comfort measures. Patient expired on 10/8/06


VAERS ID: 263554 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: West Virginia  
Vaccinated:0000-00-00
Onset:2006-08-31
Submitted: 2006-09-22
   Days after onset:22
Entered: 2006-09-26
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Respiratory distress, Viral infection
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2006-08-31
   Days after onset: 0
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: UNK
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Stool rotavirus antigen 08/31/06 positive for rotavirus.
CDC Split Type: WAES0609USA03169

Write-up: Information has been received from a physician concerning a 2-3 month old pt who in 2006 was vaccinated PO with the first 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). the physician reported that on approximately 8/31/06, the pt was hospitalized in the ICU with respiratory distress and died. The physician also reported that the pt had tested positive for rotavirus. The physician also considered respiratory distress and rotavirus to be life threatening. The reporting physician, via a follow up telephone call, indicated that she was not the pts physician and did not have any additional information to provide. She did not have the pts name as this was reported to her second hand by an employee at a hospital. No further information is available.


VAERS ID: 263568 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: North Carolina  
Vaccinated:2006-09-12
Onset:2006-09-21
   Days after vaccination:9
Submitted: 2006-09-21
   Days after onset:0
Entered: 2006-09-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0139F / 1 MO / PO

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: 2006-09-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NC06086

Write-up: Death occurred at night in home, unwitnessed, possible SIDS, previously healthy with mild CER, autopsy performed, genetics involved second to strong family history of developmental delay and psychiatric d/o. Pt in phase III clinical trial of HibMency, received vaccine 8/9/06


VAERS ID: 263635 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: California  
Vaccinated:2006-09-20
Onset:2006-09-23
   Days after vaccination:3
Submitted: 2006-09-27
   Days after onset:4
Entered: 2006-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2396AA / 2 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE839AA / 2 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y1067 / 2 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08642E / 2 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Had cold s/s at time of vaccination.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death. SIDS death? Under coroner''s investigation. 03/05/07-Autopsy report received:cause of death Sudden Infant Death Syndrome. Toxicology report received. None detected. Records copied and sent to FDA.


VAERS ID: 263719 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-09-29
Entered: 2006-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-09-02
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 06AV00272SP

Write-up: Complications from Anthrax vaccine (unevaluable reaction). Subject, age 24, reportedly died 9/2/06 from complications resulting from an Anthrax vaccine he received while serving in military.


VAERS ID: 264460 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2006-10-09
Entered: 2006-10-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA03251

Write-up: Information has been received from a certified medical assistant concerning a 4-year-old female who in approximately 2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+0 rubella virus vaccine live. In approximately 2002, suddenly after the vaccine was given, the patient died. The child''s autopsy was inconclusive. No other information was available. There was no product quality complaint. The event was also considered to be immediately life-threatening by the reporter. Additional information has been requested.


VAERS ID: 264669 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Florida  
Vaccinated:2006-10-03
Onset:2006-10-11
   Days after vaccination:8
Submitted: 2006-10-12
   Days after onset:1
Entered: 2006-10-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 69240 / UNK LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-11
   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: Flonase, Zocor, Premarin, Synthroid, Prevacid, Disaleral
Current Illness:
Preexisting Conditions: Allergic rhinitis, hypercholesterolemia, hypothyroidism, RA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was found by her son, expired. He states it looked like "she went in her sleep". 10/19/06 Received Death Certificate which states COD as Found Dead, CAD s/p angioplasty, and hypercholesterolemia with contributing factors of HTN, PVD and hypothyroidism.


VAERS ID: 264995 (history)  
Form: Version 1.0  
Age: 0.11  
Sex: Male  
Location: New York  
Vaccinated:2006-09-20
Onset:2006-10-13
   Days after vaccination:23
Submitted: 2006-10-17
   Days after onset:4
Entered: 2006-10-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR - / UNK UN / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / 2 UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0847F / UNK MO / PO

Administered by: Private       Purchased by: Private
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: 2006-10-13
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Apparent sudden infant death syndrome, fed normally at 1am, found unresponsive at 5:30am.


VAERS ID: 265325 (history)  
Form: Version 1.0  
Age: 43.0  
Sex: Female  
Location: Colorado  
Vaccinated:2006-10-21
Onset:2006-10-24
   Days after vaccination:3
Submitted: 2006-10-24
   Days after onset:0
Entered: 2006-10-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 70385 / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-24
   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: Milk of Magnesia 20 cc every bedtime; Tegretol 400 mg every am, 400 mg every pm and 600 mg every bedtime; Diflocenac 50 mg twice a day, Zantac 150 mg twice a day, Actonel 35 mg once weekly, Oxycodone/APAP 5/325 at 12 am, 6 am, noon and 2 at
Current Illness: Significant Chronic Conditions and Diagnosis list: Mental Retardation, profound (level) 318.2, (Etiology) Unknown etiology, (Seizures) Generalized Tonic/Clonic 345.1, (Vision) Legally blind; optic atrophy, bilaterally. Old retinal detachments, Cataracts, OU, per doctor name reported 7/26/1993; Cataracts both eyes, per doctor name reported 1-6-00; Exophthalmos right eye, long standing; extropia, left eye, 2-27-02. Episcleritis, right eye 3-03. (Hearing) Hearing is normal in both ears, 8-02. (Chronic Pain) Chronic pain syndrome 733.90, 5-31-01: possibly secondary to Ostoarthritis or symptomatic scoliosis. (Dental) Bruxism severe 9-25-98, (GI) Constipation 564.00, (G-Tube) Status/Post Nissen Fundoplication with Gastrostomy tube 10-04-88. (GYN) History of Dysmenorrhea and irregular periods 625.3; Fibrocystic breasts 610.1, biopsy 4 mm mass of left breast, benign, 10-19-01. (Ortho) Severe lumbar scoliosis 737.30, Spastic quadriplegia 343.2; Fracture right proximal Femur 11-27-00 with open reduction internal fixation (ORIF); refractured 3-18-01 and repeat ORIF. (ORTHO) Osteoporosis 733.0, 3-19-02, (Other) Local reaction to IV Morphine Sulfate 11-27-00; Athetoid Movement Disorder 333.90, Right sided nodular Thyroid neoplasm 193, (Respiratory) Pneumonia, 3/01, (Surgery) Abscess, left axilla, incised and drained, doctor name reported, 9-18-99; resolved, 10-4-99
Preexisting Conditions: Significant Chronic Conditions and Diagnosis list: Mental Retardation, profound (level) 318.2, (Etiology) Unknown etiology, (Seizures) Generalized Tonic/Clonic 345.1, (Vision) Legally blind; optic atrophy, bilaterally. Old retinal detachments, Cataracts, OU, per doctor name reported 7/26/1993; Cataracts both eyes, per doctor name reported 1-6-00; Exophthalmos right eye, long standing; extropia, left eye, 2-27-02. Episcleritis, right eye 3-03. (Hearing) Hearing is normal in both ears, 8-02. (Chronic Pain) Chronic pain syndrome 733.90, 5-31-01: possibly secondary to Ostoarthritis or symptomatic scoliosis. (Dental) Bruxism severe 9-25-98, (GI) Constipation 564.00, (G-Tube) Status/Post Nissen Fundoplication with Gastrostomy tube 10-04-88. (GYN) History of Dysmenorrhea and irregular periods 625.3; Fibrocystic breasts 610.1, biopsy 4 mm mass of left breast, benign, 10-19-01. (Ortho) Severe lumbar scoliosis 737.30, Spastic quadriplegia 343.2; Fracture right proximal Femur 11-27-00 with open reduction internal fixation (ORIF); refractured 3-18-01 and repeat ORIF. (ORTHO) Osteoporosis 733.0, 3-19-02, (Other) Local reaction to IV Morphine Sulfate 11-27-00; Athetoid Movement Disorder 333.90, Right sided nodular Thyroid neoplasm 193, (Respiratory) Pneumonia, 3/01, (Surgery) Abscess, left axilla, incised and drained, doctor name reported, 9-18-99; resolved, 10-4-99
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client found deceased approximately 53 hours after administration of vaccine. She had no fevers or other apparent systemic effects. She had congenital developmental delay, epilepsy, spastic quadriplegia, dysphagia, thyroid cancer. This report is submitted for the unexpected death of a patient 2 days later receiving 2006 Influenza vaccination. Client was a 43-year-old female with profound mental retardation and severe developmental disability from unknown prenatal factors. She had been a resident of a residential long term care facility since she was age 2 years. She was born at full term after an uncomplicated pregnancy except for very little fetal movement. She had an uncomplicated delivery, breathed spontaneously, weighted 8 pounds, 7 ounces but demonstrated poor tone and flaccidity during the neonatal period with no improvement. She subsequently demonstrated further profound developmental disabilities, a generalized tonic/clonic seizure disorder, spastic quadriplegia, severe lumbar scoliosis, osteoporosis, osteoarthritis, dysmenorrhea, dysphagia and episodes of aspiration pneumonitis. She had been diagnosed with a thyroid tumor in 2005, most consistent with thyroid carcinoma but her guardians had elected to not submit her for treatment of this condition. She had a diffuse, chronic pain syndrome, possibly related to neuromuscular disorders. She was legally blind and non-verbal. She was NPO and had a G-tube for all nutrition and medications. She was severely disabled, dependent on others for all ADL and had no effective means of communication. She had an Advance Directive and a DNR order. Her guardians are her parents. Client had been in a general decline in health for several years and was being treated for her acute and chronic conditions but with an emphasis on comfort measures and measures to maximize her quality of life. She received influenza vaccinations annually due to being a high risk individual resident of a long term care facility with no recorded adverse reactions. On 10-17-06 she had a routine medical evaluation and was found to be in her usual state of compromised health, with no change in treatment recommended. She was given an influenza vaccine on 10-21-06 at her residence by a facility nurse and appeared to be in stable health at that time. On daily follow up by nursing she did not appear to be in ill health or have any adverse reaction to the vaccine, with no fever, apparent pain or other discomfort, no abnormal vital signs or rash. She was last observed during a bed check by her residential staff at 3:30 am on 10-24-06, about 53 hours after the vaccination was given and was observed to be sleeping comfortably in prone position and in no distress. The staff neither heard nor witnessed anything unusual but when they checked her one hour later at 4:30 am she was found to be unresponsive, cyanotic, with no respiratory effort and no pulse. Since she had a legal DNR in effect no resuscitation effort was made. She was pronounced dead at 4:50 am on 10-24-2006 by doctor name given. The Coroner was contacted, the death was determined to be of natural causes and the body was released to Mortuary. 11/13/06 Received Death Certificate which revealed COD as cardiopulmonary arrest; generalized tonic/clonic seizure disorder; with contributing factors of congenital developmental disability.


VAERS ID: 265462 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Female  
Location: Washington  
Vaccinated:2006-10-02
Onset:2006-10-02
   Days after vaccination:0
Submitted: 2006-10-19
   Days after onset:17
Entered: 2006-10-27
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Coma, Fatigue, Irritability
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-10-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Born premature 3 weeks 1 day early and low birth weight.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After administering vaccines child became very fussy and over tired, would not wake to eat and passed away a little over a day later. Autopsy could not say that vaccines did not play role in death.


VAERS ID: 265526 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: New Hampshire  
Vaccinated:2006-04-28
Onset:2006-05-15
   Days after vaccination:17
Submitted: 2006-10-27
   Days after onset:165
Entered: 2006-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B051AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE854AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08638F / 1 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Lymphocytosis, Sudden infant death syndrome, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-05-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE, 4/13 Rocephin350 mg IM divided doses
Current Illness: 4/13/06 Fever, Cough, 4/28 no illness
Preexisting Conditions: Large umbilical hernia
Allergies:
Diagnostic Lab Data: U/B urine culture neg, CBC. 2.8 WBC (low), 71 lymphocytes.
CDC Split Type: NH06

Write-up: SIDS; gestational diabetes - uncontrolled, late prenatal care, c-section, positive tobacco use, maternal anemia


VAERS ID: 265563 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2006-10-25
Onset:2006-10-26
   Days after vaccination:1
Submitted: 2006-10-26
   Days after onset:0
Entered: 2006-10-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 69425 / UNK LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Blood glucose increased, Cerebrovascular disorder, Computerised tomogram abnormal, Death, Facial palsy, Hemiparesis, Hemiplegia, Neurological examination abnormal, Somnolence, Transient ischaemic attack
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (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), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (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: Lasix, ASA, Toprol, Nitro Furitoin, KU.
Current Illness: UTI
Preexisting Conditions: PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN.
Allergies:
Diagnostic Lab Data: Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. Blood sugar 144. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulent. Assessment: TIA versus CVA. CT scan without contrast: prominent deep white matter changes. Compared to study of 3/28/05: significant degree of decreased density in subcortical and perventricular deep white matter regions bilaterally suggesting chronic small vessel ischemic changes. No evidence of mass, hemorrhage or definite areas of acute ischemia.
CDC Split Type: ND0614

Write-up: Pt received flu vaccine on 10/25/06. Today was stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in ER with suspicion of stroke. Doing well until found this morning with left facial droop and left side hemiparesis. Presented with extreme weakness of left side. PMX significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed chronic changes of white matter without any acute changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5 in left and upper extremities. Responds to commands, follows commands. Alert but somulant. Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius. At time of injection patient lived in assisted living, after adverse event she was hospitalized and later died.


VAERS ID: 265625 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Male  
Location: New Hampshire  
Vaccinated:2006-08-31
Onset:2006-09-17
   Days after vaccination:17
Submitted: 2006-10-30
   Days after onset:43
Entered: 2006-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B055AA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE965AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08672C / 1 RL / 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: 2006-09-17
   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: NYSTATIN suspension 8/8/06 for thrush
Current Illness:
Preexisting Conditions: Thrush
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0612

Write-up: SIDS, Pt is a twin.


VAERS ID: 265665 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: New Hampshire  
Vaccinated:2006-07-15
Onset:2006-07-25
   Days after vaccination:10
Submitted: 2006-10-27
   Days after onset:94
Entered: 2006-10-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B066AA / 1 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE915AA / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08655C / 1 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Abnormal sleep-related event, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2006-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0609

Write-up: SIDS, baby was co sleeping with mom in her bed.


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