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VAERS ID: 170393 (history)  
Form: Version 1.0  
Age: 0.7  
Sex: Male  
Location: Florida  
Vaccinated:1999-01-08
Onset:1999-01-08
   Days after vaccination:0
Submitted: 2001-05-16
   Days after onset:858
Entered: 2001-05-31
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0962260 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 626A / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH M240RL / 1 LL / IM
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 45084607 / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Anaphylactic reaction, Apnoea, Brain oedema, Cerebral haemorrhage, Contusion, Convulsion, Encephalitis, Eye disorder, Fracture, Injury, Lethargy, Pneumonitis, Retinal haemorrhage, Screaming, Skin disorder, Subarachnoid haemorrhage, Subdural haematoma
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Corneal disorders (broad), Eosinophilic pneumonia (narrow), Retinal disorders (narrow), Osteoporosis/osteopenia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 1999-01-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? Yes
Previous Vaccinations: ~DTaP (no brand name)~~2.00~In Sibling
Other Medications: Tylenol
Current Illness: Gastroenteritis and vomiting for 1 day
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt experienced convulsions, eye contusion, lethargy, encephalitis, high pitched screaming, pneumonitis, apnea, anaphylaxis, sclerosis. Autopsy states cause of death as a result of blunt head trauma injuries. Autopsy reports contusions of the scalp, fractures of the parietal bone, subdural hematoma, subdural hemorrhage, subarachnoid hemorrhage, retinal hemorrhages, hemorrhage in the optic nerve, cerebral edema, contusions, abrasions.


VAERS ID: 170576 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-05-30
Entered: 2001-06-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES01052519

Write-up: Information has been received from a physician who reported that she had received a telephone call from an obstetrician. The obstetrician indicated that his child was vaccinated with Hep-B vaccine recombinant (yeast) and died of sudden infant death syndrome (SIDS). Since that time, the obstetrician had started a web site of Hep-B vaccine recombinant (yeast) and SIDS cases. The obstetrician reported that he had 40 cases (WAES 01050372) in his web site. The physician also reported that an infant vaccinated with Hep-B vaccine recombinant (yeast) developed cyanosis, jaundice, vocal cord damage and gastroesophageal reflux disease (WAES 01042680).


VAERS ID: 170577 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2001-05-03
Onset:2001-05-05
   Days after vaccination:2
Submitted: 2001-05-25
   Days after onset:20
Entered: 2001-06-06
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0299BA / UNK RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1525K / UNK LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0118 / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473349 / UNK LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Cardiac arrest, Irritability, Pyrexia, Suffocation feeling, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Hospitalized for pneumonia as neonate (2/16/01 through 2/23/01)
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type:

Write-up: The child developed a fever and irritability post vax. Continued taking a bottle however. The child improved on 5/4/01 and mother thought symptoms resolved. Child placed down for a nap at 10:00PM on 5/4/01. 2 hours later the child was discovered apneic with vomitus. Autopsy states cause of death as probable suffocation. Child taken to hospital in full cardiac arrest.


VAERS ID: 171031 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Washington  
Vaccinated:2001-05-25
Onset:2001-05-25
   Days after vaccination:0
Submitted: 2001-06-07
   Days after onset:13
Entered: 2001-06-12
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 994A2 / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5173A2 / 2 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA362AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0160 / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Diarrhoea, Lethargy, Pain, Pyrexia, Somnolence, Staring, Sudden infant death syndrome, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: diarrhea and crying and vomiting~Hep B (no brand name)~~0.00~In Patient|~Vaccine not specified (no brand name)~~0.00~In Sibling
Other Medications: NONE
Current Illness: blood in stool
Preexisting Conditions: formula allergy, hemangioma
Allergies:
Diagnostic Lab Data: autopsy - SIDS
CDC Split Type:

Write-up: Immediate projectile vomiting, diarrhea, excessive sleeping, slight fever, tenderness in both legs and feet, staring for long periods of time. Shots were given Friday, 05/25/01, baby passed away Monday in her sleep, general lethargy 05/28/01. Autopsy gives cause of death as sudden infant death syndrome.


VAERS ID: 171370 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: New Hampshire  
Vaccinated:2001-02-26
Onset:2001-03-04
   Days after vaccination:6
Submitted: 2001-06-04
   Days after onset:91
Entered: 2001-06-14
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 518A2 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-04
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0117

Write-up: The baby died from SIDS.


VAERS ID: 171754 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Oregon  
Vaccinated:2001-01-10
Onset:2001-01-11
   Days after vaccination:1
Submitted: 2001-06-11
   Days after onset:150
Entered: 2001-06-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0313BA / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1173K / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0117 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473336 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Coma, Irritability, Loss of consciousness, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Hostility/aggression (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt expired. Infant found unconscious and unresponsive. Two hours earlier infant was checked on by mother and grandmother and was alive. The infant had well baby check-up and immunizations the previous day. Mother considered infant irritable after immunizations and gave her a dose of non-prescription tylenol. Autopsy states cause of death as SIDS.


VAERS ID: 171755 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: California  
Vaccinated:2001-02-20
Onset:2001-03-22
   Days after vaccination:30
Submitted: 2001-06-11
   Days after onset:80
Entered: 2001-06-18
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473344 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-30
   Days after onset: 68
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: transient splenomegally
Allergies:
Diagnostic Lab Data: Too great to enumerate in this office.
CDC Split Type:

Write-up: One month post vax, the pt experienced right heart failure, pulmonary hypertension.


VAERS ID: 171973 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: New Hampshire  
Vaccinated:2000-05-07
Onset:2000-05-27
   Days after vaccination:20
Submitted: 2001-06-18
   Days after onset:387
Entered: 2001-06-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1947J / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: ? Murmur (5/23/01) -(meconium stained fluid)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NH0118

Write-up: SIDS


VAERS ID: 171974 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Washington  
Vaccinated:2001-03-13
Onset:2001-03-21
   Days after vaccination:8
Submitted: 2001-03-23
   Days after onset:2
Entered: 2001-06-19
   Days after submission:87
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474724 / 2 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Convulsion, Meningitis, Oral intake reduced, Pyrexia, Sepsis, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-21
   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:
Current Illness:
Preexisting Conditions: Hg C trait; Septic elbow; Septic hip; anemia; inguinal hernias; Atopic dermatitis
Allergies:
Diagnostic Lab Data: CBC; UA/UC; Chem Panel; Blood culture; Head CT; Abdominal CT; CXR
CDC Split Type:

Write-up: Came in the ER with complaint of fever, low appetite, vomiting, had seizure in ER and unstable. Transport to other facility was arranged and pt expired during transport. Pneumococcal sepsis and meningitis.


VAERS ID: 171975 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Mississippi  
Vaccinated:2001-06-12
Onset:2001-06-13
   Days after vaccination:1
Submitted: 2001-06-13
   Days after onset:0
Entered: 2001-06-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0378CA / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1522K / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0785 / 2 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474735 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Atelectasis, Hepatomegaly, Hyperplasia, Nasal congestion, Petechiae, Pulmonary congestion, Pulmonary oedema, Splenomegaly, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-13
   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: Tylenol drops
Current Illness: NONE
Preexisting Conditions: Denies any previous illnesses except teething
Allergies:
Diagnostic Lab Data: autopsy - report pending; autopsy states-petechiae in thymus, heart and lungs; acute congestion of sinuses; lymph nodes reveal changes of reactive lymphoid hyperplasia; sections of lung reveal pulmonary vascular congestion and edema with focal atelectasis; hepatomegaly and congestion (renal and splenic)
CDC Split Type: MS01024

Write-up: Received phone call on 6/13/01 from coroner''s office regarding child that had received immunizations on 6/12/01 and had expired on 6/13/01? Baby was found dead per mother in crib. Denies any previous illness except "teething". Autopsy report states COD as SIDS. F/U: coroner''s report states this is a Caucasion female


VAERS ID: 172278 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2001-08-08
Entered: 2001-06-21
   Days after submission:48
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / SC

Administered by: Other       Purchased by: Other
Symptoms: Infection
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: varicella exposure
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES01052608

Write-up: Information has been received from a physician concerning an approximately 30 year old who was possibly exposed to her 15 year old vaccinated niece who developed chickenpox and was scabbed all over on 5/4/98. It was reported that the 15 year old was vaccinated on 4/15/98. Subsequently in 1998 possible secondary transmission was reported ant the pt died presumably from chickenpox. The physician was not aware if the pt had been in contact with her niece or had any exposure to chickenpox. Additional information has been requested. Follow-up from the physician reported that the pt was taking steroids for an unknown cause. It was reported that her child developed natural chickenpox, that the pt was exposed to her child and subsequently died. The physician did not know the cause of death but she "felt that it was from natural chickenpox and she did not think that this was a complication from the vaccine." The physician did not have any further details because they were not her pts. It was reproted that the pt''s niece had no history of chickenpox and was vaccinated with the first dose of varicella vaccine live after exposure to her cousin, the pt''s child, who had natural chickenpox. No further info is expected.


VAERS ID: 172348 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Alabama  
Vaccinated:2001-05-21
Onset:2001-06-03
   Days after vaccination:13
Submitted: 2001-06-20
   Days after onset:17
Entered: 2001-06-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-03
   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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ2306120JUN2001

Write-up: A grandmother reported that her 4 month old grandson received his first dose of Prevnar on 5/21/01. On 6/3/01 he died of sudden infant death syndrome. He was seen earlier in the day by the physician and "everything was normal".


VAERS ID: 172375 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Louisiana  
Vaccinated:2001-06-11
Onset:2001-06-12
   Days after vaccination:1
Submitted: 2001-06-14
   Days after onset:2
Entered: 2001-06-26
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0325BA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0289K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0697 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 479239 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Anaemia, Brain oedema, Infection, Pulmonary congestion, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haematopoietic erythropenia (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-12
   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: UNK
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: LA010602

Write-up: Mother did not report any adverse events of anything out of the ordinary. She states that she "went to check on baby, the next morning and found baby dead in her bed". Also, stated baby was active and acted in usual manner, at bedtime, the night before. Autopsy gives cause of death as pulmonary and brain congestion/edema. Death certificate states cause of death as multiple infections (bacterial and viral) in a low resistant anemic baby.


VAERS ID: 172391 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2000-10-06
Onset:2000-10-20
   Days after vaccination:14
Submitted: 2001-05-14
   Days after onset:206
Entered: 2001-06-26
   Days after submission:43
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E68780KA / UNK - / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Asthenia, Cough, Dysarthria, Dysphagia, Paresis, Rhinitis
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-03-20
   Days after onset: 516
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: MRI - neg, Lyme - neg, EMG w/tensilon test - neg
CDC Split Type: PA0147

Write-up: Two weeks following immunizations with flu vaccine developed cough, coryza, weakness over the course of week developed dysarthia, dysphagia with cranial nerve paresis on exam. Diagnosed with ALS. According to 213289, 60 day follow up, patient died 03/20/2002 from ALS, unassociated with flu vaccine. Follow up on 09/18/2001: "The patients right arm was prepped and draped in a sterile fashion. 1% Xylocaine was employed for local anesthesia. A hand injection of contrast through a peripheral angiocath provided opacification of the deep veins of the right arm. The right basilic vein was accessed under fluoroscopic guidance with a micropuncture set. A cook PICC catheter was then trimmed to a length of 36cm and advanced through a peel-away sheath into the SVC. A hand injection of contrast through the catheter reveals the tip in the superior vena cava. The catheter was flushed and sutured in place. The catheter was then heparinized with 400 units Heparin and the patient was returned to the post-operative lounge in stable condition. "


VAERS ID: 172763 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Arkansas  
Vaccinated:2001-06-08
Onset:2001-06-12
   Days after vaccination:4
Submitted: 2001-06-15
   Days after onset:3
Entered: 2001-07-03
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0318BA / 2 RL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5177A2 / 3 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 477389 / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0595 / 2 LL / SC

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Apnoea, Sudden infant death syndrome
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-12
   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: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR0128

Write-up: Call from the child''s grandmother states the child was taking a nap, and the child woke up crying. The aunt (taking care of child) gave the child a pacifier. She checked on the baby after 20 minutes and he wasn''t breathing. Grandmother denies any problems at the time of vax. Death certificate states cause of death to be SIDS.


VAERS ID: 172888 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Illinois  
Vaccinated:2001-06-05
Onset:2001-06-15
   Days after vaccination:10
Submitted: 2001-06-16
   Days after onset:1
Entered: 2001-07-05
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 984A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1851K / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T04852 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 479792 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-15
   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: URI
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The baby was found dead in the crib. Autopsy report states death due to myocarditis.


VAERS ID: 172985 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Wisconsin  
Vaccinated:2001-06-11
Onset:2001-06-13
   Days after vaccination:2
Submitted: 2001-06-18
   Days after onset:5
Entered: 2001-07-06
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0309BA / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA558AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T0697 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 479233 / 2 LL / SC

Administered by: Private       Purchased by: Other
Symptoms: Hernia, Pulmonary haemorrhage, Sudden infant death syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-13
   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: NONE
Current Illness: NONE
Preexisting Conditions: Prematurity; Apnea and Bradycardia
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Found dead/possible SIDS. Autopsy pending. When found baby was still warm. Tried CPR to no avail. Autopsy report states final anatomic diagnoses: hemorrhges, lungs; s/p ligaton of patent ductus arteriosus; umbilical hernia, small. Death certificate states cause of death to be SIDS.


VAERS ID: 173039 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Unknown  
Vaccinated:2000-09-15
Onset:2000-10-14
   Days after vaccination:29
Submitted: 2001-07-05
   Days after onset:264
Entered: 2001-07-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 956A2 / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0494K / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 591403A / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. R06684 / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472542 / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy-SIDS
CDC Split Type: HQ3879417NOV2000

Write-up: A physician reported that a 2 month old female received Prevnar, Hib-Titer, Infanrix, IPV and Recombivax-HB vaccines on 9/15/00 as part of a study. On 10/14/00, at the age of 3 months, the child died. The cause of death was presumed to be Sudden Infant Death Syndrome. Both the medical monitor and the investigator agree that Sudden Infant Death Syndrome is not related to vaccine administration. Follow-up information received on 6/22/01, indicated that an autopsy revealed the cause of death as Sudden Infant Death Syndrome. The original assessment remained the same.


VAERS ID: 173272 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New York  
Vaccinated:2001-07-03
Onset:2001-07-04
   Days after vaccination:1
Submitted: 2001-07-10
   Days after onset:6
Entered: 2001-07-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 991A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1761K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0787 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 477455 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-04
   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: Tylenol Rx written day of vaccines
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Pt succumbed to Sudden Infant Death Syndrome (SIDS) 1 day post vax. Confirmed by autopsy results.


VAERS ID: 173485 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Unknown  
Vaccinated:2001-06-26
Onset:2001-07-05
   Days after vaccination:9
Submitted: 2001-07-19
   Days after onset:14
Entered: 2001-07-23
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM - / 2 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH - / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. - / UNK LA / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-05
   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: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQ3122311JUL2001

Write-up: Information has been recvd re: 4-month-old male who received his second dose of blinded study vaccine. The pt nursed at 4 AM on 7/5/01 and then fell asleep with his mother. He was found on his back at the edge of the bed at 10:25 AM and was cold and non-responsive. He was pronounced dead by the medical crew that answered the call. The cause of death was "probable" sudden infant death syndrome (SIDS). The investigator reported that SIDS (unexpected per the Investigator Brochure) was not related to study vaccine administration or concomitant vaccines. The medical monitor considered the event to be probably not related to the study vaccine. This case is being submitted as a 15-day expedited report as requested by the FDA. A 15-day follow up report received 4/19/2002 adds: Follow-up info was received on 11/28/2001. An autopsy revealed the cause of death to be Sudden Infant Death Syndrome. The coroner''s findings revealed the same. Both the investigator and medical monitor did not consider the event to be related to study vaccine administration or concomitant vaccinations. NOTE: This case is being submitted as a 15-day follow-up, expedited report, as requested by the FDA.


VAERS ID: 173550 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Michigan  
Vaccinated:2001-07-16
Onset:2001-07-17
   Days after vaccination:1
Submitted: 2001-07-18
   Days after onset:1
Entered: 2001-07-25
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM - / 2 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / 2 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0595 / 2 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 477454 / 2 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-17
   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:
Preexisting Conditions: Cystic adenoma malformation/PDA/Prematurity at 35 weeks
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt found unresponsive by baby sitter on 7/17/01. He was taken to ER and pronounced DOA. Unknown reason for death at this time. COD as per autopsy report-- undeterminable


VAERS ID: 173628 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Florida  
Vaccinated:2001-07-20
Onset:2001-07-21
   Days after vaccination:1
Submitted: 2001-07-24
   Days after onset:3
Entered: 2001-07-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0378AA / 1 RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5189A2 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0969K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0559 / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Atelectasis, Coma, Hypotonia, Lymphadenitis, Pneumonitis, Tracheitis
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-21
   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: Augmentin (7/16/01)
Current Illness: Infectious adenitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was found unresponsive and limp by mother. Twin had same vaccines on same day. Twin was admitted to ER for observation but had no signs and symptoms of distress. Autopsy findings report inguinal lymph node had a subacute lymadenitis with peripheral fibrosis and the spleen is slightly lymphocyte depleted; this infant had atelectasis, a desquamative interstitial pneumonitis and acute and chronic tracheitis.


VAERS ID: 173746 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Minnesota  
Vaccinated:1999-01-15
Onset:1999-01-19
   Days after vaccination:4
Submitted: 2001-07-26
   Days after onset:918
Entered: 2001-08-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0985H / 2 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Other
Symptoms: Murder
SMQs:, Hostility/aggression (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-01-19
   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: UNK
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant died on 1/19/99. Autopsy report states cause of death to be traumatic head injuries, homicide. Death certificate states: craniocerebral trauma.


VAERS ID: 173767 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Texas  
Vaccinated:2001-07-10
Onset:2001-07-10
   Days after vaccination:0
Submitted: 2001-07-20
   Days after onset:10
Entered: 2001-08-01
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0503AA / 2 LL / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 03242 / 3 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA577AA / 3 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0786 / 3 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 479233 / 3 RL / -

Administered by: Public       Purchased by: Private
Symptoms: Apnoea, Atelectasis, Bacterial infection, Brain oedema, Convulsion, Cough, Cyanosis, Electroencephalogram abnormal, Emphysema, Encephalopathy, Eye movement disorder, Gait disturbance, Heart rate increased, Hypotonia, Pulmonary congestion, Pulmonary haemorrhage, Pyrexia, Renal disorder, Respiratory rate increased, Spleen disorder
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-04-15
   Days after onset: 279
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: Per F/U 7/31/02: Amoxil 125mg for cough
Current Illness: Per F/U 7/31/02: coughing
Preexisting Conditions: Per F/U 7/31/02: history of seizure disorder. The pt is a twin and both have suffered from seizure disorder. The 1st twin died on 12/28/01. Prematurity (36 weeks)
Allergies:
Diagnostic Lab Data: CBC:1st borderline normal; x-ray: peribronchial coughing. Per F/U 7/31/02: EEG; MRI
CDC Split Type:

Write-up: Immunizations at 11am. At 2:30pm in ER for seizure activity(limp, eyeballs got rolled up). Temp 100 deg. F with some coughting. Diagnosed with bronchial infection. Per F/U 7/31/02: This pt is a twin. The pt was found unresponsive at home and transported to a hospital, arriving at 21:00 on 4/12/02. She was pronounced dead at 12:49 on 4/15/02. The other twin died on 12/28/01. Four hours, post vax, she developed onset of apnea, cyanosis and seizure-like activity with dragging of her left leg, prgressing to becoming limp. Per autopsy: There are petechial hemorrhages on the lower lobe of the left lung; bronchopneumonia with hyaline membrane formation, capillary congestion, subpleural emphysema alternating with atelectasis. Kidney: acute congestion and the spleen also shows acute congestion. Pathological findings: hypoxic ischemic encephalopathy (clinicaol); severe cerebral edema, marked. Nearly all neurons contained within sections of gray matter show eosinophilic degeneration. White matter vacuolation is seen in all sections. Discharge DX: Seizure reaction to immunization. In ER, pulse-197, RR-44, BP-115/79 and repeat BP-104/65. DX: hypocalcemia; ventricular septal defect.


VAERS ID: 173938 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Unknown  
Vaccinated:1984-08-22
Onset:1984-08-23
   Days after vaccination:1
Submitted: 2001-08-03
   Days after onset:6189
Entered: 2001-08-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (TRI-IMMUNOL) / LEDERLE LABORATORIES - / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Anorexia, Apnoea, Circulatory collapse, Crying, Eye movement disorder, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (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), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1984-08-23
   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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ4000102AUG2001

Write-up: Information has been received on 7/16/01 from an internet site through a consumer, concerning a 9 month old male who received his 3rd dose of DTP on 8/22/84. He immediately began vomiting. The next day, he stopped eating. He reportedly, stayed alert but was no longer active. That night, he cried out every 15 to 30 minutes. He was seen in the pediatrician''s office where the pediatrician immediately noted "obvious circulation collapse". His eyes rolled back in his head an he stopped breathing. He was taken to an ER. Resuscitative efforts failed and he was pronounced dead.


VAERS ID: 174134 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Tennessee  
Vaccinated:2001-03-21
Onset:2001-03-24
   Days after vaccination:3
Submitted: 2001-07-24
   Days after onset:121
Entered: 2001-08-10
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 950A2 / 4 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 474726 / 3 RL / IM

Administered by: Private       Purchased by: Other
Symptoms: Abnormal sleep-related event, Asphyxia
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-24
   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: NONE
Current Illness: recent pulmonary congestion and questionable ear infection
Preexisting Conditions: Intracranial cysts
Allergies:
Diagnostic Lab Data:
CDC Split Type: TN01035

Write-up: Child had intracranial cysts dx''d on 2/14/01. Child received vaccines 3 days before death, which was noted as asphyxia death (facial compression), face down sleeping position in bed with mother. Office felt this should be reported. Death certificate and autopsy reports states cause of death to be positional asphyxia.


VAERS ID: 174135 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Tennessee  
Vaccinated:2001-07-12
Onset:2001-07-18
   Days after vaccination:6
Submitted: 2001-07-23
   Days after onset:5
Entered: 2001-08-10
   Days after submission:18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 989A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1525K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0841 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480978 / 1 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Asphyxia, Aspiration, Atelectasis, Infection, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: TN01032

Write-up: On 7/18/01 at 04:30, infant was found by mother, not breathing. She had checked on twins at 01:30 and both were fine. Father called 911, while mother initiated CPR. Baby was DOA at ER. Autopsy findings report: proximate cause of death to be sever infectious process of perianal nd perineal area; immediate cause of death atelectasis and pulmonary edema; mechanism of death aspiration asphyxia with pulmonary inadequacy.


VAERS ID: 174547 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Connecticut  
Vaccinated:2001-08-10
Onset:2001-08-14
   Days after vaccination:4
Submitted: 2001-08-14
   Days after onset:0
Entered: 2001-08-22
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 177A2 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Bacterial infection, Heart disease congenital, Pallor
SMQs:, Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-08-14
   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: Lasix, Captopril, ASA, Zantac
Current Illness:
Preexisting Conditions: Hypoplastic left heart
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Baby became pale, was not breathing. EMS responded and baby was intubated and transported to ER. Resuscitation was attempted but was not successful. Autopsy report states baby was a twin with left hypoplastic heart syndrome, surgically corrected one week ago and complicated by lung streptococcal infection. Death certificate states cause of death as left hypoplastic heart syndrome.


VAERS ID: 174715 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Kentucky  
Vaccinated:2001-07-12
Onset:2001-07-18
   Days after vaccination:6
Submitted: 2001-08-22
   Days after onset:35
Entered: 2001-08-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 995A2 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0779K / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0760 / 2 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480978 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: SIDS


VAERS ID: 174843 (history)  
Form: Version 1.0  
Age: 1.4  
Sex: Female  
Location: Colorado  
Vaccinated:2000-10-18
Onset:2000-10-26
   Days after vaccination:8
Submitted: 2001-08-28
   Days after onset:306
Entered: 2001-08-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-10-26
   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: UNK
Current Illness: Autopsy report was negative
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ5280128AUG2001

Write-up: A pediatrician reported that a 17 month old female received injections of Prevnar, MMR, and varicella vaccines on 10/18/2000. She was noted to be a healthy child with no past history of illness and no pre-exititng illness at this time of vaccination. The child was found dead in her crib on 10/26/2000. Sudden Infant Death Syndrome was reported. An autopsy was reported to be negative. NOTE: this report of a serious, labeled event (SIDS) is being submitted in a 15 day time frame as requested by the FDA.


VAERS ID: 174865 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Texas  
Vaccinated:2001-08-08
Onset:2001-08-12
   Days after vaccination:4
Submitted: 2001-08-22
   Days after onset:10
Entered: 2001-09-04
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0739L / 2 - / SC

Administered by: Private       Purchased by: Other
Symptoms: Brain oedema, Headache, Hernia, Lethargy, Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-08-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy results state histologic findings are most consistent with a viral etiology, however, antemortem serologic tests and postmorterm cultures fail to elucidate the etiology. Although ADEM was considered, stains failed to demonstrate a demyelinating process as is classically demonstrated in this lesion.
CDC Split Type:

Write-up: On 8/12/01, pt had a headache; on 8/14/01 pt had a headache and a fever; on 8/15/01, the pt was lethargic; on 08/17/01, pt had herniation and on 8/18/01; life support removed. Death certificate states cause of death to be cerebral edema due to viral illness.


VAERS ID: 175265 (history)  
Form: Version 1.0  
Age: 0.09  
Sex: Male  
Location: California  
Vaccinated:2001-02-27
Onset:2001-03-04
   Days after vaccination:5
Submitted: 2001-09-05
   Days after onset:184
Entered: 2001-09-14
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1577K / 2 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-03-04
   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: Hep-B immunoglobulin/Nabi/3106910/LL/0 previously
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Death certifcate states cause of death to be SIDS. This is confirmed by autopsy results.


VAERS ID: 175618 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: California  
Vaccinated:2001-08-30
Onset:2001-09-01
   Days after vaccination:2
Submitted: 2001-09-19
   Days after onset:18
Entered: 2001-09-24
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 992A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1528K / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: No report from the coroner.
CDC Split Type:

Write-up: Received a letter from an RN, PHN 09/19/01, saying that this infant died on 09/01/01 with preliminary diagnosis of Sudden Infant Death Syndrome. Did not know of patient death prior to the letter. Death certificate states cause of death as "pending" and autopsy performed.


VAERS ID: 175626 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: West Virginia  
Vaccinated:2001-09-06
Onset:0000-00-00
Submitted: 2001-09-17
Entered: 2001-09-24
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 506A2 / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1588K / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0790 / 2 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480567 / 2 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Note: First time in this clinic but 2nd immunizations. Had same immunizations, 2 months before at another clinic. Autopsy results state cause of death to be SIDS.


VAERS ID: 175646 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Texas  
Vaccinated:1995-09-08
Onset:0000-00-00
Submitted: 2001-12-03
Entered: 2001-09-25
   Days after submission:69
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0410B / UNK - / SC

Administered by: Public       Purchased by: Other
Symptoms: Condition aggravated, Coordination abnormal, Encephalopathy, Hyperammonaemia
SMQs:, Liver related investigations, signs and symptoms (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), 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: 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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Diagnostic lab-hyperammonemia; physical examination-mild truncal ataxia
CDC Split Type: WAES01091716

Write-up: Information has been received from a consumer concerning his 3 year old granddaughter who about 6 years ago, in approx. 1995, was vaccinated with 1 dose of varicella virus vaccine live. Ten days to 2 weeks, post vax, the child manifested symptoms of encephalopathy, resulting in incoordination. She was taken to her pediatrician and was referred to a specialized hospital. She was found to have hyperammonemia and was dx''d with ornithine transcarbamoylase deficiency (OTC). The condition resulted in hospitalization. It was reported that the pt was treated for this condition for 6 years, but died in 2/01. The reporter stated that he did not "suspect cause and effect", but felt that varicella virus vaccine live triggered events and exposed the OTC. Additional information has been requested. Per F/U; information has been received from a health care professional concerning his 3 year old granddaughter who on 9/8/95 was vaccinated with 1 dose of varicella virus vaccine live (lot 608582/0410B). Ten days to 2 weeks, post vax, the child developed ataxis and was thought to have encephalopathy. She was taken to her pediatrician and was referred to a specialized hospital. She was found to have hyperammonemia and was dx''d with "de nova or a primary mutation of" ornithine transcarbamoylase deficiency (OTC), a urea cycle disorder, which the reporter felt was the "most likely cause of the elevated plasma ammonia and the encephalopathy. The condition resulted in hospitalization, on an unspecified date. The reporter stated he did not "suspect cause and effect" but felt that varicella virus vaccine live triggered events and exposed the OTC. F/U info was received on 10/11/01 from the initial reporter and he stated his granddaughter was a normal, healthy child, including no known history of immunosuppression prior to the events reported. She had no signs or symptoms of OTC prior to vaccination. He stated that his granddaughter died of "gross medical mismanagement", by some of the treating physicians, as well as, the managed care healthcare system. He reaffirmed that he did not necessarily believe there was a direct cause and effect relationship between vaccination with varicella virus vaccine live and the development of OTC deficiency; however, since the vaccine is a live virus, he wondered about the possibility of the vaccine "triggering" some type of response which lead to the manifestation of the OTC deficiency order. On 10/19/01, a retired office nurse, from the vaccinating physician''s office, indicated that the child was only seen in their office for a short time and then transferred to another physician. Additional information has been requested. The adverse experience of blood urea decreased has been removed as an adverse experience. Follow-up medical records received from a physician on 11/20/2001 indicated that the pt had been seen in his office on 09/19/1995. The physician noted that the pt was not administered the vaccination at his office, but that she received the vaccination 10 days prior to her presentation at another clinic. It was reported that on Sunday, the pt was fussy and acted as if dizzy or off blalance. She was eating well. The pt was seen int eh ER the night before her presentation to the physician and "woke up" with a temp of 96.8 F. It was ntoed that the pt was "off balance" the morning of her exam. The pt was irritable, whiny and couldn''t be pleased. She acted "drunk" and "staggered some." No fever or vomiting were present. It was reported that at am pre-school on Monday the pt seemed normal. A call was placed from a physician in the afternoon were it was noted that the pt was irritable, whiny and crying. At 5pm the pt staggered and ran into a car. That evening the pt was seen again in the ER. It was reported that the pt needed catheterization for a urinalysis and had a drug screen, an electrolyte screen and a CBC. An abdominal x-ray was "OK." On Thursday am the pt bumped into a wall and had an "unstable balance." It was noted that she was extra whiny and fussy. Her appetite and drinking were "OK." Her speech had changed and she was "harder to understand." A physician exam revealed the pt to have had a mild truncal ataxia. The pt was referred to the hospital for diagnostic work-up and treatment. No further info is available.


VAERS ID: 175647 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:1999-08-13
Onset:1999-09-20
   Days after vaccination:38
Submitted: 2001-12-19
   Days after onset:821
Entered: 2001-09-25
   Days after submission:85
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0711J / 1 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Chromosome abnormality, Condition aggravated, Hyperammonaemia
SMQs:, Liver related investigations, signs and symptoms (narrow), Congenital, familial and genetic disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-10-23
   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: UNK
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Diagnostic laboratory-hyperammonemia
CDC Split Type: WAES01091751

Write-up: Information has been received from a consumer concerning an approx. 7 year old female who about 2 years ago, in approx. 1999, was vaccinated with 1 dose of varicella virus vaccine. In approx. 1999, the pt developed hyperammonemia and died. Additional information has been requested. F/U information, received on 10/11/01, from the healthcare professional, indicated that "subsequent to the initial encephalopathy (the child was) dx''d with de novo or a primary mutation of ornithine transcarbamoylase deficiency (OTC), which was most likely the cause of the elevated plasma ammonia and the encephalopathy". He further indicated that he did not necessarily believe there was a direct cause and effect relationship between vaccination with varicella virus vaccine live and the development of OTC deficiency; however, since the vaccine is a live virus, he wondered about the possibility of the vaccine "triggering" some type of response which lead to the manifestation of the OTC deficiency disorder. Additional information has been requested. Follow-up info received on 11/30/2001 from a physician indicated that the pt was 8 years old, white, weighed 42 lbs, and was 45" tall. The pt who had no past medical history and no known allergies, was vaccianted SC on 08/13/1999 with the first dose of varicella virus vaccine live. It was reported that the pt''s experience began on 09/20/1999. The physician indicated that the pt died on 10/23/1999 from multiple organ failure after being diagnosed with OTC. No further info is available.


VAERS ID: 175648 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Michigan  
Vaccinated:1999-10-15
Onset:2000-12-18
   Days after vaccination:430
Submitted: 2001-09-20
   Days after onset:275
Entered: 2001-09-25
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (MENOMUNE-A/C) / CONNAUGHT LTD. 7126AA / 1 - / SC

Administered by: Other       Purchased by: Public
Symptoms: Diarrhoea, Ear pain, Meningitis, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: CDC did immuno-chemistry histology stains that confirmed cause of death as fulminant meningococcus. Typing was C from ear drainage. She was 19 at the age of her death.
CDC Split Type:

Write-up: Earache; diarrhea and vomiting; on menses. CDC confirmed and notified in 9/01 that the cause of death as fulminant meningococcus. Typing was C from ear drainage. Autopsy results received confirming this also.


VAERS ID: 175712 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Texas  
Vaccinated:2001-09-20
Onset:2001-09-21
   Days after vaccination:1
Submitted: 2001-09-24
   Days after onset:3
Entered: 2001-09-26
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / SMITHKLINE BEECHAM 996A2 / 3 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA609AA / 3 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T10982 / 3 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 481542 / 3 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Brain oedema, Cardiac arrest, Coma, Laryngitis, Pallor, Pneumonia, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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: 2001-09-21
   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: HEP-A IG/lot ISG136/IM/RL/0 previously
Current Illness: NONE
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: TX01130

Write-up: The parent reported some fever the evening of the vaccine. Normal day of 09/21/01. The family put the child down to bed, no symptoms 09/21/01 at 8:00 pm. Family checked at 9 pm, the child''s color was white, unresponsive. Rushed to the hospital, the child arrested. Autopsy findings for cause of death were bronchopneumonia, laryngitis, cerebral edema.


VAERS ID: 175866 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Virginia  
Vaccinated:2001-05-15
Onset:2001-05-21
   Days after vaccination:6
Submitted: 2001-09-12
   Days after onset:114
Entered: 2001-10-01
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 994A2 / 2 - / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 477252 / 2 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0117 / 2 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 473331 / 2 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Bacterial infection, 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: 2001-05-21
   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: Tylenol
Current Illness: NONE
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: autopsy - acute streptococcus pneumoniae pneumonia
CDC Split Type: HQ5314429AUG2001

Write-up: On 5/21/01, six days post vax, the child was found dead in her crib. Preliminary autopsy cause of death was attributed to "sudden unexplained non-traumatic infant death." The autopsy report was amended on 8/15/01 to "acute streptococcus pneumonia. Follow-up info received on 09/10/2001 revealed that on 05/20/2001, the child was fussy at bedtime and was given a dose of Tylenol.


VAERS ID: 175922 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Kentucky  
Vaccinated:2001-05-14
Onset:2001-05-18
   Days after vaccination:4
Submitted: 2001-05-18
   Days after onset:0
Entered: 2001-10-02
   Days after submission:137
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 991A2 / 2 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 475827 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T06972 / 2 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 479238 / 2 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Coma, Cyanosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-18
   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: Sudafed, Amoxil, Tylenol
Current Illness: otitis media
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY2001068

Write-up: Death. Found unresponsive and blue on 05/18/01. CPR attempted but unsuccessful. Autopsy lists cause of death as "undetermined" as the differential diagnosis of SIDS vs parental caregiver overlay cannot be determined on autopsy findings alone.


VAERS ID: 176037 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: Indiana  
Vaccinated:2001-09-12
Onset:2001-09-24
   Days after vaccination:12
Submitted: 2001-10-01
   Days after onset:7
Entered: 2001-10-04
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5171A2 / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-24
   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: Lotrimin
Current Illness:
Preexisting Conditions: diaper rash
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: The pt was presented DOA at the hospital. Cause of death not stated.


VAERS ID: 176051 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Indiana  
Vaccinated:2001-09-17
Onset:2001-09-18
   Days after vaccination:1
Submitted: 2001-09-24
   Days after onset:6
Entered: 2001-10-05
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0513BA / 2 - / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA612AA / 2 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T1273 / 2 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 481817 / 2 - / 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: 2001-09-18
   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
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IN200119

Write-up: The pt died of crib death at daycare on 9/18/01. One day post vax. The cause of death was diagnosed as SIDS. Autopsy report confirms cause of death to be SIDS. Death certificate lists cause of death as SIDS also.


VAERS ID: 176107 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Wisconsin  
Vaccinated:2001-10-02
Onset:2001-10-03
   Days after vaccination:1
Submitted: 2001-10-04
   Days after onset:1
Entered: 2001-10-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES UO532CA / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1827K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T1273 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480473 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Cold over the previous week
Preexisting Conditions: Slight prematurity and low birth weight.
Allergies:
Diagnostic Lab Data: Negative autopsy.
CDC Split Type:

Write-up: Apparent SIDS. (Pt had Hep-B/SKB/ENG5208A2/RL/0 on 7/26/01). Autopsy findings confirm cause of death to be SIDS.


VAERS ID: 176282 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Ohio  
Vaccinated:2001-08-07
Onset:2001-08-18
   Days after vaccination:11
Submitted: 2001-10-09
   Days after onset:52
Entered: 2001-10-15
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 997A2 / 1 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 472389 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-08-18
   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
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy-SIDS
CDC Split Type:

Write-up: SIDS on 8/18/01. No previous illness. Entirely healthy and normal child. Found dead by childcare personnel. Autopsy reports cause of death as SIDS


VAERS ID: 176283 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Louisiana  
Vaccinated:2001-10-10
Onset:2001-10-11
   Days after vaccination:1
Submitted: 2001-10-11
   Days after onset:0
Entered: 2001-10-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 513A2 / UNK RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA894AA / UNK LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. 2137L / UNK RL / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-11
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received immunizations on 10/10/01 and presented on 10/11/01 to ER with asystole and was unable to revive.


VAERS ID: 176319 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Wisconsin  
Vaccinated:2001-10-01
Onset:2001-10-07
   Days after vaccination:6
Submitted: 2001-10-08
   Days after onset:1
Entered: 2001-10-16
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0357CA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0483L / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T1390 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480977 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: On 10/07/01, pt died. Possibly SIDS. COD as per autopsy report -- SIDS


VAERS ID: 176377 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: New York  
Vaccinated:2001-09-05
Onset:2001-09-22
   Days after vaccination:17
Submitted: 2002-01-14
   Days after onset:114
Entered: 2001-10-17
   Days after submission:89
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / SMITHKLINE BEECHAM 147F9 / 2 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Atrioventricular block, Hypotension, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Conduction defects (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diltiazem (Tiazac;dosage unk), hydrochlorothiazide, warfarin (Coumadin), and celecoxib (Celebrex).
Current Illness:
Preexisting Conditions: Hypertension, unspecified arthritis in the knee, hypokalemia. There was no history of Lyme disease although, he frequented and endemic area.
Allergies:
Diagnostic Lab Data: 09/05/01, Lyme Elisa Antibody Index - 4.02. Lyme Western Blot - "Negative". 09/01, Autopsy - results not provided.
CDC Split Type: 20010242571

Write-up: The patient was seen by his rheumatologist on 07/18/2001. At this time, his blood pressure was 158/80 mmHg; the heart rate was not noted. The rheumatologist prescribed celecoxib (Celebrex) as need for relief of an unspecified form of knee arthritis. The patient also received, per his request, the 1st injection of Lymerix. The patient was admitted to the hospital on 08/10/01, 23 days post-immunization, with hypotension, fever of 104 F, and 2nd degree atrioventricular block (NOS). An unspecified cardiac pacemaker was inserted. The patient was seen by the rheumatologist on 09/05/01. A Lyme disease ELISA antibody screen and Western Blot were performed. The second injection of Lymerix was administered. Subsequently, the Lyme Disease ELISA showed an index of 4.02; the Western Blot was "negative". On 09/22/01, 17 days following receipt of the 2nd injection of Lymerix, the patient suffered a witnessed sudden death at a service station. An autopsy was performed; results were not available as of 10/03/01. The most recent info received on 01/14/2002 provided the lot number of vaccine administered on 09/05/2001.


VAERS ID: 176568 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Arkansas  
Vaccinated:2001-10-15
Onset:2001-10-16
   Days after vaccination:1
Submitted: 2001-10-18
   Days after onset:2
Entered: 2001-10-23
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 508A2 / 3 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0257L / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA592AA / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 481816 / 3 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Diarrhoea, Fatigue, Meningitis, Mouth haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: 6 weeks premature; hypospadias; head asymetric; history or GE Reflux
Allergies:
Diagnostic Lab Data: Autopsy to be done.
CDC Split Type:

Write-up: Unsure if related to vaccines. Mother reports fever, being more tired than usual and 3 or 4 episodes of diarrhea on 10/16/01. Dad checked on infant in evening and found him not breathing and noticed blood from mouth. Mother was at work. Infant was alone in parents bed. COD as per autopsy report: Lymphoplasmacytic Meningitis.


VAERS ID: 176906 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Texas  
Vaccinated:2001-09-05
Onset:2001-09-06
   Days after vaccination:1
Submitted: 2001-10-11
   Days after onset:35
Entered: 2001-10-31
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES UA532CB / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0518L / 1 RL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 477389 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T04952 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: autopsy states findings did not reveal a cause of death - classified as "undetermined"
CDC Split Type: TX01163

Write-up: The child was in the office for well check up. The pt was cleared by doctor as a well child. given 2 month immunizations. No reaction was noted at that time. Discharged to home with Mom and grandmother. Stated cause of death as SIDS.


VAERS ID: 176973 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Male  
Location: Unknown  
Vaccinated:2001-10-09
Onset:2001-10-12
   Days after vaccination:3
Submitted: 2002-01-22
   Days after onset:102
Entered: 2001-11-01
   Days after submission:82
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Condition aggravated, Cystitis haemorrhagic, Haemorrhage intracranial, Injection site induration, Injection site swelling
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-21
   Days after onset: 9
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: Aplastic anemia; Colitis; Hematuria; Pleural Effusion; Prostatic abscess; Sepsis; Tuberculosis
Allergies:
Diagnostic Lab Data: chest X-ray -10/19/01 - Suspicion of infilitration in both lungs bases; Compute Axial - 09/25/01 - Increase in size of left pleural effusion; Acid-fast bacilli stain -09/04/01, Urine culture -10/11/01
CDC Split Type: WAES01101833

Write-up: Information has been received from a physician concerning a 28 year old Haitian male who on 10/9/01 was vaccinated with pneumococcal vaccine 23 polyvalent. On 10/11/01, the pt was hospitalized for the following other unrelated pre-existing conditions: aplastic anemia, prostatic abscess, hematuria, sepsis, colitis and a tuberculosis pleural effusions. On 10/12/01, the pt developed a severe injection site reaction described as severe swelling and induration from the right deltoid to his mid-forearm. On that same date, the pt suffered from hemorrhagic cystitis secondary to Klebsiella infection, bibasal pneumonia and developed an intracranial hemorrhage. As of 10/19/01, the pt was on a ventilator and was doing very poorly. A chest X-ray on that same date showed a suspicion of infilitration in both lung bases and a clinical correlation was suggested. The pt was being treated with piperacillin sodium (+) tazobactam (Zosyn), gentamicin and metronidazole (Flagyl). On 10/21/01, the pt died. The cause of death. The cause of death was intracranial hemorrhage. The reporting physician did not feel that the pt''s hemorrhagic cystitis and intracranial bleed were related to his pneumococcal vaccine. Additional information is not expected.


VAERS ID: 177117 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Kentucky  
Vaccinated:2001-09-24
Onset:0000-00-00
Submitted: 2001-10-31
Entered: 2001-11-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 3328B9 / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY2001081

Write-up: SIDS death


VAERS ID: 177308 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Texas  
Vaccinated:2001-10-22
Onset:2001-10-29
   Days after vaccination:7
Submitted: 2001-10-31
   Days after onset:2
Entered: 2001-11-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0674AA / 1 - / IM

Administered by: Other       Purchased by: Military
Symptoms: Dementia, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SA0113

Write-up: The patient rapidly developed respiratory failure with oxygen desaturation days after receving the vaccination. Annual follow up states that pt did not recover. Replied to your letter dated 06/26/02 by fax on 07/17/02. Death certificate sent, as requested. Annual follow up on 11/25/03: "It is unknown if the patient recovered from the adverse event." Death Certificate Info: Immediate cause: Pneumonia. Underlying cause: Advanced Dementia. Significant Conditions: Diabetes Follow up on 06/01/2004: states it is unknown if the pt recovered from the adverse event.


VAERS ID: 177309 (history)  
Form: Version 1.0  
Age: 84.0  
Sex: Female  
Location: Texas  
Vaccinated:2001-10-22
Onset:2001-10-29
   Days after vaccination:7
Submitted: 2001-10-31
   Days after onset:2
Entered: 2001-11-07
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0674AA / 1 - / IM

Administered by: Other       Purchased by: Military
Symptoms: Apnoea, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2001-11-09
   Days after onset: 11
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: Zoloft, Deparene, Phenobarbitol, Cogentin, Premarin
Current Illness:
Preexisting Conditions: Dementia, Hypertension, Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: SA0112

Write-up: The patient rapidly developed respiratory failure and oxygen desaturation days after vaccination. Transferred to hospital. Per F/U on 6/25/02: immediate cause of death; respiratory failure and pneumonia.


VAERS ID: 177705 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Florida  
Vaccinated:2001-10-31
Onset:2001-11-03
   Days after vaccination:3
Submitted: 2001-11-07
   Days after onset:4
Entered: 2001-11-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E06221KA / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-03
   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:
Current Illness:
Preexisting Conditions: End stage cardiomyopathy; chronic atrial fibrillation; IDDM; renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt expired at 11:30 AM on 11/3/01. Death certificate states cause of death as cardiopulmonary arrest due to congestive heart failure. Other significant conditions noted were endstage cardiomyopathy and IDDM. Cause of Death as per Death Certificate was cardiopulmonary arrest.


VAERS ID: 177706 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Florida  
Vaccinated:2001-10-08
Onset:2001-10-16
   Days after vaccination:8
Submitted: 2001-11-08
   Days after onset:23
Entered: 2001-11-16
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 505A2 / UNK RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5205A2 / 2 LL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA601AA / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T13902 / UNK LL / -

Administered by: Private       Purchased by: Private
Symptoms: Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: Death (Pt had 1st Hep-B/5194A2/IM/RL on 7/31/01). COD as per autopsy report: Complications of acute upper and lower respiratory tract infections/sr


VAERS ID: 177707 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: New York  
Vaccinated:2001-10-11
Onset:2001-10-16
   Days after vaccination:5
Submitted: 2001-11-08
   Days after onset:23
Entered: 2001-11-16
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0515BA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T10982 / 1 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The baby was well on the morning of 10/16/01. She was taken to the babysitter''s house. Father picked up the baby in the afternoon of 10/16/01 to find the baby in moribund state. He rushed the baby to the ER. All resuscitation efforts failed. Baby referred to medical examiner''s office. Cause of Death as per autopsy report was SIDS


VAERS ID: 177708 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Unknown  
Vaccinated:2001-11-05
Onset:2001-11-06
   Days after vaccination:1
Submitted: 2001-11-14
   Days after onset:8
Entered: 2001-11-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pain
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Aspirin; Cardura; Cardizem; Vasotec; Effexor; Imdur; Lopressor; Plavix; Prevacid;Trazadone; Nitroglycerin; Tylenol; Zantac
Current Illness: Hemiparesis due to CVA
Preexisting Conditions: CVA with hemiparesis; hypertension and coronary bypass surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: PJP2001003870

Write-up: The pt was institutionalized in a nursing home and received a Flurvirin injection on 11/5/01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 11/6/01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unknown. Death certificate states cause of death to be coronary artery disease.


VAERS ID: 177892 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Male  
Location: Mississippi  
Vaccinated:2001-11-02
Onset:2001-11-04
   Days after vaccination:2
Submitted: 2001-11-08
   Days after onset:4
Entered: 2001-11-19
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 996A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0480L / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / CONNAUGHT LTD. T0841 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480567 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-04
   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: NONE
Preexisting Conditions: Born at 34 wks gestation
Allergies:
Diagnostic Lab Data: Autopsy results pending
CDC Split Type: MS01050

Write-up: Around 5 AM on 11/4/01, pt woke up crying so father got up and fed him formula and cereal. Father laid in recliner with baby on chest. About an hour later when mother got up and went to where they were, she found the baby dead. Father upset "that he might have smothered the baby."


VAERS ID: 177893 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: New Jersey  
Vaccinated:1992-01-01
Onset:1998-11-01
   Days after vaccination:2496
Submitted: 2001-11-15
   Days after onset:1110
Entered: 2001-11-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (ORIMUNE) / PFIZER/WYETH 0757A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Brain neoplasm malignant, Disturbance in attention, Headache, Nausea, Oesophagitis, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1999-10-07
   Days after onset: 339
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Biopsy NOS (LLT:biopsy) 08/27/1999; Meninges biopsy was positive for metastatic medulloblastoma Computerised tomogram (LLT: CT scan) 11/16/1996; CT-scan revealed a posterior foses tumor and normal ventricular size. 03/08/1999; CT scan of the abdomen was within normal limits Culture NOS (LLT: Culture NOS) 08/26/1999; Shunt culture and cerebral spinal fluid culture were negative Nuclear Magnetic Resonance Imaging (LLT: MRI) 12/01/1998; MRI of the spine revealed no evidence of metaphysis 08/00/1999; MRI of the head showed increased ventricular size Oesophagogastroduodenoscopy (LLT: Oesophagogastroduodenoscopy) 03/00/1999; revealed mild to moderate esphagitis.
CDC Split Type: HQ8460414NOV2001

Write-up: Pt recvd an unspecified number of doses of Orimune from 1992 until 6/13/97. In November, 1998, pt was diagnosed with "medulloblastoma, a tumor of the brain." Following various attempts at treatment, the pt died on 10/7/99. The pt''s parents requested testing of the tumor to determine the presence or absence of SV40. As of the date of this report, testing was ongoing. As of the date of this report, no further info was available. Reported on 02/27/2003: "Follow-up information (medical records) received 02/13/2003 provided dates of vaccination, CT-scan, and MRI results. Information was received 11/12/2001 from an attorney regarding a 6-year-old female who received three doses of Orimune from 12/1992 until 06/1997. On 11/16/16988, the patient was hospitalized due to changes in mental status. Prior to hospitalization the patient had a three week history of vomiting, headache, and malaise. A CT-scan revealed a posterior fossa tumor and normal ventricular size. The patient underwent surgery to remove the tumor and pathology revealed medulloblastoma. On 12/01/1998, a magnetic resonance imaging scan (MRI) of the spine revealed no evidence of metaphysis. In 03/1999, the patient was admitted for chemotherapy (vincristine and cisplatin), while hospitalized the patient underwent an esophagogastroduodenoscopy which revealed mild to moderate esophagitis. A CT-scan of the abdomen was performed to rule out "mass lesions" and this was found to be within normal limits. On 08/26/199, the paitent was brought to the emergency room after experiencing nausea, vomiting, headache, and altered mental status with decreased level of conscioiusness. A MRI of the head showed increased ventricular size, and a craniotomy was performed for revision of her shunt. Shunt culture and cerebral spinal fluid cultures were negative, but biopsy revealed malignant spread of the medulloblastoma to the leptomeninges. On 07/27/1999 the patient developed seizures and went into status epilepticus. Treatment included Ativan and Fosphenytoin, and the patient was subsequently incubated for respiratory failure. Physician notes stated that the new onset of seizures were likely secondary to the metastasis. Legal complaint stated that following various attempts at treatment, the patient died on 10/07/1999. The patient''s parents reequested testing of the tumor to determine the presence or absence of SV40; as of the date of this report, testing was ongoing. Follow up on 02/09/04: "Medical records received provided revised dates of vaccination. Information was received from an attorney regarding a 6 year old female who received four doses of Orimune from December 1992 until June 1997. On 11/16/1988, the pt was hospitalized due to changes in mental status. Prior to hospitalization the pt had a three week history of vomiting, headache, and malaise. A CT-scan revealed a posterior fosma tumor and normal ventricular size. The pt underwent surgery to remove the tumor and pathology revealed medulloblastoma. On 12/01/98, a magnetic resonance imaging scan (MRI) of the spine revealed no evidence of metaphysis. In March 1999, the pt was admitted for chemotherapy (vincristine and cisplatin); while hospitalized the pt underwent an esophagogastroduodenoscopy which revealed mild to moderate esophagitis. A CT-scan of the abdomen was performed to rule out "mass lesions" and this was found to be within normal limits. On 08/26/99, the pt was brought to the ER after experiencing nausea, vomiting, headache, and altered mental status with decreased level of consciousness. A MRI of the head showed increased ventricular size, and a craniotomy was performed for revision of her shunt. Shunt culture and cerebral spinal fluid cultures were negative, but biopsy revealed malignant spread of the medulloblastoma to the leptomeninges. On 08/27/99 the pt developed seizures and went into status epilepticus. Treatment included Ativan and Fosphenytoin, and the pt was subsequently intubated for respiratory failure. Physician notes stated that the new onset of seizures were likely secondary to the metastasis. Legan complaint stated that following various attempts at treatment, the pt died on 10/07/99. The pt''s parents requested testing of the tumor to determine the presence or absence of SV40; as of the date of this report, testing was ongoing. Medical records are on file.


VAERS ID: 177955 (history)  
Form: Version 1.0  
Age: 44.0  
Sex: Male  
Location: Unknown  
Vaccinated:1995-01-01
Onset:1997-04-01
   Days after vaccination:821
Submitted: 2001-11-16
   Days after onset:1690
Entered: 2001-11-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Ascites, Cardiomegaly, Chest pain, Chills, Dehydration, Dyspnoea, HIV test positive, Haemoptysis, Heart rate increased, Hepatic cirrhosis, Hepatomegaly, Hyperventilation, Hypotension, Hypoxia, Malaise, Meningitis, Night sweats, Oliguria, Pallor, Pleural effusion, Pneumonia, Sepsis, Splenomegaly, Varices oesophageal, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: lamivudine; sulfamethoxazole (+) zidovudine
Current Illness: Cirrhosis; human immunodeficiency virus antigen positive; hepatitis C; drug abuse
Preexisting Conditions: Chronic sinusitis; hepatitis B
Allergies:
Diagnostic Lab Data: RR-40/min; BP-91/60 mmHg; HR-114/min; breath sounds over his right lung field were decreased; CXR-showed an infiltrate of the entire right lung; Autopsy-showed lobar pneumonia, pleural effusion, ascites, cardiomegaly with unremarkable valves, esophageal varices, splenomegaly and hepatomegaly with liver cirrhosis. Histopathology of the lungs revealed sheets of acute and chronic inflammatory cells diffusely filling the alveolar spaces, intra-alveolar edema and capillary congestion. Histopathology of the liver revealed cirrhotic micronodules surrounded by bridging bands of fibrosis with portal ductular proliferation and moderately periductual lymphocytic infiltrate. Histopathology of the spleen showed marked sinusoidal congestion with mild depletion of the white pulp. Lymph nodes showed mild follicular depletion. Isotyping confirmed S. pneumonia, strain type 3.
CDC Split Type: WAES01110449

Write-up: It was reported that a 44 year old white male was vaccinated in 1995 with a dose of pneumococcal vaccine 23 polyvalent and a dose of influenza virus vaccine. At the time of vaccination, the pt''s CD4 count was 250 cells/microL (19%) and he was prescribed concomitantly zidovudine, lamivudine and sulfamethoxazole/trimethoprim. It was noted that over the subsequent 2 years, there was a transient increase of his CD4 count to a maximum of 370 cells/microL and then a slow decline. The pt presented in 4/97 to the ER with a 6 day history of violent shaking chills, night sweat and malaise. The pt reported shortness of breath, occasional blood-tinged sputum and pleuritic chest pain for 3 days. The pt was known to have been HIV (+) for 8 years, with risk factors including IV drug abuse. It was noted that the pt had received medical care at the infectious disease clinic at the same hospital. It was noted that at his last appointment, 3 months prior to his presentation to the ER, the pt had a CD4 cell count of 216 cells/microL (16%) and his viral load was 1270 copies/mL. It was reported that the pt completely recovered from a hepatitis b infection, but hat a history of chronic sinusitis and hepatitis C. The pt had never suffered from the opportunistic infections common in AIDS. It was reported that in the ER, the pt was poorly cooperative, appeared pale and coughed occasionally. He was afebrile, hypoxemic and had oliguria. Septic shock with severe bacterial pneumonia was dx''d. Ceftazidime, erythromycin, sulfamethoxazole/trimethoprim and IV hydration were administered. It was reported that the pt required orotracheal intubation and mechanical ventilation. About 11 hours after presenting to the ER, the pt developed recurrent ventricular tachycardia and expired. It was noted that with the exception of minimal aseptic leptomeningitis, the neuropathological findings were unremarkable. There was no evidence that the pt had a concurrent influenza infection. It was reported that Streptococcus pneumoniae was cultured from various blood samples. The organism was sensitive to penicillin, chloramphenicol, vancomycin and erythromycin. It was noted that the pneumococcal vaccine 23 polyvalent included isotype 3.


VAERS ID: 178034 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2001-11-13
Onset:2001-11-13
   Days after vaccination:0
Submitted: 2001-11-15
   Days after onset:2
Entered: 2001-11-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0676AA / UNK LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Apnoea, Cardiac arrest, Chills, Livedo reticularis, Musculoskeletal stiffness, Mydriasis, Pulse absent
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-13
   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:
Current Illness:
Preexisting Conditions: History of by-pass surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pt received Influenza 0.5ml, IM, LA at approx. 12:45. At 14:31, he was found DOA in his car at a local plaza. The fire dept report states that the pt was found slumped behind the wheel of his car. Pt was found to be pulseless/apneic and clutching a NTG bottle in his left hand. The pt was cold, mottled with pooling in the face and arms. Estimated down time 1/2 to 1 hours, according shopkeeper (maybe longer) who noticed car in space for extended time. No trauma noted. Pupils fixed/dilated, pooling in face secondary to position. Pt leaning over steering wheel; neck, arms stiff. Rigor secondary to pt pooling line in hands/forearms, extended down time. Cold, pale/mottled, dry; obvious morbidity. COD as per death certificate -- cardiorepiratory arrest


VAERS ID: 178142 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2001-11-07
Onset:2001-11-12
   Days after vaccination:5
Submitted: 2001-11-20
   Days after onset:8
Entered: 2001-11-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH - / UNK - / IM

Administered by: Private       Purchased by: Other
Symptoms: Rash maculo-papular, Vasculitis
SMQs:, Vasculitis (narrow), Hypersensitivity (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: 2001-11-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft
Current Illness: UNK
Preexisting Conditions: Aphasia; Cardiovascular disorder NOS; Cerebrovascular accident NOS
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQ8617920NOV2001

Write-up: A physician reported that a female in her late 80''s received an injection of Flu Shield (''01-''02). On 11/12/01, approx. 5 to 7 days post vax, she developed a severe, blistering, maculopapular rash on the front and back of her trunk. She was treated with valacyclovir and steroids. On 11/18/01, she died. No further information was available at the date of this report. Death certificate states cause of death as vasculitis with other significant condition of stroke.


VAERS ID: 178149 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: California  
Vaccinated:2001-11-10
Onset:2001-11-12
   Days after vaccination:2
Submitted: 2001-11-21
   Days after onset:9
Entered: 2001-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 7+ - / IM

Administered by: Other       Purchased by: Public
Symptoms: Coronary artery disease, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-12
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had been to PCP on 11/8/01 for a check-up and she was healthy, no medical problems and blood work was normal. She was found on 11/13/01 per housekeeper on the floor. MD signed the death certificate as "atrial fib" but said COD was either heart attach or CVA. No autopsy done. Actual death certificate states cause of death as ventricular fibrillation due to coronary artery disease.


VAERS ID: 178205 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New Mexico  
Vaccinated:2001-09-11
Onset:2001-09-12
   Days after vaccination:1
Submitted: 2001-09-13
   Days after onset:1
Entered: 2001-11-27
   Days after submission:75
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 505A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1527K / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: NM090101

Write-up: Baby received immunizations 09/11/2001. Was found dead less than 24 hours later. Death is being investigated as a SIDS death. Autopsy results will be reviewed by MD, Epidemiology, and shared with LHO and Immunization program. COD as per autopsy report -- SIDS


VAERS ID: 178303 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: New Mexico  
Vaccinated:2001-11-12
Onset:2001-11-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2001-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 517A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0346L / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1128 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 481818 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Adrenal haemorrhage, Atrial septal defect, Bacterial infection, Gastritis, Gastrooesophageal reflux disease, Nervous system disorder, Oesophagitis, Petechiae, Pleural effusion, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific dysfunction (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol; Pulmicort; Zantac; Reglan
Current Illness:
Preexisting Conditions: Dysmorphic syndrome suspected; ASD; GE Reflux; Chronic respiratory symptoms; developmental delay; URI; questionable heart disorder
Allergies:
Diagnostic Lab Data: O2 sat-nml; ASD by echo screening L more than right; Chromosomes not drawn yet Per autopsy F/U polybacterial pneumonia, including Streptococcus pneumoniae; failure to thrive (small for age); GI Reflux disease
CDC Split Type:

Write-up: Baby died at home early AM on 11/16/01. Autopsy results received state cause of death as pneumonia. There is an umbilical hernia; occasional posterior epicardial petechiae and pleural surfaces also have scattered petechiae on the visceral pleura and the parenchyma exudes slight to moderate amounts of blood and frothy fluid. The lungs show congestion, patchy interstitial and peribronchial acute and chronic inflammation with areas of edema bilaterally. The lungs had focal areas of pneumonia which demonstrated clusters of gram-positive cocci. Immunohistochemical staining of lung was positive for Streptococcus pneumoniae. There are scattered petechiae on the superior surface of the diaphragm. The liver and spleen are congested as are the kidneys. The brain has diffuse congestion, rare eosinophilic degeneration of neurons in the hippocampus and an infantile architecture. The adrenal has congestion and focal hemorrhage. Esophagus and stomach with mild chronic inflammation and scattered eosinophils. The thyroid has congestion.


VAERS ID: 178459 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2001-11-06
Onset:2001-11-10
   Days after vaccination:4
Submitted: 2001-11-27
   Days after onset:17
Entered: 2001-12-03
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-10
   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: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES01111393

Write-up: Information has been received from an RN concerning a 6 day old male relative who on 11/6/01 was vaccinated with Hep-B vaccine recombinant (yeast). On 11/10/01, the child died. The cause of death was unknown. Autopsy report states child''s age at time of death to be 18 days old. Cause of death is traumatic compression of head and chest due to overlaying, manner of death accidental.


VAERS ID: 178470 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Unknown  
Vaccinated:2001-11-04
Onset:2001-11-05
   Days after vaccination:1
Submitted: 2001-11-29
   Days after onset:24
Entered: 2001-12-03
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chills, Dysphagia, Pain, Pharyngolaryngeal pain, Skin exfoliation, Swelling face, Toxic epidermal necrolysis
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allopurinol; benazepril; burnetanide; KCI; simvastatin; warfarin; colchicine; prenatal vitamins; epoetin alpha; pamidronate; metolazone; insulin
Current Illness:
Preexisting Conditions: Multiple myeloma; Rheumatic heart disease with mechanical valve; Gout; DM; HTN; decreased renal function and Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt developed body aches, chills, sore throat and increasing difficulty swallowing with swelling of lip, 1 day after receiving influenza vaccine injection and about 8 weeks after beginning Allopurinol (history of receiving influenza vaccine yearly without reaction; Allopurinol initially 100mg OD but increased to 300mg several weeks later). Pt had 80% to 90% body surface area sloughing (Toxic Epidermal Necrolysis). Admitted to the hospital, 1 day after development of above mentioned signs and symptoms; allopurinol discontinued and treated with antibiotics and steroids. After 16 days in the hospital, he was transferred to another hospital service where steroids were discontinued; treated with IVIG, silver nitrate topical. Wounds continued to slough and pt expired on 5th hospital day.


VAERS ID: 178522 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Louisiana  
Vaccinated:2001-09-13
Onset:2001-09-23
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2001-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Abnormal sleep-related event, Cardiac arrest, Coma, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-23
   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: Two-month-old was found by family unresponsive in bed. Family stated pt had his first set of vaccines 7-10 days prior to event. Pt was coded, intubated and CPR was performed, but pt did not respond. Pt was taken to hospital in cardiac arrest. Pt also commonly slept in bed with other family members. COD as per autopsy report was SIDS.


VAERS ID: 178523 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2001-10-25
Onset:2001-10-27
   Days after vaccination:2
Submitted: 2001-12-03
   Days after onset:37
Entered: 2001-12-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES - / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Ascites, Cardiomegaly, Dyspnoea, Hypoxia, Mitral valve incompetence, Myalgia, Pyrexia, Respiratory disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-17
   Days after onset: 21
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: Prednisone 20 mg BID times 3 weeks. Discontinued same day.
Current Illness: Pulmonary fibrosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Bronchoscopy; open lung biopsy; CXR-infiltration
CDC Split Type:

Write-up: 2 days, post vax, the vaccinee complained of chills, myalgias and shortness of breath. 3 days, post vax, his temperature was 102F; CXR with infiltrate and pulse ox 85%. He was admitted and rx''d with Zithromax, O2 and steroids. CXR and clinical determination to ARDS, mechanical ventilation and death. Autopsy findings state cardiomegaly and left and right ventricular hypertrophy; focally calcified mitral valve. Secondary findings: ascites.


VAERS ID: 178592 (history)  
Form: Version 1.0  
Age: 99.0  
Sex: Male  
Location: Michigan  
Vaccinated:2001-11-20
Onset:2001-11-23
   Days after vaccination:3
Submitted: 2001-12-04
   Days after onset:11
Entered: 2001-12-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UO691AA / 6 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Nephritis, Pyrexia, Urinary retention, Urine analysis abnormal, White blood cell disorder
SMQs:, Acute renal failure (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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: 2001-11-23
   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: NONE
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Positive for bacteria in urine, polynephritis, WBC 40,000 +.
CDC Split Type:

Write-up: High fever 1 AM on 11/23/2001. Taken to hospital. Diagnosis of Urosepsis.


VAERS ID: 178593 (history)  
Form: Version 1.0  
Age: 25.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2001-11-02
Onset:2001-11-19
   Days after vaccination:17
Submitted: 2002-03-11
   Days after onset:112
Entered: 2001-12-05
   Days after submission:96
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0815L / 1 - / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1091L / 1 - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-19
   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: Varicella
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES01112752

Write-up: Information has been received from a physician concerning a 25 year old male with no known allergies or psychiatric history and a history of varicella who on 02-NOV-2001, at 11:00 AM, was vaccinated with a dose of MMR (second generation). Concomitant therapy included Recombivax HB. There was no other concomitant medication. It was noted that the pt was seen later that day in the early evening, at 6:00 PM, then disappeared. On 19-NOV-2001 the pt''s dead body was recovered in the river. It was reported that it was an assumed suicide. The physician reported that she only saw the client for immunizations. Unspecified medical attention was sought. Additional information has been requested. Follow-up info from the reporter indicated that "in her mind there is no connection between the vaccination and the death." Additional info has been requested.


VAERS ID: 178718 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Utah  
Vaccinated:2001-09-27
Onset:2001-10-14
   Days after vaccination:17
Submitted: 2002-03-19
   Days after onset:156
Entered: 2001-12-07
   Days after submission:102
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / CONNAUGHT LABORATORIES U0537AB / 1 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0776L / 1 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1390 / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 476385 / 1 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Apnoea, Asphyxia, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (narrow), Hostility/aggression (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-10-14
   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: UNK
Current Illness: NONE
Preexisting Conditions: Premature baby, poor weight gain
Allergies:
Diagnostic Lab Data: CFS culture-neg, Blood culture-neg, Culture NOS-neg, Autopsy results-SIDS vs. Asphyxia; WBC-3,000
CDC Split Type: WAES0201USA00430

Write-up: A pediatrician reported that a 2 month old female received a dose of Prevnar, DTaP, Comvax and IPV vaccines on 27-SEP-2001. On 14-OCT-2001, at the age of three months, the child was found apneic. Resuscitation measures were performed by the child''s mother and by emergency personnel prior to transporting the child to a local ER where she was pronounced dead. Bacterial CSF and blood and viral culture samples yielded negative results. An autopsy returned inconclusive but sudden infant death syndrome was possible. This report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA. COD as per autopsy report -- undetermined. Follow-up info from a physician stated that her practice, "did not have any concerns regarding the haemophilus b conjugate vaccine hepatitis b vaccine recombinant. Additional info from a nurse in the physician''s office stated that this pt, who was previously healthy, received haemophilus b conjugate vaccine hepatitis b vaccine recombinant. Additional info from a nurse in the physician''s office stated that another infant (WAES 0203USA00661) also received Hib + Hep-B (lot 638216/1539K) and Prevnar and died of SIDS. The physician''s office reported that they did not believe there was any association with Hib + Hep-B, but that both infants received the same lot of Prevnar. This report was also received from the Center for Biologics and Evaluation and Research and was assigned Vaers Id 180019. F/U info noted that there was no illness at the time of vaccination. The pt died of apparent SIDS, 2 1/2 weeks, post vax. The autopsy report was SIDS vs. anphyxia. The reporter listed the cause of death as SIDS. No further information is available. The follow up info received on 12/30/02 indicated that the pt''s birth weight was 4 lbs 15 oz, it was also reported that the pt was a "second twin," had hyyperglycemia, hyperbilirubinemia and was premature at 35 weeks gestation. No further info is available. Follow up on 10/20/2003: "This report was received from Wyeth Ayerst for streptococcus pneumoniae vaccine (Prevnar) and assigned manufacturer report number HQ9063604DEC2001 (also noted to be HQ9063504NOV2001, HQ7304118OCT2001 & HQ0646611FEB2002). This report is concerning a 10 week old female." A 15-day report received 10/24/2003 adds no new info.


VAERS ID: 178756 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2001-11-30
Onset:2001-12-03
   Days after vaccination:3
Submitted: 2001-12-03
   Days after onset:0
Entered: 2001-12-10
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 516A2 / 1 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0952L / 1 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T0395 / 1 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 418320 / 1 - / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Prematurity 31 weeks. Post gestational age 39 weeks.
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Infant given 2 month immunizations on Friday 11/30/2001. Monday 12/03/2001 infant was found dead in crib. Paramedics called and were unable to resuscitate. Medical examiner called. Autopsy pending. COD as per autopsy report -- SIDS


VAERS ID: 178757 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: North Carolina  
Vaccinated:2001-11-28
Onset:2001-11-29
   Days after vaccination:1
Submitted: 2001-11-29
   Days after onset:0
Entered: 2001-12-10
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR UO536CA / 1 LL / -
HBPV: HIB POLYSACCHARIDE (HIBIMUNE) / PFIZER/WYETH 480935 / 1 LL / -
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1031 / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480395 / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Cardiac 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), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-29
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Post mortem exam
CDC Split Type:

Write-up: Pt found asystolic at approximately 2 AM in his crib on 11/29/2001. COD as per autopsy report --SIDS/sr


VAERS ID: 178821 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2001-11-12
Onset:2001-11-15
   Days after vaccination:3
Submitted: 2001-12-10
   Days after onset:25
Entered: 2001-12-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER UO151A / 2 - / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 1028K / 2 - / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 1643K / 2 - / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER T1390 / 2 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH T1390 / 2 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Coma
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), 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: 2001-11-15
   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: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On 11/15/01 at 01:00, pt was fed and laid on her back. At 03:00, checked baby and determined that she was not breathing. There was no response and no pulse. Called 911 and CRP was performed. Ambulance came and transported to the hospital.


VAERS ID: 178822 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Mississippi  
Vaccinated:2001-06-13
Onset:2001-06-13
   Days after vaccination:0
Submitted: 2001-12-03
   Days after onset:173
Entered: 2001-12-11
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 988A2 / 1 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1522K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR R14372 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 477450 / 1 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Sudden infant death syndrome
SMQs:, Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-06-13
   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:
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was told that the mother placed him in his baby bed around 20:00. About an hour later, when she checked on him, he was not breathing. I was told he died at home. COD as per autopsy report -- SIDS


VAERS ID: 178823 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Ohio  
Vaccinated:2001-11-14
Onset:2001-11-17
   Days after vaccination:3
Submitted: 2001-11-29
   Days after onset:12
Entered: 2001-12-11
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484131 / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-17
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: OH0071

Write-up: The evening of 11/16/01, the child vomited X 1 and no other symptoms were present. The child died in her sleep that night. Cause of Death as per autopsy report was SIDS with focal epiglotitis.


VAERS ID: 178824 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2001-05-07
Onset:2001-05-09
   Days after vaccination:2
Submitted: 2001-05-23
   Days after onset:14
Entered: 2001-12-11
   Days after submission:202
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 986A2 / 1 RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5768A2 / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA560AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T0472 / 1 LL / SC

Administered by: Private       Purchased by: Other
Symptoms: Feeling cold, Injury, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy pending
CDC Split Type:

Write-up: Possible SIDS. Mother found infant at 06:57 on 5/9/01, lying prone in his crib (stiff and cold). Paramedics responded to 911 call and pronounced the death. No trauma or injury found. Information obtained from Sheriff-Coroner''s initial death report. Unable to contact mother. On 8/9/01, dx received from Deputy Coroner of blunt force traumatic injuries of torso.


VAERS ID: 178960 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Missouri  
Vaccinated:2001-11-28
Onset:2001-11-28
   Days after vaccination:0
Submitted: 2001-11-28
   Days after onset:0
Entered: 2001-12-13
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4018041 / 5 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Child maltreatment syndrome
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-11-28
   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: Phenobarbital; Baclofen; Robinul; Extendryl; Zyrtec Syrup; Nasonex Spray; Senocot Children''s Syrup; NaFl; Acetaminophen Solution; Atrovent Neb
Current Illness: NONE
Preexisting Conditions: Shaken baby syndrome at 5 weeks of age; Blind; CA; Seizures; 13 weeks premature; Disorder microcephaly; NPO with G-tubes
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: MO2001063

Write-up: The pt had no problems immediately after injection or prior to being discovered dead in crib at 05:45 on 11/28/01. On the last check of pt at 03:00 on 11/28/01, he was laughing and playing. Death certificate indicates the child died from shaken baby syndrome (suffering from this since 5 weeks old according to the dept of health).


VAERS ID: 179070 (history)  
Form: Version 1.0  
Age: 1.75  
Sex: Male  
Location: California  
Vaccinated:2000-12-01
Onset:2001-01-09
   Days after vaccination:39
Submitted: 2001-12-03
   Days after onset:328
Entered: 2001-12-17
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 973A2 / 2 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 471871 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR 92030 / 2 RL / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1161K / 1 RL / SC

Administered by: Private       Purchased by: Private
Symptoms: Aggression, Anorexia, Apnoea, Blister, Brain stem syndrome, Cyanosis, Epistaxis, Fatigue, Irritability, Lacrimation increased, Pyrexia, Splenomegaly, White blood cell count increased
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-09
   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: Children''s Motrin prior to vaccinations
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type:

Write-up: On 12/1/00, my son was given 4 vaccinations. His appointment was at 09:15. The morning of 12/2/00, he was out of sorts. He had a low fever, he didn''t have an appetite, he was extremely tired and very cranky. He was not acting in the usual manner at all. I know that vaccinations can sometimes cause these types of symptoms. I gave him the recommended dosages of Children''s Motrin throughout the day to lower his fever. It alternated between 100F and 101F. On 12/3/00, he continued to be very cranky but his fever had gone away. He was acting unusually aggressive. He was not his "normal" self, but he did not show extreme signs of illness. My husband and I both commented that we hoped the vaccinations had not caused him some kind of harm. This child was normally extremely easy going and never cranky. In fact, it was the 1st time we had seen him in a "bad" mood. On 12/4/00, he woke up in the morning and as I was getting him dressed, I noticed that he had 1 fluid filled blister on the top of each of his knuckles. (I had been under the impression that he had received his Varicella vaccination per the nurse at my doctor''s office). I called the advice nurse and told her about his blisters. She said that they were probably a result of his vaccination. She indicated that they were contagious until they dried up. By 12/6/00, they were completely gone. They did not crust over or anything, they just disappeared. He actually did not receive his Varicella vaccination, so they could not have been chickenpox. Throughout the month of December, he continued to act really tired and would take long naps. I did not know why he was sleeping so much, but he did not exhibit classic symptoms of obvious illness. He also had some unusual behavior that he was crankier than usual. On 1/9/00, we were playing at about 16:00. He began rubbing his eyes. I asked him if he wanted to go "night night" and he responded "yes". I took him into my bedroom and we rested on my bed. He rubbed his eyes and said, "Owie". A few tears rolled out the sides of his eyes as if his eyes were tearing. He rolled over and fell asleep. By this time it was 16:20. His older brother and a friend were playing in the room where he was sleeping. I told them to play outside so they would not wake him. I checked on him several times. At 17:00, I looked in on him and found him face down. I turned him over and he was blue, his eyes were half open and he wasn''t breathing. He had blood coming out of his nose. I began CPR. My son called 911. He never regained consciousness. He was pronounced dead at the hospital about 1.5 hours after I found him. This was a perfectly healthy child. An autopsy was done. The cause of death was undetermined. Upon 6 months of further investigation, the Medical Examiner still has no absolute cause of death. The main findings are that his spleen was enlarged and full of white pulp (denoting massive white blood cell production) and his brainstem had a foci of mild inflammation. It has always been my gut feeling that he was harmed by his vaccinations. I have never been opposed to vaccinations. My other child and this child ha both been regularly immunized. I know investigators don''t believe in intuition, but I have a very uneasy feeling about this round of immunizations. I can''t say why, it is just a feeling that I now trust. I hope you give the death of my child a thorough investigation. I would hate for another child to die or a family to have to go through this gut wrenching hell and grief. The truth is, children are rarely harmed by immunizations. I want to know if my son was that one in a million. It is very hard not to know why your perfect, healthy child suddenly dies in an instant with no explanation. I appreciate your attention and diligence in honoring the need for an extensive investigation.


VAERS ID: 179127 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Missouri  
Vaccinated:2001-11-27
Onset:2001-12-12
   Days after vaccination:15
Submitted: 2001-12-13
   Days after onset:1
Entered: 2001-12-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 514A2 / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1067L / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA604AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T13902 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480900 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Atelectasis, Coma, Eye discharge, Liver disorder, Nasal congestion, Nephritis, Petechiae, Pulmonary congestion, Pulmonary oedema
SMQs:, Acute renal failure (broad), Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-12
   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: Completed antibiotic therapy 1 week ago for upper respiratory infection.
Current Illness: NONE
Preexisting Conditions: Respiratory infection 2-3 weeks ago.
Allergies:
Diagnostic Lab Data: Autopsy results pending
CDC Split Type:

Write-up: The parent reports the pt did not have any problems after his shots. He had an upper respiratory infection about 2-3 weeks ago and completed antibiotics about 1 week ago. He was seen in ER. The ER dx''d URI with nasal congestion. He had green matter in both eyes and that was dx''d as conjunctivitis and treated with Polysporin optical ointment. The child was fed a bottle of Enfamil with Iron about 10:00 and was found unresponsive and pronounced DOA at 11:41 at the hospital. The hospital will fax Health Dept report. The baby was found by coroner with a bottle propped in the crib with a pillow and stuffed animals. COD as per autopsy report -- undetermined. Per F/U 4/13/02: Pleural surfaces have focal petechiae and are atelectatic. Lungs show edema and congestion, the liver shows congestion and the kidneys show a focal area of chronic inflammation.


VAERS ID: 179128 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Missouri  
Vaccinated:2001-11-28
Onset:2001-12-12
   Days after vaccination:14
Submitted: 2001-12-14
   Days after onset:2
Entered: 2001-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 516A2 / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1067L / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA604AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T13902 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 480900 / 1 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Anorexia, Coma, Musculoskeletal stiffness, Rhinitis allergic, Somnolence
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-12
   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: Tylenol 24 hours after immunzation
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy results pending
CDC Split Type:

Write-up: Pt was fed Enfamil with Iron. At 20:15 the pt was asleep in his crib on his abdomen. He was found unresponsive at about 21:15. DOA at the hospital at about 21:20. Other family members were ill with vomiting for 2-3 days prior to his death. On 12/13/01 at 04:15, a call was received from the child''s mother, reporting that her son died last night and wanted to let the health dept know that Family Services will be calling us regarding immunizations given, dates and possible side effects. She expressed concern about Prevnar vaccine and infant''s death. She reported that "he just did not act like the same child after he got his shots." I asked her if he ran any fever after he received his shots and she said no. She was giving him Tylenol every 4 hours for 24 hours, post vax. She noticed his "appetite had decreased a little every day since he was immunized and that his muscles seemed tense. He was not really sick and sometimes he would laugh and smile but yesterday, he did not want to eat at all and just wanted to sleep all day." He was seen at ER with a "runny nose" (allergic rhinitis), no medications on 11/1/01. On 12/5/01, his 4 year old sister was vomiting 1/2 hour after eating. Grandmother sick with acute viral gastritis. Cause of Death as per autospy report - undetermined.


VAERS ID: 179130 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: New York  
Vaccinated:2001-11-30
Onset:2001-12-01
   Days after vaccination:1
Submitted: 2001-12-13
   Days after onset:12
Entered: 2001-12-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E04831KA / 1 - / IM

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory 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), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Inderal; Metamucil; Ativan; Vitamin E; Cogentin; Risperdal
Current Illness: NONE
Preexisting Conditions: Development disability; severe MR; mild to moderate scoliosis; intermittent explosive disorder; PICA; history of pin worms; allergy to Navane and Nitrous Oxide
Allergies:
Diagnostic Lab Data: Autopsy performed
CDC Split Type:

Write-up: No symptoms of adverse reaction noted following administration of vaccine. Autopsy performed and cause of death was listed as "Cardiorespiratory failure as a consequence of seizure".


VAERS ID: 179131 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: New York  
Vaccinated:2001-11-16
Onset:2001-12-07
   Days after vaccination:21
Submitted: 2001-12-13
   Days after onset:6
Entered: 2001-12-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES E04831KA / 1 - / 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: 2001-12-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: Development disability, Down''s Syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: No symptoms of adverse reaction noted following administration of vaccine. Cause of death pneumonia.


VAERS ID: 179151 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: Ohio  
Vaccinated:2001-11-02
Onset:2001-11-29
   Days after vaccination:27
Submitted: 2001-12-17
   Days after onset:18
Entered: 2001-12-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U0675BA / UNK RA / IM

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

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

Write-up: Guillain Barre syndrome, axonal form. Per doc 214332, 60 day follow-u, patient was discharged to a rehabilitation facility. He reportedly died several days later. I am unsure at the cause of death, though I suspect he may have suffered a massive pulmonary embolism.


VAERS ID: 179213 (history)  
Form: Version 1.0  
Age: 34.0  
Sex: Female  
Location: Washington  
Vaccinated:2001-12-10
Onset:2001-12-11
   Days after vaccination:1
Submitted: 2001-12-12
   Days after onset:1
Entered: 2001-12-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UO708AA / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sulfa allergy
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type:

Write-up: Unexplained death. Awaiting autopsy COD as per autopsy report -- combination of methadone and oxycodone intoxication


VAERS ID: 179416 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Unknown  
Vaccinated:1998-01-01
Onset:0000-00-00
Submitted: 2001-12-20
Entered: 2001-12-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: UNK
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES0112USA01104

Write-up: Information has been received from a physician for a case in litigation concerning a 7 year old male who in approximately 1998 was vaccinated with MMR II, also referred to as the "triple measles vaccine" by the physician. The pt presented with a history of recent psychomotor retardation without any associated history or signs of an infectious or neoplastic process. Investigation concluded that the etiology lay in a subacute sclerosing panencephalitic process attributable to the MMR II. The pt manifested no allergies to egg protein and his immediate post vaccination course had been uneventful. There had been no evidence of measles prior to the vaccination and his psychomotor development had been normal until the onset of symptoms. Subsequently, in approximately August 2001 the pt died.


VAERS ID: 179604 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: California  
Vaccinated:2001-01-18
Onset:2001-01-31
   Days after vaccination:13
Submitted: 2001-12-27
   Days after onset:330
Entered: 2001-12-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / UNK - / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-31
   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:
CDC Split Type: U2001013110

Write-up: It was reported that a 2 month old male pt received IPOL vaccination on 18-JAN-2001. On 31-JAN-2001 the pt died. No specifics were provided. Further information is requested. COD as per autopsy report was asphyxia due to aspiration of foreign object


VAERS ID: 179775 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Tennessee  
Vaccinated:2001-12-12
Onset:2001-12-17
   Days after vaccination:5
Submitted: 2002-01-07
   Days after onset:21
Entered: 2002-01-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 524A2 / 1 RL / IM
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5208A2 / 2 RL / IM
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES UA644AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1391 / 1 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Bacterial infection, Coma, Marrow hyperplasia, Petechiae, Pleural effusion, Renal interstitial fibrosis, Sudden infant death syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Chronic kidney disease (narrow), Myelodysplastic syndrome (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-17
   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:
Preexisting Conditions: Possible Sickle Trait
Allergies:
Diagnostic Lab Data: Autopsy pending; F/U info: EKG; ECG; Testicle-there is evidence of a focus of extramedullary hematopoiesis
CDC Split Type:

Write-up: The child died on 12/17/01 with apparent SIDS. COD as per autopsy report: Bilateral focal intertial pneumonia and RL broncopneumonia. Per F/U 4/1/02, Reportedly, this full term baby boy was an uneventful delivery, had no recent illnesses. He did have IZ approx. 5 days ago, but did not have any noticeable side effects. According to parents, they checked on the baby at approx. 03:00 and he appearing to be well. When they went in to check on him at approx. 07:15, he was unresponsive. EMS was called and he was pronounced dead in the ER. The cause of death also was listed as petchiae in the thymus, pericardium and pleural surfaces of both lungs. He also had focal segmented glomerulosclerosis.


VAERS ID: 179886 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Utah  
Vaccinated:2001-10-11
Onset:2001-10-13
   Days after vaccination:2
Submitted: 2002-01-03
   Days after onset:82
Entered: 2002-01-11
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U037AA / 1 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1591K / 1 - / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T0595 / 1 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 475385 / 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: 2001-10-14
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Prematurity; twin pregnancy, hyperbilirubinaemia, hypoglycaemia NOS
Allergies:
Diagnostic Lab Data: Autopsy results-pending
CDC Split Type: HQ7285218OCT2001

Write-up: A physician reported that a 2 month old infant received an injection of Prevnar (first dose) on 11-OCT-2001. Subsequently, the pt was hospitalized and on 14-OCT-2001, the infant died. No further information was available at the date of this report. This is 1 of 2 pts from this facility who died after receipt of Prevnar lot 475-385. Cause of Death as per autopsy report was SIDS. Initial autopsy showed no cause of death. Final results were not received. The reporter noted that this was the healthier twin.


VAERS ID: 179926 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Maryland  
Vaccinated:2001-12-26
Onset:2001-12-27
   Days after vaccination:1
Submitted: 2001-12-31
   Days after onset:4
Entered: 2002-01-14
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 525A2 / 1 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 477385 / 1 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T0909 / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 481815 / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Feeding disorder neonatal, Feeling cold, Lung disorder, Nervous system disorder, Premature baby
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-27
   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: Fer-In-Sol; Poly-Vi-Sol; Synagis given on 12/17/01
Current Illness: NONE
Preexisting Conditions: Premature at (30 Wk); history of apnea/brady last 12/2/01 with no treatment
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fed poorly at midnight. Slept with mother. Mother found baby cold in mother''s bed when mother awoke. Taken to ER by ambulance. Baby DOA though some resuscitation attempted. COD: complications of prematurity as per autopsy report F/U on 5/22/02, shows changes in the lungs consistent with bronchopulmonary dysplasia with proliferation of the epithelium and uneven opening of the alveolar spaces. The brain is very small; it''s size is more appropriate for a neonate. This may be explained by history of prematurity.


VAERS ID: 179927 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2000-11-14
Onset:2000-11-14
   Days after vaccination:0
Submitted: 2000-12-15
   Days after onset:31
Entered: 2002-01-14
   Days after submission:395
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / MEDEVA PHARMA, LTD. E66350NA / UNK RA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Cardiac arrest, Coma
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-11-14
   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: NONE
Preexisting Conditions: PCN allergy; history of diabetes and hypertension.
Allergies:
Diagnostic Lab Data:
CDC Split Type: SC00094

Write-up: The pt received influenza vaccine during AM hours. The pt seemed fine for several hours but was found unresponsive by a neighbor that afternoon. Resuscitation efforts failed and the pt was pronounced dead at 17:52 on 11/14/00. Her death was felt to be sudden cardiac death with a history of diabetes and hypertension. Please not the date of the event, 11/14/01, is the correct date. The pt died on the same day he received influenza immunization.


VAERS ID: 179968 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Kentucky  
Vaccinated:2001-11-28
Onset:2001-12-18
   Days after vaccination:20
Submitted: 2002-01-11
   Days after onset:24
Entered: 2002-01-15
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 522A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1591K / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T1310 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484140 / 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: 2001-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy-results pending
CDC Split Type: KY2002001

Write-up: Infant died of SIDS 12/17/2001 at 8:38 AM. No adverse event following administration of vaccine occured other than death from SIDS 21 days post injections.


VAERS ID: 180302 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Female  
Location: South Carolina  
Vaccinated:2001-09-27
Onset:2001-09-28
   Days after vaccination:1
Submitted: 2002-01-14
   Days after onset:108
Entered: 2002-01-23
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 522561 / 3 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Bacterial infection, Bronchiolitis, Coma, Cyanosis, Epiglottitis, Petechiae, Pleural effusion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-09-28
   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: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Autopsy: blood cultures (+) for E. coli, Enterococcus species; cultures of the middle ear showed scant growth of Klebsiella oxytoca, possibly a cause of otitis media.
CDC Split Type:

Write-up: Patient died approximately 28 hours after Hepatitis B injection. Manner of death, natural, Cause of Death-- SIDS Per F/U 3/27/02: final autopsy dx: Pulmonary edema, anterior thymic petechiae, reactive chronic inflammation; bronchioles, epiglottis. Lungs were heavy for agevand exuded copious fluid. She was found to be blue and unresponsive by her father at approx. 1:50 pm on 9/28/01, after he was awakened by a telephone call. At that time, he called 911 and attempted CPR while waiting for help to arrive. When EMS personnel attempted intubation, copious vomitus exuded from the tube and oral cavity. ER personnel continued ACLS protocols without success.


VAERS ID: 180561 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Kentucky  
Vaccinated:2002-01-11
Onset:2002-01-16
   Days after vaccination:5
Submitted: 2002-01-16
   Days after onset:0
Entered: 2002-01-28
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 517A2 / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1669K / 1 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR 1446 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484199 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Phenobarbitol
Current Illness: NONE
Preexisting Conditions: Cerebral palsy; cystic encephalomalada,; seizure disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: KY2002002

Write-up: Mother found child in crib not breathing. Called an ambulance, but unable to resuscitate. COD as per death certificate -- cystic encephalomalacia


VAERS ID: 180755 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Nevada  
Vaccinated:2001-09-12
Onset:2002-01-14
   Days after vaccination:124
Submitted: 2002-03-25
   Days after onset:70
Entered: 2002-01-31
   Days after submission:53
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Diarrhoea, Heart rate increased, Meningitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-16
   Days after onset: 2
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: arginine; Diuril; Potassium; Reglan; Zantac; Albuterol; Aldactone
Current Illness: UNK
Preexisting Conditions: Premature baby; Tracheostomy; Congenital bronchomalacia; Duodenal atresia; Tracheo-oesophageal fistula NOS
Allergies:
Diagnostic Lab Data: CXR-right upper lobe atelectasis; LP-purulent CSF with WBC 7200 (90%/10%); CRP gram stain-gram positive diplococci and moderate gram positive cocci and many WBC; LP results were consistent with meningitis; blood sodium-129; potassium 2.4; BUN-25; creatinine 2.0; anion gap-positive
CDC Split Type: HQ9953618JAN2002

Write-up: A physician reported that a 13 month old male received a 3rd dose of Prevnar vaccine on 9/12/01, when he was 9 months old. On 1/12/02, the infant developed a fever that continued into 1/13/02. On 1/13/02, he developed diarrhea and then seizures. On 1/14/02, he was admitted to the hospital after biting his tongue during 1 of the seizures. While hospitalized, his temperature was 106F and his heart rate was in the 200''s. At the hospital, they were unable to obtain IV access. An intraosseous line was started and he was given 50cc/kg of fluid total. The pt was placed on a ventilator and a central line was started. Additional fluids were given and he was transferred to the PICU. He was also noted to have dehydration and hypovolemic shock associated with the diarrhea. He was treated with ceftriaxone, cefepime, vancomycin, Decadron (dexamethasone), morphine and lorazepam. On 1/16/02, the pt died. No additional information was available as of the date of this report. Follow-up info received on 02/20/2002, stated "a spinal fluid isolate was analyzed as 19F." Serum antibody levels were also requested; however, lab analysis has not been completed. Follow up info recevied on 03/19/2002 from physician. On the day of admission, it was noted that the pt was not responding to pain. His pupils were becoming larger and more sluggish. A CT scan was performed that showed multiple areas of increased water density throughout his brain. later that evening he had ventricular tachycardia that did not respond to lignocaine. He still was able to maintain a blood pressure and was subsequently loaded with amiodarone, with a good response and control of his dysrythmia. He did require some dopamine, however, at that point to maintain a good perfusion pressure. He was seen on 01/15/2002 by a physician who performed an examnation that was consistent with brain death. On 01/16/2002, the reporting physican also examined the pt and the findings were consistent with brain death. An apnea study was performed, there was no respiratory effort despite a pCO2 rising from 36 to 76, and he was pronounced dead. The death diagnosis was "brain death secondary to pneumococcal meningitis.


VAERS ID: 180784 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: New York  
Vaccinated:2001-12-26
Onset:2001-12-28
   Days after vaccination:2
Submitted: 2002-01-25
   Days after onset:28
Entered: 2002-02-01
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD) / PFIZER/WYETH 4018029 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Cardiac arrest, Chest discomfort, Dizziness, Eructation, Hypercholesterolaemia, Hyperhidrosis, Lethargy, Nasal congestion, Pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Lipodystrophy (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-12-28
   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: Atenolol; Synthroid
Current Illness: NONE
Preexisting Conditions: Chronic controlled hypertension; hypothyroidism; allergic to PCN
Allergies:
Diagnostic Lab Data: Last cholesterol was 225.
CDC Split Type:

Write-up: At 24 hours pt felt lethargic, dizzy. After dinner that night he was sweating, burping. At 48 hours pt had pain in left arm, congestion and tightness in chest. COD as per death certificate -- cardiorespiratory arrest


VAERS ID: 180945 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Unknown  
Vaccinated:2000-12-20
Onset:2001-02-15
   Days after vaccination:57
Submitted: 2002-02-04
   Days after onset:354
Entered: 2002-02-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy
CDC Split Type: HQ2181318JUN2001

Write-up: Information has been received from an investigator regarding a 2 month old male who received a dose of Prevnar on 12/20/00. On 2/15/01, the child was found dead. The following day, a postmortem was performed and results revealed acute pulmonary edema and congestion and the cause of death was listed as Sudden Infant Death (SIDS), interval-undetermined. Both the medical examiner and the investigator agreed that this event was not related to Prevnar administration. This report of a serious, labeled event is being submitted in a 15-day time frame as requested.


VAERS ID: 180950 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Unknown  
Vaccinated:2001-01-19
Onset:2001-03-26
   Days after vaccination:66
Submitted: 2002-03-25
   Days after onset:364
Entered: 2002-02-06
   Days after submission:47
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 97242 / 3 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 473337 / 3 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR T0018 / 3 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472053 / 3 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Cardio-respiratory arrest, Cerebral haemorrhage, Coma, Irritability, Lethargy, Respiratory tract malformation, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-05-26
   Days after onset: 60
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamictal
Current Illness:
Preexisting Conditions: Convulsions NOS; Toxic interaction between Lamictal with Phenobarbital; surgical repair of pyloric stenosis
Allergies:
Diagnostic Lab Data: X-ray NOS-negAutopsy-pending
CDC Split Type: HQ2487025JUN2001

Write-up: A physician reported that an 8 month old female received her 3rd doses of Prevnar, Hib-Titer, IPV and Infanrix vaccines on 1/19/01. On 5/26/01, at 12 months of age, the infant died of "presumed SIDS-like syndrome". An autopsy report is pending. The reporter did note that the infant had a history of seizures; however, she has been "seizure-free while on meds". The reporter also indicated that the infant''s death is under investigation for "possible Munchausen''s by proxy via mother" or a "possible interaction between Lamictal (lamotrigine) and phenobarbital." Both the investigator and the medical monitor agree that the event is not related to vaccine administration. This report of a serious, labeled event is being submitted as requested. COD as per autopsy report -- undetermined. Follow-up info received on 03/15/2002 indicated that on 05/26/2001, the child became fussy, then lethargic and "appeared to be breathing heavily." That same evening, the mother found the child unresponsive and not breathing. Emergency services were called. CPR attempted and the child was transported to an ER. On arrival, she was in full arrest. Resuscitation efforts continued and cardiac medications were given; however, the child was pronounced dead. A full body x-ray revealed no abnormalities. An sutopsy was performed; however, the cause of death could not be determined. The original assessments of relatedness remained the same. Per F/U 3/27/02 COD: Cardiopulmonary arrest; subdural hemorrhage and neomembrane, indeterminate age, very limited area, right fontoparietal parasagittal region, probably incidental finding. This decedent had only a partial right middle lobe (minor congenital anomaly). A fatal seizure is not ruled out, but, in view of the history of 2 recent overdoses inflicted by the mother, imposed suffocation is also considered a possible cause of death but no cause of death was determined on autopsy.


VAERS ID: 181028 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Louisiana  
Vaccinated:2002-01-09
Onset:2002-01-10
   Days after vaccination:1
Submitted: 2002-01-19
   Days after onset:9
Entered: 2002-02-07
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / SMITHKLINE BEECHAM 996A2 / 3 LL / IM
HIBV: HIB (HIBTITER) / PFIZER/WYETH 480705 / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 422373 / 3 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-01-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol Cold
Current Illness: Otitis Media/Cold
Preexisting Conditions: Otitis Media
Allergies:
Diagnostic Lab Data: Autopsy-pending
CDC Split Type:

Write-up: The pt was found at sitter''s around 14:00 not breathing and cyanotic on Thursday. He was brought to ER in asystole. Advanced life support provided but child did not respond.


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