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VAERS ID: 232761 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Unknown  
Vaccinated:2001-04-01
Onset:2001-04-09
   Days after vaccination:8
Submitted: 2005-01-21
   Days after onset:1383
Entered: 2005-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 983A2 / 1 LL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0002L / 1 LL / -
HIBV: HIB (HIBTITER) / PFIZER/WYETH 474712 / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0186 / 1 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 472053 / 1 RA / -

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: 2001-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE734820JAN05

Write-up: Information regarding Prevnar was received from an investigator regarding a 2 month old female participant in a study who experienced SIDS. The participant received the first dose on 4/4/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/4/01. Dose regimen was 1 dose. Concomitant therapy included Hib-Titer, Recombivax-HB, IPV, and Infanrix. The patient died due to SIDS on 4/9/01. The cause of death was reported as sudden infant death syndrome. The investigator considered sudden infant death syndrome remotely related to the study product. The medical monitor considered this event not related to study product. This report of a serious, labeled, non related event is being submitted in a 15-day time frame as requested by FDA. Autopsy report received which revealed COD as SIDS.


VAERS ID: 232985 (history)  
Form: Version 1.0  
Age: 0.94  
Sex: Male  
Location: Texas  
Vaccinated:2004-06-29
Onset:2004-07-02
   Days after vaccination:3
Submitted: 2005-01-27
   Days after onset:209
Entered: 2005-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0987CA / 2 - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 554082 / 3 - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE140AA / 2 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X5662 / 1 - / -

Administered by: Private       Purchased by: Public
Symptoms: Aspiration, Irritability, Malaise, Social avoidant behaviour
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-07-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Seizure activity~DTaP + Hib (no brand name)~0~0.25~In Patient
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Amyoplasia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient passed away while sleep. After vaccination, was very fussy, uncomfortable, did not want to participate in therapy. Autopsy Report received on 2/02/2005 states aspiration.


VAERS ID: 233033 (history)  
Form: Version 1.0  
Age: 0.57  
Sex: Male  
Location: Nevada  
Vaccinated:2004-09-28
Onset:2004-10-04
   Days after vaccination:6
Submitted: 2005-01-27
   Days after onset:115
Entered: 2005-01-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR - / UNK - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399K / 3 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Bacterial infection, Laboratory test abnormal, Leukocytosis, Pulmonary embolism, Pyrexia, Sepsis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-04
   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: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Blood culture (results: grew pseudomonas - no other organisms identified) and full blood count (results: white count result only - .8) were done in October 2004. Autopsy results: Pulmonary embolism, multiple pulmonary emboli - report stated a showering of emboli.
CDC Split Type: HQWYE781121JAN05

Write-up: Information regarding Prevnar was received from a registered nurse regarding a 6 month old male patient who received a third dose on 9/28/04. On the same day, the patient also received a dose of Act-Hib, a dose of Tripedia, a dose of Polio Vaccine and a dose of Engerix B. On 9/30/04, the patient developed pseudomonal sepsis and on 10/4/04, the child expired. No relevant medical history. Indication for Prevnar was immunization. Product was administered on 9/28/04. Dose regimen was 0.5ml 1 time per day (IM). Additional suspect vaccines included: Tripedia, Engerix B, Act-Hib, and Polio vaccine. Patient was not taking concomitant therapy. On 9/30/04, the patient developed a fever. On 10/2/04, the reporter stated, "the child was hospitalized with a diagnosis of sepsis." The child''s temperature on admission was 103.7 degrees F. On an unspecified date during hospitalization, a blood culture was performed which isolated pseudomonas. The reporter stated, "no other organism was identified." A complete blood count was also performed. The only result indicated by the reporter, was the white count listed as .8. On 10/4/04, the patient expired. The reported cause of death was unknown to the reporter. An autopsy was performed on an unspecified date. The reporter stated the cause of death written on the autopsy report was multiple pulmonary emboli. Also written on the autopsy report was a showering of emboli. The reporter indicated that the autopsy report recommended a genetic evaluation. The reporter indicated that the patient received Prevnar, lot A74399K; however, a product quality has verified that this is not a valid lot number. Telephone follow up conducted on 1/24/05, to obtain a valid lot number was unsuccessful. Reporter verified lot number listed on patient''s chart, as A74399K. Information regarding these events has been forwarded to the other manufacturers of the concomitantly administered vaccines. No additional information was available at the time of this report. Received Autopsy Report which revealed blood c/s & autopsy lung c/s were + for pseudomonas aeruginosa. COD stated as multiple pulmonary emboli & sepsis.


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

Administered by: Private       Purchased by: Private
Symptoms: Apnoea, Coordination abnormal, Fatigue, Myelitis transverse, Optic neuritis, Pain, Paralysis, Pyrexia, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular infections (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-01
   Days after onset: 68
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Diovan; Glyburide; Cholesterol medications
Current Illness:
Preexisting Conditions: The patient''s pre-existing medical conditions include high blood pressure, elevated cholesterol, and diabetes. She denied any illnesses at the time of vaccination.
Allergies:
Diagnostic Lab Data: Lumbar puncture was negative.
CDC Split Type: 200500215

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


VAERS ID: 233066 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Male  
Location: Iowa  
Vaccinated:2005-01-10
Onset:2005-01-14
   Days after vaccination:4
Submitted: 2005-01-28
   Days after onset:14
Entered: 2005-01-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A008AA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0095P / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74398C / 2 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Acidosis, Apnoea, Blood pressure decreased, Cardiac arrest, Cardiovascular disorder, Coma, Cyanosis, Encephalopathy, Hyperglycaemia, Hypoalbuminaemia, Hypocalcaemia, Hypokalaemia, Hypoxia, Mydriasis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-14
   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: The patient was apparently born with a cord wrapped around his neck. He had some breathing difficulties. He was in the hospital for 9 days. At that time they were told he had some sleep apnea. Apparently the child has been doing fine ever since. No fever or other symptomatology.
Allergies:
Diagnostic Lab Data:
CDC Split Type: IA05001

Write-up: ER report attached, autopsy report will not be read for about 1 month. 5 month old pt was brought in by his mother and a babysitter screaming through the door that the child was unresponsive. It was difficult to obtain the exact history but apparently they were down tending a game and they were coming back. The baby was in a car seat and they were talking and they thought the baby was maintaining normal activity. By the time they got to their destination, they thought that they didn''t hear the baby in the back seat anymore, so they investigated and found the baby not breathing and unresponsive. They drove immediately up and rushed into our facility. Physical examination revealed a 5 month old totally cyanotic dilated pupils. No response to pain or verbal stimulation. One of the nurses began mouth to mouth resuscitation. CPR was started. About 1 or 2 minutes later a pediatric mask was applied and the child was bagged which resulted in good breath sounds bilaterally. Compression was continued. There was no pulse or blood pressure. Within a few minutes, the anesthesiologist arrived and intubated the child with much difficulty. IV access was obtained. The child was given 2 doses of epinephrine, 1 dose of Atropine. CPR was continued. The child then began to respond and developed a pulse of about 120. The blood pressure of 62/34. Dr''s arrived shortly thereafter. The child was given sodium bicarb. The child continued to have no response to painful stimulation but continued to have pulse and blood pressure as noted. Air care was consulted. They arrived. After some discussion the pt was transferred to another health facility after receiving Rocephin 525mg. The pt had initially received a 100cc bolus of normal saline. The pt continued to have good color, pulse and blood pressure. Blood gases were obtained. The pt had pH of 6.5, PCO2 of 99, PO2 of 128, BE of minus 30. The second blood gases pH was 6.7, PCO2 40, PO2 388, BE was minus 27, HCO3 was 6.3. This was done approx the time that the pt left. Final Diagnosis: Code blue, full CPR, resuscitation with pulse and blood pressure. Pt sent to ICU. Discharge Summary received on 2/16/2005 states encephalopathy, acidosis, hyperglycemia, hypokalemia, hypoalbuminia and hypocalcemia. Autopsy report received revealed the COD was undetermined but likely SIDS.


VAERS ID: 233228 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: North Carolina  
Vaccinated:2005-01-17
Onset:2005-01-20
   Days after vaccination:3
Submitted: 2005-01-21
   Days after onset:1
Entered: 2005-02-01
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR 41316DA / 1 LL / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0181P / 2 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE401AA / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1040 / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74399F / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zantac; Xopenex PRN
Current Illness: NONE
Preexisting Conditions: GE Reflux; Rotation of bowel.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: NC05012

Write-up: Patient with a history of incomplete rotation of bowel and gastroesphageal reflux. Patient into office on 1/17/05 for 2 month well child check. Patient fine at appointment time. Vaccines were administered. No problems reported. Mom checked on child at 3:00 AM on 1/20/05 and patient was fine. Then around 7:00 AM, patient was found unresponsive. Patient taken to ER. ER physician states crib death. Received medical records from PCP which revealed patient treated for URI approx 1 mo prior to death. Received Autopsy Report which revealed COD as SIDS.


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-02-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: Upper respiratory infection
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Autopsy is pending
CDC Split Type:

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


VAERS ID: 233385 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Unknown  
Vaccinated:2001-05-29
Onset:2001-05-31
   Days after vaccination:2
Submitted: 2005-02-03
   Days after onset:1344
Entered: 2005-02-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 995A2 / 1 LL / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5189A2 / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T0186 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 475386 / 1 RL / -

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: 2001-05-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE733720JAN05

Write-up: Information regarding Prevnar was received from an investigator regarding a 2 month old male participant in a study who experienced SIDS. The participant received the first dose on 5/29/01. The participant also received the first dose of Infanrix, the first dose of Engerix B and the first dose of IPOL on 5/29/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 5/29/01. Dose regimen was 1 dose 1 time per day. Concomitant therapy included Infanrix, Engerix B, and IPOL. On 5/31/01, 2 days post vaccination, the patient expired as a result of SIDS per the county coroner''s office. The investigator considered the relationship between sudden infant death syndrome and Prevnar to be remote. The medical monitor considered the event to be not related to the study product. This report of a serious, labeled event is being submitted in an expedited time frame as requested by the FDA. No additional information reported on autopsy report rec''d 03/02/2005. Autopsy Report received which states COD is SIDS.


VAERS ID: 233386 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Unknown  
Vaccinated:2002-04-12
Onset:2002-05-15
   Days after vaccination:33
Submitted: 2005-02-03
   Days after onset:995
Entered: 2005-02-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 517A2 / 1 RL / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS 5261A2 / 1 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA646AA / 1 LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U0422 / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 484859 / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-05-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: HQWYE733920JAN05

Write-up: Information regarding Prevnar was received from an investigator regarding a 3month old male participant in a study who experienced SIDS. The participant received the first dose on 4/12/02. The participant also received the first dose of Infanrix, the first dose of Engerix B, the first dose of Act-HIB, and the first dose of IPOL on 4/12/02. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/12/02. Dose regimen was 1 dose 1 time per day. Concomitant therapy included Infanrix, Engerix B, Act-HIB, and IPOL. On 5/15/02, the patient expired as a result of SIDS per the county coroner''s office. The investigator and medical monitor considered sudden infant death syndrome to be not related to the study product. The report of a serious labeled event is being submitted in an expedited time frame as requested by the FDA.


VAERS ID: 233419 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Iowa  
Vaccinated:2005-01-28
Onset:2005-02-01
   Days after vaccination:4
Submitted: 2005-02-04
   Days after onset:3
Entered: 2005-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A010AA / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0494P / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57562B / 2 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Abdominal distension, Apnoea, Blood pressure increased, Cardiac failure, Cerebrovascular disorder, Coma, Convulsion, Dyskinesia, Encephalopathy, Flatulence, Fontanelle bulging, Hypoxia, Oedema, Respiratory arrest
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (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: 2005-02-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: IA05002

Write-up: I was called to the emergency room to attend to this infant who had infant respiratory arrest at the babysitter''s house. The story was that the baby had eaten his typical bottle and had been laid down for a nap on his side. When the babysitter had checked on him, he had gone ahead and rolled over to his tummy and he was noted to be not breathing at that point in time. The babysitter is an EMT and the baby received CPR at the site. Ambulance was called. The baby was bagged and mask ventilated on the way into the hospital. At that time, the EMT arrived and intubated the baby and the baby was resuscitated with Atropine and Epinephrine. The baby then had return of spontaneous heart rate with good pulses and peripheral profusion. The baby remained unresponsive to all stimuli. At the time of arrival, the baby was noted to have a heart rate in the 130''s. His color and perfusion were good. His ventilations were supported with an ET tube in good position with clear breath sounds bilaterally. His abdomen was distended. An NG tube was placed with removal of formula followed by just gas which was present in the stomach. A baby Foley catheter was placed as well and there was return of clear urine. The baby''s medical history was obtained briefly from the mother who stated that he has been in good general health. He has had no illness whatsoever. Only medication he had ever received was Tylenol. He recently had received his immunizations the Friday before his 4 month well baby exam. He had no recent sign of illness whatsoever. He had been growing and developing normally. Another hospital had already been contacted and air transfer was being arranged. the baby was evaluated with blood gases and required multiple doses of bicarbonate with gradual improvement in the pH, however, we were unable to get the pH above 7 prior to his transfer. His PCO2 was excellent. He was being ventilated well. This was all metabolic acidosis. His electrolytes were evaluated and the only abnormality was a mildly low sodium. His CBC was remarkable for a white count of 16.6 and a hematocrit of 29. Platelets were 441 and DIFF was unremarkable. We did manage to take him to a CT scan. The CT was read by our radiologist as diffuse cerebral edema versus possibility of diffuse subarachnoid hemorrhage. He did also note a small mass lesion in the frontal area which differential included mass versus abscess versus AV malformation. No other specific findings were noted. Chest x-ray was obtained that showed normal heart size, large thalamus and lung fields were inflated with no evidence of pneumothorax. Supportive therapy was continued throughout the time that he was in our emergency room. Life Flight arrived and at that time, the baby was noted to have seizure activity with mainly repetitive jerking of the left arm. This was treated with 20 per kilo of Phenobarbital with plan to give Ativan in flight if seizures recurred. During the time of evaluation, the baby was also noted to have bulging fontanelle and rapidly increasing blood pressures with was treated with Mannitol and Lasix. He had good urine output after that. Clinically, the fontanelle looked less tense prior to his discharge. He was transferred to the care of Life Flight in critical condition. Time of my attendance was 2 hours direct patient care. Discharge Summary received on 2/17/2005 states cardiorespiratory failure, cerebral edema and seizure.


VAERS ID: 233555 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Unknown  
Vaccinated:1998-02-24
Onset:2004-11-01
   Days after vaccination:2442
Submitted: 2005-02-04
   Days after onset:95
Entered: 2005-02-09
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Blister, Brain neoplasm malignant, Drug ineffective, Dyspnoea, Gastrointestinal haemorrhage, Hepatic failure, Hypoxia, Laboratory test abnormal, Liver function test abnormal, Sepsis, Skin ulcer
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-31
   Days after onset: 60
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: NONE
Allergies:
Diagnostic Lab Data: Transaminases over 13,000; Anti-varicella IgG negative; Skin biopsy results not reported; MRI: subcutaneous area of enhancement in the low back, no spine, bone or meningeal enhancement; INR 5.6; DNA: lesion specimens sent for PCR analysis; Serum alanine: $g6000 - fulminant liver failure; Serum aspartate 3620.
CDC Split Type: WAES0501USA04381

Write-up: Information has been received from a physician concerning a 7 year old female with no significant medical history who on 2/24/98, at 13 months of age was vaccinated with a first dose of varicella virus vaccine live. In November 2004, the patient was diagnosed with an inoperable, malignant brain ependymoma. The treatment plan was to shrink the tumor with chemotherapy, followed by radiation therapy. The patient began chemotherapy in November 2004 and was tolerating it well on an outpatient basis. On 12/28/04 she presented at the hospital with a chief complaint of low back pain and was afebrile with no other reported signs and symptoms. An MRI was done which showed a subcutaneous area of enhancement in the low back; there was no spine, bone or meningeal enhancement. The patient was admitted to the hospital. On 12/29/04, at approximately noon, the patient was noted to have several vesicles on the crown of the head. That same day she was started on IV acyclovir at a herpes simplex dose and was transferred to the ICU. Subsequently a skin biopsy was done and an Infectious Disease consult was requested. As a precaution while awaiting the results of the skin biopsy, the acyclovir dose was increased for varicella. Later in the day on 12/29/04, the patient developed fulminant liver failure, with ALT $g6000, AST 3620 and an INR of 5.6. She was given lots of blood and cryoprecipates; however, the liver failure persisted. On 12/30/04 her transaminases were over 13,000. The physician reported that the patient''s anti-varicella IgG was negative. On 12/30/04 she developed multi-system organ failure and was intubated. On 12/31/04, life support was withdrawn and the patient died. The physician reported that he did not know if an autopsy was done, but believes that the child died from multiorgan failure resulting from disseminated varicella. He noted that some lesion specimens were sent for PCR analysis. The physician reported that there was no known varicella exposure prior to the child''s hospitalization. The physician reported that he felt most certain that this was wild type VZV in an immunocompromised patient. Discharge Summary reviewed stated patient experienced sepsis, hypoxia, respiratory distress and GI bleed.


VAERS ID: 233708 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Wisconsin  
Vaccinated:2004-10-07
Onset:2004-10-18
   Days after vaccination:11
Submitted: 2005-02-08
   Days after onset:113
Entered: 2005-02-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-10-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Antibiotic
Current Illness: URI
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Discharge Summary states SIDS. Autopsy Report received on 2/16/2005 confirms SIDS.


VAERS ID: 233746 (history)  
Form: Version 1.0  
Age: 0.43  
Sex: Male  
Location: Texas  
Vaccinated:2005-02-08
Onset:2005-02-08
   Days after vaccination:0
Submitted: 2005-02-11
   Days after onset:3
Entered: 2005-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A013AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE528AB / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Do not know.
CDC Split Type:

Write-up: Do not know. Autopsy Report received which revealed COD as acute bronchopneumonia.


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

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2004-10-15
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: eyedrops, baby aspirin
Current Illness: senile dementia
Preexisting Conditions: senile dementia, macular degeneraiton, arteriosclerosis
Allergies:
Diagnostic Lab Data: As prescribed by hospital.
CDC Split Type:

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


VAERS ID: 233969 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: South Carolina  
Vaccinated:2004-11-18
Onset:2004-11-18
   Days after vaccination:0
Submitted: 2005-02-10
   Days after onset:84
Entered: 2005-02-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C1996 / 1 - / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0410P / 1 - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1038 / 1 - / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A7965F / UNK - / IM

Administered by: Public       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Circulatory collapse, Irritability, Oral intake reduced, Stupor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Actigall; Synthroid; Reglan; Zantac
Current Illness: NONE
Preexisting Conditions: Extreme immaturity; COPD; Esophageal reflux; Hypothyroidism
Allergies:
Diagnostic Lab Data: Autopsy: No discernible cause of death.
CDC Split Type:

Write-up: Routine immunizations given at 3:42 PM on 11/18/04. Child went home and within 2 hours began to get fussy and did not take his bottle well. Mother put him to bed and around 8:00 PM the apnea alarm went off. CPR was unsuccessful and he was pronounced dead in the ER at 9:57 PM. Autopsy report received and complete.


VAERS ID: 234154 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Illinois  
Vaccinated:2002-09-03
Onset:2002-10-25
   Days after vaccination:52
Submitted: 2005-02-15
   Days after onset:844
Entered: 2005-02-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U0547CA / 1 - / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0692M / 1 - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1336 / 1 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 485044 / 1 - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Eczema, Lymphadenopathy, Rash, Sarcoma, Similar reaction on previous exposure to drug, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-09-05
   Days after onset: 681
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: Born with small hemangioma on finger.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After 2 mo (vaccines x7) Pt developed sleeping problems, discussed at 4mo appt. At which time pt got (shots x 7) at 6 months check up pt had dry eczema on trunk and faint rash and swollen lymph node under right arm. Develops into N/R sarcoma of peripheral nerve sheath. Pt had 2 month shots, 4 month shorts, 6 months he wasn''t well, no others given. Death Certificate received which revealed COD as metastatic epitheloid sarcoma.


VAERS ID: 234883 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Tennessee  
Vaccinated:2004-04-29
Onset:2005-02-04
   Days after vaccination:281
Submitted: 2005-03-09
   Days after onset:33
Entered: 2005-03-14
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C1624AA / 4 - / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0142N / 3 - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER X0707 / 3 - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495133 / 4 - / -

Administered by: Private       Purchased by: Other
Symptoms: Bacterial infection, Blood disorder, Brain oedema, Hepatosplenomegaly, Lymphadenopathy, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: No
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Pneumococcal infection.
CDC Split Type: HQWYE856504MAR05

Write-up: Information regarding Prevnar was received from a healthcare professional regarding a 2 year old male patient who developed pneumococcal disease. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. On an unspecified date the patient developed pneumococcal disease and subsequently died. The cause of death was reported as pneumococcal infection. No additional information was available at the time of this report. Medical records from Vanderbilt U. Clinic received which revealed patient had hx of sickle cell anemia w/recent fever. Autopsy report received which revealed COD as sepsis due to streptococcus pneumonia. Also found hepatosplenomegaly, interstitial pneumonitis with nasal swab recently + for flu virus, diffuse abdominal lymphadenopathy secondary to follicular hypoplasia and cerebral edema.


VAERS ID: 235154 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: New York  
Vaccinated:2005-03-14
Onset:2005-03-15
   Days after vaccination:1
Submitted: 2005-03-18
   Days after onset:3
Entered: 2005-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A008BA / UNK LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0805P / UNK RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A065652E / UNK RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-15
   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: Synagis
Current Illness:
Preexisting Conditions: Prematurity; Inguinal hernia; GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death within 24 hours after admission of vaccination.


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

Administered by: Other       Purchased by: Public
Symptoms: Cough, Influenza like illness, Myocarditis, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-11-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Possibly with autopsy.
CDC Split Type: AR0502

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


VAERS ID: 235416 (history)  
Form: Version 1.0  
Age: 50.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2005-03-10
Onset:2005-03-10
   Days after vaccination:0
Submitted: 2005-03-18
   Days after onset:8
Entered: 2005-03-25
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / AVENTIS PASTEUR U1211DA / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiomyopathy, Coronary artery disease, Myocardial infarction, Similar reaction on previous exposure to drug
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-10
   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: Betadine
Current Illness:
Preexisting Conditions: The patient had no known allergies. He has a history of numbness after receiving TD in 1993.
Allergies:
Diagnostic Lab Data: Autopsy being done
CDC Split Type: 200500544

Write-up: From initial information received on 11Mar05 from a health care professional regarding an adverse event occurring, it was reported that a forty-nine-year old male pt was injured on the job and presented with a laceration to the tip of his fourth finger. He received a dose of Decavac vaccine with lot number U1211DA on 10Mar05 between 11 and 12AM. The route and site of administration were not reported. He also received four sutures on his fourth finger with Lidocaine and local care with Betadine on his fifth finger. The pt returned to work. Later the same day, at approx 6 PM, the pt was found dead at the plant where he worked. It was sometime between 4 and 6 PM that they think he passed away. An autopsy was being performed. Received Autopsy Report which stated COD as acute MI, coronary artery disease secondary to dilated cardiomyopathy.


VAERS ID: 235456 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: South Carolina  
Vaccinated:2005-01-20
Onset:2005-01-20
   Days after vaccination:0
Submitted: 2005-03-22
   Days after onset:61
Entered: 2005-03-28
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A004BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE312AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A79659C / 1 RL / IM

Administered by: Private       Purchased by: Unknown
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: 2005-01-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: NONE
Preexisting Conditions: Adolescent pregnancy; Material positive GBS culture; In ICU for 20 days; SGA; IUGR.
Allergies:
Diagnostic Lab Data: Direct bilirubin.
CDC Split Type:

Write-up: Infant received immunizations. Five hours later, was not breathing. Had been asleep on grandmother''s chest. Autopsy revealed SIDS death. Date of death: 1/20/05.


VAERS ID: 235675 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Georgia  
Vaccinated:2005-01-26
Onset:2005-01-27
   Days after vaccination:1
Submitted: 2005-04-01
   Days after onset:64
Entered: 2005-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 21A001AA / 2 - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0806P / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A575626 / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal sleep-related event, Apnoea, Crying, Cyanosis, Diarrhoea, Irritability, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: tylenol
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My son die the next day after receiving his vaccines. I gave him .8ml of tylenol about 4:45pm and he had a bottle an hour earlier. It was time for his nap because he was crying but never thought he wouldn''t wakeup again. My oldest son (18) pick him up and found that he wasn''t breathing and blue he called 911. He was rushed to hospital. This was about 7:30 pm. Follow up report received 04/07/2005: On the day following vaccination, child had loose stool in AM and was more fussy than usual. When son found him not breathing, he was lying on the chest of his 12 year old sister with his face turned toward the back of the sofa and his nose pressed against the sofa. Received medical records from PCP & ER. Autopsy Report received which revealed COD as SIDS while cosleeping. Therapeutic level of pseudoephedrine (0.87 mg/L) was found on autopsy.


VAERS ID: 235687 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: California  
Vaccinated:2005-03-30
Onset:2005-03-31
   Days after vaccination:1
Submitted: 2005-04-01
   Days after onset:1
Entered: 2005-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A018AA / 1 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE435AA / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A79659H / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-31
   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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: (See Box 8) Received ER medical records which state patient was in full arrest upon arrival & was unable to be resuscitated. Autopsy report received which revealed COD was undetermined. Patient was cosleeping with parents in bed which was significantly concave & had blood stains in middle of sheet per investigative report.


VAERS ID: 235891 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: California  
Vaccinated:2005-02-28
Onset:2005-03-01
   Days after vaccination:1
Submitted: 2005-04-07
   Days after onset:36
Entered: 2005-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U1345LA / UNK UN / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0807 / UNK UN / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1240 / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74400 / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Nasal congestion
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-01
   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: Congestion and dry cough
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No Preliminary diagnosis at this time. Please call for final report.
CDC Split Type:

Write-up: Decedent died one day after receiving the immunizations. He had some congestion and dry cough on that day also. Mom gave Tylenol (reportedly correct amount) on the day of the immunization. Autopsy report received & complete.


VAERS ID: 236061 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Arizona  
Vaccinated:2005-04-11
Onset:0000-00-00
Submitted: 2005-04-12
Entered: 2005-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID, ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1356AA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arrhythmia, Cardio-respiratory arrest, Injury, Loss of consciousness, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: ME doing atopsy.
CDC Split Type:

Write-up: Student received Td vaccine approx 1:45pm. At approx. 4pm student was at track practice running up and down a hill for long distance running, he collapsed. Hitting his head. He never regained consciousness. Medical records received from ER which revealed patient arrived in full arrest & was unable to be resuscitated. Additional information from autosy report rec''d 06/13/2005-- arrhythmia.


VAERS ID: 236350 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-04-15
Entered: 2005-04-20
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0815P / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Coronary artery disease, Diabetes mellitus, Lung disorder, Upper respiratory tract infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Other ischaemic heart disease (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Living in residential institution
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0504USA01878

Write-up: Information has been received from a pharmacist concerning an adult female resident in a long term care facility who was "recently" vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #650087/0815P). Approximately one week after vaccination, the pt developed an URI and was hospitalized. Subsequently, the pt died. Details of the pt''s death were not available. Additional information has been requested. No product quality complaint was involved. 4/29/05 Received Death Certificate which revealed COD as CAD & COPD complicated by IDDM, type 2.


VAERS ID: 236383 (history)  
Form: Version 1.0  
Age: 57.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2004-12-06
Submitted: 2005-04-13
   Days after onset:127
Entered: 2005-04-21
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVA065AA / UNK LA / -

Administered by: Public       Purchased by: Public
Symptoms: Arthralgia, Decreased appetite, Headache, Influenza, Malaise, Pain, Pyrexia, Somnolence, Thirst, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2004-12-06
   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: Lopressor, Lasox, Kbr -com, Digovin, Norvasa
Current Illness: NONE
Preexisting Conditions: COPD, high blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Day 1 - Complained of headache/also that his hip hurt. Day 2, Just said his body ached felt like start of flu - we had a b-day party for him, he didn''t eat much, felt sick. Day 3 Sunday - Got up, he was at his desk said he felt sick, hurt all over, approximately noon, started throwing up - again at 3 PM. He threw up again said he had the 1 day flu, he felt better in the morning. I took his temp, it was 101. He asked for some aspirin, the pain was all over his body, all day. He drank lots of water 48oz cups at least 1 to 2 hours apart. He slept off and on most of the day. His daughter came by to pick up her baby about 3:30 or so and talk to her dad. I''d brought in some crackers and more water, kept taking his temp, it was down to 99. I asked if he wanted to go the the doctor, but he said no. He got up several times to go to the rest room. The body pain he said was getting worse. He kept drinking as much water as possible. Three times Sunday night he spilled his water, but hadn''t thrown up since that afternoon. I checked on him several hours or so, checked his temp, it stayed at about 99. day 4 - since it was after midnight now, I was still getting him water. He''d get up and use the rest room, said the pain throughout his body was so bad but we both thought it was because he had the flu. At 3 AM I gave him some more aspirin for the pain. he went to the rest room and walked to the kitchen and got a glass of water. We sat and talked for a while. He told me he hadn''t had a ticket in 27 years. I told him to turn and there was a sign No Turn on Red. About 1 month before he told me that he had thrown up in over 19 years. When he had his last drink, we sat and laughed and he told me he was going to finish his paperwork for his new job, later that day, that''s the job that had him go get the Hepatitis B shot. We were really he gotten the job, the hepatitis B shot was the last thing we had to do. A woman had called Friday, he passed the physical, FBI check and had gotten the first of three shots. After a while we were talking he said his body had never hurt so bad and if I would put some Ben Gay over his back, arms, everywhere but his legs because he still had his jeans on. So I did. I massaged his lower back the most, arms, neck, and shoulders. Then I cuddled up to him with the blanket so he would not get a chill. I fell asleep for about 1/2 hour or so. My other daughter called me into her room, said she felt like she was getting a cold. At 4 AM my husband''s alarm went off, he always set it for that time, so I ran into the room to get it so it would not wake him since he was still asleep. I took it to the living room so when it went off again it would not wake him. When he didn''t wake up by 10:30 that morning I knew he would be upset if he slept too long. But when I tried to wake him I could not. He was dead.


VAERS ID: 236600 (history)  
Form: Version 1.0  
Age: 0.57  
Sex: Female  
Location: Michigan  
Vaccinated:1997-10-09
Onset:2001-10-26
   Days after vaccination:1478
Submitted: 2005-04-21
   Days after onset:1273
Entered: 2005-04-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (TETRAMUNE) / PFIZER/WYETH 446835 / 3 - / -
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0457E / 3 - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / PFIZER/WYETH 455205 / 3 - / -

Administered by: Public       Purchased by: Public
Symptoms: Anaemia, Impaired healing, Malaise, Neoplasm, Nephroblastoma, Pulmonary fibrosis, Pyrexia, Renal cell carcinoma stage unspecified, Skin disorder, Viral infection, Weight decreased
SMQs:, Haematopoietic erythropenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2003-09-19
   Days after onset: 693
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Wilms tumor/Kidney Cancer; Lung bases demonstrated multiple pulmonary masses. 3 pound tumor encompassed left kidney.
CDC Split Type:

Write-up: 2 surgeries, Chemo, Radiation. Extensive 2 5 day (in hospital) Chemo stays and Stem cell transplant. Prior 2 oral polio 06/05/97 (lot # 0756D) and 8/7/97 (lot # 444062). Died 9/19/2003. 1/5/98: Office visit - sick. 4/9/98: Office visit - leg patches between knee and ankle. 8/14/01: Preschool physical 40.5 lbs, temp 100.6, BP 76/51, tired; Hemoglobin 9.2. Within week, sick. Dropped to 36lbs. by 9/4/01. Weight increased to 38lbs. Ear cut not healing. 10/02: Extensive blood work taken in preparation for stem cell transplant revealed 3 antibodies (Varicella, CMV, and Herpes Simplex). No further information received from medical record rec''d 06/13/2005. Hospital medical records received which revealed patient had dx of Stage IV Wilm''s tumor w/+ pulmonary nodules & liver mets & had relapses.


VAERS ID: 236715 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Female  
Location: Ohio  
Vaccinated:2005-03-08
Onset:2005-03-10
   Days after vaccination:2
Submitted: 2005-04-21
   Days after onset:41
Entered: 2005-04-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE253AA / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 RL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Anorexia, Cardio-respiratory arrest, Depressed level of consciousness, High-pitched crying, Somnolence, Staring, Sudden infant death syndrome
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), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Slept a lot, harsh screaming, not alert, not playful, loss of appetite, staring off. Received medical records from PCP. Received ER medical records which states that patient arrived in full arrest & was unable to be resuscitated. Autopsy Report received which stated that patient experienced SIDS.


VAERS ID: 236822 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-03-21
Entered: 2005-05-02
   Days after submission:41
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / 4 - / -

Administered by: Military       Purchased by: Military
Symptoms: Erythema, Fall, Grand mal convulsion, Infection, Influenza like illness, Mood swings, Myalgia, Skin ulcer, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-06-01
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: FEDREG2004

Write-up: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. My brother took 3 out of the 6 shots and had to quit. Almost immediately after taking the first one, he had red spots on his legs and arms that got infected and would break open. About 6 months after taking his first shot, he had a major seizure and fell down a set of stairs. Along with the seizures, he had times where he would fall and not know it. He had mood swings, muscle pains, times where he would just feel flu symptoms and loss of eye sight. His left eye lost about 1/2 of its sight and the right had some loss also. All of these things happening within a period of about 2 years. Unfortunately, for my mom and me, we lost him in June of 2003, unexpectedly having a grand mal seizure.


VAERS ID: 236828 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Ohio  
Vaccinated:2005-04-06
Onset:2005-04-19
   Days after vaccination:13
Submitted: 2005-04-26
   Days after onset:7
Entered: 2005-05-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A013AA / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE253AA / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74404B / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Xopenex
Current Illness: Bronchiolitis
Preexisting Conditions: No prenatal care; Umbilical Hernia
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Death. Questionable SIDS. Autopsy Report received which stated patient experienced reaction unevaluable.


VAERS ID: 237012 (history)  
Form: Version 1.0  
Age: 37.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-03-29
Entered: 2005-05-05
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-02-01
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: FEDREG2004

Write-up: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. A 37 year old black male medical technician who died of a heart attack in February 2000 in the midst of an anthrax vaccine controversy at the base. The military vehemently denied any connection between his death and the anthrax vaccine, and it is unclear if a report was ever filed.


VAERS ID: 237013 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-03-29
Entered: 2005-05-05
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Biliary neoplasm, Neoplasm malignant
SMQs:, Biliary tumours of unspecified malignancy (narrow), Non-haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-05-31
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: FEDREG2004

Write-up: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. This report is on a 30 year old white male who died on 5/31/02. He developed a rare bile duct (liver) cancer following anthrax vaccination. An April 2003 medical article by four military doctors showed a positive correlation between anthrax vaccine and malignant neoplasm of the gall bladder and bile duct. Specifically, there was an adjusted incidence of 2.92 more likely to have this condition post vaccination than pre-vaccination. According to his wife, the military never submitted a report on his illness or death.


VAERS ID: 237014 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-03-29
Entered: 2005-05-05
   Days after submission:36
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS - / UNK - / -

Administered by: Military       Purchased by: Military
Symptoms: Nervous system disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2000-05-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FEDREG2004

Write-up: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. The FDA analysis does not acknowledge the death of this white male, on 5/16/00 from so-called rapid onset ALS. According to the wife, the military never submitted a report on his illness or death.


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

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Dyspnoea, Hypoxia, Malaise, Melaena, Stupor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

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

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


VAERS ID: 237516 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Female  
Location: Florida  
Vaccinated:2005-05-13
Onset:2005-05-14
   Days after vaccination:1
Submitted: 2005-05-18
   Days after onset:4
Entered: 2005-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2221AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE389AA / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1244 / 2 RL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Diarrhoea, Overdose, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Drug abuse and dependence (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-05-15
   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: PER REPORT ON TYLENOL
Current Illness: COLD
Preexisting Conditions: NONE WAS A PREMATURE BABY WHO HAD SOME TRANSIENT APNEA AND BRADYCARDIA AND BIRTH RESOLVED 7 DAYS PRIOR TO D/C
Allergies:
Diagnostic Lab Data: ONLY THAT DONE BY EMS AND MEDICAL EXAMINER PATIENT DIED OVER WEEKEND AND NO ADDITIONAL MEDICAL CARE WAS SOUGHT BETWEEN WELL VISIT AND DEATH
CDC Split Type:

Write-up: CHILD CAME IN FOR WELL VISIT, BUT WAS ALSO HAVING SNEEZING, RUNNY NOSE AND WATERY EYES. NO FEVER OR LOW GRADE ONLY. TREATMENT PRESCRIBED WAS AN ANTIHISTAMINE DONATUSSSIN, HOWEVER PATIENT DID NOT GET PRESCRIPTION FILLED AND USED OTC MEDS INSTEAD, PER REPORT. CHILD HAD SOME VOMITING AND DIARRHEA THE NEXT EVENING AND AM OF DEATH. Received Autopsy Report which revealed COD as acetominophen poisoning. Manner of death: accidental (inadvertent overmedication).


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

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

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

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


VAERS ID: 237645 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Ohio  
Vaccinated:2001-08-31
Onset:2005-04-20
   Days after vaccination:1328
Submitted: 2005-05-16
   Days after onset:26
Entered: 2005-05-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0690K / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Bacterial infection, Drug ineffective, Headache, Hypotension, Photophobia, Pulse absent, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0505USA01451

Write-up: Information has been received from a health professional concerning a 6 year old pt who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine at 3 years of age. Subsequently, at 6 years old, the pt died from pneumococcal disease. The physician indicated that she believes the child did not get a second vaccination. Additional information has been requested. Discharge Summary rec''d 06/21/2005 states additional terms as abdominal pain, tachycardia, photophobia, headache, distended abdomen, pulse absent and hypotension.


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

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Condition aggravated, Convulsion, Encephalopathy, Guillain-Barre syndrome, Hypokinesia, Laboratory test abnormal, Neuropathy, Pulmonary embolism, Urinary tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-11-21
   Days after onset: 37
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 25 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Seizure disorder: UTI
Preexisting Conditions: NKDA, MR , seizure disorder, obesity
Allergies:
Diagnostic Lab Data: Albumin 33.6% 1.78g/dL; Alpha 1 9.6% 0.51g/dl; Alpha 2 14.9% 0.79g/dL; Beta 11.9% 0.63g/dl; Gamma 30.0% 1.59g/dl. Subacute progressive axonal neuropathy, Guillain Barre
CDC Split Type:

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


VAERS ID: 238603 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-05-31
Entered: 2005-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: The subject''s medical history, concurrent conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0560376A

Write-up: This case was reported by a consumer and described the occurrence of death in a child of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On an unspecified date before 5/27/05, the subject received a dose of Pediarix (dose number not provided). The reporter stated that her, "child died one day after receiving Pediarix." It is unknown whether an autopsy was performed.


VAERS ID: 238842 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Florida  
Vaccinated:2005-05-25
Onset:2005-05-26
   Days after vaccination:1
Submitted: 2005-05-26
   Days after onset:0
Entered: 2005-06-01
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A011CA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1032P / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-05-26
   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:
Current Illness: NONE
Preexisting Conditions: Prematurity
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient found lifeless in bed; was not resuscitated successfully. Received Autopsy Report which revealed COD as SIDS w/cosleeping as contributing factor. Manner of death was undetermined.


VAERS ID: 238999 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Male  
Location: North Carolina  
Vaccinated:2005-05-19
Onset:2005-05-21
   Days after vaccination:2
Submitted: 2005-06-01
   Days after onset:11
Entered: 2005-06-03
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 600A2 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 434AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1212 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A83578D / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Apnoea, Bronchitis
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-05-21
   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: Tussi Organdin DU
Current Illness: Rhinorrhea
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Mom reported to Emergency services that infant was sleeping in bed with her and when she awoke at 6:30AM on 5/21/05, infant was not breathing. Autopsy Report received stated patient experienced bronchitis.


VAERS ID: 239003 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-05-31
Entered: 2005-06-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, Cough, Diarrhoea, Pneumonia, Pyrexia, Sepsis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Neuro-degenerative disorder
Allergies:
Diagnostic Lab Data: Chest x-ray: Bilateral pneumonia; Blood culture: H. influenzae type a; Body temp: 40 degrees C.
CDC Split Type: WAES0505USA03019

Write-up: Information has been received from the authors of a published literature article concerning a 4 month old male with a neuro-degenerative disease of unknown etiology who on an unspecified date was vaccinated with his first dose of HIB conjugate vaccine. There was no concomitant medication. Subsequently, the patient presented to the clinic with a 1 week history of cough and watery diarrhea and 1 day history of fever to 40 degrees C. Chest radiograph revealed bilateral pneumonia. The patient was hospitalized. He was treated with IV cefuroxime. Blood culture grew H. influenzae type a. The patient became afebrile after 2 days of antibiotic therapy and was discharged in his baseline state of health. The patient subsequently died of unspecified complications of his underlying neuro-degenerative disease. No further information is available. A copy of the published article is attached as further documentation of the patient''s experience.


VAERS ID: 239012 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2005-02-21
Onset:0000-00-00
Submitted: 2005-05-31
Entered: 2005-06-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Abortion, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (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: NONE
Current Illness:
Preexisting Conditions: Pregnancy NOS (LMP= unk)
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0505USA02987

Write-up: Information has been received through a pregnancy registry from a female with no pertinent medical history and no drug reactions/allergies who on 2/21/05 was vaccinated with a dose of varicella virus vaccine live, subsequently and learned that she was pregnant 2 weeks later. There were no concomitant medication. The patient indicated that she was not pregnant at the time of vaccination, because she had her period after vaccination. She indicated that she had since terminated the pregnancy. Unspecified medical attention was sought. No lab diagnostic studies were performed. There was no product quality complaint. No additional information is expected.


VAERS ID: 239566 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-06-06
Entered: 2005-06-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0506USA00124

Write-up: Information has been received from a consumer concerning her son who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, her son passed away. Medical attention was sought. No product quality complaint involved. No further information is available.


VAERS ID: 239690 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2005-06-03
Onset:2005-06-09
   Days after vaccination:6
Submitted: 2005-06-10
   Days after onset:1
Entered: 2005-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0346P / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0989 / 1 RL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cyanosis, Pulse absent
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-06-09
   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: 1)cetirizine 2.5 mg po q 24 hrs 2)fluticasone 44mcg oral inhalation aerosol, 2-3 puffs via Aerochamber mask q 12 hrs 3)ipratropium via nebulizer q 6 hrs or less frequently
Current Illness: No acute illness. Reactive airway disease under good control. Mild anemia diagnosed 6/3/2005.
Preexisting Conditions: Reactive airway disease, under good control at time of immunization. Recent PET placement for recurrent otitis. cow''s milk allergy; no anaphyllaxis.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: On the morning of 6/9/2005, patient was found in his crib apneic and without pulse. Resuscitation attempts were unsuccessful and the child was pronounced dead in the Emergency Room. Additional co start from Discharge summary rec''d 06/13/2005 -- cyanosis.


VAERS ID: 239722 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Male  
Location: Tennessee  
Vaccinated:2005-05-12
Onset:2005-05-16
   Days after vaccination:4
Submitted: 2005-05-24
   Days after onset:8
Entered: 2005-06-13
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A004CA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0604P / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67184D / 2 LL / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Apnoea, Petechiae, Pneumonia, Pulmonary oedema, Viral infection
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-05-16
   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: Autopsy performed; results unknown at present.
CDC Split Type: TN05023

Write-up: Imm on 5/12/05 Infant deceased 5/16/05 after sleeping, father reported he had fed infant, laid down to sleep checking on infant later found not breathing by father, CPR until EMS arrived at scene. Autopsy Report received which stated patient experienced pneumonitis, viral infection, petechiae and pulmonary edema.


VAERS ID: 239724 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Kentucky  
Vaccinated:2004-12-28
Onset:2005-01-03
   Days after vaccination:6
Submitted: 2005-05-31
   Days after onset:147
Entered: 2005-06-13
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A015AA / 1 RL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 02371P / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A774404E / 1 LL / -

Administered by: Private       Purchased by: Private
Symptoms: Fracture, Sudden infant death syndrome
SMQs:, Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Colic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death ruled SIDS but was 6 days after vaccines. Received Autopsy Report which revealed COD as undetermined; manner of death undetermined. Patient found supine cosleeping with twin sibling. Found 4 healing rib fractures which ME ruled as resulting from excessive force precluding SIDS.


VAERS ID: 239904 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Ohio  
Vaccinated:2005-05-20
Onset:2005-05-28
   Days after vaccination:8
Submitted: 2005-06-13
   Days after onset:16
Entered: 2005-06-16
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0608P / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0652P / UNK - / -

Administered by: Private       Purchased by: Private
Symptoms: Cardio-respiratory arrest, Cardiomyopathy, Pneumonia, Premature baby, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-05-29
   Days after onset: 1
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Albnuterol, Flovent, Zantac, Laser, KCL, O2
Current Illness: Trach feeding tube, BDP
Preexisting Conditions: Immune system disorder; prematurity; hospitalization
Allergies:
Diagnostic Lab Data: Body temp high temperatures
CDC Split Type: WAES0506USA00683

Write-up: Information has been received from a RN concerning a 21 month old immunocompromised male who was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently the pt was hospitalized and died two weeks later (not further specified). A product quality complaint was not involved. Additional information was received from the RN who reported that the pt had a lot of problems. The pt was hospitalized until he was 20 months old with a diagnosis of extreme prematurity among other problems. The nurse did not know the cause of death but did indicate that high temperatures were involved. Additional information was received from a health professional at a pediatricians office who reported that the pt''s demise had nothing to do with the vaccinations. The pt''s experience was considered to be immediately life threatening and disabling by the RN. Additional information has been requested. Received Autopsy Report which revealed COD as acute bronchopneumonia, bronchopulmonary dysplasia, dilated cardiomyopathy & prematurity.


VAERS ID: 239968 (history)  
Form: Version 1.0  
Age: 1.04  
Sex: Female  
Location: Ohio  
Vaccinated:2004-10-19
Onset:2004-10-21
   Days after vaccination:2
Submitted: 2004-11-09
   Days after onset:19
Entered: 2005-06-16
   Days after submission:218
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE118AA / 4 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (VIRIVAC) / MERCK & CO. INC. 0821N / 1 LA / SC
PPV: PNEUMO (PNU-IMUNE) / PFIZER/WYETH A74399K / 3 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood glucose increased, Bradycardia, Brain oedema, Cough, Dehydration, Hyponatraemia, Hypoventilation, Irritability, Ketoacidosis, Lethargy, Pain, Pallor, Pneumonia, Polyuria, Pyrexia, Tachycardia, Weight decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Slight Cough - T99.8 - Lungs clear
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Blood sugars, Blood tests, X-rays
CDC Split Type:

Write-up: Had been to MD week of 10/18 with normal well child exam. 10/19/2004 slight cough, chest clear temp 99.8 in our office. To MD office 10/21/04 - Dx beginning pneumonia. Antibiotic inj. given and sent home. 10/22/04 Rapid progression of pneumonia at ER. Blood sugar 700+ Dx: Diabetic Ketoacidosis. Life flight to Hosp. Brain stem swelling. Pt died 10/24. Added code of dehydration from Death Certificate rec''d 06/13/2005. From discharge Summary rec''d 06/21/2005, added terms are polyuris, lethargy, weight loss, tachycardia, dehydration, irritable, bradycardia, hypoventilation, pain, hyperventilation, pallow, and hyponatremia.


VAERS ID: 240197 (history)  
Form: Version 1.0  
Age: 0.78  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2005-06-07
Onset:2005-06-10
   Days after vaccination:3
Submitted: 2005-06-11
   Days after onset:1
Entered: 2005-06-21
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67188C / 3 RL / IM

Administered by: Private       Purchased by: Private
Symptoms: Agranulocytosis, Apnoea, Cardiac arrest, Corneal opacity, Cyanosis, Jaundice neonatal, Stupor
SMQs:, Torsade de pointes/QT prolongation (broad), Congenital, familial, neonatal and genetic disorders of the liver (broad), Anaphylactic reaction (narrow), Agranulocytosis (narrow), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Congenital biliary disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Corneal disorders (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Well
Preexisting Conditions: Congenital muscular dystrophy (merosin deficiency), central apnea, GER
Allergies:
Diagnostic Lab Data: Autopsy not done
CDC Split Type:

Write-up: Exact events unk. Pt coded. Unable to resuscitate at hospital. Autopsy not done. Discharge Summary received which stated patient experienced asytole, unresponsive, respiratory arrest, cyanosis and corneal clouding. Medical records from PCP received which revealed patient experienced muscular dystrophy, GERD, apnea, agranulocytosis, prior jaundice & equinovalgus.


VAERS ID: 240326 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Female  
Location: New York  
Vaccinated:2005-06-20
Onset:2005-06-21
   Days after vaccination:1
Submitted: 2005-06-22
   Days after onset:1
Entered: 2005-06-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1345AA / 3 - / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0004R / 2 - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE577AA / 3 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A57562K / 3 - / IM

Administered by: Private       Purchased by: Other
Symptoms: Apnoea, Cardiac arrest, Pneumonitis, Stupor, Viral infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-06-21
   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: Topical cream
Current Illness: Mild URI symptoms
Preexisting Conditions: Eczema
Allergies:
Diagnostic Lab Data: Pending
CDC Split Type:

Write-up: Seen in ER at hospital. Term stated in Autopsy report is Asystole. Additional CoStarts from Discharge Summary rec''d on 07/25/2005 -- Apnea, Stupor, heart arrest. Autopsy Report received which stated COD as interstitial pneumonitis c/w viral pneumonia. Manner of death: natural.


VAERS ID: 240408 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Tennessee  
Vaccinated:2005-06-17
Onset:2005-06-18
   Days after vaccination:1
Submitted: 2005-06-20
   Days after onset:2
Entered: 2005-06-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A018AA / 1 RL / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1016P / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A94439K / 1 LL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-06-18
   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: Taking Zantac for Reflux.
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient deceased 6/18/05 3 AM (found dead in bed). 7/29/05 D/C summary from ER received which revealed child arrived in full arrest & unable to resuscitate. 9/20/05 Received Autopsy Report which revealed COD to aspiration of stomach contents.


VAERS ID: 240849 (history)  
Form: Version 1.0  
Age: 1.23  
Sex: Male  
Location: Unknown  
Vaccinated:1998-08-01
Onset:0000-00-00
Submitted: 2005-06-27
Entered: 2005-06-30
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Sudden infant death syndrome
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Neonatal disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Autopsy: stated the cause of death was SIDS.
CDC Split Type: WAES0506USA02916

Write-up: Information has been received from a RN concerning a male who in August 1998, at 15 months old, was vaccinated with a dose of Varivax. In August 1998, one week after vaccination, at 15 months old, the child experienced a seizure. No seizure was noted prior to vaccination. Approximately one month after the seizure, 5 weeks post vaccination, in September 1998, at 16 months old, the child was found dead in his crib. The autopsy stated the cause was SIDS. Unspecified medical attention was sought. There was no product quality complaint. The reporter considered the events to be life-threatening. No additional information is expected. As per autopsy report rec''d 07/18/2005 -- remove SIDS and add Reaction unevaluable.


VAERS ID: 240945 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: West Virginia  
Vaccinated:2005-06-21
Onset:2005-06-27
   Days after vaccination:6
Submitted: 2005-06-27
   Days after onset:0
Entered: 2005-07-05
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A013AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1082P / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A94431E / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Cardio-respiratory arrest, Upper respiratory tract infection
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), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-06-27
   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: NONE
Preexisting Conditions: Colic
Allergies:
Diagnostic Lab Data: Autopsy Pending
CDC Split Type:

Write-up: Pt died 6 days after receiving vaccines. 7/21/05 Received medical records from ER which revealed patient arrived in full arrest & unable to resuscitate. Parent reported mild upper respiratory symptoms for a few days prior to death.


VAERS ID: 241411 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-07-15
Entered: 2005-07-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Anorexia, Atelectasis, Bacterial infection, Blood urea increased, Brain oedema, CSF test abnormal, Cough, Drug ineffective, Hypoxia, Laryngeal oedema, Lung disorder, Lymphopenia, Meningitis, Pallor, Platelet count decreased, Pulmonary haemorrhage, Pyrexia, Red blood cell abnormality, Thrombocytopenia, Vomiting
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: Meningitis pneumococcal abnormal csf increased BUN anemia thrombocytopenia
CDC Split Type: HQWYE187113JUL05

Write-up: Information regarding Prevnar was received from a consumer regarding a 6 month old male patient who developed pneumococcal meningitis. At 6 months of age, the patient received the third dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A mother reported that her son died of pneumococcal meningitis from a serotype included in the vaccine. His last vaccination was administered 2 weeks prior to his death. No additional information was available at the time of this report. Additional CoStarts added from Medical Record rec''d 07/25/05 -- lymphopenia, edema brain, edema larynx, atelectasis, hem lung. Discharge Summary received stated patient experienced pallor, fever, cough, congestion, decreased appetite, emesis, anemia, thrombocytopenia, bacterial infection and hypoxia.


VAERS ID: 241475 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Male  
Location: Virginia  
Vaccinated:2005-04-26
Onset:2005-05-01
   Days after vaccination:5
Submitted: 2005-07-11
   Days after onset:71
Entered: 2005-07-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2044AA / UNK LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0410P / UNK RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1191 / UNK LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67812A / UNK RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy with congestion.
Preexisting Conditions: None noted in medical records received.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Death. Received autopsy report which revealed COD as SIDS.


VAERS ID: 241542 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: New Jersey  
Vaccinated:2005-06-13
Onset:2005-06-14
   Days after vaccination:1
Submitted: 2005-06-29
   Days after onset:15
Entered: 2005-07-20
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A018AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1082P / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A94431A / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Anaemia, Apnoea, Cough, Cyanosis, Cystic fibrosis lung, Hyperbilirubinaemia, Nasal congestion, Neonatal respiratory distress syndrome, Pneumonia, Pneumothorax, Premature baby, Respiratory arrest, Sepsis
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-06-14
   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: Saline nose drops, humidification
Current Illness: URI
Preexisting Conditions: Prematurity/hx of apnea/bradycardia, on monitor
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: NJ200503

Write-up: Seen 6/13/05 cough/nasal congestion x 4d, hx of prematurity. On apnea monitor, started having increase in alarms in AM o f6/14. At 10AM alarm sounded, acrocyanosis, 911 notified, brought to ER/arrested. No additional terms from discharge summary rec''d 11/09/2005/sr 9/20/05 Received autopsy report which revealed COD as bronchopneumonia w/pneumothoraces as contributing factor.


VAERS ID: 241557 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Minnesota  
Vaccinated:2005-07-11
Onset:0000-00-00
Submitted: 2005-07-20
Entered: 2005-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B011BA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0604P / 1 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74404D / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cleft lip and palate, Coronary artery disease, 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), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-13
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: bilat cleft lip,,, cleft palate,,, muscular vsd not hemodynamically significant
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: sudden death 36 hrs after administration... classified a a sids by medical examiner... no history or evidence at autopsy of any site reaction, symptoms or fever reported by parent. no evidence of encephelopathy or inflamatiobn of brain at autopsy. pt. had bilat cleft of lip and and cleft palate, muscular vsd. evaluated by ped cardiology and ent at 2 wks of age.. vsd felt to not be significant. Autopsy Report received which stated patient experienced sudden cardiac death and acute angle of origin of coronary artery.


VAERS ID: 241575 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:2004-05-18
Onset:2004-05-18
   Days after vaccination:0
Submitted: 2005-07-18
   Days after onset:426
Entered: 2005-07-21
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug ineffective, Hepatitis, Renal failure, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatitis, non-infectious (narrow), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Immunization; dialysis
Allergies:
Diagnostic Lab Data: Serum hep B: titer drawn regularly; positive for hep B infection
CDC Split Type: WAES0507USA01718

Write-up: Information has been received from a registered nurse concerning a male dialysis patient with a long medical history who had completed a hepatitis B virus vaccine series in the past who on 2/13/03, 5/18/04, 6/18/04 was vaccinated IM with a 0.5ml dialysis formulation booster doses of hepatitis B virus vaccine. Concomitant medications were noted, however, the list was unknown. It was noted that since he was a dialysis patient, he got his antibody titer drawn regularly. The patient had surgery and received a blood transfusion. On 7/8/04, he was given an additional dose of hepatitis B virus vaccine. When his antibody levels were tested after that, he came back positive for hepatitis B infection. The infection progressed, renal failure occurred, and the patient expired. There was no product quality complaint involved. The reporter indicated that hepatitis B virus vaccine was not the cause of any adverse experiences. Additional information has been requested.


VAERS ID: 241773 (history)  
Form: Version 1.0  
Age: 0.31  
Sex: Male  
Location: Ohio  
Vaccinated:2004-12-30
Onset:2005-01-05
   Days after vaccination:6
Submitted: 2005-01-14
   Days after onset:9
Entered: 2005-07-26
   Days after submission:192
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1314DA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0369P / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X0771 / 1 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495767 / 1 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Heart disease congenital, Irritability, Pulmonary embolism
SMQs:, Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-01-05
   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: Aspirin, Digoxin, Lasix, Reglan, Enalapril
Current Illness: None
Preexisting Conditions: Hypoplastic Left Heart Syndrome (already had 2 heart surgeries)
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient had been more fussy than usual since immunizations. No fever. Went to hospital for scheduled heart catherterization on 1/5/05. Baby fine when they left hotel, but when they arrived at hospital & uncovered his car seat, he wasn''t breathing. CPR performed by staff at hospital but unable to revive. Death Certificate rec''d on 07/25/2005 adds term -- pulmonary thromboemboli & hypoplastic left heart syndrome.


VAERS ID: 242400 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Arkansas  
Vaccinated:2005-07-20
Onset:2005-07-22
   Days after vaccination:2
Submitted: 2005-07-29
   Days after onset:7
Entered: 2005-08-08
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A009CA / 1 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0237P / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67188H / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: AR0519

Write-up: Mother found infant dead in her crib at 6AM. 7/22 Coroner said infant died around 2AM. Infant was fed at 11:30 and mother heard nothing all night. Infant had no fever etc following imm. To ER by ENS, MD stated cause of death as unk on death certificate. Mother said they said if was probably SIDS. Death Certificate received and stated patient experienced unevaluated reaction.


VAERS ID: 242855 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Georgia  
Vaccinated:2005-08-01
Onset:2005-08-10
   Days after vaccination:9
Submitted: 2005-08-12
   Days after onset:2
Entered: 2005-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1349AA / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0807P / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 40264 / 1 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67186B / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-08-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Seborrheic dermatitis
Preexisting Conditions: Seborrheic dermatitis
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Infant died of apparent SIDS on 8/10/05, was co-sleeping with mother in the bed. Per F/U by FDA researcher who contacted the ME, the manner of death was undetermined and COD was unexplained infant death.


VAERS ID: 242856 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Georgia  
Vaccinated:2005-08-08
Onset:2005-08-12
   Days after vaccination:4
Submitted: 2005-08-12
   Days after onset:0
Entered: 2005-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1349BA / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0807P / 1 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 40264 / 1 LA / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67186B / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-08-12
   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: Levsin
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Infant found in respiratory arrest at home in crib (at night). EMS responded; unable to resuscitate at home or in ER. Probable SIDS. Per F/U done by FDA researcher who contacted the ME, the COD was SIDS.


VAERS ID: 242913 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-08-15
Entered: 2005-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: The subject''s medical history, concurrent conditions, and concurrent medications were not reported.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0570081A

Write-up: This case was reported by a medical technologist and described the occurrence fo fatal Guillain-Barre syndrome in an adult male subject who was vaccinated with hepatitis B vaccine (manufactured unspecified) for prophylaxis. On an unspecified date before August 14 2005, the subject received a dose of hepatitis B vaccine (dose number not provided). At an unspecified time after vaccination with hepatitis B vaccine, before August 14 2005, the subject experienced Guillain-Barre syndrome. The subject subsequently expired as a result of the Guillain-Barre syndrome.


VAERS ID: 243201 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-08-18
Entered: 2005-08-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. UNK / UNK UN / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0508USA02266

Write-up: Information has been received from a consumer concerning at least three people (ages and gender not reported) who died after being vaccinated (dates not specified) with MMR II (lot numbers not reported). No further information is available. there was no product quality complaint involved.


VAERS ID: 243253 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Alabama  
Vaccinated:2005-08-18
Onset:2005-08-19
   Days after vaccination:1
Submitted: 2005-08-22
   Days after onset:3
Entered: 2005-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B011BA / 1 LA / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE708AA / 1 LL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A94451C / 1 RL / -

Administered by: Private       Purchased by: Public
Symptoms: Neonatal respiratory distress syndrome
SMQs:, Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-08-19
   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: Prilosec PO
Current Illness: NONE (except GER).
Preexisting Conditions: Gastroesophageal reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received vaccines on 08/18 died of unexplained (so far) causes on 08/19. D/C summary received from hospital which revealed patient hospitalized for 6 days for RDS after birth.


VAERS ID: 243594 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Male  
Location: Missouri  
Vaccinated:2005-08-19
Onset:2005-08-21
   Days after vaccination:2
Submitted: 2005-08-23
   Days after onset:2
Entered: 2005-08-30
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC1A012BA / UNK LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0360R / UNK RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A56116K / UNK RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Abnormal sleep-related event, Accident, Cardio-respiratory arrest, Sudden infant death syndrome, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-08-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Well child care including immunizations given 08/19/2005 between 11AM and 12 Noon. The infant was sleeping on Mother in parent''s bed on 08/21/2005 - Infant brest fed - Mother woke at 2 AM to find baby face down in pool of vomit on her chest. EMS to ER- resuscitation attempted, pronounced dead 08/21/2005 04:45. Received medical records from ER which reveal patient in full arrest on arrival & unable to be resuscitated. Received Autopsy Report which reveals COD as suffocation & manner of death as accidental.


VAERS ID: 244138 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Georgia  
Vaccinated:2005-09-12
Onset:2005-09-13
   Days after vaccination:1
Submitted: 2005-09-14
   Days after onset:1
Entered: 2005-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21R05DA / UNK RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0208R / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A67117F / UNK LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This child died in her sleep on 9/13/05. Pronounced dead at hospital. Autopsy report rec''d 10/19/2005, COD was SIDS.


VAERS ID: 244255 (history)  
Form: Version 1.0  
Age: 0.44  
Sex: Female  
Location: Iowa  
Vaccinated:2005-09-06
Onset:2005-09-07
   Days after vaccination:1
Submitted: 2005-09-15
   Days after onset:8
Entered: 2005-09-19
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B011BA / UNK LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0186R / UNK RA / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A98338C / UNK RA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-07
   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: Right serious otitis
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Autopsy pending. Autopsy rec''d 1031/2005 -- COD was SIDS w/cosleeping w/both parents.


VAERS ID: 244907 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Ohio  
Vaccinated:2005-02-09
Onset:2005-04-08
   Days after vaccination:58
Submitted: 2005-05-03
   Days after onset:25
Entered: 2005-10-04
   Days after submission:154
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1290BA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE387AA / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR X1213 / 2 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 495720 / 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: 2005-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: On apnea monitor until the end of February.
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: None related to the shots. Died 04/08/2005, Preliminary cause of death - SIDS. Coroner''s report not final. Autopsy report received which stated COD as SIDS.


VAERS ID: 244917 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Male  
Location: California  
Vaccinated:2005-09-19
Onset:2005-09-19
   Days after vaccination:0
Submitted: 2005-09-29
   Days after onset:10
Entered: 2005-10-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B011CA / 2 LL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE719AA / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A94451K / 1 RL / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Upper respiratory tract infection
Preexisting Conditions: Former premature baby, in utero marijuana exposure
Allergies:
Diagnostic Lab Data: Died at hospital - labs are there.
CDC Split Type:

Write-up: Pt died less than two hours after vaccine. Tentative diagnosis - SIDS. Former premature baby with in utero marijuana exposure. Autopsy report rec''d 10/25/2005, box 7 complete., COD stated as SIDS.


VAERS ID: 244965 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Illinois  
Vaccinated:2005-09-29
Onset:2005-10-01
   Days after vaccination:2
Submitted: 2005-10-05
   Days after onset:4
Entered: 2005-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21A021AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 1081P / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A56117K / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal sleep-related event, Apnoea, Asphyxia, Cardio-respiratory arrest, Cyanosis, Status asthmaticus, Upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-01
   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: 33 weeks gestation/birth weight: 3#5oz
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Mother put pt to bed the noc of 09/30/05 - went to wake up next morning - baby was blue and no breathing. Records rec''d 11/7/05 - additional term Status Asthmaaticus. ER records received which revealed patient arrived in full arrest & was unable to be resuscitated. Autopsy report received which revealed COD as asphyxia, smothering in face down position on mattress. Patient was cosleeping w/2 adults & male adult was lying directly on back of patient''s head.


VAERS ID: 245056 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: California  
Vaccinated:2005-08-26
Onset:2005-09-09
   Days after vaccination:14
Submitted: 2005-10-04
   Days after onset:25
Entered: 2005-10-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2151AC / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-09
   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: Used Cipro HC otic drops 8/21 -8/25/2005
Current Illness: Resolved otitis externa
Preexisting Conditions: Rash with ceclor. H/O RAD, last wheezing 12/2002
Allergies:
Diagnostic Lab Data: Work up negative to date. Full autopsy pending.
CDC Split Type:

Write-up: Pt died suddenly from cardiac arrhythmia while walking dog. Paramedics attempted resuscitation. Pt did not respond to resuscitation efforts in the field or in the ER. Pronounced dead at 17:45. Autopsy report rec''d 10/31/2005 -- complete as reported.


VAERS ID: 245164 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2005-10-06
Entered: 2005-10-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Other
Symptoms: Demyelination, Gastrointestinal disorder, Inflammation, Muscular weakness, Polyneuropathy, Quadriplegia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Other disorders of intestine.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0510USA00245

Write-up: Information has been received from a physician concerning an 11 or 12 year old female with a history of chronic bowel disease who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) on an unspecified date. it was reported that 11-14 days after the vaccination (also reported as 10 days post vaccination) she developed chronic inflammatory demyelinating polyneuropathy. Unspecified medical attention was sought and it was noted the prescription drug treatment was required. From this disease, she developed marked weakness of all muscles and became a quadriplegic (noted to be caused from the chronic inflammatory demyelinating polyneuropathy. The physician reported that the patient died two years later (date not specified) from death of bowel or bowel volvulus. The physician reported the bowel volvulus was related to the chronic inflammatory demyelinating polyneuropathy. No product quality complaint was involved. Additional information has been requested.


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

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

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

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


VAERS ID: 245633 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Male  
Location: New Jersey  
Vaccinated:2005-09-19
Onset:0000-00-00
Submitted: 2005-10-14
Entered: 2005-10-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2253AA / 4 - / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0459 / 3 - / SC

Administered by: Private       Purchased by: Private
Symptoms: Pulse absent, Pyrexia, Red blood cell abnormality, Respiratory failure, White blood cell disorder
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (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), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-06
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: LP, 12 WBC, 74 RBC
CDC Split Type:

Write-up: Pt had fever for about 12 hours, took nap, and was found several hours later with no pulse, respiration.


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

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-14
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Celexa 40mg daily, Senna 2 tabs qHS, Losartan 100mg daily, amlodipine 10mg daily, colchicine 0.6mg daily, Miacalcin, aspirin 325mg daily, sinemet 25/100 TID, prednisone 5mg daily, meclizine.
Current Illness:
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: Recent potassium 6.5 - hemolyzed (date not indicated)
CDC Split Type:

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


VAERS ID: 245711 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Alabama  
Vaccinated:2005-10-14
Onset:2005-10-16
   Days after vaccination:2
Submitted: 2005-10-16
   Days after onset:0
Entered: 2005-10-20
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2277AA / 2 RL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0642R / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0535 / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A56117A / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-16
   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: Prevacid Solutab 15 mg 1/2 BID; Reglan 0.7 mg QIP
Current Illness: GERD
Preexisting Conditions: VATERS (vertebral anomaly, tracheoesophogeal fistula), scoliosis, GERD
Allergies:
Diagnostic Lab Data: Autopsy to be performed
CDC Split Type:

Write-up: Respiratory Arrest. Transported to the ER - when resuscitation efforts failed. Hx of TEF, GERD - Probably an aspiration event. 11/9/05 Received medical records from ER which revealed patient arrived in full arrest & was unable to be resuscitated. 4.20/06 Received Death Certificate which revealed COD as apnea and respiratory failure.


VAERS ID: 245770 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Male  
Location: Missouri  
Vaccinated:2005-10-11
Onset:2005-10-17
   Days after vaccination:6
Submitted: 2005-10-20
   Days after onset:3
Entered: 2005-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B07AA / 2 - / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE932AA / 2 - / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A98338H / 2 - / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Coma, Pulse absent, 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 (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-17
   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:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated. Dis Sum received 10/31/2005 -- terms added were unresponsive, apnea, asystole, pulseless. 01/25/2006 Term added from Autopsy report and Death Certificate: SIDS


VAERS ID: 246005 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Michigan  
Vaccinated:2005-10-18
Onset:2005-10-20
   Days after vaccination:2
Submitted: 2005-10-25
   Days after onset:5
Entered: 2005-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE664AB / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspartate aminotransferase increased, Back pain, Headache, Injection site erythema, Injection site oedema, Laboratory test abnormal, Nausea, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: 10/23/05 SGOT 67 Neutrophils 95.5%
CDC Split Type:

Write-up: 10/20/05 - Localized reation - red & swollen at injection site 10/22/05 - Fever 10/23/05 - Fever 103.5, headache, fatigue, nausea, low back pain. Presented to ER and admitted to med-surg unit. Inpatient today 10/24/2005 - IV therapy. Motrin for fever. Per follow up report- Patient died.


VAERS ID: 246079 (history)  
Form: Version 1.0  
Age: 1.01  
Sex: Male  
Location: Connecticut  
Vaccinated:2005-01-10
Onset:2005-01-12
   Days after vaccination:2
Submitted: 2005-10-18
   Days after onset:278
Entered: 2005-10-26
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVA130AB / 2 - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0437P / UNK - / IM

Administered by: Private       Purchased by: Private
Symptoms: Anaphylactic reaction, Cardiac arrest, Disseminated intravascular coagulation, Febrile convulsion, Nervous system disorder, Respiratory distress, Sepsis, Thermal burn, Thrombosis, Toxic epidermal necrolysis
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-03-02
   Days after onset: 49
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: H/O bronchitis and eczema, sister with JRA and food allergies
Allergies:
Diagnostic Lab Data: Skin BX consistent with TENS.
CDC Split Type:

Write-up: Febrile seizure 2 days after administration. Developed worsening febrile seizures. Was put on phenobarbital and eventually died from complications of TENS. Received D/C summary which revealed final dx: TENS, septicemia, cardiopulmonary arrest, DIC, ARDS, right femoral artery thrombosis. Developed TENS after receiveing Pb & augmentin for febrile sz & had anaphylaxis to IVIG given for atypical Kawasaki dx w/50% total body desquamation.


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

Administered by: Private       Purchased by: Unknown
Symptoms: Abnormal sleep-related event, Bronchitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Upper respiratory infection
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type:

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


VAERS ID: 246336 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Male  
Location: New Jersey  
Vaccinated:2005-10-20
Onset:2005-10-20
   Days after vaccination:0
Submitted: 2005-10-27
   Days after onset:7
Entered: 2005-10-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0004R / 2 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 40425 / 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: 2005-10-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: Foster care child, with no parental or birth history available.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt was administered Hep B and IPV vaccine at 9AM and pt died of unrelated causes at 12 noon same day. Case is in hands of medical examiner and has ruled out vaccine reaction as cause or contribution to death. Term added from Autopsy report rec''d 12/21/2005: SIDS/sr


VAERS ID: 246368 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Illinois  
Vaccinated:2001-10-10
Onset:2002-11-23
   Days after vaccination:409
Submitted: 2005-10-27
   Days after onset:1068
Entered: 2005-10-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK UN / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH UNK / 3 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Pneumonia, Respiratory failure, Sepsis, Viral infection
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2002-11-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: seizure~Pneumo (Prevnar)~1~0.00~In Patient
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: Convulsion (seizures)
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: HQWYE198324OCT05

Write-up: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from the mother of a 19 month old white male pt who experienced pneumonia and seizure. At 6 months of age, the pt received the third dose of Prevnar on 10Oct01. The pt also received the third dose of Diphtheria and tetanus toxoids and pertussis (manf unk) on 10Oct01. The pt has a past history of experiencing a seizure following receipt of his first and second dose of Prevnar, IPV, Comvax, and DTP (manf unk) vaccines. The child also experienced many episodes of seizures following receipt of his third doses of Prevnar and an unspecified DTP vaccine. The indication for Prevnar was immunization. Product was administered on 10Oct01. Dose regimen was 1 dose 1 time per day (IM). Concomitant medications were not reported. On an unk date in 2002, the child developed pneumonia. On 23Nov02, he experienced a seizure and died. The mother stated that the cause of death was pneumonia and a fatal seizure. No additional information was available at the time of this report. See related serious cases: HQWYE203024OCT05, HQWYE227825OCT05, and HQWYE203124OCT05. Discharge Summary received which revealed dx: respiratory failure, sepsis syndrome & multi-system failure.


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

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

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

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


VAERS ID: 246641 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Male  
Location: Missouri  
Vaccinated:2005-06-15
Onset:2005-06-21
   Days after vaccination:6
Submitted: 2005-10-26
   Days after onset:127
Entered: 2005-11-02
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS A017012BA / 3 UN / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF690AE / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A6786 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Irritability, Sudden infant death syndrome
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-06-21
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: On June 21 2005 I was called (as coroner) to the local hospital emergency room. A baby born Jan 30 2005, had died suddenly. She was a white, female, and appeared to be in good physical health. During the course of my investigation, I learned that the baby had been vaccinated one week earlier. The baby was immunized on June 16 2005 and according to the mother, been a little cranky. The mother of the baby had treated the baby with children''s Tylenol. When the child review panel discussed this babies death, there was a lot of concern about the number of blankets, stuffed animals, and general lack of air flow in the babies crib. Enclosed is the autopsy report and a copy of the death certificate. Call me if you need further information. All child deaths under the age of 18 are reviewed. All coroners and medical examiners meet once a year for the purpose of updates and continuing education. Until you called, I like many coroners, was unaware of your organization. If you would like to get some information to us as an organization, I can let you know the dates of our next training session. I think it will be in March of 2006. Autopsy Report received which stated COD as SIDS.


VAERS ID: 246730 (history)  
Form: Version 1.0  
Age: 0.58  
Sex: Male  
Location: Texas  
Vaccinated:2005-08-30
Onset:2005-09-02
   Days after vaccination:3
Submitted: 2005-11-03
   Days after onset:62
Entered: 2005-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U1396BA / 2 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1126P / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A98338H / 3 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Erythromycin Ointment
Current Illness: Eczema
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: none Sepsis (blood cultures + for grp A streptoccocus) added from autopsy report rec''d 11/10/2005/sr


VAERS ID: 247174 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Unknown  
Vaccinated:2002-11-05
Onset:2003-01-08
   Days after vaccination:64
Submitted: 2005-11-09
   Days after onset:1036
Entered: 2005-11-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 575A2 / 1 LL / ID
HEP: HEP B (ENGERIX-B) / SMITHKLINE BEECHAM 5358A2 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UA7411AA / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1234 / 1 RL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 489472 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2003-01-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Toxicologic test (LLT: Toxicology NOS) 30JAN2003 blood negative for common drugs and chemicals.
CDC Split Type: HQWYE427804NOV05

Write-up: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from an investigator regarding a 4 month old male participant in a study who expired due to SIDS. At 2 months of age, the participant received the first dose on 11/05/2005. The participant also received the first dose of Infanrix (diphtheria, tetanus toxoid, acellular pertussis vaccine), the first dose of Engerix B (hepatitis b vaccine) and the first dose of Act-Hib (haemophilus b conjugate vaccine (tetanus) on 11/05/2002. Medical history: Patient was of full term gestation, had been in good health and was taking no medication. Indication for Prevnar was immunization. Product was administered on 11/05/2005. Dose regimen was 1 dose intramuscular. Concomitant therapy included Infanrix, Engerix b, Act Hib and Polio vaccine (poliomyelitis vaccine inactivated. On Jan 08 2003, 64 days post immunization, the patient expired due to SIDS (sudden infant death syndrome). The mother reported the child was found lying on his back with his head to the left, unresponsive. Emergency services were summoned. The patient was found pulseless and apneic, death was determined to be present at 0750 hours. The reported cause of death autopsy, as per coroner, was SIDS. Toxicologic test results blood negative for common drugs and chemicals was done on 01/30/2003. The investigator(s) and medical monitor(S) considered sudden infant death syndrome not related to the study product.


VAERS ID: 247278 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2005-11-02
Onset:2005-11-04
   Days after vaccination:2
Submitted: 2005-11-11
   Days after onset:7
Entered: 2005-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 61503 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cold sweat, Coma, Pain, Pulmonary embolism
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: had UTI diagnosed 11-1-05
Preexisting Conditions: Bactrim Augmentin Flagyl
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11-4-05 C/o pain rt side rt lower lobe crackles 11-5-05 rt rib pain in morning. 5pm clammy unresponsive went to ER died at hospital. Hospital reports died from pulmonary embolism. Have not received death certificate at this time. 11/18/05 Death certificate received which revealed COD as pulmonary emboli.


VAERS ID: 247280 (history)  
Form: Version 1.0  
Age: 95.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2005-11-02
Onset:2005-11-03
   Days after vaccination:1
Submitted: 2005-11-11
   Days after onset:8
Entered: 2005-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / EVANS VACCINES 61503 / 7+ LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypotonia, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: ASA Phenergan
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 11-03-05 moist mouth breathing no verbal response. Flaccid rt arm. Bilateral rhonchi yellow phlegm. 11-04-05 Verbally responding in the am Drank water. Expired 11-05-05 at 11pm. Death certificate states respiratory failure and pneumonia as cause of death.


VAERS ID: 247296 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2005-10-03
Onset:0000-00-00
Submitted: 2005-11-13
Entered: 2005-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-08
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: I am only the aunt and do not have all the information you need but feel this needs further investigation.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Autopsy done. Report not available yet.
CDC Split Type:

Write-up: crying alot day of shots; sleeping more than usual there after.


VAERS ID: 247332 (history)  
Form: Version 1.0  
Age: 0.34  
Sex: Female  
Location: Connecticut  
Vaccinated:2005-09-22
Onset:2005-09-25
   Days after vaccination:3
Submitted: 2005-09-26
   Days after onset:1
Entered: 2005-11-14
   Days after submission:49
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B015BA / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0184R / 2 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A74406C / 2 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Moisturel; Hydrocortisone; Zantac
Current Illness:
Preexisting Conditions: Esophageal reflux; Contact dermatitis; Seborrhea capitis; Cephalohematoma; Cord granuloma.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cardiac Arrest/Respiratory Arrest around 2000 on 25 Sep 05 at home. This was over 72 hours following vaccinations below. 11/28/2005 Via phone call again to ME. Child was put down to sleep in prone position because of GERD. She also had a comforter on her. She was given a bottle at 1 pm, and was found unresponsive at 8 pm. Father started CPR and child was taken to the ER where she was pronounced. ME says the preliminary report is SIDS, final awaits the lab results. 4/10/06 Received autopsy report which states COD: Unexplained Infant Death.


VAERS ID: 247362 (history)  
Form: Version 1.0  
Age: 73.0  
Sex: Female  
Location: California  
Vaccinated:2005-11-10
Onset:2005-11-11
   Days after vaccination:1
Submitted: 2005-11-14
   Days after onset:3
Entered: 2005-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1864AA / 7+ LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-11
   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: Dyazide; Enablex; Tegretol; Norvasc; Procardia; Fosamax
Current Illness:
Preexisting Conditions: CVA, HTN, GERD, Intracerebral aneurysm, Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Expired while sleeping approximately 12 - 18 hours after Flu vaccine administered. Coroner''s case. Additonal term added from autopsy report: Atheroscleric CAD/sr


VAERS ID: 247705 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2005-08-16
Onset:2005-08-16
   Days after vaccination:0
Submitted: 2005-11-17
   Days after onset:93
Entered: 2005-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Abdominal pain, Fat tissue increased, Hyperkalaemia, Infection, Leukocytosis, Sepsis, Shock, White blood cell count increased
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-09-21
   Days after onset: 36
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:
Current Illness:
Preexisting Conditions: Abdominal abscess, appendicitis, enterocutaneous fistula, ischemic colitis, lymphadenitis, post surgical wound infection, wound evisceration.
Allergies:
Diagnostic Lab Data: White blood count 08/06/2005 19400 mm3.
CDC Split Type: B0399612A

Write-up: This case was reported by a physician and described the occurrence of abdominal infection in a male subject of unspecified age who was vaccinated with hepatitis b vaccine (Engerix B) for prophylaxis. The subjects history included abdominal abscess, appendicitis, enterocutaneous fistula, ischemic colitis, lymphadenitis, post surgical wound infection and wound evisceration. Previous or concurrent vaccination included Engerix B vaccine intramuscular given on Feb 8 2005, march 10 2005 and August 16 2005. On June 2 2005 the subject received 3rd dose of Engerix B 40 mcg, intramuscular. On Aug 5 2005, 2 months after vaccination, the subject developed hyperpotassemia and was hospitalized and and was discharged on Aug 13-14 2005. On Aug 6 2005, the subject developed abdominal pain. On the same day, he was admitted in the hospital for a study. On Aug 6 2005. leucocytosis was objectified. An abdominal CT scan was performed and showed mesenteric fat infiltration in the region of the ileocolic anastomosis, with unspecified thickness of the wall of the colic side of the anastomosis. The subject was treated with ciprofloxacin IV every 8 hours from Aug 6 to 10 2005 an till Aug 17 continued with ciprofloxacin PO. On Aug 8 2005, the abdominal pain abated, the subject recovered and was discharges from hospital. The investigator updated the patient status and Engerix dosing schedule. On June 20 2005, the subject attended a scheduled protocol visit and did not receive Engerix B. The fourth and last dose of Engerix B was administered on Aug 16 2005. The patient did not attend the protocol visit schedule for mid Sept 2005. On Sept 21 2005 the subject died of abdominal infection and septic shock. The investigator considered the event not related to study drug. Further information has been requested.


VAERS ID: 247750 (history)  
Form: Version 1.0  
Age: 81.0  
Sex: Male  
Location: Arizona  
Vaccinated:2005-11-17
Onset:2005-11-17
   Days after vaccination:0
Submitted: 2005-11-18
   Days after onset:1
Entered: 2005-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 61501 / UNK RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Anaphylactic reaction, Cardiac arrest, Hypersensitivity, Syncope, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2005-11-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prazosin 2mg;Ditropan XL; 10mg;Cozaar 50mg;Namenda 10mg;Zoloft 50mg;Diovan 160
Current Illness:
Preexisting Conditions: No allergies, Alzheimer''s, HTN, increased Prostate Specific Antigen, asbestos exposure, cardiomegaly, high cholesterol, anemia, lung asbestosis.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: While watching wife had severe allergic Rxn to flu shot ( and 10 min after her flu shot) Pt vasovagal syncope on chair and progressed to full arrest. No additional information from Medical Record rec''d 01/25/2006/sr


VAERS ID: 247838 (history)  
Form: Version 1.0  
Age: 0.36  
Sex: Female  
Location: Mississippi  
Vaccinated:2005-10-18
Onset:2005-10-19
   Days after vaccination:1
Submitted: 2005-11-14
   Days after onset:26
Entered: 2005-11-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC218005AA / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. 0347R (PRPDMP) / 1 RL / -
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A24406F WYETH / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug toxicity
SMQs:, Anticholinergic syndrome (broad), Drug abuse and dependence (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-10-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: ms0521

Write-up: RECEIVED VACCINE 10//18/05 P.M. FAMILY STATES NO UNTOWARD AFFECTS NOTD PAST IMMUNIZATION. FOUND IN BED DEAD THE 11/19/2005 A.M. Drug Toxicity added from Autopsy report rec''d 12/08/2005 was + for methadone & ETOH. Parent admitted to administering adult strength Tylenol to patient./sr


VAERS ID: 247944 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2005-11-04
Onset:2005-11-08
   Days after vaccination:4
Submitted: 2005-11-21
   Days after onset:13
Entered: 2005-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U1803AA / 6 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Asthma, Cardiac failure, Cough, Glomerulonephritis, Haemoptysis, Hypoxia, Lung disorder, Obesity, Pyrexia, Renal failure, Respiratory arrest, Sepsis, Shock, Tachypnoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-19
   Days after onset: 11
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: Influenza vaccine administered 11/4/05. Recipient life flighted to pediatric intensive care 11/8/05 and placed on ventilator and dialysis. Dx with GoodPasture Syndrome and died 11/19/05. Terms added from Discharge summary rec''d 01/08/2006: shock, anemia, cardiac failure, menoptysis, fever, hypoxia, cough, lung infiltrate, tachypnea. Terms added to pre-existing conditions: Obesity, asthma, depression, hypertension, amenorrhea./sr


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

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

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

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


VAERS ID: 248114 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Virginia  
Vaccinated:2005-11-22
Onset:2005-11-22
   Days after vaccination:0
Submitted: 2005-11-22
   Days after onset:0
Entered: 2005-11-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2222AA / 1 LL / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 0356R / UNK RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y0326 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH A94456B / 1 RL / IM

Administered by: Private       Purchased by: Public
Symptoms: Apnoea, Cardiac arrest, Cardio-respiratory 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 (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2005-11-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Oral thrush
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Found in crib non responsive by sitter later that afternoon. Asystole on admission to ER. Added from Discharge summary rec''d 12/12/2005: Cardiopulmonary arrest and apnea./sr


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