|
| VAERS ID: | 206796 | Vaccination Date: | 2003-07-21 | | Age: | 0.2 | Onset Date: | 2003-07-23 Days later: 2 | | Gender: | Male | Submitted: | 2003-07-24 | | State: | California | Entered: | 2003-07-30 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-07-23) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: NONE | | Diagnostic Lab Data: Autopsy pending | | Previous Vaccinations: | | Other Medications: NONE | | Preexisting Conditions: NONE | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21885B9 | 0 | IM | LL | | HIBV | AVENTIS PASTEUR | UA853AA | 0 | IM | RL | | PNC | LEDERLE LABORATORIES | 491183 | 0 | IM | RL | |
| Administered by: Private Purchased by: Private | | Symptoms: Unevaluable event | | Write-up: Patient received vaccines on 7/21. Patient expired during the night of 7/22-23. Do not know if expired before or after midnight of 7/22. |
|
|
| VAERS ID: | 207831 | Vaccination Date: | 2003-07-23 | | Age: | 0.3 | Onset Date: | 2003-07-26 Days later: 3 | | Gender: | Male | Submitted: | 2003-08-11 | | State: | Florida | Entered: | 2003-08-14 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-07-26) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: NONE | | Diagnostic Lab Data: NONE | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: Prematurity; No prenatal care; Jaundice; GERD | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21881E9 | 1 | IM | RL | | HIBV | MERCK & CO. INC. | 0255N | 1 | IM | LL | | PNC | LEDERLE LABORATORIES | 492856 | 1 | IM | LL | |
| Administered by: Public Purchased by: Public | | Symptoms: Sudden infant death syndrome | | Write-up: Impression: SIDS. This case was reported by a nurse and described an infant who died after receiving diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. The vaccine provider submitted a report directly to VAERS. The patient's past medical history included premature birth at 34 weeks' gestation; there had been no prenatal care. The medical history also included gastric reflux. Concurrent medications were not reported. On 7/21/03 the patient received an injection of Pediarix (lot 21881E9), as well as, other unspecified vaccines. Three days post immunization, on 7/26/03, the patient died. Cause of death was unknown. An autopsy was performed; the results were not available as of 8/13/03. Death certificate confirms the cause of death as SIDS. - 10/16/2003 autopsy report rec'd. COD confirmed as SIDS. |
|
|
| VAERS ID: | 207832 | Vaccination Date: | 2003-08-05 | | Age: | 0.1 | Onset Date: | 2003-08-06 Days later: 1 | | Gender: | Female | Submitted: | 2003-08-11 | | State: | Florida | Entered: | 2003-08-14 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-08-06) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: NONE | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: Thrush | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21881E9 | 0 | IM | RL | | HIBV | MERCK & CO. INC. | 0255N | 0 | IM | LL | | PNC | LEDERLE LABORATORIES | 492856 | 0 | IM | LL | |
| Administered by: Public Purchased by: Public | | Symptoms: Sudden infant death syndrome | | Write-up: Impression: SIDS. 9/3/03 Per review of autopsy report, final COD was confirmed as SIDS. |
|
|
| VAERS ID: | 209326 | Vaccination Date: | 2003-08-25 | | Age: | 0.3 | Onset Date: | 2003-08-27 Days later: 2 | | Gender: | Male | Submitted: | 2004-09-17 | | State: | California | Entered: | 2003-09-17 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-08-27) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Toxicology results and other labs are still pending. From additional information received on 9/13/04 from the coroner's autopsy report: 8/28/03 Autopsy findings: Petechial hemorrhages on the pleura surfaces of the lungs. Occasional petechia | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: The pt received a previous dose of Hep B vaccine, number 1736J, in the right thigh on 17May03. | | CDC 'Split Type': 200301891 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21895A2 | 0 | RL | | | HEP | MERCK & CO. INC. | 1736J | 1 | RL | | | HIBV | AVENTIS PASTEUR | UA841AC | 0 | RL | | | PNC | LEDERLE LABORATORIES | 492410 | | RL | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Anorexia, Insomnia, Sudden infant death syndrome | | Write-up: This subject was a 15 week old male, who died while enrolled in a Comparative post-marketing safety study of Daptacel administered with other recommended vaccines according to the US standard of care, Protocol number P3T08. The subject received first series of vaccines on 8/25/03. This case was discovered when telephone interviewers attempted to complete a second interview. The coroner's office findings as of yet are inconclusive and not suggestive of an obvious cause of death. The toxicology results and other labs were still pending. The parents completed their first interview approximately two hours prior to the time of death and reportedly only some restless sleep on day of vaccination and the next day, loss of appetite on day of vaccination and next day. Otherwise, parents reported no symptoms. The subject died two days after vaccination. Autopsy results are pending. The causality is pending, awaiting cause of death. From additional info received on 9/18/03. The subject's initials were previously reported incorrectly and through email correspondence received on this date, the correct info was reported. The VAERS number was also reported as 209326. Follow up on 10/01/2003: "This subject is a 15 week old male, who died while enrolled in a Comparitive post-marketing safety study of Daptacel (Diphtheria and Tetanus toxoids and Acellular Pertissis Vaccine Adsorbed) administered with other recommended vaccines according to the US standard of care, Protocol number P3T08. The subject received first series of vaccines on 08/25/2003. This case was discovered when telephone interviewers attempted to complete a second interview. The coroner's office findings as of yet are inconclusive and not suggestive of an obvious cause of death. The toxicology results and other labs were still pending. The parents completed their first interview approximately two hours prior to the time of death and reported only some restless sleep on day of vaccination and the next day, loss of appetite on day of vaccination and next day. Oth |
|
|
| VAERS ID: | 209397 | Vaccination Date: | 2003-08-28 | | Age: | | Onset Date: | 0000-00-00 Days later: | | Gender: | Male | Submitted: | 2003-09-12 | | State: | Kentucky | Entered: | 2003-09-18 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-09-11) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: Mild URI | | Diagnostic Lab Data: Per coroner preliminary autopsy no pathology, preliminary diagnosis. | | Previous Vaccinations: | | Other Medications: Diflucan, lactose syrup | | Preexisting Conditions: Laryngomalacia, thrush, constipation | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21912A2 | 0 | IM | LL | | HIBV | AVENTIS PASTEUR | UA774AA | 0 | IM | RL | | PNC | LEDERLE LABORATORIES | 493259 | 0 | IM | RL | |
| Administered by: Private Purchased by: Public | | Symptoms: Sudden infant death syndrome | | Write-up: SIDS. |
|
|
| VAERS ID: | 211047 | Vaccination Date: | 2003-10-09 | | Age: | 0.4 | Onset Date: | 2003-10-10 Days later: 1 | | Gender: | Female | Submitted: | 2003-10-23 | | State: | Georga | Entered: | 2003-10-28 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-10-10) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: NONE | | Diagnostic Lab Data: NONE | | Previous Vaccinations: | | Other Medications: NONE | | Preexisting Conditions: Prematurity | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21893B9 | 1 | IM | | | HIBV | MERCK & CO. INC. | 1170M | 1 | IM | | | PNC | LEDERLE LABORATORIES | 494303 | 1 | IM | | |
| Administered by: Private Purchased by: Public | | Symptoms: Sudden infant death syndrome | | Write-up: Unknown. Died in sleep. The autopsy report received on 3/9/04 states SIDS. |
|
|
| VAERS ID: | 211877 | Vaccination Date: | 2003-10-29 | | Age: | 0.1 | Onset Date: | 2003-11-03 Days later: 5 | | Gender: | Female | Submitted: | 2003-11-04 | | State: | Michigan | Entered: | 2003-11-07 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-11-03) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? Yes |
| Hospitalized? No | | Current Illness: NONE | | Diagnostic Lab Data: | | Previous Vaccinations: | | Other Medications: NONE | | Preexisting Conditions: Newborn rash on cheeks | | CDC 'Split Type': | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21897A9 | 0 | IM | LL | | HIBV | AVENTIS PASTEUR | UE054AA | 0 | IM | LL | | PNC | LEDERLE LABORATORIES | 494310 | 0 | IM | RL | |
| Administered by: Private Purchased by: Private | | Symptoms: Unevaluable event | | Write-up: Patient was seen for well check on 10/29/03. She received vaccines and per parents tolerated them very well. She was well over the following days but found dead on 11/03/2003 AM. |
|
|
| VAERS ID: | 213146 | Vaccination Date: | 2003-08-05 | | Age: | 0.3 | Onset Date: | 2003-09-19 Days later: 45 | | Gender: | Male | Submitted: | 2004-02-12 | | State: | California | Entered: | 2003-12-01 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-09-19) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Acylcarnitine Profile and Congenital Adrenal Hyperplasia-within normal limits.AP and lateral skull x-rays-there is an apparent endotracheal tube extending to the midchest. There is no evidence of a fracture. There are no metallic foreign bo | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: | | CDC 'Split Type': 200303060 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21883B2 | | | | | HIBV | AVENTIS PASTEUR | W0602 | | | | | PNC | LEDERLE LABORATORIES | 492929 | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Laboratory test abnormal, Sudden infant death syndrome | | Write-up: This subject is a 3 month old male, who died while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants as a booster to toddlers, Protocol number P3T08. The subject received one dose of Pediarix vaccine, ACTHIB, PRevnar. The last dose prior to the event was given on 8/5/03. The subject died 45 days post-immunization. The event of SIDS was reported by the investigator as not related to the study vaccine. The pathology report states that the subject was pronounced dead at 2346 hours of 9/19/03. The disease or condition directly leading to death is consistent with sudden infant death syndrome. Anatomical diagnoses: 1) Petechial hemorrhages, heart, lungs. Thymus; 2) No congential anomalies; 3) Pulmonary congestion and edema and 4) Visceral organ congestion. The autopsy report states body appearing the stated age of 3 months. Evidence of medical therapy is present: 1) an interosseous needle present in the left thigh. At the time of the autopsy exam, the needle has come out of the thigh. In addition, there is a second apparent needle puncture mark in the same location; 2) an oral tracheal tube secured around the neck by tape; 3) an electrical monitoring device taped to the right big toe; and 4) multiple cardiac monitoring pads over the torso. There are no blunt injuries to the body. Fontanelles are flat. Statures are moveable. Present in the right occipital area about two inches above the ear, is a 1/2 inch red defect consistent with a hemangioma. Pupils are round. Irides are brown. Sclerae are white. No petechial hemorrhages are noted. Ears, nose and lips are non remarkable. Neck is normal. Chest is flat. The breasts are consistent with an infant male. The umbilicus is well-healed. The abdomen is flat. The external genitalia are non remarkable. Legs and feet are normal. Each foot and hand has five digits. No simian folds are present. The back is non remarkable. The anus is p |
|
|
| VAERS ID: | 213203 | Vaccination Date: | 2003-04-15 | | Age: | 0.5 | Onset Date: | 2003-08-14 Days later: 121 | | Gender: | Female | Submitted: | 2004-02-11 | | State: | California | Entered: | 2003-12-01 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-08-14) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: | | Diagnostic Lab Data: Specimen: heart blood sample. 0.28mg/L of Atropine was detected in a heart blood sample. No other common acidic, neutral or basic drugs were detected. No blood Ethyl Alcohol or other alcohols or acetone were detected. No analgesics or barbi | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: | | CDC 'Split Type': 200303053 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21883B2 | | | | | HIBV | AVENTIS PASTEUR | W1005 | | | | | PNC | LEDERLE LABORATORIES | 491168 | | | | |
| Administered by: Unknown Purchased by: Unknown | | Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome | | Write-up: This subject is a 6 month old female, who was pronounced dead due to sudden infant death syndrome while enrolled in a Comparative post-marketing study of CPDT Vaccine Absorbed administered with other recommended vaccines according to the US standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received one dose of Pediarix on 4/15/03. Other vaccines received on the same day were PRP T and Prevnar. THe subject was pronounced dead at 18:26 hours on 8/14/03. The condition directly leading to death was consistent with sudden infant death syndrome. Anatomical diagnoses reported included pulmonary congestion and edema as well as visceral congestion. There were no congenital anomalies. 0.28mg/L of Atropine was detected in a heart blood sample. No other common acidic, neutral or basic drugs were detected. No blood Ethyl Alcohol or other alcohols or acetone were detected. No analgesics or barbiturates were detected by specific Immunoassay. According to the autopsy report, there were no blunt injuries to the body. The outcome of this event is fatal. The event of sudden infant death syndrome was reported by the investigator as unlikely/not related to the study vaccine. |
|
|
| VAERS ID: | 216572 | Vaccination Date: | 2003-11-04 | | Age: | 0.2 | Onset Date: | 2003-11-05 Days later: 1 | | Gender: | Female | Submitted: | 2004-01-03 | | State: | Colorado | Entered: | 2004-02-17 | |
| Life Threatening Illness? No |
| Died? Yes (date died: 2003-11-05) |
| Disability? No |
| Recovered? No | | ER or Doctor Visit? No |
| Hospitalized? No | | Current Illness: recovering URI | | Diagnostic Lab Data: Autopsy: "cause undetermined" | | Previous Vaccinations: | | Other Medications: | | Preexisting Conditions: prematurity, twin infant | | CDC 'Split Type': C0030044 | |
| Vaccination | Manufacturer | Lot | Dose | Route | Site | | DTAPHE | GLAXOSMITHKLINE BIOLOGICALS | 21912AZ | 0 | SC | RL | | HIBV | MERCK & CO. INC. | 0663N | 0 | SC | LL | | PNC | LEDERLE LABORATORIES | 493266 | 0 | SC | LL | |
| Administered by: Private Purchased by: Public | | Symptoms: Unevaluable event | | Write-up: Pt. given first set of immunizations. Found dead at 8am the next morning. Autopsy shows cause "undetermined". |
|
|