Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC, DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: Anorexia, Insomnia
Clinical narrative: 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.  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 information received on 09/18/2003.  The subjects initial were previously reported incorrectly and through e-mail correspondence received on this date, the correct information was reported.  The VAERS number was also reported as 209326.  From additional information received on 09/24/2003 from the site, the date of death was reported as 19:15, a corrected date of injection for the Hep B vaccine was reported as 05/17/2003, and the lot number for Pediarix was reported as 21895A2.  No other information was provided.  From additional information received on 09/25/2003 from VAERS (209326) it was reported that the Deputy Coroner, who contacted VAERS, stated that she thought there was a preliminary cause of death listed as SIDS.  Additional details provided were that the child was put to sleep by his father at 13:30, he was wrapped in a comforter.  five and a half hours later the father found the baby, cold and blue.  He called 911 and they instructed him to start CPR.  Upon arrival of the ambulance, they found the baby to have lividity and rigor and he was pronounced dead.  VAERS stated that they would call us back after their conversation with the coroner." Follow up on 10/10/2003: "Follow up information indicated that the "date" of death was 19:15.  The deputy coroner stated that she thought there was a preliminary cause of death listed as SIDS.  It was reported that the child was put to sleep by his father at 13:30, he was wrapped in a comforter.  Five and a half hours later the father found the baby cold and blue.  He called 911 and they instructed him to start CPR.  Upon irrival of the ambulance, they found the baby to have lividity and rigor and he was pronounced dead.  Additional details to be provided after a conversation with the coroner.  At this time, relationship of the adverse experiences to study therapy is unknown.  Other business partner numbers include 2003-01891.  Additional information is expected." A follow up report received 10/15/2003 adds no new info. Follow up on 12/19/03: "From additional information received 12/04/03, no updated information regarding this subject has been obtained.  Preliminary information is still indicating SIDS, per the coroner's office, who will give candid information via voice, but will not provide anything in writing until finalized.  Per the interview with the father (scheduled call back at 48 hours post immunization, as per protocol) on 08/27/03 at 17:00, it was not known if the infant had a temperature.  The infant had been given an antipyretic after the vaccination (product frequency or dose not reported).  ACTHIB Lot # UA841AC/W1254-2." Medical assesment: File to be completed.  Follow up on 05/24/04 states: "From additional information received on 05/20/04 from the study site, it was reported that the autopsy reports are pending. Preliminary autopsy information shows no unusual findings. Update of 05/18/04; still incomplete findings howevere, a verbal confirmation of SIDS was provided. The event of SIDS was reported as unrelated to the vaccines. This subject did not receive the study vaccine." From additional information received on 9/13/04 from the coroner's autopsy report, it was reported that the patient was pronounced deceased on 8/27/03 at 1915 hours by the fire chief. At the time the coroner arrived at the scene he observed that the infant was on the floor next to the parent's bed. His clothes had been cut off and were under his body. The infant was wearing a white diaper, which appeared to be wet. Fixed lividity was present to his back, head and bottom of his feet. The coroner observed no visual trauma. On 8/25/03, the patient had received Polio, DtaP/DTP, HIB, Hepatitis B and Pneumococcal immunizations and had a check up. On the day of his death, he was crying al ot and not eating too much. Nothing else out of the ordinary was noted. According to the autopsy findings: Petechial hemorrhages on the pleural surfaces of the lungs. Occasional petechial hemorrhages on the thymus gland. There is no evidence of recent trauma. Opinion as to the cause of death: sudden unexplained death in an infant. Manner of death: natural. Per the investigator the adverse event of sudden unexplained death in an infant is considered unrelated to the study vaccine. The serious adverse event report list the immunizations given on 8/25/03 as PEDIARIX, PRP-T, and PREVNAR. No further information is anticipated, this case is considered as closed.