Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: This report describes sudden infant death syndrome in a 2 month old male who received Infanrix. The vaccinee's medical history included one previous episode of wheezing. At the time of immunization he was experiencing a "mild" upper respiratory infection *and that the PT did not have any wheezing on the day of vax. The PT was not on any medications to the MD's knowledge* He had experienced no adverse events following prior immunizations. On 04/19/2002 at 15:00, the vaccinee received his first injection of Infanrix. On the same date, he received injections of PedvaxHIB, inactivated poliomyelitis virus vacicne, Prevnar, and his second injection of hep B vaccine. On 04/20/2002 at 6am, the infant was found not breathing. *The PT died on 4/20/02." The assistant medical examiner reportedly felt that the infant had experienced SIDS, which was not related to the immunizations administered the previous day. *The PT had no history of adverse events after prior vax. It was reported that an autopsy was done, but that the results were pending.* The most recent info received on 06/17/2002, provided the infant's birth weight and lot numbers of vaccines administered. Following info received through telephone contact with MD on 6/19/02: MD reported that autopsy was done-preliminary results were SIDS but it is not confirmed at this time, awaiting confirmation. She verified that the lot number for IPOL in the records as U0179 (yellow fever). MD was made aware this lot number is not a valid number for IPOL and requested that she call with any additional info. She is requesting the letter with FDA regulations that authorities the release of these records when they become available. From follow-up #3 faxed correspondence received at manufacturer on 6/17/02 from manufacturer the lot number for the second dose of the Hib product administered to the pt was provided: (lot number 1521K reported, invalid for the (Hib) product)." Follow up info received 10/4/02 from physician contained autopsy report which confirms cause of death to be Sudden Unexpected Death in Infancy. Additional info received from manufacturer on 6/11/02 reuslted in a revision of the reported adverse events of death to sudden infant death syndrome. Initial info was received from a physician on 5/24/02. A physician reported that a reported that a two month old male received a 1st dose of Prevnar,Infanrix, Pedvax Hib, Polio vaccine, and 2nd dose of Recombivax vaccines on 4/19/02. Medical history includes one previous episode of wheezing. Concurrent illness included "mild" upper respiratory infection. Concomitnat medication included Albuterol. On 4/20/02, at 6am, the infant was found not breathing. The assistant medical examiner reportedly felt that the infant had experienced SIDS, which was not related to the immunizations administered the previous day. An autopsy report was not available. No additional info was available as of the date of this report. A copy of this report has been forwarded to manufacturer and manufacturers of the concomitnatly administered vaccines. The manufacturer control number for this case is A0368613A. Follow up correspondence received on 10/30/02: Autopsy was performed on 4/21/02. Following are the autopsy results. External examination: Unremarkable. Internal examination: No abnormalities. Microscopic examination: No abnormalities. Neuropathology report: Within normal limits. Cause of death: Sudden unexpected death in infancy. Pathology: No gross or microscopic abnormalities, negative toxicology. Manner of death: Undetermined. No additional info available. The case is closed. The follow up states the vaccine provider notified manufacturer of the event (HQ2420023May2002). The most recent info received from manufacturer on 5/29/02, provided the infant's date of birth.