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: It was reported that a two month old male received DTaP, HIB, IPV, PCVT and Hep B vaccines on 04/19/2002. Pt found dead/not breathing at 6am on 04/20/2002. Follow-up telephone call on 06/03/2002 for additional info on pt, doctor stated that without pt's full name she is unable to provide any information. Doctor also stated that the administered product was IPOL and not IPV. AS per regulatory affairs, the lot number (U0179) that had been originally reported for IPV was that of Yellow Fever. The lot number for IPOL produce was not reported. From faxed correspondence received on 06/10/02 it was reported. "This report was received for Streptococcus pneumoniae vaccine (Prevnar) and was assigned manufacturer control number HQ2420023MAY2002. Info has also been received from a physician concerning an 11 week old male pt with a history of one previous episode of wheezing (time not specified, treated with albuterol), no other significant past medical history and no concurrent conditions, who on 04/19/02 at 15:00 was vaccinated in the right thigh with the first dose (lot 152K reported, invalid for the product) of Haemophilus B conjugate vaccine (reported as HIb). Concomitant therapy that same day at 15:00 included the second dose (illegible lot number reported) in the right thigh of ep B vaccine recombinant, the first dose (lot U0179) in the left thigh of IPOL, the first dose  in the left thigh of Infanrix, and the first dose (lot 485043) in the right thigh of Prevnar. It was reported that the pt had a mild upper respiratory infection at the time of vaccination, and that the pt did not have any wheezing on the day of vaccination. The pt was not on any medications to the physician's knowledge. It was noted that the episode of wheezing has not been in the several days prior to the vaccinations. On 04/20/02 at6:00, the pt was found not breathing. The pt died on 04/20/02. The pt had no history of adverse events after prior vaccination. It was reported that an autopsy was done, but that the results were pending. Additional info has been requested. From mailed correspondence received on 06/10/02, it was reported that 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. This case is closed. Follow-up #2 faxed correspondence received on 06/17/02 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. Following info received through telephone contact on 06/19/02 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). Doctor 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 authorize the release fo these records when they become available. Follow-up info received through telephone contact 200 doses received and gave (lot U0179-2). Also received faxed invoice for vaccine. Follow-up with regulatory affairs and confirmed lot number U0179-2 is for IPOL. A 15-day follow up report received 10/25/2002 adds: The vaccine provider supplied a copy of the autopsy report (available upon request) on 10/08/2002. The pathologist noted that "The pulmonary parenchyma was dark red-purple, exuding slight to moderate amounts of blood and frothy fluid; no focal lesions were noted." The pathologist's final diagnosis was recorded as "Sudden Unexpected Death in Infancy (SUDII): A. No gross or microscopic abnormalities. B. Negative toxicology. C. Deceased found unresponsive in bed with an adult. OPINION: This 2 month old black male infant...died of Sudden Unexpected Death in Infancy (SUDII). In cases of death of an infant, once abnormalities such as congenital defects, infection or toxicology are ruled out, Sudden Infant Death Syndrome (SIDS) becomes a possibility. The criteria for a diagnosis of SIDS is very strict and this by definition is a diagnosis of exclusion. As this infant was sharing a bed with an adult, while unlikely, the possibility of asphyxia due to accidental overlying cannot be definitely ruled out. The physical findings can be the same in SIDS and accidental overlying. Therefore, this death is ruled a Sudden Unexpected Death in Infancy (SUDII). The manner of death is UNDETERMINED. Alcohol or drugs were not detected on toxicologic analysis." The vaccine provider stated that SUDII was "possibly related but presumed not related" to Infanrix administration.