Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAPHEPBIP, HIBV, PNC, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: 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 medical history was not reported. The patient had thrush at the time of immunization. Concurrent medications were not reported. On 8/5/03 or 8/6/03 the patient received an injection of Pediarix (lot 21881E9), as well as, other unspecified vaccines. Less than 23 hours post immunization, on 8/6/03, the patient died. Cause of death was unknown. An autopsy was performed; the results were not available as of 8/13/03. A 15-day follow up report received 8/29/2003 add that the pt was a 7-week-old female. At time of immunization, concurrent medications included an unspecified "solution for thrush". The most recent info was received from another nurse at the vaccination clinic on 08/26/2003. She reported than an autopsy was performed and "did not reveal any problems." She stated that the cause of death was sudden infant death syndrome. She also stted that she did "not think the vaccine caused" the death, but was "hesitant to give any further info because law suits are now pending." Comment: This reporter also indicted that another infant died following receipt of Pediarix and other vaccines (please see report A0420913A). Cancelled report: This report has been determined to be a duplicate of report HQWYE442002SEP03.  Information regarding Prevnar was received from a consumer regarding a 1 month old female patient who experienced sudden infant death syndrome.  The patient received the first dose on 08/05/2003.  The patient also received the first dose of HIB, the first dose of DTAP, the first dose of IPOL, and the first dose of Hep B on 08/05/2003.  MEDICAL HISTORY: The infant had no relevant medical history.  PRODUCT DETAILS: Indication for Prevnar was immunization.  Product was administered on 08/05/2003.  Dose regimen was one dose of 0.5ml (IM).  CONCOMITANT THERAPY: Concomitant medications were not reported.  EVENT DETAILS: The patient died on 08/05/2003.  The cause of death was reported as sudden infant death syndrome.  No additional information was available at the time of this report.  MANUFACTURER'S COMMENT: Information about this event has been forwarded to AP, manufacturer of IPOL."  Follow up on 12/08/2003: "Follow up info received on 11/25/03 provided the Prevnar lot number.  This report was determined to be a duplicate of report HQWYE389327AUG03.  Report HQWYE389327AUG03 has been cancelled and appended to report HQWYE442002SEP03, which will remain the case of record.  A nurse reported that a 1 month old female received a dose of Prevnar on 08/05/03. On 08/05/03, less than 24 hours post-immunization, the patient died.  On 08/26/03, another nurse at the vaccination clinic reported that an autopsy was performed and "did not reveal any problems".  The autopsy cause of death was reported as Sudden Infant Death Syndrome.  It was stated that she did "not think the vaccine caused" the death, but was "hesitant to give any further information because law suits are now pending."  This report was received from GSK (Ref. No. A2422280A)."