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Life Threatening? No
Write-up: Initial SAE report received on 13 May 2005. Additional information received on 06 June 2005. This subject is 16 month old male, who died from the congential anomaly static encephalopathy while enrolled in a study of DAPTACEL administered with other recommended vaccine according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dose of study vaccine. The last dose prior to the event was given on 03 November 2004. On that same date, the subject concomitantly received a dose of ActHib, lot number UE237AA (lot number 200672); a dose MMR/Measles, Mumps and Rubella Vaccine lot number 0181N and a dose of Prevenar lot number A74399C. The subject suffered from static encephalopathy and had a past medical history of central hypoventilation syndrome. The subject died on 28/Nov/2004, 25 days post-vaccination. Autopsy information is pending. The event of static encephalopathy was reported by the investigator as not related to the study vaccine. From additional information received on 06 June 2006 it was reported that pathological studies determined that the patient had Rett Syndrome. During internal review on 17 June 2005 it was noted that congenital anomaly was ticked in error for serious criteria. A corrective version was created to amend this. List of additional information available in source documents. Death certificate received which revealed COD: cardiopulmonary failure, arrhythmia-V-tach, encephalopathy and seizure disorder/ss
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