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Life Threatening? No
Write-up: unexpected sudden death 4 days after vaccinations given; This case was reported by a physician via regulatory authority and described the occurrence of sudden infant death in a 13-week-old male patient who received Rota (Rotarix liquid formulation) (batch number AROLA014CA, expiry date unknown) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD199A, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number ABX756AA, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number X46171, expiry date unknown) for prophylaxis. On 15th January 2019, the patient received Rotarix liquid formulation (unknown), Infanrix hexa (intramuscular), Bexsero (intramuscular) and PREVENAR 13 (intramuscular). On 19th January 2019, 4 days after receiving Rotarix liquid formulation, Infanrix hexa and Bexsero, the patient experienced sudden infant death (serious criteria death and GSK medically significant). On 19th January 2019, the outcome of the sudden infant death was fatal. The patient died on 19th January 2019. The reported cause of death was sudden infant death. An autopsy was performed. It was unknown if the reporter considered the sudden infant death to be related to Rotarix liquid formulation, Infanrix hexa and Bexsero. Additional details: Age at vaccination was not reported however patient could be 12 or 13 weeks old at time of vaccination. Batch number for ROTARIX was reported as AROLCO14CA , however on batch number review it was corrected as AROLA014CA. It was unknown if the reporter considered the sudden infant death to be related to Prevenar 13. Initial information was received from a physician via regulatory authority on 20th February 2019. unexpected sudden death 4 days after vaccinations given. Note: Route of administration for Rotarix was discrepantly reported as Intramuscular however it was supposed to be administered orally.; Reported Cause(s) of Death: Sudden infant death
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