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Life Threatening? No
Write-up: Death; This case was reported by a physician via regulatory authority and described the occurrence of death unexplained in a 8-week-old female patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD450A, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLC259AE, expiry date unknown) for prophylaxis, Men B NVS (Bexsero) (batch number abx7abaa ?, expiry date unknown) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number AN3638, expiry date unknown) for prophylaxis. Concomitant products included sodium feredetate (Sytron) and vitamins nos (Dalivit). On 21st November 2019, the patient received Infanrix hexa (unknown), Rotarix liquid formulation (unknown), Bexsero (intramuscular) and PREVENAR 13 (unknown). On 22nd November 2019, 1 days after receiving Infanrix hexa, Rotarix liquid formulation and Bexsero, the patient experienced death unexplained (serious criteria death and GSK medically significant). On 22nd November 2019, the outcome of the death unexplained was fatal. The patient died on 22nd November 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death unexplained to be related to Infanrix hexa, Rotarix liquid formulation and Bexsero. Additional details: The age at vaccination was not reported. The reported batch number abx7abaa for bexsero did not match with GSK lot number. Initial information was received from a physician via regulatory authority on 11 December 2019: Death unexplained.; Reported Cause(s) of Death: Death unexplained
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