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Life Threatening? No
Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of death unexplained in a 8-week-old male patient who received INFANRIX HEXA (batch number A21CD114A, expiry date unknown) for prophylaxis. Co-suspect products included BEXSERO (batch number 172601, expiry date unknown) for prophylaxis, ROTARIX liquid formulation (batch number AROLB846BF, expiry date unknown) for prophylaxis and PREVENAR 13 (batch number W91639, expiry date unknown) for prophylaxis. On 24th October 2018, the patient received INFANRIX HEXA (intramuscular), BEXSERO (intramuscular) 1 dosage form(s), ROTARIX liquid formulation (oral) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 26th October 2018, 2 days after receiving INFANRIX HEXA, BEXSERO and ROTARIX liquid formulation, the patient experienced death unexplained (serious criteria death and GSK medically significant). On 26th October 2018, the outcome of the death unexplained was fatal. The patient died on 26th October 2018. 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, BEXSERO and ROTARIX liquid formulation. Additional information: The age at vaccination was not reported. However, the patient could be 8 weeks or less than 8 weeks at the time of vaccination. Initial information was received a other health professional via regulatory authority on 8th January 2019: Child died 2 days after vaccination. I do not think the vaccination was the cause of the death. I have been advised to complete a yellow card and submit to the RA in line with best practice. Reported Cause(s) of Death: Death unexplained.
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