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Life Threatening? No
Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden death unexplained in a 4-month-old female patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included BEXSERO for prophylaxis and PREVENAR 13 for prophylaxis. Previously administered products included INFANRIX HEXA with an associated reaction of no adverse event, BEXSERO with an associated reaction of no adverse event and PREVENAR 13 with an associated reaction of no adverse event. Additional patient notes included No previous reaction to immunisation. Concomitant products included paracetamol. On 11th July 2018, the patient received the 3rd dose of INFANRIX HEXA (intramuscular), the 2nd dose of BEXSERO (intramuscular) and the 2nd dose of PREVENAR 13 (intramuscular). On an unknown date, less than a month after receiving INFANRIX HEXA and BEXSERO, the patient experienced sudden death unexplained (serious criteria death, GSK medically significant and other: serious per reporter). On 13th July 2018, the outcome of the sudden death unexplained was fatal. The patient died on 13th July 2018. The reported cause of death was sudden death unexplained. It was unknown if the reporter considered the sudden death unexplained to be related to INFANRIX HEXA and BEXSERO. Additional information: The age at vaccination was not reported. However, the patient could be 3 or 4-months-old at the time of vaccination. Initial information was received from a physician via regulatory authority on 8th August 2018: Sudden death unexplained. Reported Cause(s) of Death: Sudden death.
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