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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death unexplained in a 2-month-old male patient who received INFANRIX HEXA for prophylaxis. Co-suspect products included ROTARIX for prophylaxis, BEXSERO for prophylaxis, paracetamol unknown for fever and PREVENAR 13 for prophylaxis. On 5th June 2018, the patient received INFANRIX HEXA(intramuscular), ROTARIX (oral) and BEXSERO (intramuscular). On 6th June 2018, the patient started paracetamol (oral) at an unknown dose and frequency. On 5th June 2018, the patient received PREVENAR 13 (intramuscular). On 8th June 2018, 3 days after receiving INFANRIX HEXA, ROTARIX and BEXSERO and 2 days after starting paracetamol, the patient experienced death unexplained (serious criteria death, GSK medically significant and other: serious per reporter). In June 2018, the patient experienced feeling unwell (serious criteria other: serious per reporter) and high temperature (serious criteria other: serious per reporter). Paracetamol was discontinued on 7th June 2018. On 8th June 2018, the outcome of the death unexplained was fatal. On an unknown date, the outcome of the feeling unwell and high temperature were unknown. The patient died on 8th June 2018. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the death unexplained, feeling unwell and high temperature to be related to INFANRIX HEXA, ROTARIX, BEXSERO and paracetamol. Additional information: It was unknown if the reporter considered the death unexplained, feeling unwell and high temperature to be related to PREVENAR 13. Age at vaccination was not reported, However the patient could be 1 or 2 months old at the time of vaccination. Initial information was received from a physician via regulatory authority on 3rd December 2018: Death unexplained, feeling unwell and high temperature.; Reported Cause(s) of Death: Death unexplained.
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