Sex: U
Vaccine: DTAPHEPBIP, PNC13, RV5, UNK, UNK
Symptoms: Cardiac disorder, Death, Ear infection, Pulse absent, Shock
Clinical narrative: Shock-associated circulatory or cardiac conditions; cardiac conditions, Unexpected death; Found pulseless; Ear infection; This case was reported by a consumer via other manufacturer and described the occurrence of shock in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis and TOZINAMERAN (PFIZER CORONAVIRUS VACCINE) for prophylaxis.   On 16th September 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, PREVNAR 13, ROTATEQ and PFIZER CORONAVIRUS VACCINE. In September 2022, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced ear infection (serious criteria death). On 26th September 2022, the patient experienced shock (serious criteria death and GSK medically significant), heart disorder (serious criteria death and GSK medically significant) and pulseless (serious criteria death). On an unknown date, the outcome of the shock, heart disorder, ear infection and pulseless were fatal. The patient died on 26th September 2022. The reported cause of death was shock, heart disorder, pulseless and ear infection.   It was unknown if the reporter considered the shock, heart disorder, ear infection and pulseless to be related to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments: The reporter reported that baby (patient) dies suddenly from cardiac conditions 10 days after receiving 4 vaccines.  The patient received Pediarix, FluLaval Seasonal Quadrivalent Influenza, Prevnar13, Rotateq, Pfizer coronavirus vaccine on 16th September 2022 and the baby experienced shock associated circulatory or cardiac conditions. It was an unexpected death, the patient was taking a nap in the afternoon and found pulseless in a crib and died on the 26th September 2022. The baby had an ear infection at the time. It was unknown if the reporter considered the shock, heart disorder, pulseless and ear infection to be related to Prevnar13, Rotateq, Pfizer coronavirus vaccine. Additional Supportive Information: As it was not clear if the patient had ear infection at the time of vaccination or death, hence conservatively captured as event.; Reported Cause(s) of Death: Shock; Heart disorder; Pulseless; Ear infection