Sex: M
Vaccine: DTAP, FLU3, FLU3, FLU3, HEP, HEPA, HEPA, HIBV, PNC13, RV5, DTAP, DTAPHEPBIP, FLU3, FLU4, FLU4, HEPA, HEPA, HIBV, PNC13, RV5
Symptoms: Autopsy, Death, Product administered to patient of inappropriate age
Clinical narrative: The boy passed away while napping; Overdose; This serious case was reported by a consumer via other manufacturer and described the occurrence of unknown cause of death in a 2-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis, DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, Influenza vaccine (Fluzone) for prophylaxis, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (batch number FX6077) for prophylaxis, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (batch number FX6077) for prophylaxis, HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for prophylaxis and HEPATITIS A VACCINE INACT (VAQTA) for prophylaxis.   Previously administered products included Prevenar (Received dose 1 on 03-NOV-2022; Lot Number: FN5555, received on Doctor's office/urgent care) and Prevenar (received dose 2 on 29-DEC-2022; Lot Number: FN5555, received on Doctor's office/urgent care). Concurrent medical conditions included drug allergy.   On 02-MAR-2023, the patient received Pediarix, FluLaval Quadrivalent 2022-2023 season, Fluarix Quadrivalent 2022-2023 season, Infanrix, Havrix, Fluzone, ROTATEQ, the 3rd dose of PREVNAR 13, PEDVAXHIB and VAQTA. On 02-MAR-2023, not applicable after receiving Pediarix, Fluarix Quadrivalent 2022-2023 season, Infanrix and Havrix and an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced overdose (Verbatim: Overdose). On 09-MAR-2025, the patient experienced unknown cause of death (Verbatim: The boy passed away while napping) (serious criteria death and GSK medically significant). The outcome of the overdose was not applicable. The patient died on 09-MAR-2025. The reported cause of death was unknown. An autopsy was performed.   It was unknown if the reporter considered the unknown cause of death to be related to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Fluarix Quadrivalent 2022-2023 season, Infanrix, Infanrix Pre-Filled Syringe Device and Havrix.     The company considered the unknown cause of death to be unrelated to Pediarix, Pediarix Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season, Fluarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device and Havrix.   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: 31-Mar-2025 The 2 years old boy passed away while napping with no previous conditions on 09 March 2025. An autopsy was performed. Autopsy remarks were reported as pending. The reported cause of death was unknown. No other vaccines were administered within four weeks prior to the suspect vaccine. It was unknown if other medications were administered within two weeks of the event.; Sender's Comments: Death is an unlisted event which is considered unrelated to GSK vaccine Pediarix, Pediarix PRE-FILLED SYRINGE DEVICE, FluLaval Quadrivalent 2022-2023 season, FluLaval Tetra PRE-FILLED SYRINGE DEVICE, Fluarix Quadrivalent 2022-2023 season, Fluarix PRE-FILLED SYRINGE DEVICE, Infanrix, Infanrix PRE-FILLED SYRINGE DEVICE and Havrix.; Reported Cause(s) of Death: unknown cause of death