Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
pediatric patient received Pediarix and Engerix-B the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (received on 24-SEP-2024). On 03-FEB-2025, the patient received Engerix B and Pediarix. On 03-FEB-2025, an unknown time after receiving Engerix B and Pediarix, the patient experienced overdose (Verbatim: pediatric patient received Pediarix and Engerix-B the same day). The outcome of the overdose was not applicable. 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: 03-FEB-2025. Practice Manager and explained that they administered an extra dose of Hepatitis B vaccine, since a pediatric patient received Pediarix and Engerix-B the same day which led to overdose. Caller mentioned that patient received a prior Pediarix dose and no prior Engerix-B doses. Lot number and expiration date for the vaccines were not asked by the agent, but practice manager gave consent to follow up with safety if additional information was needed.