Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | J3952 | — |
Administration of an Engerix-B adult dose to a 4-year-old patient; Administration of an Engerix-B adult dose to a 4-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 4-year-old female patient who received HBV (Engerix B adult) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis. On 18-SEP-2025, the patient received Engerix B adult. On 18-SEP-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Administration of an Engerix-B adult dose to a 4-year-old patient) and overdose (Verbatim: Administration of an Engerix-B adult dose to a 4-year-old patient). The outcome of the adult product administered to child and overdose were 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: 22-SEP-2025 A healthcare professional reported regarding the administration of an Engerix-B adult dose to a 4-year-old patient and asked for guidance to handle this situation which led to adult product administration to child and overdose.