Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | H39Z4 | — |
pediatric patient received an adult dose; pediatric patient received an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis. On 03-MAR-2025, the patient received Engerix B adult. On 03-MAR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: pediatric patient received an adult dose) and overdose (Verbatim: pediatric patient received an adult dose). 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: 18-MAR-2025 Nurse called to inform that a pediatric patient received an adult dose of Engerix-B, which led to adult product administered to child and overdose.