Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | EB9ZX | — |
adult version of Engerix was given to a pediatric patient; adult version of Engerix was given to a pediatric patient; 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 13-year-old female patient who received HBV (Engerix B adult) (batch number EB9ZX) for prophylaxis. On 08-SEP-2025, the patient received Engerix B adult. On 08-SEP-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: adult version of Engerix was given to a pediatric patient) and overdose (Verbatim: adult version of Engerix was given to a pediatric 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:08-SEP-2025 Nurse reported that the adult version of Engerix was given to a pediatric patient, which led to adult product administered to child and Overdose.