Received May 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | J3952 | — |
Unapproved vaccine administration; Overdose; 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 6-month-old male patient who received HBV (Engerix B adult) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis. On 15-OCT-2024, the patient received the 2nd dose of Engerix B adult. On 15-OCT-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Unapproved vaccine administration) and overdose (Verbatim: Overdose). 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: 23-MAY-2025 Health Care Provider called to inform that during an audit it was found an adult dose of Engerix-B was administered to a child which led adult product administered to child and overdose. She wanted safety data for infants that received Engerix-B adult dose. The reporter consented to follow up.