Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 47XP4 | — |
Engerix-B Pediatric Dose on a female adult patient; Engerix-B Pediatric Dose on a female adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. On 04-MAR-2025, the patient received Engerix B pediatric. On 04-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B Pediatric Dose on a female adult patient) and underdose (Verbatim: Engerix-B Pediatric Dose on a female adult patient). The outcome of the adult use of a child product and underdose 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 04-MAR-2025 Registered Nurse called to report the maladministration of an Engerix-B pediatric dose on a female adult patient and was seeking for advice on this situation (revaccination/how to proceed).