Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 7NX57 | — |
Engerix-B pediatric dose administered to a 28-year-old patient; Engerix-B pediatric dose administered to a 28-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 28-year-old female patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. Previously administered products included Hepatitis B vaccine (completed a Hepatitis B vaccination series in 1998). On 12-NOV-2025, the patient received the 1st dose of Engerix B pediatric. On 12-NOV-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix-B pediatric dose administered to a 28-year-old patient) and adult use of a child product (Verbatim: Engerix-B pediatric dose administered to a 28-year-old patient). The outcome of the underdose and adult use of a child product 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: 03-DEC-2025 A healthcare provider sought guidance on how to proceed with a 28-year-old patient who had received a pediatric dose of Engerix-B as the first dose in the series. The provider reported that the patient had decided to restart the series due to job requirements.