Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | A5DP7 | — |
underdose; Adult dose to pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number A5DP7, expiry date 11-AUG-2027) for prophylaxis. On 15-JUL-2025, the patient received Engerix B adult 1 ml. On 15-JUL-2025, an unknown time after receiving Engerix B adult, the patient experienced underdose (Verbatim: underdose) and adult product administered to child (Verbatim: Adult dose to pediatric patient). The outcome of the underdose and adult product administered to child 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: 16-JUL-2025 The registered nurse gave an adult dose of Engerix-B (1 milliliter) to a 19 year old patient on 15th July 2025 which led to adult product administered to child and underdose.