Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 3 | 4BX39 | — |
A 2-year-old patient received an adult dose of Engerix-B; A 2-year-old patient received an adult dose of Engerix-B; 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 2-year-old female patient who received HBV (Engerix B adult) (batch number 4BX39, expiry date 29-JUL-2027) for prophylaxis. Previously administered products included Engerix B (received 1st dose on an unknown date) and Engerix B (received 2nd dose on an unknown date). On an unknown date, the patient received the 3rd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: A 2-year-old patient received an adult dose of Engerix-B) and overdose (Verbatim: A 2-year-old patient received an adult dose of Engerix-B). 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: 20-JUN-2025 The medical assistant called to reported that they administered an adult dose of Engerix-B to a patient who was 2 years old which led to, adult product administered to child and overdose. The reporter mentioned that this was the 3rd dose of Engerix-B that the patient had received. The reporter had a questioned what was next steps to follow.