Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 4BX39 | — |
first dose taken in 2008 and 2nd dose on 16 Jun 2025; An 18 years old male patient received an adult dose of Engerix-B; An 18 years old male 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 drug dose administration interval too long in a 18-year-old male patient who received HBV (Engerix B adult) (batch number 4BX39, expiry date 29-JUL-2027) for prophylaxis. Previously administered products included Engerix B (received first dose in 2008). On 16-JUN-2025, the patient received the 2nd dose of Engerix B adult. On 16-JUN-2025, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: first dose taken in 2008 and 2nd dose on 16 Jun 2025), adult product administered to child (Verbatim: An 18 years old male patient received an adult dose of Engerix-B) and overdose (Verbatim: An 18 years old male patient received an adult dose of Engerix-B). The outcome of the drug dose administration interval too long, 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: 16-JUN-2025 On 16 Jun 2025 they administered an adult dose of Engerix-B to a male patient who was 18 years old which led to Adult product administered to child and overdose. The patient received 1 dose in 2008, that was his first dose but did not complete the series. The adult dose of Engerix-B that the patient received today was his second dose which led to Drug dose administration interval too long.