Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 79S54 | — |
Inappropriate dose; Inappropriate dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis. On 03-APR-2025, the patient received the 1st dose of Engerix B adult. On 03-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Inappropriate dose) and adult product administered to child (Verbatim: Inappropriate dose). The outcome of the overdose 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: 08-APR-2025 The reporter called to inform that he/she had a 19-year-old patient that received the adult dose of Engerix-B, which led to overdose and adult product administered to child. According to reporter, such dose was the 1st of the series and was administered in 3rd April 2025. Also, according to reporter, the patient was going to turn 20 years-old in 15th May 2025. The reporter consented to follow up.