Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | K4JH7 | — |
received first dose of Engerix-B but it was the adult dose instead of the pediatric one; received first dose of Engerix-B but it was the adult dose instead of the pediatric one; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 28-APR-2025, the patient received the 1st dose of Engerix B adult. On 28-APR-2025, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: received first dose of Engerix-B but it was the adult dose instead of the pediatric one) and adult product administered to child (Verbatim: received first dose of Engerix-B but it was the adult dose instead of the pediatric one). 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: 28-MAY-2025 Registered Nurse explained that 2 patients that were twins received their first dose of Engerix-B but it was the adult dose instead of the pediatric one, which led to overdose and adult product administered to child. On the day of reporting, the patients received their second dose and that one was the correct pediatric dose. Both patients had the same demographics, even initials for their names. Lot number and expiration date where the same for the first and second dose. The case was linked with case US2025066874, reported by the same reporter for different patient.; Sender's Comments: US-GSK-US2025066874:Same reporter US-GSK-US2025066874:Same reporter,Different patient