Received Nov 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 324BY | LA |
5-year-old male administered Twinrix adult; 5-year-old male administered Twinrix adult; This non-serious case was reported by the other health professional via sales rep and described the occurrence of adult product administered to child in a 5-year-old male patient who received HAB (Twinrix adult) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis. On 24-APR-2025, the patient received Twinrix adult (left deltoid) .5 ml. On 24-APR-2025, an unknown time after receiving Twinrix adult, the patient experienced adult product administered to child (Verbatim: 5-year-old male administered Twinrix adult) and overdose (Verbatim: 5-year-old male administered Twinrix adult). The outcome of the adult product administered to child and overdose were not applicable. It was unknown if the reporter considered the adult product administered to child and overdose to be related to Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the adult product administered to child and overdose to be related to Twinrix Pre-Filled Syringe Device. 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: 24-NOV-2025 A 5-year-old male administered 0.5ml on left deltoid to complete hep A and Hep B catch up schedule per doctor recommendation due to out of stock monovalent. Wellness follow up was done by phone and no symptoms or side effects reported. The batch number was not provided, and we are unable to contact the reporter.