Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | P2443 | LA |
accidental administration of Twinrix to an 8 year old which is outside the age range of approved package labeling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received HAB (Twinrix) (batch number P2443) for prophylaxis. On 15-SEP-2025, the patient received Twinrix (left deltoid). On an unknown date, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidental administration of Twinrix to an 8 year old which is outside the age range of approved package labeling). The outcome of the inappropriate age at vaccine administration was unknown. 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: 23-SEP-2025, 25-SEP-2025 Customer requests information from medical regarding administration of Twinrix to an 8 year old so they can inform the parent if they need to take additional steps. Patient didn't report any side effects.