Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Administration to 16 YO patient; Administration to 16 YO patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old male patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. On 08-MAY-2025, the patient received the 2nd dose of Twinrix. On 08-APR-2025, the patient received the 1st dose of Twinrix. On 08-APR-2025, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to 16 YO patient). On 08-MAY-2025, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to 16 YO patient). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration 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: 18-SEP-2025 The healthcare professional (HCP) reported that a 16-year-old pediatric patient had received two doses of Twinrix, possibly administered in country. The first dose was given on April 8, 2025, and the second on May 8, 2025. The HCP was seeking guidance on how to complete the Hepatitis A and Hepatitis B vaccination series for the patient. This case was reported as a possible adverse event due to the patient's age and the country in which the vaccine was administered.