Received May 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 92DJ3 | — |
Maladministration of Engerix-B After the Expiration Date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received HBV (Engerix B) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis. On 21-MAY-2025, the patient received the 1st dose of Engerix B. On 21-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B After the Expiration Date). The outcome of the expired vaccine used was 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: 22-MAY-2025 The medical assistance reported that a pediatric male patient received on 21th May 2025 an expired Engerix-B first dose which led to expired vaccine administered. The patient already has a combination vaccine with hep B. The vaccine administration facility was the same as primary reporter.