Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 2 | EP724 | — |
expired vaccine administered; Late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 25-MAR-2025, the patient received the 2nd dose of Engerix B. On 25-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired vaccine administered) and drug dose administration interval too long (Verbatim: Late second dose). The outcome of the expired vaccine used and drug dose administration interval too long 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: 04-APR-2025 Nurse explained that an 18-year-old patient got an expired dose of Engerix- B on March 25th 2025, the vaccine expired on March 14th 2025,which led to expired vaccine used. Patient received 1 prior dose of Engerix-B on January 14th 2025. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule.
ENGERIX B