Received May 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | UNK | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | F5L5E | — |
EXPIRED DOSE ADMINISTERED; INTERCHANGE OF VACCINES.; This non-serious case was reported by a physician via call center representative and described the occurrence of expired drug administered in a 17-year-old female patient who received HBV (Engerix B) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis. On 21-APR-2025, the patient received the 1st dose of Engerix B. In MAR-2025, the patient received Heplisav b. On 21-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired drug administered (Verbatim: EXPIRED DOSE ADMINISTERED) and interchange of vaccine products (Verbatim: INTERCHANGE OF VACCINES.). The outcome of the expired drug administered and interchange of vaccine products were not applicable. Additional Information: GSK Receipt Date: 30-APR-2025 The physician reported that a patient received Engerix on April 21st and unfortunately we found out later that the vaccine had expired on April 11th, which led to expired vaccine used. The reporter was ask what are the adverse effects on that also ask unfortunately received as well heplisav a month prior and we found out after that the Heplisav is not approved for her age range, which led to interchange of vaccine products. The reporter was ask if they should expect any adverse effects for administering an expired Engerix and if there is like additional adverse effects to be expected for her receiving Heplisav a month before that.