Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 42B22 | — |
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis. In JUN-2025, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug 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: 03-JUL-2025 The pharmacy technician reported that they have the Hep B vaccine in his/her refrigerator, Engerix B, and they going to need some information about temperature it went out of range for 5 minutes. And then, his/her county needs information about its use. The reporter would tell you right now that it had already been used. The reporter did not have the patient's information and said that the administration might have administered the same day of the excursion (26-JUN-2025) or probably 2 days after that. The Engerix B vaccine stored outside recommended conditions and administered to patient, which led to an incorrect storage of drug.