Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2GZ34 | — |
Administration after Below temperature excursion; 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 male patient who received HBV (Engerix B) suspension for injection in pre-filled syringe (batch number 2GZ34) for prophylaxis. On 26-MAY-2026, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: Administration after Below temperature excursion). 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. Linked case(s) involving the same patient: US2026074478 Additional Information: GSK Receipt Date: 04-JUN-2026 A medical assistant reported an excursion (that happened on 11-MAY-2026) for Boostrix, Engerix-B, Havrix, Menveo and Shingrix vaccines with a minimum temperature of 30-degree F, for 2 hours. The Assistant Medical Affairs Specialist (AMAS) reported that 19 patients received the vaccines after the excursion and was asking if the patients would need to be revaccinated. This was the report 16 of 19 patients, the patient received Engerix-B on 26-MAY-2026; Sender's Comments: US-GSK-US2026074479: US-GSK-US2026074483:SAME REPORTER US-GSK-US2026074480:SAME REPORTER US-GSK-US2026074484:SAME REPORTER