Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
ENGERIX-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions; 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) for prophylaxis. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: ENGERIX-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes). No other excursions). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 06-JUN-2025 MA reports that Engerix-B was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was 9.76C and they were above range for 1 hour and 15 minutes in total (5 into15 minutes). No other excursions. The majority of all vaccines reported were administered to patients, which led to incorrect storage of vaccine.; Sender's Comments: US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071804:Same reporter, Different suspect