Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | K4JH7 | — |
Engerix-B unstable after temperature excursion administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old male patient who received HBV (Engerix B) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis. On 11-DEC-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: Engerix-B unstable after temperature excursion administration). 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: 12-DEC-2025 A pharmacist had reported that Engerix-B (with different lot numbers) had gone through a temperature excursion and exceeded the lower stability limit before being administered to several patients. The vaccine administration facility was the same as the primary reporter. This case was the one of linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025160786:Same reporter/Different patient US-GSK-US2025160787:Same reporter/Different patient US-GSK-US2025160789:Same reporter/Different patient US-GSK-US2025160789:Same reporter/Different patient US-GSK-US2025160785:Same reporter/Different patient US-GSK-US2025160777:Same reporter/Different patient US-GSK-US2025160774:Same reporter/Different patient US-GSK-US2025160770:Same reporter/Different patient US-GSK-US2025160797:Same reporter/Different patient US-GSK-US2025160799:Same reporter/Different patient US-GSK-US2025160776:Same reporter/Different patient US-GSK-US2025160784:Same reporter/Different patient