Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9G523 | — |
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 neonate male patient who received HBV (Engerix B) (batch number 9G523, expiry date 20-MAY-2027) for prophylaxis. On 08-DEC-2025, the patient received Engerix B. On 08-DEC-2025, 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 reported that the Engerix-B (different lot numbers) went through a temperature excursion and exceeded the below limit for stability were administered to several patients. The vaccine administration facility was the same as primary reporter. This is 1 of 20 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025160772:SAME REPORTER US-GSK-US2025160785:Same reporter/Different patient US-GSK-US2025160797:SAME REPORTER US-GSK-US2025160774:Same reporter/Different patient US-GSK-US2025160787:Same reporter/Different patient US-GSK-US2025160789:SAME REPORTER US-GSK-US2025160777:Same reporter/Different patient US-GSK-US2025160786:Same reporter/Different patient US-GSK-US2025160799:SAME REPORTER US-GSK-US2025160780:Same reporter/Different patient GSK-US2025160794:Same reporter/Different patient GSK-US2025160788:Same reporter/Different patient GSK-US2025160773:Same reporter/Different patient US-GSK-US2025160776:Same reporter/Different patient US-GSK-US2025160769:Same reporter/Different patient US-GSK-US2025160775:Same reporter/Different patient GSK-US2025160791:Same reporter/Different patient US-GSK-US2025160793:Same reporter/Different patient US-GSK-US2025160796:Same reporter/Different patient