Received Jul 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7NX57 | — |
Engerix B administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received HBV (Engerix B) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. On 19-JUN-2025 09:30, 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 administration after 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. Additional Information: GSK Receipt Date: 24-JUN-2025 The pharmacist called to verify if doses of vaccines that had been exposed to low temperatures (26.5° Fahrenheit) and on 19 June 2025 at 09:30 am was administered to the patient which led to incorrect storage of drug. The reporter wanted to know if the dose should be repeated. The Vaccine Administration Facility is the same as Primary Reporter.