Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
the stability of Engerix-B after it had been exposed to 8.6 degrees Celsius for 2 hours and 30 minutes, and confirmed that they had already been administered, but did not specify to whom or which lots; 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 an unspecified number of patients 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: the stability of Engerix-B after it had been exposed to 8.6 degrees Celsius for 2 hours and 30 minutes, and confirmed that they had already been administered, but did not specify to whom or which lots). 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:02-SEP-2025 Other Health Professional called in to request data about the stability of Engerix-B after it had been exposed to 8.6 degrees Celsius for 2 hours and 30 minutes, after review of temperature logs. They stated that the vaccines were gone to which probing questions were made and the healthcare professional confirmed that they had already been administered but did not specify to whom or which lots, which led to incorrect storage of drug. The HCP was consented to receive follow-up for this scenario. The Vaccine Administration Facility was the same as Primary Reporter.