Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | 3L339 | — |
Vaccine stored outside recommended conditions and administered to patient; 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 14-year-old patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis. On 25-FEB-2025, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). 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: 26-FEB-2025 The patient was administered one Bexsero vaccine the day before reporting, after a below temperature excursion happened on February 7th, 2025, which led to incorrect storage of vaccine. The reporter was not aware of the excursion and reported it until at the time of reporting. the reporter was not sure if he/she could provide patient's personal information. The conditions of the excursion were temperature, 0.44 degree C for 36 minutes. The reporter consented to follow up.