Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | FH443 | — |
Patient administered Bexsero/Improper Storage Error; 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 17-year-old female patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) for prophylaxis. On 21-JAN-2025, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Patient administered Bexsero/Improper Storage Error). The outcome of the incorrect storage of drug was unknown. 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: 13-FEB-2025 The reporter requested a stability data on Bexsero, Havrix, Kinrix, Infanrix, Engerix-B, Rotarix (liq) stored at 1st on 07th January 2025 at 46,7 Fahrenheit in to 30 mins and 2nd on 21st January 2025 at 49.4 Fahrenheit in to 2hrs 30mins. The reporter mentioned that the patient administered Bexsero vaccine which led to, incorrect storage of drug.