Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
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 an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis. In MAR-2025, the patient received Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Improper Storage Error). 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: 25-MAR-2025 The health care professional requested data for Bexsero, Menveo (1-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Rotarix (liquid) stored at 0 degree Celsius unknown amount of time. Excursion started on 20-MAR-2025. No signs of freezing or slushing. Vaccines had been used in patients but not aware of number of patients, which led to incorrect storage of drug.