Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | 52N4S | — |
leakage on a BEXSERO dose; Product complaint; Underdose/Incomplete dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis. This case was associated with a product complaint. On 05-MAY-2025, the patient received Bexsero. On 05-MAY-2025, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: Underdose/Incomplete dose). On an unknown date, the patient experienced product leakage (Verbatim: leakage on a BEXSERO dose) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental underdose, product leakage and pharmaceutical product complaint were 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: 12-MAY-2025 and 13-MAY-2025 The nurse reported a leakage on a Bexsero dose given to a patient which led to accidental underdose and mentions maybe only one drop leaked and was not administered to the patient.