Received Aug 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | AMAB064A | — |
Menveo vaccine reconstituted with non-approved diluent; Menveo vaccine reconstituted with non-approved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAB064A, expiry date 31-DEC-2025) for prophylaxis. On 28-JUL-2025, the patient received Menveo. On 28-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo vaccine reconstituted with non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: Menveo vaccine reconstituted with non-approved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-JUL-2025 Reporter requested data on re-vaccination of patient following administration of 2-vial Menveo vaccine reconstituted with non-approved diluent. Menveo reconstituted with non-approved diluent, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.