Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | AMVB064A | — |
Use of a Non-approved diluent; Use of a 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 AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 28-MAY-2025, the patient received Menveo. On 28-MAY-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Use of a Non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: Use of a 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: 03-JUN-2025 A Medical assistant called and reported that the Menveo vaccine was administered, and he/she used a different sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked if the patient needs to retake the vaccine. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.