Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | AMVB064A | IM / LA |
received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that is used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo; received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that is used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 16-JUL-2025, the patient received Menveo (intramuscular, left deltoid). On 16-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that is used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo) and inappropriate dose of vaccine administered (Verbatim: received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that is used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 17-JUL-2025 The reporter was a nurse calling to report that a patient received the Lyophilized Conjugate component only of Menveo reconstituted with a MERCK diluent that was used for the PROQUAD Vaccine instead of reconstituted with the Liquid conjugate for Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The case had been linked to US2025091800, reported by the same reporter, for a different patient.; Sender's Comments: US-GSK-US2025091800:same reporter, different patient, 2 of 2