Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | — |
Lyophilized vial reconstituted with sterile water; patients where administered with Menveo (2-vial) not reconstituted properly; 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 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On 06-FEB-2025, the patient received Menveo. On 06-FEB-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Lyophilized vial reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: patients where administered with Menveo (2-vial) not reconstituted properly). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 10-FEB-2025 The reporter reported that two 2 where administered with Menveo (2-vial) not reconstituted properly, since the lyophilized component was diluted with sterile water instead of the liquid component vial which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Lot number and expiration date for the vaccine was unknown by reporter. It was the first dose of a Meningococcal vaccine for those two patients in that facility, but reporter did not know if any of the patients received a prior Meningococcal dose in another facility. This case is linked with US2025017240, reported by same reporter.; Sender's Comments: US-GSK-US2025017240:Same reporter/Different patient