Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MNQ | MENINGOCOCCAL CONJUGATE (MENVEO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | AMVV064A | — |
sterile water was used to reconstitute the lyophilized component of Menveo; sterile water was used to reconstitute the lyophilized component of Menveo; arm turning really red; arm hot; arm turned a knot; This non-serious case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVV064A) for prophylaxis. On 19-JUN-2025, the patient received Menveo. In JUN-2025, an unknown time after receiving Menveo, the patient experienced erythema of extremities (Verbatim: arm turning really red), extremities hot feeling of (Verbatim: arm hot) and local swelling (Verbatim: arm turned a knot). On 19-JUN-2025, the patient experienced wrong solution used in drug reconstitution (Verbatim: sterile water was used to reconstitute the lyophilized component of Menveo) and inappropriate dose of vaccine administered (Verbatim: sterile water was used to reconstitute the lyophilized component of Menveo). The outcome of the erythema of extremities, extremities hot feeling of and local swelling were not reported and the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. It was unknown if the reporter considered the erythema of extremities, extremities hot feeling of and local swelling to be related to Menveo. It was unknown if the company considered the erythema of extremities, extremities hot feeling of and local swelling to be related to Menveo. Additional Information: GSK Receipt Date: 24-JUN-2025 Medical assistant called to report on 19th June 2025 sterile water was used to reconstitute the lyophilized component of Menveo and vaccine was administered which led to wrong solution used wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Once they spoke with the parents, they did note he had a pretty significant reaction as far as his arm turning really red, hot and a knot. They just wanted to make sure there was not any indication that he should not receive the full vaccine.