Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (PRIORIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4N222 | — |
It was not reconstituted with the antigen component; Priorix diluent only was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of active ingredient not added to diluent in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced active ingredient not added to diluent (Verbatim: It was not reconstituted with the antigen component) and inappropriate dose of vaccine administered (Verbatim: Priorix diluent only was administered to a patient). The outcome of the active ingredient not added to diluent and inappropriate dose of vaccine administered were not applicable. It was unknown if the reporter considered the active ingredient not added to diluent and inappropriate dose of vaccine administered to be related to Priorix and Priorix Pre-Filled Syringe Device. It was unknown if the company considered the active ingredient not added to diluent and inappropriate dose of vaccine administered to be related to Priorix and Priorix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-APR-2025 Pharmacist reported that the Priorix diluent only was administered to a patient. It was not reconstituted with the antigen component which led to active ingredient not added to diluent and inappropriate dose of vaccine administered. Consented to follow up.