Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (PRIORIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 43G92 | — |
Febrile seizures; This serious case was reported by a pharmacist via sales rep and described the occurrence of febrile seizure in a 1-year-old patient who received MMR (Priorix) (batch number 43G92) for prophylaxis. On 06-MAR-2025, the patient received the 1st dose of Priorix. In MAR-2025, an unknown time after receiving Priorix, the patient experienced febrile seizure (Verbatim: Febrile seizures) (serious criteria hospitalization and GSK medically significant). The outcome of the febrile seizure was resolving. The reporter considered the febrile seizure to be related to Priorix and Priorix Pre-Filled Syringe Device. The company considered the febrile seizure to be unrelated 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: 07-MAR-2025 The patient received a first dose of Priorix and experienced febrile seizure after vaccination. The patient required hospitalization and rapid response.; Sender's Comments: Febrile convulsion is a listed event which, due to the following criteria (insufficient information regarding medical history, concurrent conditions, concomitant medications, time to onset, confirmation of disease) is considered unrelated to GSK vaccine Priorix and Priorix PRE-FILLED SYRINGE DEVICE.