Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
febrile seizure; This spontaneous case was reported by a consumer and describes the occurrence of FEBRILE CONVULSION (febrile seizure) in a 23-month-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 04-Dec-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .25 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 05-Dec-2025 at 10:30 AM, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced FEBRILE CONVULSION (febrile seizure) (seriousness criterion hospitalization). On 05-Dec-2025, FEBRILE CONVULSION (febrile seizure) had resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.