Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 11-Aug-2025, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. Concomitant medication use information was not provided by reporter. The patient suffered a stroke in the first week of August and experienced it for the first time on 11-Aug-2025. The COVID-19 vaccine was available last year, and the reporter was pretty sure that the patient received that one. So, if the patient got it, then it would probably be okay to get it again. It was reported that there was no implication at any point that her stroke was related to receiving the vaccine. However, it was mentioned that she possibly received Spikevax 24/25 last year and had a stroke this year. It was unknown if the patient experienced any additional symptoms or events. Treatment medication use information was not provided by reporter.; Reporter's Comments: The age is a confounder for the event. Due to nonsuggestive temporal association (long latency), the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.