Received Jun 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
Stroke; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 75-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2024, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2024, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. The patient had a stroke approximately three weeks after receiving the second dose of the Spikevax vaccine. This incident occurred approximately 2 years ago. Treatment medication use information was not provided by reporter.; Reporter's Comments: Patient' advanced age was assessed as confounding factor. Missing information regarding MH, risk factors and exact onset latency preclude proper medical assessment. The benefit-risk relationship of product is not affected by this report.