Received Jun 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3046732 | IM |
Reemergence of stroke symptoms, facial droop and slight speech issues; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis. The patient's past medical history included Carotid artery dissection (Prior stroke 2016 due to dissection of carotid). Previously administered products included for COVID-19 prophylaxis: Moderna vaccine. Past adverse reactions to the above products included No adverse effect with Moderna vaccine. Concurrent medical conditions included Stroke (Prior stroke 2016 due to dissection of carotid). On 22-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 22-May-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) (seriousness criterion medically significant). On 23-May-2025, CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: (Negative) negative for stroke. On an unknown date, Magnetic resonance imaging: (Negative) negative for stroke. No concomitant medication was reported. The patient had reemergence of stroke symptoms, facial droop, and slight speech issues. Prior stroke 2016 due to dissection of carotid. The patient went to ER had CAT scan and follow up MRI all results were negative for stroke. The patient had previous Moderna covid vaccines with no adverse effects. All vaccines were administered at local pharmacy. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Stroke (Prior stroke 2016 due to dissection of carotid)
Medical History/Concurrent Conditions: Carotid artery dissection (Prior stroke 2016 due to dissection of carotid)
Test Name: CAT scan; Test Result: Negative ; Test Name: MRI; Test Result: Negative