Received Sep 25, 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 an 81-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Pacemaker insertion (cardiac). Previously administered products included for Product used for unknown indication: Herpes zoster (Shingles). Past adverse reactions to the above products included No adverse effect with Herpes zoster. Concomitant products included Atorvastatin calcium (Atorvastatin) for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In February 2025, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in February 2025 due to CEREBROVASCULAR ACCIDENT. The patient was treated with Clopidogrel bisulfate (Clopidogrel) for Anticoagulant therapy, at a dose of 75 milligram. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) had resolved with sequelae. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. It was reported that, the patient had every vaccine from Moderna. She had a stroke 8 months ago, she had confirmed it occurred in beginning of February 2025, for which she went to hospital. She had been living in an assisted living or a nursing home since then. She had gotten vaccines her whole life aside from the Moderna COVID-19 vaccines as she believed in vaccines. She had received her shingles and had gotten them all. But she clarified that, she had not received anything this year including flu shot and shingles shot. It was reported that, she wanted to know if she should get Moderna COVID-19 vaccine and if there was a relationship between COVID-19 shots and stroke. The patient did not experience any additional symptoms/events.; Reporter's Comments: Patient's advanced age and unreported cardiovascular medical history (suggested by Pacemaker insertion and concomitant medication) was assessed as strong confounding factor. The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Pacemaker insertion (cardiac)
Atorvastatin