Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | 4 | — | IM |
stroke in the small capillary veins in the top of brain; unconscious; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke in the small capillary veins in the top of brain) and LOSS OF CONSCIOUSNESS (unconscious) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Concurrent medical conditions included Cholesterol low. In April 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In June 2023, the patient experienced CEREBROVASCULAR ACCIDENT (stroke in the small capillary veins in the top of brain) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in 2023 due to CEREBROVASCULAR ACCIDENT and LOSS OF CONSCIOUSNESS. The patient was treated with Rehabilitation therapy (A little rehab to see if the patient would walk and swallow.) for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke in the small capillary veins in the top of brain) had not resolved and LOSS OF CONSCIOUSNESS (unconscious) had resolved. No concomitant medications provided by the reporter. It was reported that the patient took 2nd booster on Apr-2023 and in 2 months the patient experienced a stroke that could not be explained. The patient had no blood pressure issues but had this stroke in the small capillary veins in the top of brain. The patient was on an iv(Intravenous) and tube down the patient nose for 2 weeks. The patient was unconscious the whole time. The patient just woke up after pulling all iv(Intravenous) and tubes out. The Patient was put on a little rehabilitation to see if the patient would walk and swallow. The patient was released to nursing home for 2 more weeks. The patient visited hematologist who ran all kinds of tests and the concluded that the vaccine did some type changes to blood which caused the stroke. The patient was on blood thinners twice. This case was linked to US-MODERNATX, INC.-MOD-2026-793532 (E2B Linked Report). This case was linked to MOD-2021-406584, MOD-2021-406624 (Patient Link).; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2026-793532:same reporter, different patient
Cholesterol low