Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | IM |
bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Controlled hypertension. On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) (seriousness criteria disability and medically significant). The patient was treated with Meclozine hydrochloride (Meclizine) at an unspecified dose and frequency. At the time of the report, CEREBELLAR STROKE (bilateral cerebellar stroke/progressively got worse with vertigo/ he badged in but then fell down/he fell again, speech slurred and he started vomiting) had not resolved. No concomitant medications were reported. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. The reporter stated that, her husband's vertigo started after the second vaccine. He went to a couple of doctors for that, they prescribed Meclizine. Was also told it could be allergies, etc. Nothing helped and he progressively got worse with vertigo. He drove an hour to work after 12 days off for the holidays, which was 03-Jan. Once he got to work, he badged in but then fell down. They tried to help him up and he fell again, speech slurred, and he started vomiting. They took him to the closest hospital. He suffered a bilateral cerebellar stroke. He was then permanently disabled and would never work or drive again. At the time of reporting, he was 50 years old with no quality of life. The patient did not experience any additional symptoms/events. There were no lab data/results available.; Reporter's Comments: Concurrent medical condition Controlled hypertension is a confounder for the event. . The benefit -risk relationship of product is not affected by this report.
Controlled hypertension