Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral artery thrombosis, Cerebrovascular accident, Computerised tomogram, Jugular vein thrombosis
Clinical narrative: 100 blood clots in 4 arteries of the brain; clot in the jugular vein; got a massive stroke; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (got a massive stroke), CEREBRAL ARTERY THROMBOSIS (100 blood clots in 4 arteries of the brain) and JUGULAR VEIN THROMBOSIS (clot in the jugular vein) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Percocet). Concomitant products included FENOFIBRATE, PANTOPRAZOLE, ATORVASTATIN and METFORMIN for an unknown indication.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (got a massive stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CEREBRAL ARTERY THROMBOSIS (100 blood clots in 4 arteries of the brain) (seriousness criteria hospitalization and medically significant) and JUGULAR VEIN THROMBOSIS (clot in the jugular vein) (seriousness criterion hospitalization). At the time of the report, CEREBROVASCULAR ACCIDENT (got a massive stroke), CEREBRAL ARTERY THROMBOSIS (100 blood clots in 4 arteries of the brain) and JUGULAR VEIN THROMBOSIS (clot in the jugular vein) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Blood clot.         Patient experienced a similar event in the past. Patient never had COVID positive test or diagnosis. The patient had not taken any vaccines given within one month prior to Moderna COVID-19 vaccine. The patient seek medical care for AE cause. Treatment information was not reported.  Company comment: This spontaneous case concerns a 59 year old male patient, with concomitant use of fenofibrate, atorvastatin and metformin, who experienced the unexpected, serious (hospitalization, medically significant) adverse events of special interest Cerebrovascular accident, Cerebral artery thrombosis and Jugular vein thrombosis, which occurred 2 months after the second dose of mRNA-1273 vaccine administration. It was reported that patient presented with mild headache and CT scan done showed 100 blood clots in 4 arteries of the  brain and clot in the jugular vein. patient was hospitalized and underwent surgery, after which patient reported blindness, decrease in strength and memory impairment. Concomitant use of fenofibrate, atorvastatin and metformin suggests presence of dyslipidemia and diabetes, which could be confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 59 year old male patient, with concomitant use of fenofibrate, atorvastatin and metformin, who experienced the unexpected, serious (hospitalization, medically significant) adverse events of special interest Cerebrovascular accident, Cerebral artery thrombosis and Jugular vein thrombosis, which occurred 2 months after the second dose of mRNA-1273 vaccine administration. It was reported that patient presented with mild headache and CT scan done showed 100 blood clots in 4 arteries of the  brain and clot in the jugular vein. patient was hospitalized and underwent surgery, after which patient reported blindness, decrease in strength and memory impairment. Concomitant use of fenofibrate, atorvastatin and metformin suggests presence of dyslipidemia and diabetes, which could be confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.