Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Syncope
Clinical narrative: Faint; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and SYNCOPE (Faint) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Double vessel bypass graft. Concurrent medical conditions included Rheumatoid arthritis and Psoriatic arthritis.   In April 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In June 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). In September 2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and SYNCOPE (Faint) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a 70-year-old male patient with medical history of Coronary artery bypass, who experienced the unexpected, serious (medically significant) adverse event of special interest of Cerebrovascular accident and the unexpected, serious (medically significant) event of Syncope. The patient had stroke and double vision approximately 2 months after receiving the first dose of mRNA-1273 vaccine. The patient fainted approximately 5 months after receiving the said dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. Medical history of coronary artery bypass indicating a coronary heart disease could be contributory factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old male patient with medical history of Coronary artery bypass, who experienced the unexpected, serious (medically significant) adverse event of special interest of Cerebrovascular accident and the unexpected, serious (medically significant) event of Syncope. The patient had stroke and double vision approximately 2 months after receiving the first dose of mRNA-1273 vaccine. The patient fainted approximately 5 months after receiving the said dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown at the time of the report. Medical history of coronary artery bypass indicating a coronary heart disease could be contributory factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.