Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysarthria, Facial paralysis, Facial paresis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (every couple weeks she shows signs of a CVA) and FACIAL PARALYSIS (Only affects one side of the face. Whichever side it affects, droop) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (every couple weeks she shows signs of a CVA) (seriousness criterion medically significant), FACIAL PARALYSIS (Only affects one side of the face. Whichever side it affects, droop) (seriousness criterion medically significant), FACIAL PARESIS (Only affects one side of the face. Whichever side it affects, weakness) and DYSARTHRIA (Only affects one side of the face. Whichever side it affects, slurred speech). At the time of the report, CEREBROVASCULAR ACCIDENT (every couple weeks she shows signs of a CVA), FACIAL PARALYSIS (Only affects one side of the face. Whichever side it affects, droop), FACIAL PARESIS (Only affects one side of the face. Whichever side it affects, weakness) and DYSARTHRIA (Only affects one side of the face. Whichever side it affects, slurred speech) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant Drugs Not Reported. Every couple weeks patient showed signs of a CVA. Only affects one side of the face. Whichever side it affects, had weakness, droop and slurred speech for hours. Treatment information was provided. 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. Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who received a dose of mRNA-1273 (unknown schedule)  and experienced the serious medically significant unexpected AESI of cerebrovascular accident and the medically significant unexpected facial paralysis. Vaccination date and onset date of the event were not provided; hence, latency and temporal association cannot be properly assessed. The report mentioned the patient every couple weeks shows signs of a CVA, with affection of only one side of the face. Whichever side it affects, she presents with weakness, droop, and slurred speech that last for hours. She consulted at hospital; however, no diagnosis was disclosed. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who received a dose of mRNA-1273 (unknown schedule) and experienced the serious medically significant unexpected AESI of cerebrovascular accident and the medically significant unexpected facial paralysis. Vaccination date and onset date of the event were not provided; hence, latency and temporal association cannot be properly assessed. The report mentioned the patient every couple weeks shows signs of a CVA, with affection of only one side of the face. Whichever side it affects, she presents with weakness, droop, and slurred speech that last for hours. She consulted at hospital; however, no diagnosis was disclosed. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.