Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident
Clinical narrative: Stroke; Has lost part of her vision in her left eye; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS (Has lost part of her vision in her left eye) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included Stroke.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening). In April 2021, the patient experienced BLINDNESS (Has lost part of her vision in her left eye) (seriousness criterion medically significant). The patient was hospitalized from 05-Apr-2021 to 06-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS (Has lost part of her vision in her left eye) outcome was unknown.            Concomitant products were not provided.  Treatment medication were not reported.  The patient stated she got notification that she could get her booster dose but want to get it because she experienced a stroke after receiving the Moderna 2nd.  The patient got the vaccine a little after noon and typically went to sleep around 10:00 PM.  She stated that the stroke happened while she was sleeping, and she did go to the hospital. The patient was kept overnight at the hospital and released the following day.   Company comment: This case concerns a 69-year- old female patient with relevant medical past history of strokes (no more information available in SD), who experienced the serious unexpected AESI of CEREBROVASCULAR ACCIDENT and the serious unexpected event of blindness (lost part of her vision in her left eye) after second dose of mRNA-1273. The event cerebrovascular accident occurred approximately within the first 24 hours after vaccination and the event blindness was reported that occurred following the stroke. The re-challenge is not applicable since events occurred after second dose and events outcome were unknown. Patient past medical history remains a contributing factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69-year- old female patient with relevant medical past history of strokes (no more information available in SD), who experienced the serious unexpected AESI of CEREBROVASCULAR ACCIDENT and the serious unexpected event of blindness (lost part of her vision in her left eye) after second dose of mRNA-1273. The event cerebrovascular accident occurred approximately within the first 24 hours after vaccination and the event blindness was reported that occurred following the stroke. The re-challenge is not applicable since events occurred after second dose and events outcome were unknown. Patient past medical history remains a contributing factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.