Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident
Clinical narrative: no vision on her left eye due to a stroke; Woke up with no vision on left eye due to a stroke; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (no vision on her left eye due to a stroke) and BLINDNESS UNILATERAL (Woke up with no vision on left eye due to a stroke) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A, 006M20A and 004M20A) for COVID-19 vaccination.     Patient reported no allergies and never tested positive for COVID-19.  Concurrent medical conditions included Blood pressure high, Restless legs syndrome and Lipids abnormal.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, the patient experienced CEREBROVASCULAR ACCIDENT (no vision on her left eye due to a stroke) (seriousness criterion medically significant) and BLINDNESS UNILATERAL (Woke up with no vision on left eye due to a stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (no vision on her left eye due to a stroke) and BLINDNESS UNILATERAL (Woke up with no vision on left eye due to a stroke) outcome was unknown.            Concomitant medication reported as medication for high blood pressure, restless legs syndrome, blood thinner and cholesterol medication. On 26-Aug-2021, the patient received a first booster dose (Lot: 026C21A) of Moderna vaccine. It was reported that patient woke up with no vision on left eye due to stroke. Treatment medication reported as blood thinners which she started taking them after this incident. She stated that doctors did a lot of tests and did not find a cause for this incident.  Company Comment:  This spontaneous case concerns an 83-year-old female patient with concurrent high blood pressure, and lipid disorder as suggested by the concomitant unspecified cholesterol medication reported, who experienced the unexpected, serious  (medically significant) adverse event of special interest Cerebrovascular accident, and unexpected, serious  (medically significant) event of Blindness unilateral (reported as Woke up with no vision on left eye due to a stroke) 9 months and 1 day  after receiving the first booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series.  Patient woke up with no vision on the left eye reportedly due to stroke. Various unspecified tests were carried out to which no attributable cause was found. Patient was treated with blood thinners.  She previously received 2-dose primary series of mRNA-1273 vaccine given 28 days apart.   The concurrent high blood pressure remains a confounder while lipid disorder(as suggested by the concomitant unspecified cholesterol medication) and the advanced age of the patient could be considered as predisposing factors.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 83-year-old female patient with concurrent high blood pressure, and lipid disorder as suggested by the concomitant unspecified cholesterol medication reported, who experienced the unexpected, serious  (medically significant) adverse event of special interest Cerebrovascular accident, and unexpected, serious  (medically significant) event of Blindness unilateral (reported as Woke up with no vision on left eye due to a stroke) 9 months and 1 day  after receiving the first booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series.  Patient woke up with no vision on the left eye reportedly due to stroke. Various unspecified tests were carried out to which no attributable cause was found. Patient was treated with blood thinners.  She previously received 2-dose primary series of mRNA-1273 vaccine given 28 days apart.   The concurrent high blood pressure remains a confounder while lipid disorder( as suggested by the concomitant unspecified cholesterol medication) and the advanced age of the patient could be considered as predisposing factors.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.