Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident, Head discomfort
Clinical narrative: Lost sight in eye from one stroke; Pressure in back of head and temples; Probably had 3 strokes, 2 of them were very close together; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Probably had 3 strokes, 2 of them were very close together), BLINDNESS (Lost sight in eye from one stroke) and HEAD DISCOMFORT (Pressure in back of head and temples) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030120A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy, Blood pressure high and Stroke (Stroke in eye). Concomitant products included GABAPENTIN for Neuropathy, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Stroke, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Probably had 3 strokes, 2 of them were very close together) (seriousness criteria hospitalization and medically significant) and HEAD DISCOMFORT (Pressure in back of head and temples) (seriousness criterion hospitalization). On an unknown date, the patient experienced BLINDNESS (Lost sight in eye from one stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 02-Mar-2021 due to BLINDNESS, CEREBROVASCULAR ACCIDENT and HEAD DISCOMFORT. At the time of the report, CEREBROVASCULAR ACCIDENT (Probably had 3 strokes, 2 of them were very close together), BLINDNESS (Lost sight in eye from one stroke) and HEAD DISCOMFORT (Pressure in back of head and temples) outcome was unknown.            Concomitant medications also included High blood pressure medication. No treatment medications were reported.  Company Comment: This case concerns a 81-year-old female patient with medical history of Neuropathy, Blood pressure high and Stroke (Stroke in eye) as well as history of polypharmacy, who experienced serious (hospitalization and AESI) unexpected events of cerebrovascular accident, blindness. The events occurred 6 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable. The medical history of Neuropathy, Blood pressure high and Stroke (Stroke in eye) are confounders for the events and the outcome of the case. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-345616 (Patient Link).; Sender's Comments: This case concerns a 81-year-old female patient with medical history of Neuropathy, Blood pressure high and Stroke (Stroke in eye) as well as history of polypharmacy, who experienced serious (hospitalization and AESI) unexpected events of cerebrovascular accident, blindness. The events occurred 6 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable. The medical history of Neuropathy, Blood pressure high and Stroke (Stroke in eye) are confounders for the events and the outcome of the case. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.