Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue
Clinical narrative: Stroke; Stroke; wiped out; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CEREBROVASCULAR ACCIDENT (Stroke) and the second episode of CEREBROVASCULAR ACCIDENT (Stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced FATIGUE (wiped out). On 01-Sep-2021, the patient experienced the first episode of CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, disability and medically significant). On 12-Sep-2021, the patient experienced the second episode of CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, disability and medically significant). The patient was hospitalized from 01-Sep-2021 to 07-Sep-2021 due to CEREBROVASCULAR ACCIDENT, and then from 12-Sep-2021 to 14-Sep-2021 due to CEREBROVASCULAR ACCIDENT. On 25-Aug-2021, FATIGUE (wiped out) had resolved. On 14-Sep-2021, last episode of CEREBROVASCULAR ACCIDENT (Stroke) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: negative (Negative) Negative.   No concomitant medication details were provided.  No treatment information was mentioned.  The patient stated that during first stroke after hospitalization, she had moved to rehab until 10Sep2021 when she returned home. The patient also stated that they released her on 14-Sep-2021 with a Biotel Moniter that she will wear for 30 days  so far there is no evidence of afib.  Company Comment: This case concerns a  82-year-old, female patient with relevant medical history of hypertension, who experienced the unexpected event of Cerebrovascular accident (two episodes). The first episodes occurred approximately 10 days after the third dose of mRNA-1273 (Moderna Covid-19 vaccine) and resolved on the sixth day; while second episodes occurred 6 days after the resolution of first episode, and finally resolved  third day afterwards. The rechallenge was not applicable as events occurred after the third dose. In this advanced aged patient, the underlying medical condition of hypertension remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) in not affected by this report.   This case was linked to MOD-2021-337574, MOD-2021-337582 (Patient Link).; Sender's Comments: This case concerns a  82-year-old, female patient with relevant medical history of hypertension, who experienced the unexpected event of Cerebrovascular accident (two episodes). The first episodes occurred approximately 10 days after the third dose of mRNA-1273 (Moderna Covid-19 vaccine) and resolved on the sixth day; while second episodes occurred 6 days after the resolution of first episode, and finally resolved  third day afterwards. The rechallenge was not applicable as events occurred after the third dose. In this advanced aged patient, the underlying medical condition of hypertension remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) in not affected by this report.