Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Headache, Pyrexia
Clinical narrative: Mild Stroke; Severe Headache; Fever 101 F; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Mild Stroke) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 016M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   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 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced HEADACHE (Severe Headache), PYREXIA (Fever 101 F) and FATIGUE (Fatigue). On 07-Nov-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Mild Stroke) (seriousness criterion medically significant). The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Adverse event, at a dose of 1 dosage form and ROSUVASTATIN CALCIUM (CRESTOR) for Adverse event, at a dose of 1 dosage form. On 07-Nov-2021, HEADACHE (Severe Headache), PYREXIA (Fever 101 F) and FATIGUE (Fatigue) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Mild Stroke) outcome was unknown.            Concomitant product was not provided by the reporter Patient was diagnosed with mild stroke and they kept under watch until the night on 07-NOV-2021. She visited the ER and had a CT and MRI done. She was diagnosed with mild stroke and they kept her under watch until the night on 07NOV2021.  This case concerns a 70 year old female with no reported medical history , who experienced Serious ( medically significant ) , unexpected , AESI event of Cerebrovascular accident which occurred 4 days after vaccination with the 3rd dose ( Booster  dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ). The patient was seen at the ER where CT Scan and MRI  was done results were not reported . Patient was  observed at the ER and sent home with medications. The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the event was unknown. The age of the patient may be considered as a confounder for this case (since aging   affects the atherosclerotic chages in blood vessels  that may lead to cardio-vascular or acute brain attack ). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-387042 (Patient Link).; Sender's Comments: This case concerns a 70 year old female with no reported medical history , who experienced Serious ( medically significant ) , unexpected , AESI event of Cerebrovascular accident which occurred 4 days after vaccination with the 3rd dose ( Booster  dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ). The patient was seen at the ER where CT Scan and MRI  was done results were not reported . Patient was  observed at the ER and sent home with medications. The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the event was unknown. The age of the patient may be considered as a confounder for this case (since aging   affects the atherosclerotic chages in blood vessels  that may lead to cardio-vascular or acute brain attack ). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.