Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Patient had a stroke/Patient had a stroke after the 1st booster dose/In speech therapy for 6 weeks/ Does have some deficits following the stroke following the stroke hence the speech therapy per the caller) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 031L20A and 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2022, the patient experienced CEREBROVASCULAR ACCIDENT (Patient had a stroke/Patient had a stroke after the 1st booster dose/In speech therapy for 6 weeks/ Does have some deficits following the stroke following the stroke hence the speech therapy per the caller) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 16-Mar-2022 to 18-Mar-2022 due to CEREBROVASCULAR ACCIDENT. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN 81) for Adverse event, at an unspecified dose and frequency and ROSUVASTATIN CALCIUM (CRESTOR) for Adverse event, at an unspecified dose and frequency. On 18-Mar-2022, CEREBROVASCULAR ACCIDENT (Patient had a stroke/Patient had a stroke after the 1st booster dose/In speech therapy for 6 weeks/ Does have some deficits following the stroke following the stroke hence the speech therapy per the caller) had resolved with sequelae. No concomitant medications reported by reporter. It was reported that patient had a follow up with neurology, electrophysiology and was currently wearing a heart monitor for 2 weeks for testing. The patient was also in speech therapy for at least 6 weeks and would be following up with the doctor next week and with hematology in early May and back to neurologist in June. Prior to the stroke, patient had no health issues and was not on any medications. All the medical tests showed no cause to the stroke, no AFib, no clots, no bleeding, and no tumors. The patient did not have any high blood pressure before or after the stroke but had some deficits following the stroke hence the speech therapy. Patient did not have COVID in the past. Company comment: This spontaneous case concerns a 64 year old female patient with no medical history reported, who experienced Serious ( hospitalization, medically significant), unexpected, AESI event of Cerebrovascular accident which occurred 4 months, 7 days post vaccination with the third dose of mRNA-1273 vaccine. The dose 1 and dose 2 Covid-19 vaccine of this patient were also mRNA-1273 vaccine. This patient was hospitalized for 3 days.   She was  on heart monitor for two weeks and also under speech therapy for at least 6 weeks. Other details regarding the hospitalization like treatment information, results of laboratories /diagnostic procedures were not reported. She will be on follow up with neurology, electrophysiology as well as hematology. All the medical tests showed no cause to the stroke, no atrial fibrillation, no clots, no bleeding, and no tumor noted as per reporter. The patient was reported to have some deficits after the stroke. Outcome of the event stroke was reported as resolved with sequelae. The age of this patient may be considered as confounder for the event. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a 64 year old female patient with no medical history reported, who experienced Serious (hospitalization, medically significant), unexpected, AESI event of Cerebrovascular accident which occurred 4 months / 7 days post vaccination with the third dose of mRNA-1273 vaccine. The dose 1 and dose 2 Covid-19 vaccine of this patient were also mRNA-1273 vaccine. This patient was hospitalized for 3 days. She was on heart monitor for two weeks and also under speech therapy for at least 6 weeks. Other details regarding the hospitalization like treatment information, results of laboratories /diagnostic procedures were not reported. She will be on follow up with neurology, electrophysiology as well as hematology. All the medical tests showed no cause to the stroke, no atrial fibrillation, no clots, no bleeding, and no tumor noted as per reporter. The patient was reported to have some deficits after the stroke. Outcome of the event stroke was reported as resolved with sequelae. The age of this patient may be considered as confounder for the event. The benefit -risk relationship of mRNA -1273 ( Moderna Covid-19 Vaccine) is not affected by this report.