Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure systolic, Blood pressure systolic increased, Cerebrovascular accident, Delirium
Clinical narrative: Stroke; Sounded delirious; Could not form words; My blood pressure was 250 over something; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), DELIRIUM (Sounded delirious), APHASIA (Could not form words) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21-2A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for Rheumatoid arthritis, FOLIC ACID, ALENDRONATE SODIUM (FOSAMAX), VITAMIN B12 [VITAMIN B12 NOS] and CALCIUM for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization), DELIRIUM (Sounded delirious) (seriousness criterion hospitalization), APHASIA (Could not form words) (seriousness criterion hospitalization) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) (seriousness criterion hospitalization). The patient was hospitalized from 03-Apr-2021 to 05-Apr-2021 due to APHASIA, BLOOD PRESSURE SYSTOLIC INCREASED, CEREBROVASCULAR ACCIDENT and DELIRIUM. On 05-Apr-2021, CEREBROVASCULAR ACCIDENT (Stroke) had resolved. At the time of the report, DELIRIUM (Sounded delirious), APHASIA (Could not form words) and BLOOD PRESSURE SYSTOLIC INCREASED (My blood pressure was 250 over something) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure systolic: 250 (High) 250. In 2021, Magnetic resonance imaging: abnormal (abnormal) confirmed that Patient had a stroke.         Patient stated that on 3APR2021, 4 days after receiving the 2nd dose of the COVID-19 vaccine, she experienced a stroke. She says that she was with her daughter and per her daughter, the patient starting sounding delirious and not making any sense. She could not form words. The patient's daughter called 911. When the paramedics checked her blood pressure, the systolic number was 250. Patient does not remember the diastolic blood pressure. She was told to go to the ER. When she reached there, she says that she was having difficulty forming words. This was happening randomly and not all the time. She was admitted to the hospital for 2 days. An MRI done at the hospital confirmed that the patient had suffered a stroke. She was put on Lipitor and Plavix at the hospital and told to continue those medications for a month. She was discharged from the hospital and sent back home on 5APR2021. She states that with all the tests that were done at the hospital, the doctors are unsure what could have caused the stroke.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.