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Life Threatening? No
Write-up: seizure; very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included No adverse event (No Medical history was reported). On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (very tired). On 12-Apr-2021 at 3:00 AM, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) and FATIGUE (very tired) outcome was unknown. No Treatment related information was reported. Patient went to bed like normal that night. Patient called a nearby family member, who took patient to her neurologist later the next day.; Sender''s Comments: This case concerns a 63-year-old female with a serious unexpected event of seizure, and nonserious expected fatigue. Event onset 1 day after first dose mRNA-1273, with seizure occurring 2 days after vaccination. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
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