Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Malaise, Mobility decreased, Palpitations, Sluggishness
Clinical narrative: possible 2nd stroke  with weakness on left side; MRI showed that she had stroke; heart was racing; wasn't feeling well at times/something wasn't right; I wasn't myself. It wasn't me. I was not the same person/I still don't feel myself; has to walk with cane,; can't drive; can't do a lot of things yet; tired/still little tired; sluggish; could not move anything on right side; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI showed that she had stroke) and HEMIPARESIS (possible 2nd stroke  with weakness on left side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), OMEPRAZOLE and AMITRIPTYLINE for an unknown indication.   On 01-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 06-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (MRI showed that she had stroke) (seriousness criteria hospitalization, medically significant and life threatening), SLUGGISHNESS (sluggish), MOBILITY DECREASED (could not move anything on right side) and FATIGUE (tired/still little tired). On 13-Jul-2021, the patient experienced HEMIPARESIS (possible 2nd stroke  with weakness on left side) (seriousness criteria hospitalization and medically significant) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't drive; can't do a lot of things yet). On an unknown date, the patient experienced PALPITATIONS (heart was racing), MALAISE (wasn't feeling well at times/something wasn't right), FEELING ABNORMAL (I wasn't myself. It wasn't me. I was not the same person/I still don't feel myself) and WALKING AID USER (has to walk with cane,). At the time of the report, CEREBROVASCULAR ACCIDENT (MRI showed that she had stroke), HEMIPARESIS (possible 2nd stroke  with weakness on left side), SLUGGISHNESS (sluggish), MOBILITY DECREASED (could not move anything on right side), PALPITATIONS (heart was racing), MALAISE (wasn't feeling well at times/something wasn't right), FEELING ABNORMAL (I wasn't myself. It wasn't me. I was not the same person/I still don't feel myself), WALKING AID USER (has to walk with cane,) and FATIGUE (tired/still little tired) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't drive; can't do a lot of things yet) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Magnetic resonance imaging: abnormal (abnormal) Confirmed stroke. On 13-Jul-2021, Magnetic resonance imaging: negative (Negative) negative for stroke.         Based on the current available information; although the use of the product and the start date of the events were more than 3 months apart, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were more than 3 months apart, a causal relationship cannot be excluded.  Further information has been requested.