Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Atrial fibrillation, Cerebral haemorrhage, Cerebrovascular accident, Electrocardiogram, Fall
Clinical narrative: broken foot; Fall; Unevaluable event; Atrial fibrillation; Fall; Cerebral bleeding; Stroke; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), the first episode of FALL (Fall), FOOT FRACTURE (broken foot), the second episode of FALL (Fall) and UNEVALUABLE EVENT (Unevaluable event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Depression, Bladder disorder, Cholesterol, Abstains from alcohol and Non-smoker. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (DITROPAN) for Bladder disorder, ATORVASTATIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METOPROLOL for Heart disorder, MIRTAZAPINE (REMERON) for Unevaluable reaction.   In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of FALL (Fall) (seriousness criteria hospitalization and disability). In February 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral bleeding) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 10-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant) and UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). On 08-Jun-2021, the patient experienced FOOT FRACTURE (broken foot) (seriousness criteria hospitalization and disability) and the second episode of FALL (Fall) (seriousness criteria hospitalization and disability). The patient was hospitalized from 15-Feb-2021 to 18-Feb-2021 due to ATRIAL FIBRILLATION, CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT and FALL. On 08-Jun-2021, last episode of FALL (Fall) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), FOOT FRACTURE (broken foot) and UNEVALUABLE EVENT (Unevaluable event) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Magnetic resonance imaging head: confirmed brain is bleeding (abnormal) Confirmed brain is bleeding. On 10-Mar-2021, Electrocardiogram: confirmed atrial fibrillation (abnormal) Confirmed Atrial fibrillation. On 08-Jun-2021, X-ray limb: confirmed broken foot (abnormal) Confirmed broken foot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was sent to urgent care because the patient fell again and it was determined that her left foot was broken where a boot cast was put on her left leg and was advised to have bed rest and had the left leg elevated. The patient was waiting for brain bleeding to heal.   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.