Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation
Clinical narrative: Patient ended up in the emergency with a-fib after her last Moderna vaccine in 2022; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Patient ended up in the emergency with a-fib after her last Moderna vaccine in 2022) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     Concurrent medical conditions included Lactose intolerant and Seasonal allergy. Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.    On 06-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ATRIAL FIBRILLATION (Patient ended up in the emergency with a-fib after her last Moderna vaccine in 2022) (seriousness criteria hospitalization and medically significant). At the time of the report, ATRIAL FIBRILLATION (Patient ended up in the emergency with a-fib after her last Moderna vaccine in 2022) had not resolved.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was admitted to the hospital within 5 or 6 hours after her Moderna vaccine. She stayed at the hospital overnight. She stated that she has not had a vaccine since then because her doctor advised her not to as she still has a-fib. She stated that her day-to-day activities were still guided due to the fact that she cannot take another vaccine. She stated that she had several attacks of A-fib leading up to her attack after her fifth dose which caused her hospitalization. She asked the staff when she was in the emergency room if that a-fib could be related to the COVID vaccine, and the staff said yes. No treatment information was reported. Company comment-This is a spontaneous case concerning an 86-year-old female patient with no relevant medical history reported, who experienced the serious (hospitalization and medically significant) unexpected AESI atrial fibrillation the same day a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was given as a fifth dose of COVID-19 vaccination schedule. It was reported patient was admitted to the hospital within 5 or 6 hours after her Moderna vaccine. She stayed at the hospital overnight. She stated that she had several attacks of A-fib leading up to her attack after her fifth dose which caused her hospitalization. No further details were provided for medical review. Patient´s age remains as a risk factor. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-773043, US-MODERNATX, INC.-MOD-2024-773041 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773041:Patient 2 out of 3 (same reporter) US-MODERNATX, INC.-MOD-2024-773043:Patient 3 out of 3 (same reporter)