Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Erythema, Influenza like illness, Peripheral swelling
Clinical narrative: Redness in my arm; Swelling in my arm/It was about the size of a baseball; Flu like symptoms; Patient started getting signs of afib/It's grown in intensity since patient got it/It's just gotten worse; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Patient started getting signs of afib/It's grown in intensity since patient got it/It's just gotten worse) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 021B21A and 027A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (Patient started getting signs of afib/It's grown in intensity since patient got it/It's just gotten worse) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced ERYTHEMA (Redness in my arm), PERIPHERAL SWELLING (Swelling in my arm/It was about the size of a baseball) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, ATRIAL FIBRILLATION (Patient started getting signs of afib/It's grown in intensity since patient got it/It's just gotten worse) had not resolved and ERYTHEMA (Redness in my arm), PERIPHERAL SWELLING (Swelling in my arm/It was about the size of a baseball) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medications were reported.  Patient had redness & swelling in the arm. It was about the size of a baseball, flu like symptoms. Patient's arm reacted a lot worse than the other two doses. Patient started getting signs of Afib. It just gotten worse.  Patient had to see a cardiologist. Patient had to wear a Holter monitor and now using a cardio mobile to detect heart arrhythmias. Patient would not think going to get the new Moderna booster. None of the doctors could tell patient whether to get it. No treatment information was provided.  Company comment.  This spontaneous case concerns a 62  year  old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of atrial fibrillation. The event occurred on the same month after the third (booster) dose of mRNA-1273 vaccine. Latency cannot be properly assessed since exact onset date was not provided. The report stated that the patient started getting signs of atrial fibrillation around Thanksgiving (2021) which grown in intensity since it started (vaccination date 22-Nov-2021). A Holter monitor was performed, although the result was not provided. No further clinical details were provided for medical reviewing. Patient´s age could be a confounding factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-664628, MOD-2021-093399 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62  year  old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant) AESI of atrial fibrillation. The event occurred on the same month after the third (booster) dose of mRNA-1273 vaccine. Latency cannot be properly assessed since exact onset date was not provided. The report stated that the patient started getting signs of atrial fibrillation around Thanksgiving (2021) which grown in intensity since it started (vaccination date 22-Nov-2021). A Holter monitor was performed, although the result was not provided. No further clinical details were provided for medical reviewing. Patient´s age could be a confounding factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.