Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac flutter, Erythema, Palpitations, Peripheral swelling, Tachycardia
Clinical narrative: She also had heart palpitation on and off; 1 day after receiving the bivalent dose, she started having Red, and Swollen left arm from elbow to shoulder.; 1 day after receiving the bivalent dose, she started having Red, and Swollen left arm from elbow to shoulder.; fast heart beat; flutter; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (flutter) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had clear relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-May-2023, 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 02-May-2023, the patient experienced PALPITATIONS (She also had heart palpitation on and off), PERIPHERAL SWELLING (1 day after receiving the bivalent dose, she started having Red, and Swollen left arm from elbow to shoulder.) and ERYTHEMA (1 day after receiving the bivalent dose, she started having Red, and Swollen left arm from elbow to shoulder.). In May 2023, the patient experienced CARDIAC FLUTTER (flutter) (seriousness criterion medically significant) and TACHYCARDIA (fast heart beat). In May 2023, CARDIAC FLUTTER (flutter), PALPITATIONS (She also had heart palpitation on and off), PERIPHERAL SWELLING (1 day after receiving the bivalent dose, she started having Red, and Swollen left arm from elbow to shoulder.), ERYTHEMA (1 day after receiving the bivalent dose, she started having Red, and Swollen left arm from elbow to shoulder.) and TACHYCARDIA (fast heart beat) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   She did not have a medical history of heart problems. She did not receive any other vaccinations on 01 MAY 2023 and nothing within 4 months of the Bivalent shot. She showed her arm to a pharmacist, and she was told that it was normal.  The concomitant medication was not reported by reporter.   The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case concerning a 74-year-old female patient with no medical history reported, who experienced the serious (per medically significant) unexpected event of Cardiac flutter which occurred on the same month after a dose of mRNA-1273 received as the fifth dose for COVID-19 Vaccination. She states that after vaccination, from time to time she feels she is having a flutter and fast heartbeat, but it goes away. She does not have a medical history of heart problems. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. Patient's advanced age remains a confounding risk factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2024-758523 (Patient Link).