Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Electrocardiogram abnormal
Clinical narrative: basal heart rate had gone up; Nasal Swab tes positive - May-2022; I had a-fib, flutter/ annual physical EKG showed Af b and Flutter.; I had a-fib, flutter/ annual physical EKG showed Af b and Flutter.; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (I had a-fib, flutter/ annual physical EKG showed Af b and Flutter.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot number: ER8727) on 25-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and Batch/Lot No: EW0162) on 15-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Hyperlipidemia, Type 2 diabetes mellitus and Drug allergy (drug name not reported). Concomitant products included SIMVASTATIN and METFORMIN for an unknown indication.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ATRIAL FIBRILLATION (I had a-fib, flutter/ annual physical EKG showed Af b and Flutter.) (seriousness criterion medically significant) and ATRIAL FLUTTER (I had a-fib, flutter/ annual physical EKG showed Af b and Flutter.). In May 2022, the patient experienced COVID-19 (Nasal Swab tes positive - May-2022). On an unknown date, the patient experienced HEART RATE INCREASED (basal heart rate had gone up). At the time of the report, ATRIAL FIBRILLATION (I had a-fib, flutter/ annual physical EKG showed Af b and Flutter.) and ATRIAL FLUTTER (I had a-fib, flutter/ annual physical EKG showed Af b and Flutter.) had not resolved, HEART RATE INCREASED (basal heart rate had gone up) outcome was unknown and COVID-19 (Nasal Swab tes positive - May-2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Electrocardiogram: normal.. On 29-Dec-2021, Electrocardiogram: showed a-fib and flutter.. On 15-Feb-2022, SARS-CoV-2 test: Negative. In March 2022, SARS-CoV-2 test: Negative. In May 2022, SARS-CoV-2 test: Positive. In August 2022, SARS-CoV-2 test: Negative. In February 2023, SARS-CoV-2 test: Negative. On an unknown date, Electrocardiogram: any of prior years did not show any cardiac rhythmic abnormalities. On an unknown date, Heart rate: It's now around 80. and normal heartrate was around 58 or 60. It used to be around 60 till 2020..         The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that patient got annual physical exam every year in quarter 4. 12 days after the third dose of Moderna vaccine (29-Dec-2021), at the annual physical, the patient's PCP did the electrocardiogram and found that the patient had a-fib & flutter. The patient never had that before. The patient's 2020 annual physical or any of the prior years did not show any cardiac rhythmic abnormalities. Also basal heart rate had gone up. The patient had been seeing a cardiologist for the heart. The patient was scheduled for a cardiac oblation to burn the place in the heart in hope of stopping it. On 20-DEC-2022, patient received additional dose - Pfizer bivalent.  Company comment: This is a spontaneous case, reported by a patient, concerning a 52-year-old male patient with concurrent Hyperlipidemia, Type 2 diabetes mellitus, who experienced the unexpected, serious (due to medically significant criteria) event of atrial fibrillation (AESI) approximately 12 days after the third dose of mRNA-1273 vaccine administration. Non-serios events atrial flutter, heart rate increased and COVID-19 were also reported. The patient previously received two doses of PFIZER BIONTECH COVID-19 VACCINE as first and second dose; and an additional dose after Moderna vaccination (fourth dose). The events were diagnosed at the annual physical examination. A cardiologist consultation was done, and a cardiac oblation was scheduled. No further clinical information was available for medical review.  At the time of the latest report, the event had not resolved. The mentioned concurrent conditions remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2023: Live Significant follow-up appended: Patient details updated, Medical history updated, new event added, Suspect product information updated, Lab data added and narrative updated. On 19-May-2023: Live follow up received with no significant information