Received Apr 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 004M20A | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | SANOFI PASTEUR | UNK | — | — |
seven asymptomatic infections; mild influenza A(H3N2) infection; symptomatic COVID-19 Omicron BA.1 infection; two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation; two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation; increase in frequency of premature atrial contractions (PACs); increase in the frequency of Premature ventricular contractions (PVCs); This literature-non-study case was reported in a literature article and describes the occurrence of ATRIAL FIBRILLATION (two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation) and DISEASE RECURRENCE (two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Co-suspect product included non-company product Influenza vaccine inact split 3v (Trivalent influenza vaccine) for an unknown indication. The patient's past medical history included Paroxysmal atrial fibrillation (At 57-year. He was initially treated with flecainide and Eliquis. Eliquis anticoagulation therapy was continued following the ablation) in 2019, Atrial flutter (Arrhythmias did not resolve; a pulmonic vein isolation ablation procedure would be considered in a future ablation. As a result, this individual began an aggressive monitoring of his heart rhythm for any reoccurrence of arrhythmias) in 2019 and Cardiac ablation (referred to an electrophysiologist for a Cavotricuspid isthmus ablation at the age of 57.7 years. This ablation was chosen because the atrial fibrillation patterns were frequently preceded by atrial flutter rhythms suggesting that the atrial flutter might be disintegrating into atrial fibrillation. Fourier spectral analysis of the atrial fibrillation patterns revealed 150 and 300 bpm spectral components suggesting atrial flutter as a possible trigger). Previously administered products included for Paroxysmal atrial fibrillation: Flecainide (Referred to a cardiac clinic for evaluation and initially treated with flecainide. Following the ablation and the flecainide therapy was discontinued) in 2019. Past adverse reactions to the above products included No adverse effect with Flecainide. Concurrent medical conditions included Type II diabetes mellitus (16-year history of well-controlled Type II diabetes mellitus). Concomitant products included Apixaban (Eliquis) for Paroxysmal atrial fibrillation and Atrial flutter. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine inact split 3v (Trivalent influenza vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VENTRICULAR EXTRASYSTOLES (increase in the frequency of Premature ventricular contractions (PVCs)). In January 2022, the patient experienced COVID-19 (symptomatic COVID-19 Omicron BA.1 infection). In 2022, the patient experienced ATRIAL FIBRILLATION (two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation) (seriousness criterion medically significant), DISEASE RECURRENCE (two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation) (seriousness criterion medically significant) and SUPRAVENTRICULAR EXTRASYSTOLES (increase in frequency of premature atrial contractions (PACs)). In 2024, the patient experienced H3N2 INFLUENZA (mild influenza A(H3N2) infection). On an unknown date, the patient experienced COVID-19 (seven asymptomatic infections). At the time of the report, ATRIAL FIBRILLATION (two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation), DISEASE RECURRENCE (two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation) and H3N2 INFLUENZA (mild influenza A(H3N2) infection) had resolved, VENTRICULAR EXTRASYSTOLES (increase in the frequency of Premature ventricular contractions (PVCs)) and SUPRAVENTRICULAR EXTRASYSTOLES (increase in frequency of premature atrial contractions (PACs)) was resolving and COVID-19 (symptomatic COVID-19 Omicron BA.1 infection) and COVID-19 (seven asymptomatic infections) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Heart rate: The most pronounced increase in ectopic heart beats occurred following the second mRNA COVID-19 vaccine dose or 12-16 weeks after the first vaccine dose. In May 2021, Electrocardiogram ambulatory: An episode of ventricular bigeminy was recorded on a 24-h Holter monitor 15 weeks after the first mRNA COVID-19 vaccine dose. This episode occurred during the PVC rate peak, May-2021, and lasted 30 seconds. The individual only reported minimal palpitations. There was no shortness of breath or chest discomfort.. In 2021, SARS-CoV-2 antibody test: An increase in the SARS-CoV-2 IgG titer did occur as a result of those mRNA injections. In January 2022, Heart rate: The peak in ectopic beats occurred at 12 weeks following the symptomatic COVID-19 Omicron BA.1 infection. The double peak increase in resting heart rate over a ten-day period from the Omicron BA.1 infection at age 60 years. In 2022, Cardiac stress test: Negative. In 2024, Heart rate: Unlike the COVID-19 Omicron infection, he only observed a single-peak increase in resting heart rate peaking at 4-5 days. On an unknown date, Electrocardiogram: During a period exceeding five years between ages 57 and 62 years, this individual accumulated over six thousand 30-seconds rhythm strips with multiple recordings every day. On an unknown date, Heart rate: Frequency of ectopic heart beats initially decreased following the cavotricuspid isthmus ablation later increased following each exposure to the COVID-19 spike protein, typical heart rates range from 46 to 56 bpm depending on the food eaten for dinner the previous evening, Over the course of the pandemic, he observed seven more double peak increases in resting heart rates with no symptoms and The increased heart rates ranged from 7 days in length for EG.5 to 12 days in length for FL.1.5. On an unknown date, SARS-CoV-2 antibody test: received titers after three of events showing that the titers were off-scale, suggesting frequent exposure to these viruses in his clinic environment. Three markedly elevated spike protein IgG titers after three of these exposures confirming frequent exposures to this virus in a clinical work environment. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VENTRICULAR EXTRASYSTOLES (increase in the frequency of Premature ventricular contractions (PVCs)) to be related. No further causality assessments were provided for ATRIAL FIBRILLATION (two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation), DISEASE RECURRENCE (two lone atrial fibrillation episodes/reoccurrence of paroxysmal atrial fibrillation), SUPRAVENTRICULAR EXTRASYSTOLES (increase in frequency of premature atrial contractions (PACs)), H3N2 INFLUENZA (mild influenza A(H3N2) infection), COVID-19 (symptomatic COVID-19 Omicron BA.1 infection) and COVID-19 (seven asymptomatic infections). In 2019 prior to the COVID-19 pandemic, medical worker was referred to a cardiac clinic for evaluation and treatment of symptomatic paroxysmal atrial fibrillation and atrial flutter. Patterns in the frequency of premature atrial contractions (PACs) and Premature ventricular contractions (PVCs) began to emerge during the COVID-19 pandemic. He also received the first two COVID-19 mRNA Moderna vaccine doses at age 59 years in Jan-2021. Both doses were received in Jan-2021 with the first dose received on the 4th day of the month. Patient along with other workers in his clinic and hospital contracted a symptomatic COVID-19 Omicron infection in Jan-2022. This was believed to be the Omicron BA.1 strain because several hospital workers tested positive for that strain. He observed a double peak increase in resting heart rate over a ten-day period from the Omicron BA.1 infection at age 60 years. Over the course of the pandemic, he observed seven more double peak increases in resting heart rates with no symptoms. At the age of 62.2 years, he contracted a mild influenza A(H3N2) infection followed by a reoccurrence of paroxysmal atrial fibrillation 6 weeks later at age 62.4 years. This event was intermittent lasting from 12 second to one hour per 24 hours period over a 2-week period. He had two lone atrial fibrillation episodes at the age of 60.7 and 62.4 years, the atrial fibrillation and futter episodes were mostly eliminated. He was vaccinated with the annual trivalent influenza vaccine that reportedly did not fully protect from the influenza A(H3N2) strain. Three months after the Omicron BA.1 infection, this worker recognized an increase in frequency of PACs. He also recalled an increase in PVCs starting 1 year earlier that appeared to be resolved by Oct-2022. As a result, the rhythm strips were reviewed to calculate the actual frequency of PACs and PVCs averaged over each month. Furthermore, the data were sorted into resting and exercise states because the original atrial fibrillation episodes at age 57 were most common immediately following strenuous exercise. The first plot was stunning in that it showed a dramatic increase in the frequency of PVCs following the Moderna mRNA-1273 COVID-19 vaccines and later the frequency of PACs following the COVID-19 BA.1 infection. The first COVID-19 infection, Omicron BA.1, was symptomatic with seven asymptomatic infections over the following 2 years as BA.5 (asymptomatic), XBB.1.5 (asymptomatic), XBB.1.16 (asymptomatic), EG.5 (asymptomatic), FL.1.5.1 (asymptomatic), JN.1 (asymptomatic), JN.1.13 (asymptomatic). These data were later extended to the end of Dec-2024 eight months after he contracted a mild influenza A(H3N2) infection. The frequency of PACs and PVCs between Jul-2019 and Dec-2024 determine. The largest increase was in the form of PVCs following the Moderna mRNA-1273 vaccines and PACs following exposures to the various COVID-19 viral strains. Except for the mRNA vaccine, most of the ectopic peaks occurred on days of strenuous physical activity. The vaccine caused a predominately PVC pattern with a slightly higher frequency occurring on rest days compared to strenuous physical activity. The influenza also caused a slightly higher frequency of PACs during rest. The increase in PAC-induced paroxysmal atrial fibrillations following an asymptomatic COVID-19 BA.5 exposure and a symptomatic influenza A(H3N2) infection. The delayed onset of ectopic heart beats following exposures to COVID-19 spikes, by direct virus contact, suggest an autoantibody origin for these features. The data were replotted as a function of weeks following the exposure date as determined by the start of the double-peak rise in the resting heart rate. The data were also summed into weekly segments for better resolution, and all the ectopic beats (PACs and PVCs) were counted together to improve the statistics. Each progressive exposure to a COVID-19 strain in the clinic over the next 2.5 years showed a progressively earlier response strongly suggesting an autoantibody adaptive immune response to the COVID-19 spike proteins. By the time the JN.1.13 strain was circulating, the data were beginning to drop into the background noise. Although exposure to the strains after BA.1 was asymptomatic indicating natural immunity, some notable arthralgia was reported 2 weeks after exposure to the JN.1 strain. It was possible that the COVID-19 virus and/or mRNA COVID-19 vaccines could potentially damage pacemaker cells. Inflammatory cytokines could also impair cardiomyocytes. The outcome results in "sick" pacemaker cells or cardiomyocytes capable of evoking arrhythmias independent of autoimmunity. These changes could also occur very early in an infection. The appearance of atrial fibrillation occurred twice during a five-year period following the Cavo tricuspid isthmus ablation. A lone episode occurred six weeks after the exposure to COVID-19 BA.5 strain, and paroxysmal AFib episodes reoccurred 6 weeks post-influenza A(H3N2) infection. Both events occurred after a rise in the frequency of PACs, suggesting a common etiology for both of these ECG features. Three to six peaks of increased PVC rates occurred with the last recorded PVC occurring 675 days after the first COVID-19 vaccination. These PVCs were believed to be caused by circulating spike proteins induced from the mRNA vaccines. A baseline PVC rate between Jan-2023 and Jan-2025 remained at a relatively low rate of 0.049% Author concluded that in this study, the etiology of lone atrial fibrillation in COVID-19 appears to be subclinical myopericarditis (mRNA and spike protein in the myocardium-causing inflammation) with cardiac electrical irritability manifested by frequent PACs and PVCs. It was possible that autoantibodies directed toward viral antigens, i.e., COVID-19 and influenza A(H3N2), later cross-react with the calcium channel gates of the pulmonic vein. This results in premature triggering of these gates leading to an improper depolarization of the atrial conduction system. This study was the first to actually reveal a progressive adaptive immune response to a specific class of viral pathogens. Fortunately, many supraventricular arrhythmias could be managed with a pharmacologic rate and rhythm control. More invasive treatment procedures to fill or obliterate the left atrial appendage or catheter ablation to electrically isolate the pulmonic vein from the atrial endothelium were frequently useful in lowering the rate of these arrhythmias. Company comment: Causality for Atrial fibrillation, Disease recurrence, and Supraventricular extrasystoles was assessed as not related, due to long latency; Causality for H3N2 Influenza was assessed as not related due to lack of biological plausibility. Underlying medical history of paroxysmal atrial fibrillation and atrial flutter remain as risks factors for Atrial fibrillation, Disease recurrence, Ventricular extrasystoles and Supraventricular extrasystoles. The benefit-risk relationship of product is not affected by this report.
Type II diabetes mellitus (16-year history of well-controlled Type II diabetes mellitus)
Medical History/Concurrent Conditions: Atrial flutter (Arrhythmias did not resolve; a pulmonic vein isolation ablation procedure would be considered in a future ablation. As a result, this individual began an aggressive monitoring of his heart rhythm for any reoccurrence of arrhythmias); Cardiac ablation (referred to an electrophysiologist for a Cavotricuspid isthmus ablation at the age of 57.7 years. This ablation was chosen because the atrial fibrillation patterns were frequently preceded by atrial flutter rhythms suggesting that the atrial flutter might be disintegrating into atrial fibrillation. Fourier spectral analysis of the atrial fibrillation patterns revealed 150 and 300 bpm spectral components suggesting atrial flutter as a possible trigger); Paroxysmal atrial fibrillation (At 57-year. He was initially treated with flecainide and Eliquis. Eliquis anticoagulation therapy was continued following the ablation)
Eliquis
Test Date: 2022; Test Name: cardiac stress test; Test Result: Negative ; Test Name: Rhythm Strips; Result Unstructured Data: During a period exceeding five years between ages 57 and 62 years, this individual accumulated over six thousand 30-seconds rhythm strips with multiple recordings every day; Test Date: 202105; Test Name: Holter monitor; Result Unstructured Data: An episode of ventricular bigeminy was recorded on a 24-h Holter monitor 15 weeks after the first mRNA COVID-19 vaccine dose. This episode occurred during the PVC rate peak, May-2021, and lasted 30 seconds. The individual only reported minimal palpitations. There was no shortness of breath or chest discomfort.; Test Name: resting heart rates; Result Unstructured Data: Frequency of ectopic heart beats initially decreased following the cavotricuspid isthmus ablation later increased following each exposure to the COVID-19 spike protein; Test Name: resting heart rates; Result Unstructured Data: typical heart rates range from 46 to 56 bpm depending on the food eaten for dinner the previous evening; Test Name: resting heart rates; Result Unstructured Data: Over the course of the pandemic, he observed seven more double peak increases in resting heart rates with no symptoms; Test Name: resting heart rates; Result Unstructured Data: The increased heart rates ranged from 7 days in length for EG.5 to 12 days in length for FL.1.5; Test Date: 202101; Test Name: resting heart rates; Result Unstructured Data: The most pronounced increase in ectopic heart beats occurred following the second mRNA COVID-19 vaccine dose or 12-16 weeks after the first vaccine dose; Test Date: 202201; Test Name: resting heart rates; Result Unstructured Data: The peak in ectopic beats occurred at 12 weeks following the symptomatic COVID-19 Omicron BA.1 infection. The double peak increase in resting heart rate over a ten-day period from the Omicron BA.1 infection at age 60 years; Test Date: 2024; Test Name: resting heart rates; Result Unstructured Data: Unlike the COVID-19 Omicron infection, he only observed a single-peak increase in resting heart rate peaking at 4-5 days; Test Name: SARS-CoV-2 IgG; Result Unstructured Data: received titers after three of events showing that the titers were off-scale, suggesting frequent exposure to these viruses in his clinic environment. Three markedly elevated spike protein IgG titers after three of these exposures confirming frequent exposures to this virus in a clinical work environment; Test Date: 2021; Test Name: SARS-CoV-2 IgG; Result Unstructured Data: An increase in the SARS-CoV-2 IgG titer did occur as a result of those mRNA injections