Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Cardiac pacemaker insertion, Haemorrhage, Tuberculin test
Clinical narrative: Atrial fibrillation; Hemorrhage; Pacemaker insertion; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), HAEMORRHAGE (Hemorrhage) and CARDIAC PACEMAKER INSERTION (Pacemaker insertion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and APIXABAN (ELIQUIS) tablet for Atrial fibrillation and Hemorrhage.    The patient's past medical history included Ex-tobacco user (Up to a pack of cigarettes per day) from 1972 to 2021, Ex-alcohol user (Vodka and grape just socially on weekends) in 1992 and Fatty liver. Previously administered products included for Infection: Prednisone. Past adverse reactions to the above products included Blood sugar increased with Prednisone. Concurrent medical conditions included Blood pressure high since 1992, Plaque psoriasis since 2010, Chronic obstructive pulmonary disease since 2017, Type 2 diabetes mellitus (HIGH SUGARS), Iron supplementation, Fluid retention, Sleep disorder, Restless legs and Depression. Concomitant products included METOPROLOL for Blood pressure high, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), BUDESONIDE (PULMICORT) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB) for Chronic obstructive pulmonary disease, SERTRALINE for Depression, FUROSEMIDE (LASIX [FUROSEMIDE]) for Fluid retention, GLIMEPIRIDE (AMARYL) for Glucose high, FERROUS SULFATE for Iron supplementation, MONTELUKAST for Lung disorder, GABAPENTIN for Restless legs, CLONAZEPAM (KLONOPIN) and TRAZODONE for Sleep disorder, POTASSIUM, VITAMIN D3, VITAMIN C [ASCORBIC ACID], VITAMIN B12 [VITAMIN B12 NOS] and ZINC for Supplementation therapy.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient started APIXABAN (ELIQUIS) (Oral) 2.5 milligram every other day. In 2022, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant), HAEMORRHAGE (Hemorrhage) (seriousness criteria hospitalization and medically significant) and CARDIAC PACEMAKER INSERTION (Pacemaker insertion) (seriousness criteria hospitalization and medically significant). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Atrial fibrillation, at an unspecified dose and frequency. In 2022, HAEMORRHAGE (Hemorrhage) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and CARDIAC PACEMAKER INSERTION (Pacemaker insertion) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, COVID-19: (Positive) Positive. On an unknown date, Tuberculin test: A purified protein derivative PPD test is done every six months.         The patient took Eliquis for atrial fibrillation and hemorrhage, so patient was switched to baby Aspirin. Patient reported he never had heart surgery or pacemaker insertion for atrial fibrillation, only blood thinners. He saw his physician for an outpatient visit for atrial fibrillation. He could not remember hospitalization details of the hemorrhage. The alternative etiology as per reporter for event of hemorrhage was Eliquis use. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company comment: This spontaneous case concerns a 74-years-old male patient, with medical history related of Ex-tobacco use, Fatty liver, Concurrent medical conditions included Blood pressure high, Plaque psoriasis since 2010, Chronic obstructive pulmonary disease, Type 2 diabetes mellitus, Atrial fibrillation, fluid retention, concomitant products included prednisone, metoprolol, fluticasone, umeclidinium, vilanterol, salbutamol, budesonide, ipratropium, sertraline, furosemide, glimepiride, montelukast, gabapentin, clonazepam, trazodone, in 2017 the patient started adalimumab and in 2022 the co-suspected eliquis and baby aspirin who experienced the unexpected seriousness criterion medically significant and hospitalization events of atrial fibrillation, hemorrhage and the unexpected event of cardiac pacemaker insertion unknown days after 3rd. dose of  mrna-1273 vaccine.  The medical history of atrial fibrillation, chronic obstructive pulmonary disease, concomitant medications of metoprolol, salbutamol, vilanterol and fluticasone are contributors for the event atrial fibrillation. Co-suspect medication of eliquis and baby aspirin are confounders for the event hemorrhage. The benefit-risk relationship of mrna-1273 is not affected by this report. events seriousness was assessed based on medical judgement.   This case was linked to MOD-2022-630800 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-years-old male patient, with medical history related of Ex-tobacco use, Fatty liver, Concurrent medical conditions included Blood pressure high, Plaque psoriasis since 2010, Chronic obstructive pulmonary disease, Type 2 diabetes mellitus, Atrial fibrillation, fluid retention, concomitant products included prednisone, metoprolol, fluticasone, umeclidinium, vilanterol, salbutamol, budesonide, ipratropium, sertraline, furosemide, glimepiride, montelukast, gabapentin, clonazepam, trazodone, in 2017 the patient started adalimumab and in 2022 the co-suspected eliquis and baby aspirin who experienced the unexpected seriousness criterion medically significant and hospitalization events of atrial fibrillation, hemorrhage and the unexpected event of cardiac pacemaker insertion unknown days after 3rd. dose of  mrna-1273 vaccine.  The medical history of atrial fibrillation, chronic obstructive pulmonary disease, concomitant medications of metoprolol, salbutamol, vilanterol and fluticasone are contributors for the event atrial fibrillation. Co-suspect medication of eliquis and baby aspirin are confounders for the event hemorrhage. The benefit-risk relationship of mrna-1273 is not affected by this report. events seriousness was assessed based on medical judgement.