Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Inappropriate schedule of product administration
Clinical narrative: A-Fib again and it continued; First Primary monovalent dose on 08FEB2021/2nd Primary monovalent dose on 16MAR2021; A-Fib; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (A-Fib) and ATRIAL FIBRILLATION (A-Fib again and it continued) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A, 048A21A, 053E21A and 065K21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation (A-Fib since 2019 and it was resolved in 2019 with Balloon) in 2019. Concurrent medical conditions included Glaucoma (for 10 years) and Diabetic (since 42 years old). Concomitant products included SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), VITAMIN C [ASCORBIC ACID], ATORVASTATINE [ATORVASTATIN], VITAMIN D3, ENALAPRIL, GLYBURIDE, SITAGLIPTIN PHOSPHATE (JANUVIA), LATANOPROST, MELATONIN, METFORMIN, TIMOLOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIZIDE), WARFARIN and CALCIUM CARBONATE, COLECALCIFEROL, MAGNESIUM OXIDE, ZINC OXIDE (CALCIUM MAGNESIUM ZINC VITAMIN D3) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ATRIAL FIBRILLATION (A-Fib) (seriousness criterion medically significant). On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08FEB2021/2nd Primary monovalent dose on 16MAR2021). On an unknown date, the patient experienced ATRIAL FIBRILLATION (A-Fib again and it continued) (seriousness criterion medically significant). The patient was treated with DILTIAZEM from 2021 to 2022 for Atrial fibrillation, at a dose of 120 milligram once a day; DILTIAZEM in 2022 for Atrial fibrillation, at a dose of 120 milligram twice a day; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at a dose of Daily for 30 days. Patient does not take it all the time and Surgery (Oblation on 03-Apr-2023) for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (A-Fib) had resolved, ATRIAL FIBRILLATION (A-Fib again and it continued) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08FEB2021/2nd Primary monovalent dose on 16MAR2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Electrocardiogram: showed A-Fib.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that the next day after the first primary shot on 09-Feb-2021 he did an apple watch EKG and it showed A-Fib and it last for 2 weeks. He did not have any symptoms. In 2021 the doctor prescribed Diltiazem ER 120 mg once a day for his A-Fib after vaccination. He was not able to see the doctor for another year. In 2022, The doctor increased Diltiazem ER 120 mg to two capsules a day.  After the 2nd shot, on 16-Mar-2023, he was on A-Fib again and it continued. It did not stop. He still did not have symptoms. He states that his doctor finally decided to have oblation done on 03-April-2023. He had an Echocardiogram done on 11-Apr-2023. After ablation on 03-April-2023 the doctor prescribed Prilosec daily for 30 days. He does not take it all the time. He states that the doctor told him to get a 6th shot.  On 08-Sep-2022, the patient received Moderna Bivalent Booster dose from lot AS7140C.  Company Comment: This is a spontaneous case regarding a 72-year-old male patient, with medical history of atrial fibrillation resolved in 2019 with Balloon and concurrent medical condition of diabetes, who experienced 2 episodes of unexpected and medically significant event atrial fibrillation (AESI) after receiving mRNA-1273 vaccine. Patient received 5 doses of Moderna COVID-19 vaccine; the next day after the first primary dose, patient did an apple watch EKG and it showed A-Fib that lasted 2 weeks. He did not have any symptoms; doctor prescribed Diltiazem ER 120 mg once a day. Approximately 1 year after, doctor increased Diltiazem ER 120 mg to two capsules a day. Patient stated that, after the second vaccination, he developed asymptomatic A-Fib again and it continued. His doctor  decided to perform ablation and prescribed Prilosec daily for 30 days. No further details regarding diagnostic tests were disclosed. Medical history of atrial fibrillation, concurrent medical condition of diabetes and concomitant product timolol remain confounding factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-719402, US-MODERNATX, INC.-MOD-2023-719403 (Linked Report). This case was linked to MOD-2023-719332 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2023: Live follow up received contains non significant information.; Sender's Comments: This is a spontaneous case regarding a 72-year-old male patient, with medical history of atrial fibrillation resolved in 2019 with Balloon and concurrent medical condition of diabetes, who experienced 2 episodes of unexpected and medically significant event atrial fibrillation (AESI) after receiving mRNA-1273 vaccine. Patient received 5 doses of Moderna COVID-19 vaccine; the next day after the first primary dose, patient did an apple watch EKG and it showed A-Fib that lasted 2 weeks. He did not have any symptoms; doctor prescribed Diltiazem ER 120 mg once a day. Approximately 1 year after, doctor increased Diltiazem ER 120 mg to two capsules a day. Patient stated that, after the second vaccination, he developed asymptomatic A-Fib again and it continued. His doctor  decided to perform ablation and prescribed Prilosec daily for 30 days. No further details regarding diagnostic tests were disclosed. Medical history of atrial fibrillation, concurrent medical condition of diabetes and concomitant product timolol remain confounding factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-719402:This case is for Doctor 1 out  of 2 doctors US-MODERNATX, INC.-MOD-2023-719403:This case is for Doctor 2 out  of 2 doctors