Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Swelling face
Clinical narrative: part of my face; body aches; fever; chills; heart was racing to 180-190 beats per minute; heart ablation for a-fib; lip swelled way up/bubble lip/big bubble lip; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (heart ablation for a-fib) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Meningitis, H1N1 influenza (swine flu), Cardiac tamponade (In 2007, a surgeon poked a hole in heart during a procedure, which resulted in a cardiac tamponade.) and Surgery (In 2007, a surgeon poked a hole in heart during a procedure) in 2007. Concurrent medical conditions included Heart disorder and Diabetes.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced LIP SWELLING (lip swelled way up/bubble lip/big bubble lip). On 02-Jul-2021, the patient experienced ATRIAL FIBRILLATION (heart ablation for a-fib) (seriousness criterion medically significant) and PALPITATIONS (heart was racing to 180-190 beats per minute). On an unknown date, the patient experienced SWELLING FACE (part of my face), PAIN (body aches), PYREXIA (fever) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE for Lip swelling, at a dose of took every 4 hours and FAMOTIDINE for Lip swelling, at a dose of took every 4 hours. At the time of the report, ATRIAL FIBRILLATION (heart ablation for a-fib), LIP SWELLING (lip swelled way up/bubble lip/big bubble lip), SWELLING FACE (part of my face) and PALPITATIONS (heart was racing to 180-190 beats per minute) outcome was unknown and PAIN (body aches), PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, Heart rate: 180-190 (High) heart was racing to 180-190 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.  It was reported that both doses were given in his upper right arm but from different vaccination sites. After the second dose, the patient started having fever, chills, and body aches for about two and a half days. The biggest thing that scared him was that his lip swelled way up and part of his face. He had a big bubble lip. This happened the second day later that night and not 15-30 minutes after getting the vaccine. His wife told him to take diphenhydramine (the little pink and white pills) and famotidine. He took those every 4 hours for a day, so he took at least 5-6 doses to get the lip swelling down. He states he has heart problems and diabetes. He's had history of meningitis and swine flu. He states that in 2007 a surgeon poked a hole in his heart during a procedure, which resulted in a cardiac tamponade, so he is lucky to be alive still. On 02Jul2021, he had a heart ablation for a-fib because his heart was racing to 180-190 beats per minute.  Company comment: This case concerns a 61-year-old, male patient with previous relevant medical history of meningitis, cardiac tamponade with surgery, heart disorder, diabetes, hypertension and high cholesterol, who experienced the unexpected event of atrial fibrillation. The event occurred 4 months and 18 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The medical history of cardiac tamponade with surgery, heart disorder, diabetes, hypertension and high cholesterol remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, male patient with previous relevant medical history of meningitis, cardiac tamponade with surgery, heart disorder, diabetes, hypertension and high cholesterol, who experienced the unexpected event of atrial fibrillation. The event occurred 4 months and 18 days after the second dose of mRNA-1273. The rechallenge was not applicable since the event happened after the second dose. The medical history of cardiac tamponade with surgery, heart disorder, diabetes, hypertension and high cholesterol remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.