Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Palpitations
Clinical narrative: Cardiac flutter; HEART FLUTTERS/PALPITATIONS/palpitations had increased in frequency since first starting; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Cardiac flutter) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 19-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Dec-2021, the patient experienced CARDIAC FLUTTER (Cardiac flutter) (seriousness criterion medically significant) and PALPITATIONS (HEART FLUTTERS/PALPITATIONS/palpitations had increased in frequency since first starting). At the time of the report, CARDIAC FLUTTER (Cardiac flutter) outcome was unknown and PALPITATIONS (HEART FLUTTERS/PALPITATIONS/palpitations had increased in frequency since first starting) had resolved.            No concomitant medications were reported. The patient experienced heart flutters/palpitations that started about two or three days after his initial dose of SKYRIZI.  He did receive his Covid booster two days after his first SKYRIZI dose and the palpitations had increased in frequency since first starting. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of Cardiac flutter and Palpitations was Not reported for cosuspect SKYRIZI. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 45-year-old male patient in treatment with RISANKIZUMAB for Plaque psoriasis, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of Cardiac flutter and non serious event of palpitations on the same day after receiving third dose. Events started about two or three days after his initial dose of SKYRIZI and palpitations had increased in frequency since first starting. Outcome of cardiac flutter was reported as unknown, and outcome of event palpitations was reported as resolved. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case reported by a consumer. A 45-year-old male patient in treatment with RISANKIZUMAB for Plaque psoriasis, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of Cardiac flutter and non serious event of palpitations on the same day after receiving third dose. Events started about two or three days after his initial dose of SKYRIZI and palpitations had increased in frequency since first starting. Outcome of cardiac flutter was reported as unknown, and outcome of event palpitations was reported as resolved. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.