Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Sinus tachycardia, Tachycardia
Clinical narrative: Heart flutter; INAPPROPRIATE SINUS TACHYCARDIA; TACHYCARDIA PROBLEM; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in an adult female 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 ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled penUNK. On an unknown date, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant), SINUS TACHYCARDIA (INAPPROPRIATE SINUS TACHYCARDIA) and TACHYCARDIA (TACHYCARDIA PROBLEM). At the time of the report, CARDIAC FLUTTER (Heart flutter) outcome was unknown, SINUS TACHYCARDIA (INAPPROPRIATE SINUS TACHYCARDIA) was resolving and TACHYCARDIA (TACHYCARDIA PROBLEM) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  Primary reporter did not have the lot number information, because the packaging was discarded for second regimen.  The reporters causality for the events of HEART FLUTTER and TACHYCARDIA PROBLEM was not provided. The reporters causality for the event of INAPPROPRIATE SINUS TACHYCARDIA with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication 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, concerning an adult female patient, with relevant medical condition of ankylosing spondylitis, who experienced the unexpected and serious (due to medically significant) AESI of Cardiac flutter, and the unexpected and non-serious AESI of Sinus tachycardia, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for ankylosing spondylitis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, Sinus tachycardia was resolving. Underlying ankylosing spondylitis could be a contributory factor for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2022: Follow up received contains significant information Moderna suspect start dates were updated, added additional dose of suspect drug Humira, event SINUS TACHYCARDIA was added.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of ankylosing spondylitis, who experienced the unexpected and serious (due to medically significant) AESI of Cardiac flutter, and the unexpected and non-serious AESI of Sinus tachycardia, which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for ankylosing spondylitis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, Sinus tachycardia was resolving. Underlying ankylosing spondylitis could be a contributory factor for the events. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.