Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain
Clinical narrative: Chest pain; Heart fluttering; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 61-year-old 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In August 2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CARDIAC FLUTTER (Heart fluttering) and CHEST PAIN (Chest pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  The patient received COVID vaccine and had flutter in the heart after the fifth day. She had chest pain as well.  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 spontaneous case concerns a 61  year  old, female patient, with current condition of Rheumatoid arthritis, who received a dose of mRNA-1273 vaccine (reported as first dose of her COVID  19 immunization schedule) and experienced the serious (medically significant) unexpected AESI of cardiac flutter. The event was reported as occurring on the same month of vaccination; since exact onset date was not provided, latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented chest pain, which could be related with cardiac flutter. No further clinical information was available for medical reviewing. Patient´s mentioned medical history and co  suspect product Upadacitinib remains as confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61  year  old, female patient, with current condition of Rheumatoid arthritis, who received a dose of mRNA-1273 vaccine (reported as first dose of her COVID  19 immunization schedule) and experienced the serious (medically significant) unexpected AESI of cardiac flutter. The event was reported as occurring on the same month of vaccination; since exact onset date was not provided, latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented chest pain, which could be related with cardiac flutter. No further clinical information was available for medical reviewing. Patient´s mentioned medical history and co  suspect product Upadacitinib remains as confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.