Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flares; Achiness and low grade fever after COVID vaccine.; Achiness and low grade fever after COVID vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares) in a 66-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 ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's relevant history was not reported and patient had no known allergies.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-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) Daily dose: Solution for injection in pre-filled pen. In December 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Achiness and low grade fever after COVID vaccine.) and PYREXIA (Achiness and low grade fever after COVID vaccine.). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flares), PAIN (Achiness and low grade fever after COVID vaccine.) and PYREXIA (Achiness and low grade fever after COVID vaccine.) outcome was unknown.            Concomitant drugs were not reported, as patient had not taken concomitant drugs.  Treatment medications were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of 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 66-year-old female patient, in treatment with ADALIMUMAB (HUMIRA)  for Rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine and experienced medically significant event of rheumatoid arthritis flare up  (AESI) approximately 6 months after second dose. In addition, patient experienced non serious events of pain and fever after vaccination. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Rheumatoid arthritis can flare as part of its natural history. The event Rheumatoid arthritis was considered not related to mRNA-1273 per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 66-year-old female patient, in treatment with ADALIMUMAB (HUMIRA)  for Rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine and experienced medically significant event of rheumatoid arthritis flare up  (AESI) approximately 6 months after second dose. In addition, patient experienced non serious events of pain and fever after vaccination. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Rheumatoid arthritis can flare as part of its natural history. The event Rheumatoid arthritis was considered not related to mRNA-1273 per the reporter's assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.