Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rheumatoid arthritis, Stress
Clinical narrative: TWO FLARES RHEUMATOID ARTHRITIS DUE TO STRESS; TWO FLARES RHEUMATOID ARTHRITIS DUE TO STRESS; HEADACHE AFTER SECOND AND THIRD MODERNA COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (TWO FLARES RHEUMATOID ARTHRITIS DUE TO STRESS) in a 50-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) for Rheumatoid arthritis.    There was no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In December 2021, the patient experienced HEADACHE (HEADACHE AFTER SECOND AND THIRD MODERNA COVID VACCINE). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (TWO FLARES RHEUMATOID ARTHRITIS DUE TO STRESS) (seriousness criterion medically significant) and STRESS (TWO FLARES RHEUMATOID ARTHRITIS DUE TO STRESS). At the time of the report, RHEUMATOID ARTHRITIS (TWO FLARES RHEUMATOID ARTHRITIS DUE TO STRESS), STRESS (TWO FLARES RHEUMATOID ARTHRITIS DUE TO STRESS) and HEADACHE (HEADACHE AFTER SECOND AND THIRD MODERNA COVID VACCINE) had resolved.            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.  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.   The reporter's causality for the event(s) of two flares rheumatoid arthritis due to stress unknown onset, two flares rheumatoid arthritis due to stress unknown onset and headache after second and third moderna covid vaccine with humira(adalimumab) was no reasonable possibility.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 50-year-old female patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (reported as two flares rheumatoid arthritis due to stress), which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. Underlying rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. 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, concerning a 50-year-old female patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (reported as two flares rheumatoid arthritis due to stress), which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had resolved. Underlying rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.