Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Arthralgia, Contusion, Eye inflammation, Rheumatoid arthritis, Vaccination site pain
Clinical narrative: Rheumatoid arthritis flare up; left side eye sight seeing black spots; inflammation in eye; bruised ankles both on left; soreness in arm after covid vaccine; wrist pain after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) 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 products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), VISUAL IMPAIRMENT (left side eye sight seeing black spots), EYE INFLAMMATION (inflammation in eye), CONTUSION (bruised ankles both on left), VACCINATION SITE PAIN (soreness in arm after covid vaccine) and ARTHRALGIA (wrist pain after covid vaccine). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), VISUAL IMPAIRMENT (left side eye sight seeing black spots), EYE INFLAMMATION (inflammation in eye) and VACCINATION SITE PAIN (soreness in arm after covid vaccine) had not resolved, CONTUSION (bruised ankles both on left) outcome was unknown and ARTHRALGIA (wrist pain after covid vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product reported by reporter. No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in  Company Comment:  This spontaneous case concerns an adult female patient with concurrent Rheumatoid arthritis on Adalimumab, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency cannot be determined as both the dates of vaccination and onset of event were not disclosed. Outcome of the event was reported as not resolved. No information on any other doses of COVID-19 vaccination was provided. The concurrent Rheumatoid arthritis can be exacerbated by triggers that increase inflammatory activity that result in flares, thus, considered a confounder.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient with concurrent Rheumatoid arthritis on Adalimumab, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency cannot be determined as both the dates of vaccination and onset of event were not disclosed. Outcome of the event was reported as not resolved. No information on any other doses of COVID-19 vaccination was provided. The concurrent Rheumatoid arthritis can be exacerbated by triggers that increase inflammatory activity that result in flares, thus, considered a confounder.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.