Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Bronchitis, Feeling abnormal, Finger deformity, Memory impairment
Clinical narrative: Rheumatoid arthritis flare up; MEMORY PROBLEM/ Memory issue; NERVE PROBLEM IN ARM AND BACK; Feeling bad; Sinus disorder/DEVIATED SEPTUM; Finger deformity; Deviated nasal septum; Pain in fingers; Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 64-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. Concurrent medical conditions included Rheumatoid arthritis. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third 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. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), MEMORY IMPAIRMENT (MEMORY PROBLEM/ Memory issue), NERVOUS SYSTEM DISORDER (NERVE PROBLEM IN ARM AND BACK), FEELING ABNORMAL (Feeling bad), SINUS DISORDER (Sinus disorder/DEVIATED SEPTUM), FINGER DEFORMITY (Finger deformity), NASAL SEPTUM DEVIATION (Deviated nasal septum), PAIN IN EXTREMITY (Pain in fingers) and BRONCHITIS (Bronchitis). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), MEMORY IMPAIRMENT (MEMORY PROBLEM/ Memory issue) and NERVOUS SYSTEM DISORDER (NERVE PROBLEM IN ARM AND BACK) had not resolved, FEELING ABNORMAL (Feeling bad), SINUS DISORDER (Sinus disorder/DEVIATED SEPTUM), FINGER DEFORMITY (Finger deformity), NASAL SEPTUM DEVIATION (Deviated nasal septum) and PAIN IN EXTREMITY (Pain in fingers) outcome was unknown and BRONCHITIS (Bronchitis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: unknown.         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   Reporter causality for the events of memory problem/ memory issue, nerve problem in arm and back and BRONCHITIS with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FEELING BAD, SINUS ISSUES, ONE FINGER WAS CURLING, DEVIATED SEPTUM, ONE FINGER WAS HAVING PAIN and RHEUMATOID ARTHRITIS FLARE UP was not provided.  No concomitant medication was provided by reporter. No Treatment medication was provided by reporter.  Company comment: This spontaneous case concerns a 64-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the first dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Live Significant Follow-up - Event information, reporter opinion of causality, laboratory/diagnostic, suspect drug information and narrative description; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the first dose of mRNA-1273. The event is described as a flare up. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.