Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthma, Nasopharyngitis, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Cold; Asthma Flare; 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 product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid Arthritis).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 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), NASOPHARYNGITIS (Cold) and ASTHMA (Asthma Flare). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), NASOPHARYNGITIS (Cold) and ASTHMA (Asthma Flare) outcome was unknown.            No concomitant medications were reported.  There was no reported medical history, and it was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided by the reporter.  The reporter's causality for the events of Rheumatoid arthritis flares, Cold and Asthma flare for Humira was not reported.  Company Comment:  This is a spontaneous case concerning an adult female patient with relevant medical condition of moderate to severe Rheumatoid Arthritis, who experienced the unexpected serious (medically significant) adverse event of special interest Rheumatoid arthritis, reported as rheumatoid arthritis flare up, in the context of the third/booster dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine approximately 9 months prior to third mRNA-1273 vaccination. The patient also experienced colds and asthma flare up. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The medical condition of moderate to severe Rheumatoid Arthritis remains as a confounder for the Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning an adult female patient with relevant medical condition of moderate to severe Rheumatoid Arthritis, who experienced the unexpected serious (medically significant) adverse event of special interest Rheumatoid arthritis, reported as rheumatoid arthritis flare up, in the context of the third/booster dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. Patient had received 2-dose primary series of mRNA-1273 vaccine approximately 9 months prior to third mRNA-1273 vaccination. The patient also experienced colds and asthma flare up. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The medical condition of moderate to severe Rheumatoid Arthritis remains as a confounder for the Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.