Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Rheumatoid arthritis, SARS-CoV-2 test, Sensitivity to weather change
Clinical narrative: Sensitivity to weather change; COVID-19; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 54-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 (Rheumatoid arthritis illness).   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In January 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and COVID-19 (COVID-19). On an unknown date, the patient experienced SENSITIVITY TO WEATHER CHANGE (Sensitivity to weather change). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved, SENSITIVITY TO WEATHER CHANGE (Sensitivity to weather change) outcome was unknown and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. COVID-19 was resolved at an unknown date in 2022. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SENSITIVE TO WEATHER, RHEUMATOID ARTHRITIS FLARE UP, HAD BEEN  HARD TO TELL IF HUMIRA WAS WORKING AS WELL and COVID onset in January 2022 was not provided. The reporter's  causality for the event of COVID onset in January 2022 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Company comment: This spontaneous case concerns a 54 year old female patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis; unexpected non serious AESI of COVID-19, approximately 8 months after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. She tested positive for COVID-19 about the same time. Patient reported flare up of rheumatoid arthritis despite taking the drug adalimumab. The event COVID-19 resolved and the event Rheumatoid arthritis was not resolved. Concomitant adalimumab and the ongoing pandemia could be risk factors for the event COVID-19. Medical history of Rheumatoid arthritis could be confounding for the event Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54 year old female patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected serious (medically significant) AESI of Rheumatoid arthritis; unexpected non serious AESI of COVID-19, approximately 8 months after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. She tested positive for COVID-19 about the same time. Patient reported flare up of rheumatoid arthritis despite taking the drug adalimumab. The event COVID-19 resolved and the event Rheumatoid arthritis was not resolved. Concomitant adalimumab and the ongoing pandemia could be risk factors for the event COVID-19. Medical history of Rheumatoid arthritis could be confounding for the event Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report.