Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; First dose of Moderna vaccine caused shoulder and arm to hurt; First dose of Moderna vaccine caused shoulder and arm to hurt; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a female patient of an unknown age 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).   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-2021, received second 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, Solution for injection in pre-filled pen. In September 2021, the patient experienced PAIN IN EXTREMITY (First dose of Moderna vaccine caused shoulder and arm to hurt) and ARTHRALGIA (First dose of Moderna vaccine caused shoulder and arm to hurt). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and PAIN IN EXTREMITY (First dose of Moderna vaccine caused shoulder and arm to hurt) and ARTHRALGIA (First dose of Moderna vaccine caused shoulder and arm to hurt) outcome was unknown.      Concomitant medications were not reported. Treatment information was not provided. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of First dose of Moderna vaccine caused shoulder and arm to hurt with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of Rheumatoid arthritis flare up with HUMIRA(ADALIMUMAB) was a reasonable possibility.  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.  Company comment: This spontaneous case concerns a female patient, of unknown age, with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up, and other unexpected and expected, non-serious events. The event rheumatoid arthritis flare-up occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not reported while the event onset date was not provided, hence, the onset latency could not be assessed. The non-serious events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in Sep2021, hence, the onset latency could not be assessed. It was reported that the patient experienced rheumatoid arthritis flare-up, however, no flare symptoms were reported. The event had not resolved at the time of the report. It was also reported that the first dose of the mRNA-1273 vaccine caused the patient's shoulder and arm to hurt. No additional details were provided. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis flare-up. The co-suspect product Humira also remains a confounder for the event rheumatoid arthritis flare-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, serious (medically significant) AESI of rheumatoid arthritis flare-up, and other unexpected and expected, non-serious events. The event rheumatoid arthritis flare-up occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the administration date of Humira was not reported while the event onset date was not provided, hence, the onset latency could not be assessed. The non-serious events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in Sep2021, hence, the onset latency could not be assessed. It was reported that the patient experienced rheumatoid arthritis flare-up, however, no flare symptoms were reported. The event had not resolved at the time of the report. It was also reported that the first dose of the mRNA-1273 vaccine caused the patient's shoulder and arm to hurt. No additional details were provided. The medical history of Rheumatoid Arthritis, a chronic inflammatory disorder characterized by flares and remission, remains a confounder for the event rheumatoid arthritis flare-up. The co-suspect product Humira also remains a confounder for the event rheumatoid arthritis flare-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.