Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Myalgia, Osteoarthritis, Pain in extremity, Peripheral swelling
Clinical narrative: rheumatoid arthritis / severe pain in one of her arms; osteoarthritis / pain, the index finger on left had is also swollen.; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis / severe pain in one of her arms) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that patient had no family history of arthritis.  The patient's past medical history included Influenza (She was very healthy and had influenza 30 years ago). Family history included Rheumatoid arthritis (Oldest brother has RA) since an unknown date.    On 06-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Dec-2022, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis / severe pain in one of her arms) (seriousness criterion medically significant), OSTEOARTHRITIS (osteoarthritis / pain, the index finger on left had is also swollen.) and MYALGIA (Muscle pain). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis / severe pain in one of her arms), OSTEOARTHRITIS (osteoarthritis / pain, the index finger on left had is also swollen.) and MYALGIA (Muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: alright.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  From 19-Dec-2022, patient went to primary care doctor with severe pain in one of arms. Blood work taken there was alright. She was diagnosed with rheumatoid arthritis and osteoarthritis. In addition to that pain, the index finger on left had been also swollen. Pain comes and goes. Had an appointment with arthritis doctor this month.  Patient thinks that rheumatoid arthritis might be hereditary.  No treatment drug was reported.  Company comment: This is a spontaneous case concerning a 69-years-old female patient, with no relevant medical history reported, who experienced the unexpected and serious (medically significant) event of rheumatoid arthritis (RA) (AESI) that occurred approximately 2,5 months after dose mRNA-1273.222 administration, which was 4th dose in COVID-19 vaccination schedule. The event was accompanied by non-serious events of osteoarthritis and myalgia.  The patient was vaccinated with mRNA-1273 as primary series and 3rd dose of COVID-19 vaccination schedule; muscle pain observed afterwards. No further clinical information clinical course of the event, diagnostic work up, concurrent conditions and concomitant medications, differential diagnosis, treatment and outcome were provided for medical review. It was reported that there was family history of rheumatoid arthritis diagnosed in the patient's oldest brother. Based on the provided information it cannot be differentiated if this event represented an instance of reactive arthritis or rheumatoid arthritis itself. Outcome of rheumatoid arthritis was not recovered at the time of the report. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to MOD-2023-722965 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2023: Follow-up was received: Medical (family) history and narrative was updated.