Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis B virus test, Hepatitis C virus test, Physical examination, Red blood cell sedimentation rate, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis overlap syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis overlap syndrome) in a 36-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     Family history included Systemic lupus erythematosus.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis overlap syndrome) (seriousness criterion medically significant). The patient was treated with METHOTREXATE at an unspecified dose and frequency; LEFLUNOMIDE at an unspecified dose and frequency and ADALIMUMAB at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis overlap syndrome) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-cyclic citrullinated peptide antibody (0-19): more than 250 U/mL. On an unknown date, Antinuclear antibody: more than 8.0 IU/ mL; reference, <1 IU/mL and notable for a fluorescent antinuclear antibody with a 1:1280 titer (centromere pattern). On an unknown date, C-reactive protein (0-0.5 mg/dl): 7 mg/dl. On an unknown date, Chest X-ray: (Negative) negative for an acute cardiopulmonary process. On an unknown date, HIV test: (Negative) Negative. On an unknown date, Hepatitis B virus test: (Negative) Negative. On an unknown date, Hepatitis C virus test: (Negative) Negative. On an unknown date, Physical examination: On initial examination, synovitis was noted at the bilateral second to fourth metacarpophalangeal (MCP) joints, second and third proximal interphalangeal (PIP) joints, wrists, and elbows.. On an unknown date, Red blood cell sedimentation rate (0-20 mm/hr): 40 mm/hr. On an unknown date, Rheumatoid factor (0-13.9): Elevated (>130 IU/mL). On an unknown date, SARS-CoV-2 test: (Negative) Negative.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered RHEUMATOID ARTHRITIS (Rheumatoid arthritis overlap syndrome) to be related.    Concomitant medications were not reported.  It was reported that patients were initially seen in primary care and then referred to rheumatology for further evaluation and management.  Patient had 2 months of symmetric polyarthritis involving the shoulders, elbows, wrists, hands, knees, and toes with prolonged morning stiffness. Symptom onset occurred 1 day after completing the Moderna-NIAID vaccination series.  Patient had no clinical signs or symptoms of limited cutaneous systemic sclerosis and no personal history of autoimmune disease or COVID infection. The patient never received immunosuppression in the past, and no medication changes were made at the time of vaccination. Bilateral hand and foot radiographs were negative for erosive changes.  Reported that patient met the 2010 Rheumatology classification criteria for rheumatoid arthritis, her symmetric polyarthritis may represent the initial manifestation of an overlap syndrome between rheumatoid arthritis and systemic sclerosis, which was then to manifest.  After intolerance to treatment with both Methotrexate and Leflunomide, the patient achieved clinical remission with Adalimumab. In was reported that close observation for the development of signs or symptoms of systemic sclerosis was ongoing.  Author stated involved the development of new rheumatic disease that was temporally associated with mRNA vaccination against COVID-19.   This case was linked to US-MODERNATX, INC.-MOD-2022-661399, US-MODERNATX, INC.-MOD-2022-661400, US-MODERNATX, INC.-MOD-2022-661401, US-MODERNATX, INC.-MOD-2022-661402 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2022: Follow up received by safety on 21-Oct-2022 has Email with full text article and contains significant information. Reporter information, literature information, patient details, family history, lab data, treatment and event details updated.; Sender's Comments: This literature non-study case concerns a 36-year-old female patient, with medical history of systemic lupus erythematosus, who experienced the serious (medically significant) unexpected AESI of rheumatoid arthritis, after receiving the second dose of mRNA-1273 vaccine. No details of previous doses were provided. She presented with 2 months of symmetric polyarthritis involving the shoulders, elbows, wrists, hands, knees, and toes with prolonged morning stiffness that occurred 1 day after vaccination. On initial examination, synovitis was noted at the bilateral second to fourth metacarpophalangeal joints, second and third proximal interphalangeal joints, wrists, and elbows. Laboratory evaluation was remarkable for an elevated rheumatoid factor (>130 IU/mL; reference range, 013.9 IU/mL), anticitrullinated peptide antibody (>250 U/mL; reference range, 019U/mL), erythrocyte sedimentation rate (ESR) (40mm/h; reference range, 020 mm/h), and C-reactive protein (CRP) (7.0mg/ dL; reference range, 00.5 mg/dL). Evaluation was also notable for a fluorescent antinuclear antibody with a 1:1280 titer (centromere pattern) and positive anticentromere antibodies (>8.0 IU/mL; reference, <1 IU/mL). She had no clinical signs or symptoms of limited cutaneous systemic sclerosis. Serologic testing for hepatitis B virus, hepatitis C virus, HIV, and COVID-19 were negative. Bilateral hand and foot radiographs were negative for erosive changes. Chest x-ray was negative for an acute cardiopulmonary process. She met the criteria for rheumatoid arthritis, but her symmetric polyarthritis may represent the initial manifestation of an overlap syndrome between rheumatoid arthritis and systemic sclerosis. After intolerance to treatment with both methotrexate and leflunomide, the patient achieved clinical remission with adalimumab. Close observation for the development systemic sclerosis was ongoing. It was reported that there was a temporally association between de development of a new rheumatic disease with vaccination. No further clinical information was available for medical review. Patient´s age and gender, and her medical history of systemic lupus erythematosus could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-661402:Patient 5 (Elderly Male) US-MODERNATX, INC.-MOD-2022-661401:Patient 4 (Elderly Female) US-MODERNATX, INC.-MOD-2022-661399:Patient 2 (Elderly Female) US-MODERNATX, INC.-MOD-2022-661400:Patient 3 (Elderly Female)