COVID vaccine-associated new-onset rheumatoid arthritis; This is a literature report.  A 74-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obstructive sleep apnea" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Idiopathic pulmonary fibrosis" (unspecified if ongoing); "Asbestos exposure" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Gout" (unspecified if ongoing); "Polyarthralgia" (unspecified if ongoing); "polymyalgia rheumatica (PMR)" (unspecified if ongoing), notes: without any symptoms or findings for giant cell arteritis (GCA); "cough" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nintedanib for idiopathic pulmonary fibrosis; Antihistamines for serum sickness-like reaction due to the COVID-19 vaccine; Steroid creams for symptoms of rash. Vaccination history included: Pfizer-biontech sars-cov-2 mrna vaccine (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunisation, reaction(s): "serum sickness-like reaction". The first and second doses of the vaccine were administered in January 2021 and February 2021, respectively. Ten days after the first dose, the patient reported bilateral hip and shoulder pain, associated with 15 minutes of morning stiffness, as well as left thumb pain. He also developed a rash overlying a few joints (the left ankle, the right knee, and the right wrist). He reported that the rash was migratory, pruritic, and papular in quality. Dermatology was consulted in February before the second dose. He was diagnosed with a serum sickness-like reaction due to the COVID-19 vaccine and was treated with antihistamines and steroid creams for the symptoms of rash. He was also referred to an infectious disease specialist who recommended the administration of the second dose as he did not have an anaphylactic or severe reaction to the vaccine. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "COVID vaccine-associated new-onset rheumatoid arthritis". The event "covid vaccine-associated new-onset rheumatoid arthritis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Anti-cyclic citrullinated peptide antibody: (05Mar2021) less than 1.5, notes: Units: U/ml; Antinuclear antibody: (18Feb2021) 1:320 homogeneous; (18Feb2021) Negative; Blood albumin: (31Mar2021) 3.5 g/dl; (14Apr2021) 3.6 g/dl; Blood creatine phosphokinase: (31Mar2021) 67 IU/l, notes: Units U/L; Blood lactate dehydrogenase: (31Mar2021) 258 IU/l, notes: Units U/L; Blood uric acid: (18Feb2021) 3.6 mg/dl; (03Sep2021) 3.6 mg/dl; Complement factor C3: (05Mar2021) 123 mg/dl; Complement factor C4: (05Mar2021) 21 mg/dl; C-reactive protein: (unspecified date) 15 mg/l; (18Feb2021) 15.4 mg/l; (05Mar2021) 27.2 mg/l; (31Mar2021) 55.9 mg/l; (14Apr2021) 10.5 mg/l; (03Jun2021) 5 mg/l; (03Sep2021) 35 mg/l; Haemoglobin: (18Feb2021) 15.8 g/dl; (31Mar2021) 14.6 g/dl; (03Jun2021) 14.7 g/dl; (03Sep2021) 14.9 g/dl; grind test: (18Feb2021) Positive; Physical exam revealed motor power: (unspecified date) 5/5 in all limbs; (18Feb2021) He was noted to have tenderness to palpation of, notes: the first carpometacarpal (CMC) joint with a positive grind test and tenderness to palpation of the right acromioclavicular (AC) joint, with mildly limited range of motion. No rash was present at that time; Platelet count: (18Feb2021) 236000, notes: Units: k/cmm; (31Mar2021) 253000, notes: Units: k/cmm; (03Jun2021) 208000, notes: Units: k/cmm; (03Sep2021) 23900, notes: Units: k/cmm; Red blood cell sedimentation rate: (18Feb2021) 6, notes: Units: mm/h; (31Mar2021) 14, notes: Units: mm/h; (03Jun2021) 4, notes: Units: mm/h; (03Sep2021) 32, notes: Units: mm/h; Rheumatoid factor: (18Feb2021) 24 IU/ml, notes: IU/ml. Therapeutic measures were taken as a result of rheumatoid arthritis. Clinical course: The patient reported the same joint pain after the second dose, so he presented to the rheumatology outpatient clinic in late February. On physical exam, he was noted to have tenderness to palpation of the first carpometacarpal (CMC) joint with a positive grind test and tenderness to palpation of the right acromioclavicular (AC) joint, with mildly limited range of motion. No rash was present at that time. Pending the results, the patient's pruritic rash resumed in early March, and weakness in his thigh and shoulder muscles was noted. He started using a cane to walk, fell multiple times around the house, could not bend over, had difficulty rising from a seated position, and had trouble raising his hands above his head. Pain and stiffness were worse in the morning and at night, but improved during the daytime and after taking ibuprofen. He presented with these symptoms to the emergency department and was given an intramuscular ketorolac injection, which relieved most of his symptoms. On the same day, he contacted his rheumatology provider, with only a few labs available. His CRP was 15 mg/L, and RF was 24 IU/ml (low positive). He was initially diagnosed with PMR, without any symptoms or findings for giant cell arteritis (GCA). He was prescribed prednisone 20 mg orally daily with a slow taper. Subsequently, he was seen in the clinic in late March (two weeks after starting the steroids). Physical exam revealed motor power of 5/5 in all limbs. He reported improvement on the 20-mg prednisone dose, but symptoms recurred when the dose was tapered down to 15 mg. He had more pain and stiffness lasting two hours in the morning, with motor weakness. His prednisone dose was increased to 30 mg, pending labs. On the same day, he presented again to the same emergency department with a cough that persisted for five days, which had not improved with azithromycin. He was discharged on a levofloxacin course upon being diagnosed with mild pneumonitis. He gradually started tapering his steroids after symptoms improved, and his CRP trended down. However, whenever he tried to taper the prednisone below 10 mg, his symptoms returned, and he resumed the 10-mg daily prednisone dose. In June, his symptoms resolved with an associated normalization of inflammatory markers, CRP 5 mg/L, and ESR 4 mm/h. Over the next two months, the patient attempted to decrease his prednisone dose further as instructed by his provider, but symptoms recurred when the daily prednisone dose was tapered below 10 mg. In early September, he developed arthritis of the right wrist and multiple MCPs. He also began experiencing stiffness and pain in the morning that improve during the day and with NSAIDs. Being the primary caretaker of his household, he had significant difficulty with his daily living activities. Six months after his initial presentation, the repeat laboratory testing showed a highly positive RF of 74. Hence, the clinical assessment at that time changed to RA, and a steroid-sparing agent was started. Given his pulmonary history, methotrexate was not an option, so he was started on leflunomide after his TB Quantiferon and hepatitis panel testing results were negative.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on limited information in the case a possible causal association between the reported event Rheumatoid arthritis and the suspect drug   BNT162B2 cannot be excluded and also a contributory role of medical history.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201280036 Same Article/drug/patient and different event;US-PFIZER INC-202201287753 Same article/patient and different drug/event;