Sex: M
Vaccine: COVID19
Symptoms: Scleroderma-like reaction
Clinical narrative: SCLERODERMA-LIKE SYNDROME FOLLOWING BNT162B2 MRNA COVID-19 VACCINATION; This is a literature report for the following literature source(s).  CASE PRESENTATION: The patient is an 82-year-old gentleman who presented with progressive dyspnea on exertion and a non-productive cough. Medical history was only signi?cant for low-grade urothelial carcinoma for which he was undergoing yearly surveillance CT scans of his chest, abdomen, and pelvis. He denied any respiratory issues until three months prior to his presentation. He was treated with multiple courses of antibiotics and empiric inhaler therapy that had minimal effect. Additionally, he endorsed diffuse thickening of his hands and ?ngers bilaterally and Raynaud's phenomenon; these symptoms were also absent three months ago. Curiously, these symptoms emerged within weeks of receiving the BNT162b2 mRNA COVID- 19 vaccine. He denied any symptoms suggestive of an acute respiratory infection at that time no fevers or chills and was fully adherent to masking guidelines. He denied any dif?culty swallowing or symptoms of gastroesophageal re?ux. He denied any new medications. He denied any new environmental or occupational exposures. He underwent repeat chest imaging that revealed the presence of non-speci?c interstitial pneumonia that was previously absent on a surveillance CT scan six months prior. Laboratory data revealed a positive ANA (1:320, speckled pattern) and elevated CRP and ESR; these serologies were negative one year ago. Multiple tests for COVID-19 infection dating back six months prior to presentation were negative. Following multi- disciplinary discussion with rheumatology, authors believed the patient to have a scleroderma-like reaction to his vaccination. He declined lung biopsy and was empirically treated with prednisone and mycophenolate mofetil. Following one year of treatment, his lung disease has remained stable and he remains on a maintenance dose of mycophenolate mofetil. DISCUSSION: Drug induced interstitial lung disease (ILD) is characterized by bilateral ground glass opacities with or without consolidation and accounts for 3-5% of ILD cases. Cases of ILD following COVID-19 vaccination have been reported though the mechanism is poorly understood. Proposed mechanisms included cytotoxic lung injury and immune mediated lung injury similar to previous reports of drug induced ILD following in?uenza vaccination. Raynaud's phenomenon has also been observed after COVID-19 vaccination.The temporal relationship between vaccination and symptom onset in our patient implicates a casual effect between development of this scleroderma-like syndrome and BNT162b2 vaccination. CONCLUSIONS: Vaccination remains a valuable tool for prevention of severe COVID-19, but patients do need to be monitored closely for potential adverse effects.; Sender's Comments: The event scleroderma-like reaction is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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 Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.