This literature-non-study case was reported in a literature article and describes the occurrence of SCLERODERMA (New-onset scleroderma-myositis) and MYOSITIS (New-onset scleroderma-myositis) in a 60-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: Sclerotic skin disease development following COVID-19 vaccination. Case Rep. 2022;22:74-7. Concurrent medical conditions included Discoid lupus erythematosus (Patient had 14 year history of discoid lupus which progressed to new onset scleroderma-myositis). Concomitant products included HYDROXYCHLOROQUINE for Discoid lupus erythematosus, CLOBETASOL for Discoid lupus erythematosus. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCLERODERMA (New-onset scleroderma-myositis) (seriousness criterion medically significant) and MYOSITIS (New-onset scleroderma-myositis) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and MYCOPHENOLATE MOFETIL for Adverse event, at an unspecified dose and frequency. At the time of the report, SCLERODERMA (New-onset scleroderma-myositis) and MYOSITIS (New-onset scleroderma-myositis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Aldolase (3.3-10.3): 40.8 u/l (High) 40.8 U/L. On an unknown date, Biopsy: dermal mucin deposition (abnormal) A biopsy from the right side of the back demonstrated dermal mucin deposition and a perivascular and perifollicular lymphoplasmacytic infiltrate. and dermal sclerosis (abnormal) A second biopsy from thickened skin on the left side of the chest demonstrated dermal sclerosis. Altogether, these findings were consistent with new-onset scleroderma-myositis overlap. On an unknown date, Blood  creatine phosphokinase (32-182): 2757 u/l (High) 2757 U/L. On an unknown date, Physical examination: hidebound skin with shiny surfaces (abnormal) hidebound skin with shiny surfaces on the face, chest, lower portion of the legs, back, abdomen, and forearms. For mRNA-1273 (Spikevax) (Unknown), the reporter considered SCLERODERMA (New-onset scleroderma-myositis) and MYOSITIS (New-onset scleroderma-myositis) to be related. After 2 weeks of first dose of Moderna vaccine, the patient had symptoms with severe widespread muscle pain and a new rash associated with Moderna first dose of vaccine. The second vaccine dose was given 4 weeks after the first, and the patient did not notice any change in her rash or muscle pain. She reported no flares of her cutaneous lupus in the 6 months prior to receiving her first vaccine dose. Tests for Ku, U1 small nuclear ribonucleoprotein particle and U2 small nuclear ribonucleoprotein particle antibodies are positive. Company Comment: This is a literature non-study case concerning a 30-year-old female patient with reported medical history of Discoid lupus erythematosus, who experienced the unexpected serious events of Scleroderma and Myositis. The events were medically significant and occurred approximately 2 weeks after receiving the first dose of mRNA-1273 Vaccine. As reported, the patient presented with new onset rash and muscle pain 2 weeks after the 1st dose of the mRNA-1273, physical examination revealed, hidebound skin with shiny surfaces on the face, chest, lower portion of the legs, back, abdomen, and forearms. Creatine Kinase and Aldolase were elevated, U1 and U2 small nuclear ribonucleoprotein particle antibodies were positive, and two skin biopsy was done revealing dermal mucin deposition, perivascular and perifollicular lymphoplasmacytic infiltrate and dermal sclerosis. All these combined were consistent for new-onset scleroderma-myositis overlap. Patient was treated with prednisone and mycophenolate mofetil stabilizing Creatine Kinase levels while skin thickening continued to progress. The medical history of Discoid lupus erythematosus remain a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The events were considered related to the product per the reporter's assessment. Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received by safety on 07-Apr-2022 has email with FTA received from team and contains significant information: reporter information, corresponding author details, literature information, lab data, treatment drugs, concomitant drugs and event information were updated. Sender's Comments: This is a literature non-study case concerning a 30-year-old female patient with reported medical history of Discoid lupus erythematosus, who experienced the unexpected serious events of Scleroderma and Myositis. The events were medically significant and occurred approximately 2 weeks after receiving the first dose of mRNA-1273 Vaccine. As reported, the patient presented with new onset rash and muscle pain 2 weeks after the 1st dose of the mRNA-1273, physical examination revealed, hidebound skin with shiny surfaces on the face, chest, lower portion of the legs, back, abdomen, and forearms. Creatine Kinase and Aldolase were elevated, U1 and U2 small nuclear ribonucleoprotein particle antibodies were positive, and two skin biopsy was done revealing dermal mucin deposition, perivascular and perifollicular lymphoplasmacytic infiltrate and dermal sclerosis. All these combined were consistent for new-onset scleroderma-myositis overlap. Patient was treated with prednisone and mycophenolate mofetil stabilizing Creatine Kinase levels while skin thickening continued to progress. The medical history of Discoid lupus erythematosus remain a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The events were considered related to the product per the reporter's assessment.