Received Jan 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
diagnosed with systemic sclerosis after worsening diffuse cutaneous thickening/ de novo systemic sclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC SCLERODERMA (diagnosed with systemic sclerosis after worsening diffuse cutaneous thickening/ de novo systemic sclerosis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. LITERATURE REFERENCE: No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SYSTEMIC SCLERODERMA (diagnosed with systemic sclerosis after worsening diffuse cutaneous thickening/ de novo systemic sclerosis) (seriousness criterion medically significant). At the time of the report, SYSTEMIC SCLERODERMA (diagnosed with systemic sclerosis after worsening diffuse cutaneous thickening/ de novo systemic sclerosis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: (Positive) SSA-52 antibodies. On an unknown date, Computerised tomogram thorax: revealed non-UIP interstitial fibrosis. On an unknown date, Endoscopy: Follow-up endoscopies showed improved esophagitis and gradual symptom relief after serial dilations to 20 mm. On an unknown date, Gastrointestinal examination: showed marked esophageal involvement. On an unknown date, Oesophageal manometry: High-resolution manometry demonstrated absent contractility and elevated lower esophageal sphincter pressure (possibly due to coughing and poor tolerance). On an unknown date, Oesophagogastroduodenoscopy: showed LA grade B esophagitis, foamy stasis, lower esophagus stricture and a dilated esophagus. EndoFLIP revealed a normal distensibility index (3.7-5.3 at 60 mL), absent contractility, and a maximum esophagogastric junction diameter of 14 mm. Balloon dilation up to 18 mm was performed. On an unknown date, Oesophagram: revealed tertiary contractions, distal stricture, and upstream dilation. On an unknown date, Rheumatoid factor: elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SYSTEMIC SCLERODERMA (diagnosed with systemic sclerosis after worsening diffuse cutaneous thickening/ de novo systemic sclerosis) to be related. Concomitant and specific treatment medications were not reported. Patient received her second Moderna COVID-19 vaccine in Feb-2021. Within weeks, she developed dysphagia to solids and liquids, regurgitation, early satiety, altered bowel habits, and weight loss. She also experienced progressive joint stiffness, swelling, and skin tightening. Initially misdiagnosed as rheumatoid arthritis based on elevated rheumatoid factor, she also tested positive for anti-PL-12. Her symptoms progressed, and she was later diagnosed with systemic sclerosis after worsening diffuse cutaneous thickening previously thought to be edema. Patient was treated with high dose BID proton pump inhibitors and referred to a scleroderma center. Author stated that this case highlights a rare case of de novo systemic sclerosis with multi-organ involvement following COVID-19 vaccination. Although COVID-19 vaccines were generally safe, rare autoimmune responses could occur, and clinicians should be cognizant of this possibility. Esophageal dysfunction was a frequent and debilitating SS manifestation, impairing peristalsis and predisposing to esophagitis and strictures. Early diagnosis with motility test, endoscopic stricture dilation to larger diameter, and multidisciplinary care are essential for optimal outcomes.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Test Name: SSA-52 antibodies; Test Result: Positive; Test Name: Chest computed tomography; Result Unstructured Data: revealed non-UIP interstitial fibrosis; Test Name: endoscopies; Result Unstructured Data: Follow-up endoscopies showed improved esophagitis and gradual symptom relief after serial dilations to 20 mm; Test Name: GI evaluation; Result Unstructured Data: showed marked esophageal involvement; Test Name: High-resolution manometry; Result Unstructured Data: High-resolution manometry demonstrated absent contractility and elevated lower esophageal sphincter pressure (possibly due to coughing and poor tolerance); Test Name: Esophagogastroduodenoscopy; Result Unstructured Data: showed LA grade B esophagitis, foamy stasis, lower esophagus stricture and a dilated esophagus. EndoFLIP revealed a normal distensibility index (3.7-5.3 at 60 mL), absent contractility, and a maximum esophagogastric junction diameter of 14 mm. Balloon dilation up to 18 mm was performed; Test Name: Esophagram; Result Unstructured Data: revealed tertiary contractions, distal stricture, and upstream dilation; Test Name: Rheumatoid factor; Result Unstructured Data: elevated