Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
novel occurrence of generalized morphea profunda arising in close temporal association with the COVID-19 messenger ribonucleic acid vaccination series; This is a literature report for the following literature source(s). An 80-year-old man with coronary artery disease and insulin-dependent type II diabetes mellitus presented with numerous areas of firm, tight skin across his trunk and extremities with associated itching and burning. His first lesion developed on his left forearm approximately one month after completing the Pfizer-BioNTech COVID-19 mRNA vaccination series. The lesions then spread to both upper extremities, both lower extremities, and across his waistline. As the plaques enlarged and thickened, he reported significant nocturnal pruritus and feelings of stiffness with movement. He denied any preceding illnesses, including COVID-19, and denied any other recent vaccinations. He also denied symptoms of systemic sclerosis including stiffness of his fingers, shortness of breath, Raynaud phenomenon, and joint pain/swelling. Of note, the patient was previously seen by an outside dermatologist who biopsied the patient and histopathology from his right forearm was read as septal panniculitis consistent with erythema nodosum; he sought a second opinion prior to receiving any treatment. Physical examination revealed indurated, hyperpigmented plaques on the bilateral dorsal forearms, symmetric, indurated plaques with central areas of porcelain-white color change on the anterior waistline, and indurated plaques with sclerotic yellow centers and erythematous borders on the bilateral legs. There was no evidence of sclerodactyly or inflammatory arthritis. Punch biopsies of the left anterior leg and calf showed thickened collagen bundles in the reticular dermis, diminished periadnexal fat, and a perivascular and interstitial mononuclear cell infiltrate. The hyalinizing fibrosing reaction extended into the fat and was manifested by a striking pattern of expansion of the interlobular septa of the fat by dense collagen. Complete blood count, comprehensive metabolic panel, erythrocyte sedimentation rate, and antinuclear antibody were within normal limits. Based on clinical presentation, histopathology, and laboratory testing, the patient was diagnosed with generalized morphea profunda and started on methotrexate 10mg weekly, titrated to 15mg weekly within 8 weeks. Prednisone was avoided owing to concerns for hyperglycemia in the setting of diabetes mellitus. After four weeks of treatment, the patient's symptoms of pruritus and burning were improved. At 14-month follow-up, the involved sites were softer, less indurated, and nearly asymptomatic.; Sender's Comments: The event morphoea is conservatively assessed as related to the suspect drug BNT162B2 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.
Medical History/Concurrent Conditions: Coronary artery disease; Erythema nodosum; Insulin-requiring type 2 diabetes mellitus; Septal panniculitis
Test Name: antinuclear antibody; Result Unstructured Data: Test Result:within normal limits; Test Name: Punch biopsies of the left anterior leg and calf; Result Unstructured Data: Test Result:showed thickened collagen bundles in the reticular; Comments: dermis, diminished periadnexal fat, and a perivascular and was manifested by a striking pattern of expansion of the interlobular septa of the fat by dense collagen.; Test Name: Complete blood count; Result Unstructured Data: Test Result:within normal limits; Test Name: histopathology from his right forearm; Result Unstructured Data: Test Result:was read as septal panniculitis consistent; Comments: with erythema nodosum; Test Name: comprehensive metabolic panel; Result Unstructured Data: Test Result:within normal limits; Test Name: Physical examination; Result Unstructured Data: Test Result:revealed indurated, hyperpigmented plaques; Comments: on the bilateral dorsal forearms, symmetric, indurated plaques with central areas of porcelain-white color change on the anterior waistline and indurated plaques with sclerotic yellow centers and erythematous borders on the bilateral legs. There was no evidence of sclerodactyly or inflammatory arthritis.; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: Test Result:within normal limits