Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Panslerotic morphea; This literature-non-study case was reported in a literature article and describes the occurrence of MORPHOEA (Panslerotic morphea) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.         The patient's past medical history included Acute limb ischemia, COVID-19 pneumonia in August 2022, Gastroesophageal reflux, Anxiety, Depression, Pruritus, Insomnia and Neck tightness. Family history included Coronary artery disease since an unknown date, Hypertension since an unknown date, Hyperlipidemia since an unknown date, Stroke since an unknown date and Alzheimer's disease since an unknown date. Concurrent medical conditions included Peripheral vascular disease, Hyperlipidemia and Ex-smoker (30-pack-year smoking history. Patient quit smoking two years prior to presentation and denied drinking alcohol or using other substances.).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MORPHOEA (Panslerotic morphea) (seriousness criterion medically significant). The patient was treated with TOCILIZUMAB at an unspecified dose and frequency; METHOTREXATE at an unspecified dose and frequency and GABAPENTIN for Pain and Itching, at an unspecified dose and frequency. At the time of the report, MORPHOEA (Panslerotic morphea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-RNA polymerase III antibody: (Negative) 3 Units  Reference Range- (0-19 Units). On an unknown date, Antibody test: (Negative) less than 0.2 AI  Reference Range- (<1.0 AI). On an unknown date, Antinuclear antibody: Negative and (Negative) less than 0.2 AI  Reference Range- (<1.0 AI). On an unknown date, Basophil count (0.5-1 %): 1.0 % Normal. On an unknown date, Biopsy skin: Sclerosis of the mid to deep reticular dermis and thickened collagen bundles with lymphoplascytic infiltrations suggestive of morphea. and Anterior (A) and posterior (B) skin exam findings on initial presentation showing sclerotic skin changes of involving the neck, upper chest, the entire back and torso with sparing of the areola.. On an unknown date, Computerised tomogram: Chest showed severe emphysema and a 3.1 cm x 3.0 cm atypical multiloculated cyst of undetermined significance with multiple small, calcified granulomas.. On an unknown date, Double stranded DNA antibody: (Negative) less than 1.0 IU/mL  Ref Range (<10 IU/mL). On an unknown date, Echocardiogram: Demonstrated abnormal left ventricular diastolic filling and normal global systolic left ventricular function.. On an unknown date, Eosinophil count (1-4 %): 3.1 % Normal. On an unknown date, Haematocrit (36-47 %): 41.0 % Normal. On an unknown date, Haemoglobin (12.0-16.0 g/dL): 13.7 g/dL Normal. On an unknown date, Histone antibody: (Negative) less than 0.2 AI  Reference Range- (<1.0 AI) and (Negative) 0.4 Units  Ref Range (<0.9 Units). On an unknown date, Lymphocyte count (1-4 %): 29.8 %. On an unknown date, Monocyte count (2-10 %): 10 % Normal. On an unknown date, Neutrophil count (40-60 %): 53 % Normal. On an unknown date, Physical examination: Remarkable for hardened, thickened skin of the neck, upper chest, the entire back, and torso that spared the areola bilaterally (Figure 1). There were petechiae under both breasts. She was able to make a fist, the skin pinch test was normal, and the digits were without ulcerations. There was no sclerodactyly. Capillaroscopy demonstrated thickened nail beds with moderate nail fold capillary dropout. There was no joint swelling, conjunctival erythema, sicca, or oral ulcerations. On an unknown date, Platelet count: 251K   Ref range (150-400K)  Normal. On an unknown date, Red blood cell count: 4.52 mill/uL   ref range (4.0-5.0 mill/uL)  Normal. On an unknown date, Weight decreased: twenty-pound over  the last year. On an unknown date, White blood cell count: 6.2 K/uL   Ref range: (4.0-13 K/uL).  Normal.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient presented to the rheumatology clinic for evaluation of an expansive, tightened skin plaque. The changes began one week after receiving the Moderna COVID-19 vaccination, otherwise, the patient had no changes in medications or lifestyle. The patient had no family history of autoimmune disorders.  Based on investigational findngs, various differential diagnoses of systemic scleroderma, morphea, eosinophilic fasciitis, systemic lupus erythematosus, carcinoma en cuirasse and cutaneous T-cell lymphoma were made. However, final diagnosis was noted as pansclerotic morphea.  A broad differential diagnosis was considered including autoimmune processes, malignancies, infections, and exposure-mediated skin reactions.  Laboratory data included: Anti-serum soluble substance (SSA) Antibody was negative, and level was <0.2 AI (reference range <0.9).  The patient's prior COVID-19 infection and COVID-19 vaccination were considered a possible trigger. The overlapping mechanisms of inflammatory cascades between mRNA COVID vaccinations and sclerotic skin disease.  This study concluded that patient agreed to start methotrexate and tocilizumab based on the recommendation of the rheumatology/dermatology clinic. She was also started on gabapentin for associated pain and itching. This treatment resulted in significant improvement in itching and sensation of skin tightness. Also, continuous improvement was noted.  Company comment: This literature non study case concerns a 77-year-old, female patient with medical history of COVID 19 pneumonia, who experienced the unexpected serious (medically significant) event of morphea. The event occurred approximately one week after a dose of mRNA-1273. As reported, patient presented to the rheumatology clinic for evaluation of an expansive, tightened skin plaque. The changes began one week after receiving the Moderna COVID-19 vaccination, otherwise, she had no changes in medications or lifestyle. Six months prior to her presentation, patient went to her dermatologist who performed a biopsy with histologic findings suggestive of morphea. Initially, systemic treatment with mycophenolate was offered but patient declined at the time. Unfortunately over the next six months, the lesion expanded across the trunk and back, becoming pruritic and thickened. Due to disease progression, patient presented to rheumatology for further evaluation and treatment. Patient had a positive review of systems for fatigue, twenty-pound weight loss over, the last year, severe pruritus causing insomnia, and neck tightness and skin biopsy which showed sclerosis of the mid to deep reticular dermis and thickened collagen bundles with lymphoplascytic infiltrations suggestive of morphea. Patient's physical exam showed sclerotic lesions of four different areas, lack of distal extremity involvement, the classic "tank top sign", and the biopsy were suggestive of a diagnosis of morphea.  The authors considered prior COVID 19 infection and COVID 19 vaccination as a potential trigger for patient's skin changes, considering close administration to the onset of symptoms but could not definitely state if the presentation was triggered by vaccination. Patient's above mentioned medical history of COVID 19 infection and age are a confounders for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.