Sex: F
Vaccine: COVID19
Symptoms: Physical examination
Clinical narrative: This is a literature report for the following literature source(s): "Sclerotic skin disease development following COVID-19 vaccination", Case Reports, 2022; Vol:22, pgs:74-77, DOI:10.1016/j.jdcr.2022.02.008. A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Morphea" (unspecified if ongoing), notes: limited to the abdomen diagnosed one year previously that had resolved. The patient's concomitant medications were not reported. Past drug history included: Betamethasone cream for Morphea, reaction(s): "No adverse event", notes: 0.05%; Calcipotriene cream for Morphea, reaction(s): "No adverse event", notes: 0.005%. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation. The following information was reported: EOSINOPHILIC FASCIITIS (medically significant), outcome "recovering", described as "New-onset eosinophilic fasciitis/began within 4 weeks of receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: eosinophil count (0-700): 1280 /mm3; eosinophil percentage (0-6): 13.9%; laboratory test: eosinophil count of 1280/mm3 (reference range, notes: 0-700mm3 or 13.9% eosinophils (reference range, 0%-6%); magnetic resonance imaging: moderate diffuse skin thickening, notes: Magnetic resonance imaging of the calf demonstrated moderate diffuse skin thickening with perifascial and intramuscular edema; physical examination: skin thickening, notes: Physical examination revealed skin thickening on the arms and legs, as well as puckering of skin on the arms. Therapeutic measures were taken as a result of eosinophilic fasciitis. Clinical course was reported as: A 72-year-old woman presented with a new rash that began within 4 weeks of receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine. She had a history of morphea limited to the abdomen diagnosed one year previously that had resolved with 0.05% betamethasone cream and 0.005% calcipotriene cream. Physical examination revealed skin thickening on the arms and legs, as well as puckering of skin on the arms. Laboratory testing revealed an eosinophil count of 1280/mm3 (reference range, 0- 700/mm3) or 13.9% eosinophils (reference range, 0%-6%). Magnetic resonance imaging of the calf demonstrated moderate diffuse skin thickening with perifascial and intramuscular edema (Fig 4). These findings were consistent with new-onset eosinophilic fasciitis. Treatment with mycophenolate mofetil and prednisone led to normalization of the eosinophil count and skin softening. No follow-up attempts are needed. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event "Eosinophilic fasciitis" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. 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.