Sex: F
Vaccine: COVID19
Symptoms: Cardiopulmonary exercise test, Complement factor C3, Complement factor C4, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: Anti-MDA5 dermatomyositis; This is a literature report.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: well-controlled; "mild COVID-19 infection" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DERMATOMYOSITIS (medically significant) with onset 15Jun2021, outcome "unknown", described as "Anti-MDA5 dermatomyositis". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (normal high range 52): 29 IU/l, notes: normal; Aldolase (normal high range 7.6): 4.4 IU/l, notes: normal; Antibody test (normal high range 10): 54, notes: Positive; 23, notes: Positive; Antinuclear antibody: positive at 1:640 with a fine speckled nuclear, notes: pattern; negative; negative; negative; Aspartate aminotransferase (normal high range 32): 35 IU/l, notes: slightly increased; Biopsy skin: showed findings consistent with interface, notes: dermatitis; Blood creatine phosphokinase (normal high range 223): 64 IU/l, notes: normal; Blood immunoglobulin G: normal; Blood lactate dehydrogenase (normal high range 214): 234 IU/l, notes: slightly increased; Cardiopulmonary exercise test: normal; Complement factor C3: normal; Complement factor C4: normal; Computerised tomogram abdomen: without signs of interstitial lung disease or, notes: malignancy; Computerised tomogram pelvis: without signs of interstitial lung disease or, notes: malignancy; Computerised tomogram thorax: without signs of interstitial lung disease or, notes: malignancy; C-reactive protein (normal high range 0.30): 1.61 mg/dl, notes: elevated; Double stranded DNA antibody: negative; Full blood count: normal; myositis panel: positive for anti-MDA5 (54, N < 10) and anti-Ro-52, notes: antibodies (23, N < 10); physical exam: showed intense erythema over the forehead and, notes: cheeks (sunburn sign), eyelids (heliotrope rash), chest (V-sign), erythematous maculopapular lesions over the MCPs (Gottron's papules), periungual erythema, and mechanic hands. There was no synovitis or muscle weakness; Red blood cell sedimentation rate (normal high range 20): 26, notes: unit: mm/h, elevated; Renal function test: normal; Thyroid function test: normal; Urine analysis: normal.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event DERMATOMYOSITIS Cannot be excluded.  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.,Linked Report(s) : US-PFIZER INC-PV202200000729 Same article/drug/event, different patient;US-PFIZER INC-202200889817 Same patient, same drug, different event separated in time;