Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood creatine phosphokinase, Blood immunoglobulin G, Blood lactate dehydrogenase, C-reactive protein
Clinical narrative: She received the second dose of the vaccine on July 12th which exacerbated the previously mentioned symptoms; She received the second dose of the vaccine on July 12th which exacerbated the previously mentioned symptoms; This is a literature report.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 12Jul2021 as dose 2, 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. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 01Jun2021, for COVID-19 immunization, reaction(s): "Anti-MDA5 dermatomyositis". The following information was reported: DERMATOMYOSITIS (medically significant), outcome "recovered", CONDITION AGGRAVATED (medically significant), outcome "unknown" and all described as "She received the second dose of the vaccine on July 12th which exacerbated the previously mentioned symptoms". 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: 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. Therapeutic measures were taken as a result of dermatomyositis.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 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, different patient;US-PFIZER INC-202200889816 Same patient, same drug, different event separated in time;