Sex: F
Vaccine: COVID19
Symptoms: Prothrombin time, Red blood cell count, Red cell distribution width increased, Treponema test, White blood cell count
Clinical narrative: LEUKOCYTOCLASTIC VASCULITIS/with the second dose of the vaccine; This is a literature report.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "skin reaction" (unspecified if ongoing), notes: on 1st day normal. The patient took concomitant medications. Vaccination history included: bnt162b2 (dose 1), administration date: 08Apr2021, for COVID-19 immunisation. The following information was reported: CUTANEOUS VASCULITIS (medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "LEUKOCYTOCLASTIC VASCULITIS/with the second dose of the vaccine". The patient underwent the following laboratory tests and procedures: Activated partial thromboplastin time prolonged: 24.7; Alanine aminotransferase: 20 IU/l; Antibody test: negative; negative; negative; Antinuclear antibody: negative; negative; Aspartate aminotransferase: 18 IU/l; Biopsy: showed interstitial edema in papillary dermis with, notes: superficial and deep perivascular lymphohistiocytic inflammatory infiltrate (Figure 2a, 2b), accompanied with neutrophils with leukocytoclasia (Figure 2d), some of them within the blood vessels walls, which at the same time showed inflammation of endothelial cells, fibrinoid necrosis and extravasated red blood cells (Figure 2c); Blood immunoglobulin E: 65.7 IU/ml; Double stranded DNA antibody: negative; Eosinophil count: 170; Haematocrit: 42.9; Haemoglobin: 14.2; Hepatitis B surface antigen: 0.18; Hepatitis C antibody: 0.03; HIV antibody: 0.050, notes: LESS THAN; Lymphocyte count: 2390; Mean cell volume: 90.7; Monocyte count: 430; Neutrophil count: 4060; Platelet count: 273000; Prothrombin time: 11.1; Red blood cell count: 4730; Red cell distribution width increased: 11.9; Treponema test: UNKNOWN RESULTS; White blood cell count: 7230. Therapeutic measures were taken as a result of cutaneous vasculitis.  Clinical information: The patient consulted for a clinical picture that started the second day after the vaccine administration, with appearance of macules in the external malleolar region of both lower limbs and with the second dose of the vaccine, these extended to the dorsal region of legs, feet and then arms. After the administration of oral corticosteroids, the skin clinical condition remitted. Immediate hypersensitivity reactions have been described more frequently after administering the COVID-19 vaccine  Follow up (25MAY2022/ 30May2022): This is a literature report. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and 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