Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Biopsy, Blood immunoglobulin A, C-reactive protein
Clinical narrative: Henoch-Schonlein purpura (HSP); This is a literature report, Program ID: for the following literature source(s):   A 24-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HENOCH-SCHONLEIN PURPURA (medically significant), outcome "unknown", described as "Henoch-Schonlein purpura (HSP)". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: titer was 1:320; negative; Antinuclear antibody: positive, notes: with titer was 1:160; 28.1, notes: CU; negative; Biopsy: leukocytoclastic vasculitis depicted by small, notes: blood vessel damage with neutrophilic debris and erythrocytes as well as neutrophils surrounding and infiltrating its walls, consistent with leukocytoclastic vasculitis; Blood immunoglobulin A: 437 g/dl; C-reactive protein: 1.5 mg/dl; Double stranded DNA antibody: negative; Double stranded DNA antibody: 40.4 IU/ml; Physical examination: petechiae with nonblanching erythematous macules, notes: and papules covering the legs below the knees and also the back of the right arm; White blood cell count: 17.08 x10 9/l, notes: elevated. Therapeutic measures were taken as a result of henoch-schonlein purpura.  Clinical course: A 24-year-old-man developed Henoch-Schonlein purpura (HSP) following tozinameran vaccination [dosage, route and time to reaction onset not stated]. The man presented with a 3 week history of rash that appeared 1 week after receiving the 2nd booster dose of tozinameran [pfizer-BioNTech COVID-19 vaccine]. Physical examination showed petechiae with nonblanching erythematous macules and papules covering the legs below the knees and also the back of the right arm. Few days later, he developed arthralgia in the knees, hands and feet. He also experienced epigastric abdominal pain that gradually worsened. His white blood cell count was 17.08x103 /uL and seen elevated. His serum IgA was 437 g/dL, C-reactive protein was 1.5 mg/dL, anti-Smith antibody was 28.1CU, positive antinuclear antibody with titer was 1:160, anti-dsDNA was 40.4 IU/mL, cytoplasmic antineutrophil cytoplasmic antibody (c-ANCA) titer was 1:320. Proteinuria was also observed. His rash progressively worsened over the next days. Biopsy of a purpuric papule revealed leukocytoclastic vasculitis depicted by small blood vessel damage with neutrophilic debris and erythrocytes as well as neutrophils surrounding and infiltrating its walls, consistent with leukocytoclastic vasculitis. Based on these, he was diagnosed with HSP attributed to tozinameran vaccination. Hence, the man was given treatment with tofacitinib, which stopped as per physician's recommendation due to clotting concerns. His rash and arthralgia temporarily improved for 1 week, but relapsed. Then he given prednisone with a plan to taper. Following this, the arthralgia and abdominal pain resolved and the rash became lighter in color. After 1 week, his rash resolved completely. His repetitive blood tests were negative for anti-Smithanti-dsDNA and c-ANCA. His prednisone was tappered over the course of 3 months and he lost to follow-up.; Sender's Comments: Based on the information provided , temporal association and the known effects of the suspect drug, a possible contributory role of the suspect drug in triggering the onset of  the event Henoch-Schonlein purpura cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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