Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood potassium, Blood pressure measurement
Clinical narrative: He was diagnosed with AV-associated renal vasculitis following COVID-19 vaccination; This is a literature report for the following literature source(s):   A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "ischemic heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: RENAL VASCULITIS (medically significant), 12 days after the suspect product(s) administration, outcome "recovering", described as "He was diagnosed with AV-associated renal vasculitis following COVID-19 vaccination".The patient underwent the following laboratory tests and procedures: Antibody test: Negative; Anti-glomerular basement membrane antibody: Negative; Antineutrophil cytoplasmic antibody: 131 IU/ml, notes: greater than; which showed positive ANCA titers; 69 IU/ml; Antinuclear antibody: Negative; Auscultation: he had normal vesicular breathing and, notes: regular heart sounds; Biopsy kidney: diffuse global sclerosis, notes: fibro-cellular crescents in glomeruli arterial hyalinosis, moderate arteriosclerosis, and focal tubal interstitial scarring; Blood chloride (98-107): 101 mEq/l, notes: +17; 98 mEq/l, notes: +26; 99 mEq/l, notes: +36; Blood creatine (0.5-0.9): 3.25 mg/dl, notes: +17; 3.00 mg/dl, notes: +26; 2.75 mg/dl, notes: +36; Blood creatinine: elevated despite intravenous hydration; improved; Blood creatinine (0.7-1.2): 3.5 mg/dl; Blood culture: Negative; Blood immunoglobulin A (0.8-3.0): 1.9 g/l, notes: within the normal range; Blood immunoglobulin G (6-16): 7.1 g/l, notes: within the normal range; Blood immunoglobulin M (40-240): 101 mg/dl, notes: within the normal range; Blood potassium (3.5-5.0): 4.1 mEq/l, notes: +17; 4.6 mEq/l, notes: +26; 3.9 mEq/l, notes: +26; Blood pressure measurement: 130/85 mmHg; Blood sodium (135-145): 135 mEq/l, notes: +17; 132 mEq/l, notes: +26; 141 mEq/l, notes: +36; Blood urea (13-21): 59 mg/dl; Body temperature: mild and intermittent, notes: fever; Body temperature: 99 Fahrenheit, notes: febrile; Brain natriuretic peptide (normal high range 450): 2100 pg/mL, notes: greater than; Chest X-ray: unremarkable; Complement factor C3 (80-178): 114 mg/dl, notes: within the normal range; Complement factor C4 (12-42): 21 mg/dl, notes: within the normal range; Culture urine: Negative; Double stranded DNA antibody: Negative; Glucose urine: trace, notes: +17; Reference: Negative; trace, notes: +26; Reference: Negative; unknown results, notes: +36; Reference: Negative; Haemoglobin (13.2-16.6): 9.9 g/dl, notes: low; Heart rate: 89, notes: /min; Immunoglobulins: Negative; c-ANCA; anti-MPO antibody: 1:120, notes: unknown units; urinary protein to creatinine ratio: 0.90 mg/g; Nitrite urine: Negative, notes: +17; Reference: Negative; Positive, notes: +26; Reference: Negative; unknown results, notes: +36; Reference: Negative; Occult blood: 2 plus, notes: +17; Reference: Negative; 1 plus, notes: +26; Reference: Negative; unknown results, notes: +36; Reference: Negative; physical examination: unremarkable for synovitis involving multiple, notes: joints except for mild pain on active movements; Platelet count (150,000-350,000): 201,000, notes: cells/mm3; Protein total: 2 plus, notes: +17; Reference: Negative; 1 plus, notes: +26; Reference: Negative; unknown results, notes: +36; Reference: Negative; Red blood cell count (0-5): 0-29, notes: +17; 5-9, notes: +26; unknown results, notes: +36; Red blood cell count (4.20-5.65): 4.31, notes: million cells/ul; Red blood cell sedimentation rate (0-22): 25, notes: mm/hr; Respiratory rate: 21, notes: /min; Specific gravity urine (1.010-1.030): 1.015, notes: +17; Units unknown; 1.016, notes: +26; Units unknown; unknown results, notes: +36; Units unknown; Ultrasound abdomen: parenchymal echogenicity and normal renal, notes: dimensions; Urine analysis: proteinuria, notes: positive occult blood, red cell casts, and microscopic hematuria; White blood cell count (0-6): Numerous, notes: +17; Many, notes: +26; unknown results, notes: +36; White blood cell count (4000-11000): 8900, notes: cells/mm3. Therapeutic measures were taken as a result of renal vasculitis.  Clinical course: A 59-year-old male with a past medical history of hypertension and ischemic heart disease presented with fever, malaise, and polyarthralgia for the last five days. His fever was mild and intermittent, associated with nausea and anorexia. He received his second dose of the Pfizer COVID-19 vaccine 17 days ago. He was compliant with his medications. He had no history of trauma, travel, alcohol abuse, and substance abuse. He had no history of smoking and COVID-19 infection. He also had no family of autoimmune disease. A renal biopsy was performed, which showed diffuse global sclerosis, fibro-cellular crescents in glomeruli, arterial hyalinosis, moderate arteriosclerosis, and focal tubal interstitial scarring. Based on serology and renal biopsy findings, he was diagnosed with pauci-immune glomerulonephritis (GN) due to COVID-19 vaccination because no other etiology was identified. He was managed with pulse therapy of methylprednisolone 1 g daily for three days and intravenous rituximab 375 mg/m2, followed by a tapering dose of prednisone 1 mg/kg daily. A follow-up dose of rituximab was given two weeks apart. His serum creatinine and proteinuria improved on his recent follow-up, and his clinical symptoms gradually improved.; Sender's Comments: Based on the available information and on the compatibility with the drug's known safety profile, the company considers that a causal relationship between the reporter event -Renal vasculitis 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