Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood albumin, Blood creatinine, Blood pressure measurement, Diagnostic procedure
Clinical narrative: Relapse of nephrotic syndrome/minimal change disease; This is a literature report.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Nephrotic syndrome" (ongoing); "minimal change disease" (ongoing), notes: Achieved complete remission with steroid therapy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: GLOMERULONEPHRITIS MINIMAL LESION (medically significant, life threatening), outcome "recovering", described as "Relapse of nephrotic syndrome/minimal change disease". The patient underwent the following laboratory tests and procedures: Biopsy kidney: Minimal change disease; Blood albumin: 3.0 g/dl; Blood creatinine: 10.1; 1.1, notes: 2 weeks after initiation of steroids; Normal; Blood pressure measurement: 152/78 mmHg; Diagnostic procedure: revealed hypertriglyceridemia, normal serum, notes: creatinine; Laboratory test: showed spot urine protein; Protein urine: Unknown results; Serology test: Negative; Weight increased: 10 lbs. Therapeutic measures were taken as a result of glomerulonephritis minimal lesion.  Clinical course: A 63-year-old male, with history of nephrotic syndrome secondary to kidney biopsy proven MCD, who had achieved complete remission with steroid therapy, had follow up labs done that showed spot urine protein: creatinine of 10.1 and albumin of 3.0g/dL. He had received the booster dose of Pfizer-BioNTech SARS-CoV-2 vaccine 2 weeks ago, and endorsed generalized weakness, puffiness over face, edema over upper extremities that appeared within a week after administration of the vaccine, and weight gain of 10 lbs over past week. Blood pressure was elevated (152/78 mmHg). He denied any recent infections, use of Nonsteroidal Anti-Inflammatory Drugs, or antibiotics. Other diagnostic work up revealed hypertriglyceridemia, normal serum creatinine. Serological work up for secondary causes of glomerular diseases was negative. He was initiated on oral prednisone therapy. Spot urine protein:creatinine decreased to 1.1, 2 weeks after initiation of steroids. Vaccination is a recognized trigger for relapse of nephrotic syndrome. mRNA vaccines are expected to produce a higher antibody response as well as increased production of cytokines and chemokines.; Sender's Comments: Based on the available reported information, the causal association between the event 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.