Sex: M
Vaccine: COVID19
Symptoms: Glomerular filtration rate, Glomerulonephritis minimal lesion, HIV test, Hepatitis B virus test, Hepatitis C virus test
Clinical narrative: de novo Minimal change disease; This is a literature report for the following literature source(s):  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "edema" (unspecified if ongoing), notes: 4-week history. Concomitant medication(s) included: AMLODIPINE; IRBESARTAN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: GLOMERULONEPHRITIS MINIMAL LESION (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "de novo Minimal change disease". The patient underwent the following laboratory tests and procedures: Anti-glomerular basement membrane antibody: Negative; Antineutrophil cytoplasmic antibody: Negative; Antinuclear antibody: Negative; Biopsy: MCD EM normal but proteinuria, notes: already resolving by time of biopsy; Biopsy kidney: Unknown results, notes: On the 2nd day of hospitalization; Blood albumin: 2.0 g/dl; Blood creatinine: 0.81 mg/dl; Blood fibrinogen: Negative; Blood immunoglobulin A: Negative; Blood immunoglobulin G: Negative; Blood immunoglobulin M: Negative; Blood pressure measurement: 116/42 mmHg; Complement factor C1: Negative; Complement factor C3: Negative; Negative; Complement factor C4: Negative; Negative; Glomerular filtration rate: 71.0, notes: Units: mL/min/1.73m2; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; HIV test: Negative; Immunohistochemistry: Negative; kappa: Negative; Negative; 0.10; Microscopy: showed no extensive, notes: foot process effacement, deposits, or basement membrane abnormalities; There were no significant findings; showed no significant glomerular abnormalities,notes: and electron microscopy showed no extensive foot process effacement, deposits, or basement membrane abnormalities; Protein urine: resolving, notes: proteinuria; Urinary sediment: showed no red cells; Urine protein/creatinine ratio: 9.1, notes: units: g/g; 0.62, notes: decreased; Weight: 7 kg, notes: increase. Therapeutic measures were taken as a result of glomerulonephritis minimal lesion. Clinical Course: He had received 2nd dose of Pfizer/BioNTech vaccine 2 days before the onset date of edema. Units: 71.0 mL/min/1.73m2 (Modification of Diet in Renal Disease). Spontaneous remission from nephrotic syndrome was observed approximately 6 week after the onset of symptoms.; Sender's Comments: Based on available information, a contributory role of BNT162B2 to the event  glomerulonephritis minimal lesion cannot be fully 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.