Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney, Blood albumin, Blood creatinine, Blood pressure measurement
Clinical narrative: Anuric acute kidney injury; Collapsing focal and segmental glomerulosclerosis; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE KIDNEY INJURY (Anuric acute kidney injury) and FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Collapsing focal and segmental glomerulosclerosis) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE KIDNEY INJURY (Anuric acute kidney injury) (seriousness criteria hospitalization and medically significant) and FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Collapsing focal and segmental glomerulosclerosis) (seriousness criterion hospitalization). At the time of the report, ACUTE KIDNEY INJURY (Anuric acute kidney injury) and FOCAL SEGMENTAL GLOMERULOSCLEROSIS (Collapsing focal and segmental glomerulosclerosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: showed segmental sclerosis with associated hyperplastic visceral epithelial cells with intracytoplasmic protein reabsorption droplets. The associated capillary loops appeared collapsed. On an unknown date, Blood albumin: 2.6 g/dL. On an unknown date, Blood creatinine: 8.2 mg/dl. On an unknown date, Blood pressure measurement: 210/110 mmHg. On an unknown date, Echocardiogram: normal. On an unknown date, Immunology test: showed segmental glomerular staining for IgM, C3 and C1q (3 plus). On an unknown date, Microscopy: showed numerous granular casts and tubular epithelial cells. On an unknown date, Protein urine: 6.9 g 24 hr urinary collection revealed proteinuria. On an unknown date, Ultrasound kidney: kidneys were normal in size with increased cortical echogenicity.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient with unremarkable medical history was admitted anasarca started 6 weeks after receiving the second dose of Moderna vaccine. Patient was found to have anuric acute kidney injury. Comprehensive workup was unremarkable.  Authors suggested that cell mediated immune reaction that might cause podocyte injury or recurrence of glomerular disease. Potential mechanism of podocyte injury post SARS- CoV-2 mRNA vaccine might be triggered by cytokine-medicated response, direct toxic effect or a rapid T cell- medicated immune response and lead to podocytopathy.  Company comment: This is a literature non-study case. A 75-year-old female with unremarkable medical history, who experienced the unexpected, serious (hospitalized, medically significant) AESI of Acute kidney injury (anuric acute kidney injury) and unexpected, serious (hospitalized) event of Focal segmental glomerulosclerosis (Collapsing focal and segmental glomerulosclerosis), about 6 weeks after receiving the second dose of mRNA-1273 vaccine. She was admitted for anasarca after 6 weeks of vaccination. Her blood pressure was 210/110 mmHg. Laboratory results showed serum creatinine 8.2 mg/dl, serum albumin 2.6 g/dl. Urine microscopy showed numerous granular casts and tubular epithelial cells. 24 hr urinary collection revealed proteinuria of 6.9 g. Transthoracic echocardiogram was normal. Kidneys were normal in size with increased cortical echogenicity on renal ultrasound. Unremarkable comprehensive workup. Kidney biopsy showed segmental sclerosis with associated hyperplastic visceral epithelial cells with intracytoplasmic protein reabsorption droplets. The associated capillary loops appeared collapsed. Immunofluorescence showed segmental glomerular staining for IgM, C3 and C1q (3+). Authors stated that SARS-CoV-2 mRNA vaccines generate humoral and cell- mediated immune response by CD4 and CD8 expansion to T helper-based response with production of interferon gamma, tumor necrosis factor- alpha, interleukin-2 and antibody production predominantly of immunoglobulin G1 and IgG subclass. Cell mediated immune reaction may cause podocyte injury or recurrence of glomerular disease. Potential mechanism of podocyte injury post SARS- CoV-2 mRNA vaccine may be triggered by cytokine-medicated response, direct toxic effect or a rapid T cell- mediated immune response and lead to podocytopathy. No information on treatment of the events and details pertaining to the first dose was available in the report. Elderly age of the patient could be a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a literature non-study case. A 75-year-old female with unremarkable medical history, who experienced the unexpected, serious (hospitalized, medically significant) AESI of Acute kidney injury (anuric acute kidney injury) and unexpected, serious (hospitalized) event of Focal segmental glomerulosclerosis (Collapsing focal and segmental glomerulosclerosis), about 6 weeks after receiving the second dose of mRNA-1273 vaccine. She was admitted for anasarca after 6 weeks of vaccination. Her blood pressure was 210/110 mmHg. Laboratory results showed serum creatinine 8.2 mg/dl, serum albumin 2.6 g/dl. Urine microscopy showed numerous granular casts and tubular epithelial cells. 24 hr urinary collection revealed proteinuria of 6.9 g. Transthoracic echocardiogram was normal. Kidneys were normal in size with increased cortical echogenicity on renal ultrasound. Unremarkable comprehensive workup. Kidney biopsy showed segmental sclerosis with associated hyperplastic visceral epithelial cells with intracytoplasmic protein reabsorption droplets. The associated capillary loops appeared collapsed. Immunofluorescence showed segmental glomerular staining for IgM, C3 and C1q (3+). Authors stated that SARS-CoV-2 mRNA vaccines generate humoral and cell- mediated immune response by CD4 and CD8 expansion to T helper-based response with production of interferon gamma, tumor necrosis factor- alpha, interleukin-2 and antibody production predominantly of immunoglobulin G1 and IgG subclass. Cell mediated immune reaction may cause podocyte injury or recurrence of glomerular disease. Potential mechanism of podocyte injury post SARS- CoV-2 mRNA vaccine may be triggered by cytokine-medicated response, direct toxic effect or a rapid T cell- mediated immune response and lead to podocytopathy. No information on treatment of the events and details pertaining to the first dose was available in the report. Elderly age of the patient could be a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.