Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Urine protein/creatinine ratio
Clinical narrative: Minimal change disease relapse; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease relapse) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    The patient's past medical history included Nephrotic syndrome (Patient had complete remission with glucocorticoids.) in July 2016, Graft versus host disease (Patient had mild graft versus host disease (GVHD) in the liver following hematopoietic stem cell transplantation (HSCT).), Nephrotic syndrome (Patient had a short course of steroids and achieved remission.) in May 2018, Minimal change disease and Allogeneic stem cell transplantation in 2015. Previously administered products included for Minimal change disease: Tacrolimus (subsequently was tapered off tacrolimus.) in July 2016, Tacrolimus (patient was off tacrolimus in December 2020.) from May 2018 to December 2020 and Prednisone (Patient remained on low-dose prednisone 1 mg daily.) until February 2021. Past adverse reactions to the above products included No adverse event with Prednisone, Tacrolimus and Tacrolimus. Concurrent medical conditions included Acute myeloid leukemia and Diabetes steroid-induced.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease relapse) (seriousness criterion medically significant). The patient was treated with RITUXIMAB on 06-May-2021 at a dose of 1 gram  Infusion; RITUXIMAB on 19-May-2021 at a dose of 1 gram  Infusion and PREDNISONE at an unspecified dose and frequency. At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease relapse) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2016, Biopsy kidney: was consistent with MCD likely representing GVHD in the kidney.. In 2018, Biopsy kidney: had findings similar to the previous biopsy.. In February 2021, Blood albumin: Normal prior to administration of moderna vaccine. In February 2021, Blood creatinine: ranged between 1.3 and 1.5 mg/dL, prior to administration of moderna vaccine.. In February 2021, Glomerular filtration rate: range between 45 and 55 millilitre per minute per 1.73 square metre, prior to administration of moderna vaccine.. In April 2021, Biopsy kidney: showed podocyte, tubular epithelial, and endothelial injury suggestive of graft versus host disease (GVHD), findings similar to those of the two prior biopsies. Capillary loops were patent without any proliferative, necrotizing, or thrombotic changes.. In April 2021, Blood creatinine: 3 mg/dl renal function continued to deteriorate. In April 2021, Blood pressure systolic: in the 150s. In April 2021, Immunology test: unremarkable. In April 2021, Microscopy: showed extensive effacement of the podocyte foot processes consistent with MCD. There were severe degenerative changes in the endothelium. There were no immune deposits, fibrils, tubuloreticular inclusions, or amyloid.. In April 2021, Physical examination: significant findings included generalized pitting edema.. On 23-Apr-2021, Blood albumin: 2.5 g/dL. On 23-Apr-2021, Blood creatinine: 1.8 mg/dl. On 23-Apr-2021, Protein total: 23 gram per day. On 23-Apr-2021, Urine protein/creatinine ratio: 20 gram per gram. In May 2021, Blood albumin: 2.3 g/dL After 4 weeks. In May 2021, Blood creatinine: 1 mg/dl After 4 weeks. In May 2021, Urine protein/creatinine ratio: 2.2 gram per gram After 4 weeks. In December 2021, Blood creatinine: ranged between 1.3 to 1.4 similar to his baseline before his recent relapse.. In December 2021, Urine protein/creatinine ratio: 0.5 gram per gram as of early December 2021 and 0.2 gram per gram as of late December  2021..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease relapse) to be related.    No concomitant medications were reported. Treatment included corticosteroids  It was reported patient received the 2nd dose of Moderna/ NIAID, within a week of 2nd dose patient noted foamy and dark urine, periorbital and leg edema as well as abdominal bloating, patient did not seek medical attention. The interstitium showed patchy mononuclear inflammatory infiltrates mainly T cells, rare B cells, there was focal tubular inflammation and degenerative changes in tubules.  Partial remission occurred after 4 months and complete remission after 7 months.  Patient renal function continued to deteriorate patient received short course of high dose prednisone as well loop diuretics showed improvement.  Peripheral CD19/20 cells remain undetectable as of late December 2021. Given the risk-benefit ratio, especially with the newer COVID-19 variants and the fact that his CD19/20 cells were suppressed, patient was advised to take the booster dose. Patient took the booster on 12-Dec-2021 and did not notice any change in the color of his urine or foamy urine.  Company Comment: This is a literature non-study case concerning a 71-year-old male patient with relevant medical history of acute myeloid leukemia with subsequent allogenic hematopoietic stem cell transplantation and recurrent nephrotic syndrome with renal biopsy consistent of minimal change disease likely representing graft versus host disease in the kidney, who experienced the unexpected, serious (medically significant) event of Minimal change disease. 7 days after receiving the second dose of mRNA-1273 vaccine, the patient noted foamy and dark urine, periorbital and leg edema as well as abdominal bloating. 11 days after receiving the said dose of mRNA-1273, laboratory tests showed serum creatinine 1.8 mg/dL, serum albumin 2.5 g/dL, and urine protein-to- creatinine ratio was 20 g/g. A subsequent 24-hour urine collection showed protein excretion of 23 g. On physical examination, significant findings included systolic blood pressure in the 150s and generalized pitting edema. A renal biopsy performed showed podocyte, tubular epithelial, and endothelial injury suggestive of graft versus host disease (GVHD) (similar to the two prior biopsies). The interstitium showed patchy mononuclear inflammatory infiltrates mainly T cells, rare B cells, there was focal tubular inflammation and degenerative changes in tubules. Electron microscopy showed extensive effacement of the podocyte foot processes consistent with minimal change disease (MCD). There were severe degenerative changes in the endothelium and his renal function continued to deteriorate with serum creatinine rising to 3 mg/dL. He received rituximab 1 g infusion (2 doses) and a short course of high dose prednisone as well as loop diuretics with improvement. The patient had partial remission after 4 months and complete remission after 7 months. The patient took the unspecified booster dose approximately 7 months after the second dose of mRNA-1273  and did not notice any change in the color of his urine or foamy urine. Medical history of acute myeloid leukemia with subsequent allogenic hematopoietic stem cell transplantation and recurrent nephrotic syndrome with renal biopsy consistent of minimal change disease likely representing GVHD in the kidney remain as risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was linked to US-MODERNATX, INC.-MOD-2022-628782 (E2B Linked Report).; Sender's Comments: This is a literature non-study case concerning a 71-year-old male patient with relevant medical history of acute myeloid leukemia with subsequent allogenic hematopoietic stem cell transplantation and recurrent nephrotic syndrome with renal biopsy consistent of minimal change disease likely representing graft versus host disease in the kidney, who experienced the unexpected, serious (medically significant) event of Minimal change disease. 7 days after receiving the second dose of mRNA-1273 vaccine, the patient noted foamy and dark urine, periorbital and leg edema as well as abdominal bloating. 11 days after receiving the said dose of mRNA-1273, laboratory tests showed serum creatinine 1.8 mg/dL, serum albumin 2.5 g/dL, and urine protein-to- creatinine ratio was 20 g/g. A subsequent 24-hour urine collection showed protein excretion of 23 g. On physical examination, significant findings included systolic blood pressure in the 150s and generalized pitting edema. A renal biopsy performed showed podocyte, tubular epithelial, and endothelial injury suggestive of graft versus host disease (GVHD) (similar to the two prior biopsies). The interstitium showed patchy mononuclear inflammatory infiltrates mainly T cells, rare B cells, there was focal tubular inflammation and degenerative changes in tubules. Electron microscopy showed extensive effacement of the podocyte foot processes consistent with minimal change disease (MCD). There were severe degenerative changes in the endothelium and his renal function continued to deteriorate with serum creatinine rising to 3 mg/dL. He received rituximab 1 g infusion (2 doses) and a short course of high dose prednisone as well as loop diuretics with improvement. The patient had partial remission after 4 months and complete remission after 7 months. The patient took the unspecified booster dose approximately 7 months after the second dose of mRNA-1273  and did not notice any change in the color of his urine or foamy urine. Medical history of acute myeloid leukemia with subsequent allogenic hematopoietic stem cell transplantation and recurrent nephrotic syndrome with renal biopsy consistent of minimal change disease likely representing GVHD in the kidney remain as risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-628782:23 yr female patient