Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Rheumatoid factor, SARS-CoV-2 RNA, Urine analysis, Urine protein/creatinine ratio
Clinical narrative: Glomerulonephritis proliferative; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS PROLIFERATIVE (Glomerulonephritis proliferative) in a 6-decade-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     The patient's past medical history included Diverticulitis, Breast cancer (treated with chemotherapy, and no evidence of recurrence.), Mastectomy bilateral (breast cancer treatment), Radiotherapy (breast cancer treatment) and Hemodialysis. Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced GLOMERULONEPHRITIS PROLIFERATIVE (Glomerulonephritis proliferative) (seriousness criterion hospitalization). At the time of the report, GLOMERULONEPHRITIS PROLIFERATIVE (Glomerulonephritis proliferative) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: (Negative) anti-SCl-70 antibodies, anti-SSA-Ab, anti-SSB-Ab, anti-histone antibodies were negative.. On an unknown date, Antinuclear antibody: (Negative) Negative at admission  Normal range: less than 1:80. On an unknown date, Biopsy bone marrow: A bone marrow biopsy showed 8% plasma cells with IgG lambda staining. On an unknown date, Biopsy kidney: The first kidney biopsy showed glomeruli with diffuse endocapillary hypercellularity, endothelial cell swelling and CD68+ macrophage infiltrates, The second kidney biopsy showed diffuse endocapillary hypercellularity/endothelial swelling with segmental membranoproliferative features macrophage infiltrates and segmental subendothelial hyaline deposits, and patchy acute tubular injury. and The third kidney biopsy revealed diffuse endocapillary hypercellularity, segmental hyaline deposits, and segmental duplication of glomerular basement membranes. Numerous CD68+ macrophages were seen. There was a patchy acute tubular injury but the degree of tubulointerstitial scarring and inflammation remained minimal. On an unknown date, Blood albumin: 3.5 g/dL at admission, 2 g/dL 12 months later and 2.5 g/dL 24 months later. On an unknown date, Blood creatinine (0.1-1.5): 8.4 mg/dl at admission, 7.42 mg/dl 12 months later, 3.89 mg/dl 20 months later, 1.3 mg/dl, 1.6 mg/dl and 1.6 mg/dl. On an unknown date, Blood culture: revealed no growth. On an unknown date, Blood pressure measurement: 113/70 mmHg. On an unknown date, Blood urea (5-25): 70 mg/dl  at admission, 97 mg/dl 12 months later and 60 mg/dl 20 months later. On an unknown date, Body temperature: 100.8 F, 104 F and 98.5. On an unknown date, Chest X-ray: Chest x-ray findings were suspicious for pneumonia. and Chest x-ray did not show any evidence of cardiopulmonary disease.. On an unknown date, Complement factor C3: Decreased (Normal range: 87-200 mg/dl) at admission, Decreased 12 months later and Decreased 20 months later. On an unknown date, Complement factor C4: Decreased at admission  Normal range: 19-52 mg/dl, Decreased 12 months later  Normal range: 19-52 mg/dl and Decreased 20 months later  Normal range: 19-52 mg/dl. On an unknown date, Cryoglobulins: (Negative) Negative at admission  Normal: Negative, (Negative) Negative 12 months later Normal: Negative and (Negative) Negative 24 months later Normal: Negative. On an unknown date, Culture urine: revealed no growth. On an unknown date, Electrophoresis protein: serum and urine protein electrophoresis and immunofixation revealed the presence of monoclonal IgG and lambda light chain.. On an unknown date, Haematocrit: 38 at admission, 37.6 12 months later and 39.8 20 months later. On an unknown date, Haemoglobin: 9.8 at admission, 12.5 12 months later and 12.8 20 months later. On an unknown date, Heart rate: 104 beats per minute. On an unknown date, Hepatitis A antibody: (Negative) Negative. On an unknown date, Hepatitis B antibody: (Negative) Negative at admission. On an unknown date, Hepatitis B surface antibody: (Negative) Negative. On an unknown date, Hepatitis B surface antigen: (Negative) Negative. On an unknown date, Hepatitis C antibody: (Negative) Negative at admission. On an unknown date, Immunology test: The first kidney biopsy results revealed the patchy acute tubular injury and minimal interstitial fibrosis, edema, and inflammation. Immunofluorescence (IF) demonstrated trace to 1+ segmental tuft staining for IgM, kappa, lambda, and C3., The second kidney biopsy results showed 1+ mesangial and capillary wall staining for IgM only and The third kidney biopsy showed segmental capillary wall staining for IgG and lambda (Figures 2G-2I). IF staining for IgG heavy chains showed no clearcut staining for IgG1, IgG2, IgG3, or IgG4, and was non-contributory. However, staining for heavy and light chains revealed positivity for IgG lambda but not IgG kappa, IgM kappa, or IgM lambda.. On an unknown date, Influenza A virus test: (Negative) Negative. On an unknown date, Influenza B virus test: (Negative) Negative. On an unknown date, Microscopy: The first kidney biopsy revealed endothelial cell swelling, but no electron-dense deposits were identified (Figure 3A). A diagnosis of endocapillary proliferative glomerulonephritis of unclear etiology was made., The second kidney biopsy showed a few mesangial and capillary wall immune-type electron-dense deposits, without an organized substructure and The third kidney biopsy showed multiple large subendothelial electron-dense deposits, some of which appeared to be undergoing ingestion by intracapillary leukocytes. On an unknown date, Platelet count: 124 per microlitre 12 months later and 97 per microlitre 24 months later. On an unknown date, Respiratory rate: 18 breaths per minute. On an unknown date, Rheumatoid factor: (Negative) Negative at admission, (Negative) Negative 12 months later and (Negative) Negative 24 months later. On an unknown date, SARS-CoV-2 RNA: (Negative) Negative. On an unknown date, Urine analysis: 3+ protein, 11-20 RBCs, 11-20 WBCs at admission, 3+ protein, >5 RBCs, >5WBCs 12 months later and 2+ protein, >5 RBCs, >5WBCs 24 months later. On an unknown date, Urine protein/creatinine ratio: 10000 milligram per gram 12 months later and 500 milligram per gram 24 months later. On an unknown date, White blood cell count: 13.4 thousand per microlitre at admission, 7.9 thousand per microlitre 12 months later and 6.9 thousand per microlitre 20 months later.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered GLOMERULONEPHRITIS PROLIFERATIVE (Glomerulonephritis proliferative) to be related.    Patient in her 50s presented with diffuse abdominal pain, generalized myalgia, nasal congestion, an erythematous maculopapular rash of the upper extremities, fatigue, fever, shortness of breath, and diarrhea for three days. Medication history included statin. Following a kidney biopsy, the patient underwent hemodialysis for the rise in creatinine and decreased urine output and received corticosteroid therapy (pulse dose steroids), with the prompt recovery of kidney function.   The patient was well until 12 months later, when she developed fever (104° F), chills, rigors, and headache, two days after receiving a dose of COVID-19 vaccine.  The patient again underwent hemodialysis (three sessions) for acute renal failure and received corticosteroid therapy (pulse dose steroids and subsequent oral steroids), with the recovery of kidney function.  Immunofixation in serum was reported as IgG lambda band at 12 months.  Eight months later, patient again presented with fever, myalgias, malaise, flu-like symptoms, and inability to urinate, despite adequate fluid intake.  There was bilateral 1+ pitting edema in the lower extremities and erythematous rashes on both forearms. Work-up for the infectious disease was negative.  Following each biopsy, the patient received intravenous steroids and dialysis, and kidney function improved rapidly. At the last follow-up (four months after the third biopsy), patient was asymptomatic.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2022: Live follow up received by safety on 30-Sep-2022 has Email received and contains new updates. Reporter information, Literature information, Medical history, lab data, product and event details updated.  Company comment: This is a literature non-study case concerning an adult female patient with medical history of hemodialysis due to Glomerulonephritis proliferative (findings on the first kidney biopsy), who was hospitalized due to the unexpected, serious event of Glomerulonephritis proliferative (Proliferative Glomerulonephritis With Monotypic Immunoglobulin Deposits). The patient developed fever, chills, rigor and headache 2 days after receiving a dose of mRNA-1273 vaccine. Chest x-ray findings were suspicious for pneumonia, creatinine and blood urea nitrogen were elevated, decreased C3 and C4, urinalysis showed proteinuria, hematuria and leukocytoria and urine protein/creatinine ratio is 10,000 mg/g. A kidney biopsy (second) was performed where the microscopic and immunohistochemical findings showed diffuse endocapillary hypercellularity/endothelial swelling with segmental membranoproliferative features, macrophage infiltrates and segmental subendothelial hyaline deposits and patchy acute tubular injury and immunofluorescence staining showed 1+ mesangial and capillary wall staining for IgM only and electron microscopy findings showed a few mesangial and capillary wall immune-type electron-dense deposits without an organized substructure. Serum and urine protein electrophoresis and immunofixation revealed the presence of monoclonal IgG and lambda light chain. A bone marrow biopsy showed 8% plasma cells with IgG lambda staining. The patient underwent hemodialysis (three sessions) for acute renal failure and received corticosteroid therapy (pulse dose steroids and subsequent oral steroids) with the recovery of kidney function. 8 months later, the patient presented with fever, myalgias, malaise, flu-like symptoms and inability to urinate despite adequate fluid intake. There was bilateral 1+ pitting edema in the lower extremities and erythematous rashes on both forearms. Chest x-ray did not show any evidence of cardiopulmonary disease and work-up for the infectious disease was negative. The patient presented again with elevated creatinine and blood urea nitrogen, decreased C3 and C4, urinalysis showed proteinuria, hematuria and leukocytoria and urine protein/creatinine ratio is 500 mg/g. A repeat kidney biopsy (third) was performed which showed clearcut monotypic IgG lambda deposits, consistent with Proliferative Glomerulonephritis With Monotypic Immunoglobulin Deposits (PGNMID). The patient received intravenous steroids and dialysis and kidney function improved. 4 months after the third biopsy, serum creatinine was normal and the patient was asymptomatic. Medical history of Glomerulonephritis proliferative 12 months prior remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a literature non-study case concerning an adult female patient with medical history of hemodialysis due to Glomerulonephritis proliferative (findings on the first kidney biopsy), who was hospitalized due to the unexpected, serious event of Glomerulonephritis proliferative (Proliferative Glomerulonephritis With Monotypic Immunoglobulin Deposits). The patient developed fever, chills, rigor and headache 2 days after receiving a dose of mRNA-1273 vaccine. Chest x-ray findings were suspicious for pneumonia, creatinine and blood urea nitrogen were elevated, decreased C3 and C4, urinalysis showed proteinuria, hematuria and leukocytoria and urine protein/creatinine ratio is 10,000 mg/g. A kidney biopsy (second) was performed where the microscopic and immunohistochemical findings showed diffuse endocapillary hypercellularity/endothelial swelling with segmental membranoproliferative features, macrophage infiltrates and segmental subendothelial hyaline deposits and patchy acute tubular injury and immunofluorescence staining showed 1+ mesangial and capillary wall staining for IgM only and electron microscopy findings showed a few mesangial and capillary wall immune-type electron-dense deposits without an organized substructure. Serum and urine protein electrophoresis and immunofixation revealed the presence of monoclonal IgG and lambda light chain. A bone marrow biopsy showed 8% plasma cells with IgG lambda staining. The patient underwent hemodialysis (three sessions) for acute renal failure and received corticosteroid therapy (pulse dose steroids and subsequent oral steroids) with the recovery of kidney function. 8 months later, the patient presented with fever, myalgias, malaise, flu-like symptoms and inability to urinate despite adequate fluid intake. There was bilateral 1+ pitting edema in the lower extremities and erythematous rashes on both forearms. Chest x-ray did not show any evidence of cardiopulmonary disease and work-up for the infectious disease was negative. The patient presented again with elevated creatinine and blood urea nitrogen, decreased C3 and C4, urinalysis showed proteinuria, hematuria and leukocytoria and urine protein/creatinine ratio is 500 mg/g. A repeat kidney biopsy (third) was performed which showed clearcut monotypic IgG lambda deposits, consistent with Proliferative Glomerulonephritis With Monotypic Immunoglobulin Deposits (PGNMID). The patient received intravenous steroids and dialysis and kidney function improved. 4 months after the third biopsy, serum creatinine was normal and the patient was asymptomatic. Medical history of Glomerulonephritis proliferative 12 months prior remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.