Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Protein urine, Urine analysis
Clinical narrative: ANCA associated-glomerulonephritis with a necrotizing and crescentic pattern; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (ANCA associated-glomerulonephritis with a necrotizing and crescentic pattern) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.        Concurrent medical conditions included Monoclonal gammopathy of unknown significance, Paroxysmal atrial fibrillation and Hypertension.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (ANCA associated-glomerulonephritis with a necrotizing and crescentic pattern) (seriousness criteria hospitalization and medically significant). The patient was treated with RITUXIMAB for Glomerulonephritis, at a dose of 1000 milligram every two weeks; PREDNISONE for Glomerulonephritis, at a dose of 60 milligram, slow taper and PREDNISONE ongoing since an unknown date for Glomerulonephritis, at a dose of 5 milligram. At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (ANCA associated-glomerulonephritis with a necrotizing and crescentic pattern) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Biopsy kidney: abnormal (abnormal) 22 glomeruli, 4 of which were globally sclerotic. Out of the remaining glomeruli,11 had cellular or fibrocellular crescents, 1 had a fibrous crescent, and 3 had segmental fibrinoid necrosis. There was 20% IFTA. Immune complex deposits were not seen by IF. EM showed no EDD. The biopsy findings were consistent with ANCA associated-glomerulonephritis with a necrotizing and crescentic pattern.. On 17-May-2021, Blood creatinine: 1.39 mg/dl At her last visit 3 months after the discharge, her creatinine has improved to 1.39 mg/dL. On an unknown date, Antineutrophil cytoplasmic antibody: presence of myeloperoxidase presence of myeloperoxidase(MPO) ANCA.. On an unknown date, Antinuclear antibody: positive (Positive) Serologic workup showed weakly positive ANA (1 : 80). On an unknown date, Blood creatinine: 0.86 mg/dl 0.86 mg/dL 6 months prior to the vaccination, 1.4 mg/dl On admission, 1.4 mg/dL, 1.2 mg/dl trended down to 1.2 mg/dL with volume resuscitation, 2.05 mg/dl On re-admission 4 weeks later, 2.05 mg/dL, 2.92 mg/dl Serum creatinine peaked at 2.92mg/dL and 0.9mg/dl Baseline serum creatinine 0.9mg/dL. On an unknown date, Protein urine: 3,200 mg/g upcr Peak 3,200 mg/g UPCR Post vaccine, 500 mg/g Nadir 500 mg/g Post vaccine, 0.5 g/g 0.5 g/g At her last visit 3 months after discharge and 1.39 mg/dl Nadir 1.39 mg/dL Post vaccine. On an unknown date, Urine analysis: microscopic hematuria and leukocyturia Urine analysis showed microscopic hematuria and leukocyturia with 1.3 g of protein on 24-hour urine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (ANCA associated-glomerulonephritis with a necrotizing and crescentic pattern) to be related.    Lab test of urine dipstick was negative, no prior quantification of baseline proteinuria was determined.  Company comment: This case concerns a 77-year-old female patient with relevant medical history of hypertension, atrial fibrillation and monoclonal gammopathy of unknown significance and no prior history of kidney disease who experienced serious unexpected event of Glomerulonephritis rapidly progressive. Serum creatinine 6 months prior to the vaccination was 0.86 mg/dL. Eight weeks after the second dose of mRNA-1273, she was admitted with symptomatic bradycardia. She was noted to have AKI with serum creatinine of 1.4 mg/dL that trended down to 1.2 mg/dL with volume resuscitation. She was re-admitted 4 weeks later, again with bradycardia and further increase in serum creatinine to 2.05 mg/dL. Urine analysis showed microscopic hematuria and leukocyturia with 1.3 g of protein on 24- hour urine. Serum creatinine peaked at 2.92 mg/dL. Serologic workup showed weakly positive ANA (1 : 80) and presence of myeloperoxidase ANCA. Kidney biopsy revealed 22 glomeruli, 4 of which were globally sclerotic. Out of the remaining glomeruli, 11 had cellular or fibrocellular crescents, 1 had a fibrous crescent, and 3 had segmental fibrinoid necrosis. There was 20% IFTA. Immune complex deposits were not seen by IF. EM showed no EDD. The biopsy findings were consistent with ANCA associated- glomerulonephritis with a necrotizing and crescentic pattern. She received 2 doses of 1,000 mg rituximab, 2 weeks apart, and 60 mg prednisone with slow taper. At her last visit 3 months after the discharge, her creatinine has improved to 1.39 mg/dL and proteinuria had decreased to 0.5 g/g. At the time of the report, the patient was on 5 mg prednisone and the event was resolving. Causality is confounded with patient's advanced age and patient's reported medical history. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-485478, MOD-2022-483213 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2022: Follow up received by safety on 17-Feb-2022 has Email received from team and  contains significant information. Patient information, medical history, treatment drugs, events were added.; Sender's Comments: This case concerns a 77-year-old female patient with relevant medical history of hypertension, atrial fibrillation and monoclonal gammopathy of unknown significance and no prior history of kidney disease who experienced serious unexpected event of Glomerulonephritis rapidly progressive. Serum creatinine 6 months prior to the vaccination was 0.86 mg/dL. Eight weeks after the second dose of mRNA-1273, she was admitted with symptomatic bradycardia. She was noted to have AKI with serum creatinine of 1.4 mg/dL that trended down to 1.2 mg/dL with volume resuscitation. She was re-admitted 4 weeks later, again with bradycardia and further increase in serum creatinine to 2.05 mg/dL. Urine analysis showed microscopic hematuria and leukocyturia with 1.3 g of protein on 24- hour urine. Serum creatinine peaked at 2.92 mg/dL. Serologic workup showed weakly positive ANA (1 : 80) and presence of myeloperoxidase ANCA. Kidney biopsy revealed 22 glomeruli, 4 of which were globally sclerotic. Out of the remaining glomeruli, 11 had cellular or fibrocellular crescents, 1 had a fibrous crescent, and 3 had segmental fibrinoid necrosis. There was 20% IFTA. Immune complex deposits were not seen by IF. EM showed no EDD. The biopsy findings were consistent with ANCA associated- glomerulonephritis with a necrotizing and crescentic pattern. She received 2 doses of 1,000 mg rituximab, 2 weeks apart, and 60 mg prednisone with slow taper. At her last visit 3 months after the discharge, her creatinine has improved to 1.39 mg/dLand proteinuria had decreased to 0.5 g/g. At the time of the report, the patient was on 5 mg prednisone and the event was resolving. Causality is confounded with patient's advanced age and patient's reported medical history. The benefit-risk relationship of mRNA-1273 is not affected by this report.