Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Biopsy, Biopsy kidney, Blood albumin
Clinical narrative: De novo minimal change disease; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (De novo minimal change disease) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, 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 (De novo minimal change disease) (seriousness criterion medically significant). The patient was treated with PREDNISONE (oral) for Minimal change disease, at a dose of 70 milligram and FUROSEMIDE for Minimal change disease, at a dose of low dose. At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (De novo minimal change disease) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antineutrophil cytoplasmic antibody: (Negative) Negative. On an unknown date, Antinuclear antibody: (Negative) Negative. On an unknown date, Biopsy: MCD IgA mesangial staining but no immune deposits on EM. On an unknown date, Biopsy kidney: contained at least 20 glomeruli with no glomerulosclerosis, necrosis, or crescent formation. Some glomeruli exhibited mild and focal mesangial expansion, but there was no evidence of endocapillary proliferation. On an unknown date, Blood albumin: 2.8 g/dL and 4.4 g/dL At the 3-month follow-up, the patient remained in complete remission with albumin levels. On an unknown date, Blood creatinine: 0.6 mg/dl, 0.7 mg/dl At the 3-month follow-up, the patient remained in complete remission with creatinine levels and 0.6 mg/dl 4 weeks after initiation of the steroid treatment. On an unknown date, Blood pressure measurement: elevated blood pressure of 150/80 mmHg. On an unknown date, Complement factor C3: (Negative) Negative. On an unknown date, Complement factor C4: (Negative) Negative. On an unknown date, Double stranded DNA antibody: (Negative) Negative. On an unknown date, HIV test: (Negative) Negative. On an unknown date, Hepatitis B virus test: (Negative) Negative. On an unknown date, Hepatitis C virus test: (Negative) Negative. On an unknown date, Immunology test: showed 2+ granular mesangial staining for IgA and C3; rest negative. On an unknown date, Microscopy: showed patent capillary loops and mild mesangial expansion, but no electron-dense deposits were identified. Podocyte foot processes were diffusely effaced and Urine microscopy showed 0 - 2 red cells/HPF with no cellular casts. On an unknown date, Protein urine: 4.1 gram per day. On an unknown date, Serology test: (Negative) Negative. On an unknown date, Ultrasound kidney: showed normal-sized kidneys with no significant abnormalities. On an unknown date, Urine analysis: noted to have 3+ proteinuria and On presentation, urine dipstick showed 4+ protein. On an unknown date, Urine protein/creatinine ratio: 0.3 gram per gram 4 weeks after initiation of the steroid treatment, urine protein-creatinine ratio was < 0.3 g/g and 0.049 gram per gram At the 3-month follow-up, the patient remained in complete remission with urine protein-to-creatinine ratio.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (De novo minimal change disease) to be related.    Patient had no significant past medical history and presented with 5 days of generalized swelling and frothy urine 7 days after receiving 2nd dose of the Moderna vaccine.   Patient was not taking any prescription or over-the-counter medications and had no history of nonsteroidal anti-inflammatory drug use.  On presentation to nephrology, patient exhibited 3+ bilateral leg edema, mild periorbital edema.  Based on the histologic findings, the patient was diagnosed with MCD.  Complete remission was achieved 4 weeks after initiation of the steroid treatment and tapering of the steroid dosage began at 8 weeks.  Author discussed that patient had mild and focal mesangial expansion as well as evidence of IgA deposits on IF. However, there were no electron dense immune deposits on EM which would not be consistent with IgA nephropathy. The IgA deposits on IF likely represent lanthanic deposits in this patient.  Company comment: This literature-non-study case concerns a female patient aged 23 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Glomerulonephritis minimal lesion. Patient presented with 5 days history of generalized swelling and frothy urine 7 days after 2nd dose of mRNA-1273 vaccination. She had 3+ proteinuria on a urine dipstick and was referred to nephrology. On presentation, she exhibited 3+ bilateral leg edema, mild periorbital edema, an elevated blood pressure of 150/80 mmHg, and a urine 4+ protein. Urine microscopy showed 0-2 red cells/HPF with no cellular casts. Initial reports of creatinine and albumin levels were 0.6 mg/dL and 2.8 g/dL, respectively, and 24-hour urine protein was 4.1 g. Serological tests for autoimmunity including antinuclear antibodies (ANA), anti-double stranded DNA (ds-DNA), antineutrophil cytoplasmic antibodies (ANCA), complements (C3, C4) and hepatitis B/C, HIV were negative. A renal ultrasound showed normal-sized kidneys with no significant abnormalities. A kidney biopsy showed no glomerulosclerosis, necrosis, or crescent formation. Some glomeruli exhibited mild and focal mesangial expansion, with no evidence of endocapillary proliferation. Direct immunofluorescence (IF) showed 2+ granular mesangial staining for IgA and C3; rest negative. Electron microscopy (EM) showed patent capillary loops and mild mesangial expansion, but no electron-dense deposits were identified. Podocyte foot processes were diffusely effaced. Based on these histologic findings, the patient was diagnosed with MCD. The patient was started on a 1 mg/kg (70 mg) dose of oral prednisone together with a low dose of furosemide to help control her edema. Complete remission with urine protein-creatinine ratio of < 0.3 g/g and serum creatinine level 0.6 mg/dL was achieved 4 weeks after initiation of the steroid treatment and tapering of the steroid dosage began at 8 weeks. At the 3-month follow-up, the patient remained in complete remission with creatinine and albumin levels of 0.7 mg/dL and 4.4 g/dL, respectively and a urine protein-to-creatinine ratio of 0.049 g/g. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.  This case was linked to US-MODERNATX, INC.-MOD-2022-628827 (Linked Report).; Sender's Comments: This literature-non-study case concerns a female patient aged 23 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Glomerulonephritis minimal lesion. Patient presented with 5 days history of generalized swelling and frothy urine 7 days after 2nd dose of mRNA-1273 vaccination. She had 3+ proteinuria on a urine dipstick and was referred to nephrology. On presentation, she exhibited 3+ bilateral leg edema, mild periorbital edema, an elevated blood pressure of 150/80 mmHg, and a urine 4+ protein. Urine microscopy showed 0-2 red cells/HPF with no cellular casts. Initial reports of creatinine and albumin levels were 0.6 mg/dL and 2.8 g/dL, respectively, and 24-hour urine protein was 4.1 g. Serological tests for autoimmunity including antinuclear antibodies (ANA), anti-double stranded DNA (ds-DNA), antineutrophil cytoplasmic antibodies (ANCA), complements (C3, C4) and hepatitis B/C, HIV were negative. A renal ultrasound showed normal-sized kidneys with no significant abnormalities. A kidney biopsy showed no glomerulosclerosis, necrosis, or crescent formation. Some glomeruli exhibited mild and focal mesangial expansion, with no evidence of endocapillary proliferation. Direct immunofluorescence (IF) showed 2+ granular mesangial staining for IgA and C3; rest negative. Electron microscopy (EM) showed patent capillary loops and mild mesangial expansion, but no electron-dense deposits were identified. Podocyte foot processes were diffusely effaced. Based on these histologic findings, the patient was diagnosed with MCD. The patient was started on a 1 mg/kg (70 mg) dose of oral prednisone together with a low dose of furosemide to help control her edema. Complete remission with urine protein-creatinine ratio of < 0.3 g/g and serum creatinine level 0.6 mg/dL was achieved 4 weeks after initiation of the steroid treatment and tapering of the steroid dosage began at 8 weeks. At the 3-month follow-up, the patient remained in complete remission with creatinine and albumin levels of 0.7 mg/dL and 4.4 g/dL, respectively and a urine protein-to-creatinine ratio of 0.049 g/g. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. US-MODERNATX, INC.-MOD-2022-628827:71 yr male patient