Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerulonephritis minimal lesion, SARS-CoV-2 test, Urine analysis, Urine protein/creatinine ratio
Clinical narrative: Minimal change disease occurred a week following the first dose of the vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease occurred a week following the first dose of the vaccine) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia (11 months post-KT contracted COVID-19 pneumonia), Delayed graft function (Complicated by delayed graft function), Lupus nephritis and Kidney transplant (Deceased donor kidney transplant from a 20 yr old male, kidney donor profile index 16%, panel reactive antibody 0%.) in September 2021. Concurrent medical conditions included End stage renal disease (history of ESKD from lupus nephritis). Concomitant products included TACROLIMUS and MYCOPHENOLIC ACID for Immunosuppression.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease occurred a week following the first dose of the vaccine) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Minimal change disease, at a dose of 1 mg/kg, qd. At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease occurred a week following the first dose of the vaccine) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: abnormal (abnormal) Allograft biopsy showed mild tubulitis and interstitial nephritis on light microscopy (LM), immunofluorescence negative for C4d, electron microscopy with moderate foot process effacement and no electron dense deposits, suspicious for MCD. On an unknown date, Blood albumin: 2.1g/dl albumin 2.1 g/dl consistent with NS and 3.3g/dl (Low) 4 weeks after Prednisone 3.3 g/dl. On an unknown date, Blood creatinine: 0.8mg/dl On day 27 post transplantation serum creatinine (Scr) improved to 0.8 mg/dl, 2.10mg/dl Initial Scr 2.10 mg/dl and 0.8mg/dl 4 weeks after Prednisone 0.8 mg/dl. On an unknown date, Blood immunoglobulin G: positive (Positive) 3.87 s/co (0-0.99). On an unknown date, DNA antibody: 5 anti-DNA antibody 5 IU/m. On an unknown date, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 PCR negative. On an unknown date, Urine analysis: abnormal (abnormal) urine analysis 4 + protein / 2 RBCs. On an unknown date, Urine protein/creatinine ratio: 9.6 urine protein to creatinine ratio (UPCR) 9.6 g/g and 1.12 4 weeks after Prednisone UPCR 1.12 g/g.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (Minimal change disease occurred a week following the first dose of the vaccine) to be possibly related.    Patient developed anasarca 4 days post-mRNA-1273 vaccine.  This a seropositive SARS-CoV-2 kidney transplant recipients (KTR) from previous COVID-19 pneumonia who developed NS and Acute kidney Injury(AKI) following the mRNA-1273 vaccine. Biopsy consisted with Minimal change disease (MCD). Timing from vaccine exposure to development of MCD ranges from days to months, our patient mounted an immune response in 4 days. The acute tubular injury seen in LM is atypical, unclear if this is a cell mediated process from allograft rejection or part of the pathogenesis postimmunization.  This case concerns a 45-year-old female patient with relevant medical history of End stage renal disease from lupus nephritis, kidney transplant and delayed graft function who experienced serious unexpected event of Glomerulonephritis minimal lesion. The event occurred a week following the first dose of mRNA-1273. The rechallenge was not applicable as no information regarding the second dose was available and outcome of the event was unknown. The patient developed nephrotic syndrome and acute kidney injury following the first dose of mRNA-1273 vaccine. Biopsy results were consistent with minimal change disease. The patient was treated with prednisone which led to improvement of laboratory results, (blood albumin levels improved from 2.1 g/dl to 3.3 g/dl, blood creatinine levels improved from 0.8 mg/dl to 2.10 mg/dl and urine protein/creatinine ratio improved from 9.6 g/g to 1.12 g/g) however, outcome of the event was not provided. Causality is confounded with patient's reported medical history as authors themselves stated that the acute tubular injury seen in light microscopy was atypical, and it is unclear if this was a cell mediated process from allograft rejection or part of the pathogenesis postimmunization. The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received by safety on 11-Nov-2021 included an Email with FTA received from Med team and contains significant information; Sender's Comments: This case concerns a 45-year-old female patient with relevant medical history of End stage renal disease from lupus nephritis, kidney transplant and delayed graft function who experienced serious unexpected event of Glomerulonephritis minimal lesion. The event occurred a week following the first dose of mRNA-1273. The rechallenge was not applicable as no information regarding the second dose was available and outcome of the event was unknown. The patient developed nephrotic syndrome and acute kidney injury following the first dose of mRNA-1273 vaccine. Biopsy results were consistent with minimal change disease. The patient was treated with prednisone which led to improvement of laboratory results, (blood albumin levels improved from 2.1 g/dl to 3.3 g/dl, blood creatinine levels improved from 0.8 mg/dl to 2.10 mg/dl and urine protein/creatinine ratio improved from 9.6 g/g to 1.12 g/g) however, outcome of the event was not provided. Causality is confounded with patient's reported medical history as authors themselves stated that the acute tubular injury seen in light microscopy was atypical, and it is unclear if this was a cell mediated process from allograft rejection or part of the pathogenesis postimmunization. The benefit risk relationship of mRNA-1273 is not affected by this report.