Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood creatinine, IgA nephropathy, Urine protein/creatinine ratio
Clinical narrative: de novo IgA nephropathy (M1 E1 S0 T0 C1); This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (de novo IgA nephropathy (M1 E1 S0 T0 C1)) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history included Nephrolithiasis and Ulcerative colitis.    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, the patient experienced IGA NEPHROPATHY (de novo IgA nephropathy (M1 E1 S0 T0 C1)) (seriousness criterion medically significant). The patient was treated with MYCOPHENOLATE MOFETIL at an unspecified dose and frequency. At the time of the report, IGA NEPHROPATHY (de novo IgA nephropathy (M1 E1 S0 T0 C1)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: iga nephropathy IgA nephropathy (M1 E1 S0 T0 C1). On an unknown date, Blood creatinine: 1.0 mg/dl 1.0 mg/dL (Prior to vaccination) and 1.3 mg/dl 1.3 mg/dL (Following vaccination). On an unknown date, Urine protein/creatinine ratio: not available Not available (Prior to vaccination) and 656 mg/g 656 mg/g (Following vaccination).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (de novo IgA nephropathy (M1 E1 S0 T0 C1)) to be related.    No concomitant medication was reported.   Patient developed gross hematuria and foamy urine 2 days after receiving his second mRNA- 1273 vaccination. He was also noted to have sub-nephrotic proteinuria and mild acute kidney injury. Due to persistent proteinuria and hematuria, he underwent a kidney biopsy that showed IgA nephropathy (M1 E1 S0 T0 C1)  Company Comment: This literature case concerns a 35-year-old, male patient, with relevant medical history of nephrolithiasis and ulcerative colitis, who experienced the unexpected, serious (medically significant) event of IgA nephropathy which occurred 2 days after receiving a second dose of mRNA-1273 vaccine.  Patient had gross hematuria, foamy urine, sub-nephrotic proteinuria, and mild acute kidney injury. He underwent kidney biopsy confirming IgA nephropathy and was treated with mycophenolate mofetil.  After around 4 weeks, creatinine and proteinuria improved but was not yet back to baseline.  Baseline creatinine prior to vaccination was 1 mg/dl.  Following vaccination, creatinine became 1.3 mg/dl with urine protein creatinine ratio of 656 mg/dl.  The medical history of nephrolithiasis could be a confounding factor for acute kidney injury and haematuria while the medical history of ulcerative colitis and male gender could be associated factors for IgA nephropathy. The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538651 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow up received by safety on 13-Apr-2022 included an Email received from team and contains significant information. Reporter information updated, literature information updated, race information updated, medical history and  laboratory data updated. Treatment medication and events added.; Sender's Comments: This literature case concerns a 35-year-old, male patient, with relevant medical history of nephrolithiasis and ulcerative colitis, who experienced the unexpected, serious (medically significant) event of IgA nephropathy which occurred 2 days after receiving a second dose of mRNA-1273 vaccine.  Patient had gross hematuria, foamy urine, sub-nephrotic proteinuria, and mild acute kidney injury. He underwent kidney biopsy confirming IgA nephropathy and was treated with mycophenolate mofetil.  After around 4 weeks, creatinine and proteinuria improved but was not yet back to baseline.  Baseline creatinine prior to vaccination was 1 mg/dl.  Following vaccination, creatinine became 1.3 mg/dl with urine protein creatinine ratio of 656 mg/dl.  The medical history of nephrolithiasis could be a confounding factor for acute kidney injury and haematuria while the medical history of ulcerative colitis and male gender could be associated factors for IgA nephropathy.  The benefit risk relationship of mRNA-1273 is not affected by this report.