Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Urine protein/creatinine ratio
Clinical narrative: mild acute kidney injury; gross hematuria; worsening of proteinuria; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE KIDNEY INJURY (mild acute kidney injury) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Concurrent medical conditions included IgA nephropathy (IgA nephropathy 2 years prior to vaccination) and Proteinuria (sub-nephrotic proteinuria without hematuria).    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 ACUTE KIDNEY INJURY (mild acute kidney injury) (seriousness criterion medically significant), HAEMATURIA (gross hematuria) and PROTEINURIA (worsening of proteinuria). At the time of the report, ACUTE KIDNEY INJURY (mild acute kidney injury), HAEMATURIA (gross hematuria) and PROTEINURIA (worsening of proteinuria) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: 0.7 mg/dl 0.7 mg/dL (prior to vaccination), 1.07 mg/dl 1.07 mg/dL (following vaccination) and scr returned to baseline In 3 weeks, sCr and UPCR returned to baseline. On an unknown date, Renal function test: normal (normal) Normal. Patient had normal and stable kidney function and sub-nephrotic proteinuria without hematuria. On an unknown date, Urine protein/creatinine ratio: 1410 mg/g 1410 mg/g (prior to vaccination), 4760 mg/g 4760 mg/g (following vaccination) and upcr returned to baseline In 3 weeks, sCr and UPCR returned to baseline.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE KIDNEY INJURY (mild acute kidney injury), HAEMATURIA (gross hematuria) and PROTEINURIA (worsening of proteinuria) to be related.    The patient belonged to ancestry.  Concomitant medication and treatment medication information was not reported.  Patient had experienced episodes of gross hematuria and worsening of proteinuria that resolved with supportive care alone by 3 weeks post vaccine.  Company Comment: This literature case concerns a 25 year old, female patient, with relevant medical history of IgA nephropathy and sub-nephrotic proteinuria without hematuria, who experienced unexpected, serious (medically significant) AESI acute kidney injury together with haematuria and worsening of proteinuria, one day after receiving a second dose of mRNA-1273.  She was given supportive care alone, and the events resolved after around 3 weeks.  Medical history of IgA nephropathy and sub-nephrotic proteinuria without hematuria are confounders.  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538653.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2022: Follow up received by safety on 13-Apr-2022 included an Email and other received from team and contains significant information: literature citation details, medical history, lab data and event details were updated.; Sender's Comments: This literature case concerns a 25 year old, female patient, with relevant medical history of IgA nephropathy and sub-nephrotic proteinuria without hematuria, who experienced unexpected, serious (medically significant) AESI acute kidney injury together with haematuria and worsening of proteinuria, one day after receiving a second dose of mRNA-1273.  She was given supportive care alone, and the events resolved after around 3 weeks.  Medical history of IgA nephropathy and sub-nephrotic proteinuria without hematuria are confounders.  The benefit risk relationship of mRNA-1273 is not affected by this report.