Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital oedema, Product dose omission issue, Proteinuria, Renal tubular injury, Tubulointerstitial nephritis
Clinical narrative: nephrotic syndrome; minimal change disease; focal acute interstitial nephritis; mild acute tubular injury; uncontrolled hypertension; foamy urine; Hypoalbuminemia; proteinuria; hyperlipidemia; Product dose omission; fatigue; dyspnea; progressive anasarca; periorbital edema; This literature-non-study case was reported in a literature article and describes the occurrence of NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury) and DYSPNOEA (dyspnea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Concurrent medical conditions included Hypertension and Tobacco use disorder (dependence).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea) (seriousness criterion medically significant) and FATIGUE (fatigue). On an unknown date, the patient experienced NEPHROTIC SYNDROME (nephrotic syndrome) (seriousness criterion medically significant), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease) (seriousness criterion medically significant), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis) (seriousness criterion medically significant), RENAL TUBULAR INJURY (mild acute tubular injury) (seriousness criterion medically significant), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia) and PRODUCT DOSE OMISSION ISSUE (Product dose omission). The patient was treated with VALSARTAN (oral) for Renin-angiotensin system inhibition, at a dose of 80 mg twice a day; DIURETICS for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE (METHYLPREDNISOLON [METHYLPREDNISOLONE]) (intravenous) for Adverse event, at a dose of 500 mg, pulse, for 3 days and PREDNISONE (oral) for Adverse event, at a dose of 1 mg/kg,unk. At the time of the report, NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia), PRODUCT DOSE OMISSION ISSUE (Product dose omission) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Biopsy kidney: minimum change disease (abnormal) pathology confirmed minimal change disease with mild acute tubular injury and a focal acute interstitial nephritis was also present. Four of 69 sampled glomeruli were globally sclerosed. There was 10% tubulointerstitial fibrosis. The glomeruli were found to have 100% foot process effacement. In April 2021, Blood albumin: 0.7 g/dl (abnormal) 0.7 g/dl. In April 2021, Blood cholesterol: 450 mg/dl mg/dl (abnormal) 450 mg/dl. In April 2021, Blood creatinine: 1.48 mg/dl mg/dl (abnormal) 1.48 mg/dl baseline was 0.7mg/dl. In April 2021, Blood pressure measurement: 181/82 mmhg mmHg (abnormal) 181/82 mmHg. In April 2021, Blood triglycerides: 221 mg/dl mg/dl (abnormal) hyperlipidemia. In April 2021, Creatinine renal clearance: 13.4 g g (abnormal) 13.4 g. In April 2021, Urine analysis: 3+ proteinuria (abnormal) 3+ proteinuria (without microscopic hematuria).     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NEPHROTIC SYNDROME (nephrotic syndrome), GLOMERULONEPHRITIS MINIMAL LESION (minimal change disease), TUBULOINTERSTITIAL NEPHRITIS (focal acute interstitial nephritis), RENAL TUBULAR INJURY (mild acute tubular injury), HYPERTENSION (uncontrolled hypertension), URINE ABNORMALITY (foamy urine), GENERALISED OEDEMA (progressive anasarca), PERIORBITAL OEDEMA (periorbital edema), DYSPNOEA (dyspnea), HYPOALBUMINAEMIA (Hypoalbuminemia), PROTEINURIA (proteinuria), HYPERLIPIDAEMIA (hyperlipidemia) and FATIGUE (fatigue) to be possibly related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Product dose omission).    No prior history of renal failure. No concomitant medications reported.  Patient advised to forgo the second dose of mRNA-1273 vaccination. The authors believe further rechallenges or boosters of this particular vaccine in this patient would be unwise until this potential relationship is more clear.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  However, for the event Intentional Dose Omission of mRNA-1273, causality is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  However, for the event Intentional Dose Omission of mRNA-1273, causality is not applicable.