Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood creatine phosphokinase, Blood creatinine, Blood immunoglobulin A, Blood pressure measurement
Clinical narrative: IgA nephropathy; brown-colored urine; Fever; Chills; Headache; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA nephropathy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IGA NEPHROPATHY (IgA nephropathy) (seriousness criterion medically significant), CHROMATURIA (brown-colored urine), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with LOSARTAN for Adverse event, at a dose of 25 mg once a day. At the time of the report, IGA NEPHROPATHY (IgA nephropathy) was resolving and CHROMATURIA (brown-colored urine), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. patient had no previous history. Presented with gross hematuria and subnephrotic proteinuria . Diagnostic was confirmed by biopsy    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy kidney: abnormal (abnormal) light microscopy revealed nine glomeruli with mild mesangial expansion and hyper cellularity without endocapillary hyper cellularity, one of which showed segmental adhesion of a capillary loop to a capsule.. In 2021, Blood creatine phosphokinase (49-439): 254 (normal) U/L. In 2021, Blood creatinine (0.76-1.27): 1.03 (normal) remained stable after six weeks of therapy and 1.02 (normal) mg/dL. In 2021, Blood immunoglobulin A (90-386): 444 (High) mg/dL. In 2021, Blood pressure measurement: 125/73 (normal) mmHg. In 2021, C-reactive protein: normal (normal) normal. In 2021, Complement factor C3 (82-167): 105 (normal) mg/dL. In 2021, Complement factor C4 (12-38): 19 (normal) mg/dL. In 2021, Glomerular filtration rate: 98 (normal) cc/min/1.73m2. In 2021, Immunology test: abnormal (abnormal) 3+ diffuse granular mesangial staining for IgA. Staining was weekly positive for C3 and negative for IgG and other immunoglobulins/complement antibodies. ultrastructural examination revealed scattered immune-type electron-dense deposits in the mesangium and mild podocyte foot process effacement.. In 2021, Physical examination: normal (normal) normal, lack of lower extremity edema, rash, lymphadenopathy and throat erythema. In 2021, Protein urine: 800 (normal) mg. In 2021, Red blood cell sedimentation rate: normal (normal) normal. In 2021, Serology test: negative (Negative) negative for glomerulonephritis, Hepatitis B, C, HIV, anti-nuclear and anti-neutrophil cytoplasmic antibodies. In 2021, Ultrasound kidney: abnormal (abnormal) mildly increased echogenicity of normal size and cortical thickness.. In 2021, Urine analysis: positive 4+ protein (ref: negative), >30 RBC/HPF (ref: 0-3), 11-30 WBC/HPF (ref: 0-4), and 3+ blood (ref: negative), urinalysis after centrifugation revealed numerous acanthocytes, but no red blood cell casts.. In 2021, Urine protein/creatinine ratio (0-0.2): 0.43 g/g (High) improved after six weeks of therapy and 0.8 (High) g/g.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IGA NEPHROPATHY (IgA nephropathy), CHROMATURIA (brown-colored urine), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) to be possibly related.    Patient had no known past medical history, had never been tested for COVID-19 infection, no known COVID-19 exposure, no flu like illness throughout COVID-19 pandemic, no family history of kidney disease, including IgAN. Concomitant medication not provided.  The patient received the doses of Moderna product with an interval of 28 days. For the first dose, the patient did not present adverse events.  Company comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received by safety on 28-Jul-2021 included abstract propagated ICSR forms. No new information.; 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.