Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, IgA nephropathy, Myalgia, Protein urine, Pyrexia
Clinical narrative: Exacerbation of IgA nephropathy; Exacerbation of IgA nephropathy; Body aches; Headache; Fever; Chills; Fatigue; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (Exacerbation of IgA nephropathy) and CONDITION AGGRAVATED (Exacerbation of IgA nephropathy) in a 38-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.   LITERATURE REFERENCE: Gross hematuria following vaccination for severe acute respiratory syndrome coronavirus 2 in 2 patients with IgA nephropathy.    The patient's past medical history included Gastroenteritis (the patient had gross hematuria during gastroenteritis). Previously administered products included for an unreported indication: influenza vaccine (Patent had gross haematuria occasionally after yearly influenza vaccine). Concurrent medical conditions included IgA nephropathy (Patient was treated with renin-angiotensin-aldosterone system  inhibitor. Patient also had Persistent microscopic hematuria) since 2005.   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, 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 (Exacerbation of IgA nephropathy) (seriousness criterion medically significant), CONDITION AGGRAVATED (Exacerbation of IgA nephropathy) (seriousness criterion medically significant), MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, IGA NEPHROPATHY (Exacerbation of IgA nephropathy), CONDITION AGGRAVATED (Exacerbation of IgA nephropathy), MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Protein urine: 0.63 g/d 0.63 g/d. On an unknown date, Biopsy: abnormal (abnormal) biopsy proven IgA nephropathy. On an unknown date, Blood creatinine: normal (normal) did not increase. On an unknown date, Protein urine: <1 g/d <1 g/d, 0.82 g/d proteinuria was 0.82 g/d between SARS-Cov-2 vaccine doses. and 1.40 g/d proteinuria was 1.40 g/d  3 weeks after last SARS-CoV-2 vaccine dose. On an unknown date, Renal function test: unknown well-preserved. On an unknown date, Urine analysis: gross haematuria (macroscopic) (abnormal) gross haematuria (macroscopic).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (Exacerbation of IgA nephropathy), CONDITION AGGRAVATED (Exacerbation of IgA nephropathy), MYALGIA (Body aches), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) to be possibly related.    The patient had with biopsy proven IgA nephropathy with persistent microscopic hematuria. At baseline, the patient had proteinuria of <1 g/d and well-preserved kidney function. Several hours after the second dose of vaccine was given, the patient developed systemic symptoms, ranging from body aches, headache, and fatigue to fever and chills. Between 8 and 24 hours after systemic symptoms appeared, the patient noticed gross hematuria that resolved after 3 days. Serum creatinine did not increase, but proteinuria increased.  Gross hematuria was presented in this patient during 1 episode of gastroenteritis and occasionally after yearly influenza vaccine.  Concomitant medication included renin-angiotensin-aldosterone system inhibitor that were used for IgA nephropathy.  Treatment medication for this episode of IgA exacerbation was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events (body aches, headache, fatigue, fever and chills developed several hours after the second dose of vaccine was given, and symptoms of IgA nephropathy exacerbation developed 8 and 24 hours after the systemic symptoms),  a causal relationship cannot be excluded.; 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 (body aches, headache, fatigue, fever and chills developed several hours after the second dose of vaccine was given, and exacerbation of IgA nephropathy with gross hematuria and proteinuria developed 8 and 24 hours after these systemic symptoms), a causal relationship cannot be excluded.