Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Proteinuria, Renal impairment, Urine protein/creatinine ratio
Clinical narrative: Kidney function decline; Gross hematuria; IgA vasculitis; proteinuria; This literature-non-study case was reported in a literature article and describes the occurrence of RENAL IMPAIRMENT (Kidney function decline) in a 67-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.       The patient's past medical history included Hypertension (Medications reported was RAASi (renin-angiotensin-aldosterone system inhibition)) since an unknown date. Concurrent medical conditions included Chronic kidney disease and Proteinuria.   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 RENAL IMPAIRMENT (Kidney function decline) (seriousness criterion medically significant), HAEMATURIA (Gross hematuria), HENOCH-SCHONLEIN PURPURA (IgA vasculitis) and PROTEINURIA (proteinuria). The patient was treated with PREDNISONE for Hematuria, at a dose of 40 milligram. At the time of the report, RENAL IMPAIRMENT (Kidney function decline) was resolving and HAEMATURIA (Gross hematuria), HENOCH-SCHONLEIN PURPURA (IgA vasculitis) and PROTEINURIA (proteinuria) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: iga vasculitis IgA vasculitis   abnormal. On an unknown date, Blood creatinine: 1.20 Baseline value was 1.20, 2.90 At Presentation value was 2.90 and 1.40 Follow-up 1 month post second dose was 1.40. On an unknown date, Blood urine present: 0 to 3 Baseline value was 0 to 3, greater than 50 At Presentation value was Greater than 50 and 0 to 3 Follow-up 1 month post second dose was 0 to 3. On an unknown date, Urine protein/creatinine ratio: 0.05 Baseline value was 0.05, 2.10 At Presentation value was 2.10 and 0.09 Follow-up 1 month post second dose was 0.09.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RENAL IMPAIRMENT (Kidney function decline), HAEMATURIA (Gross hematuria), HENOCH-SCHONLEIN PURPURA (IgA vasculitis) and PROTEINURIA (proteinuria) to be related.    Patient developed gross hematuria followed by lower extremity rash 1 month after his first vaccine dose (5 days before second dose); skin biopsy showed IgA vasculitis. Cutaneous but not renal symptoms of IgA vasculitis worsened though 10 days after second vaccine dose, and he received a 1-week course of prednisone 40 mg daily, with resolution of rash and improved renal function.  Follow-up 1 month post second dose Serum Creatinine (SCr) improving but above baseline.  Bilateral lower extremity maculopapular rash was the evidence of systemic IgA vasculitis after vaccination.  Company Comment: This case concerns a 67 year-old, male patient with a history of Hypertension, Chronic kidney disease, proteinuria and concomitant use of renin-angiotensin-aldosterone system inhibition, who experienced the  serious (due to medically significant) unexpected AESI renal impairment and the non serious events of Haematuria, Henoch-Schonlein purpura and Proteinuria. The events occurred approximately 5 days after the second dose of mRNA-1273 vaccine and 1 month after the first dose.  The medical history, of Hypertension and concomitant use of renin-angiotensin-aldosterone system inhibition remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-387565, MOD-2021-387566, MOD-2021-387504 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Upon internal review on 26-May-2023 significant corrections performed to upgrade the seriousness for IME event Renal impairment.