Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Protein urine, SARS-CoV-2 test, Urinary sediment, Urine protein/creatinine ratio
Clinical narrative: IgA vasculitis; Asymptomatic COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of HENOCH-SCHONLEIN PURPURA (IgA vasculitis) and ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19) in a 24-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   Concurrent medical conditions included Cerebral palsy.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HENOCH-SCHONLEIN PURPURA (IgA vasculitis) (seriousness criterion hospitalization). an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19) (seriousness criterion hospitalization prolonged). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for IgA vasculitis, at a dose of pulse dose; PREDNISONE for IgA vasculitis, at a dose of taper; CYCLOPHOSPHAMIDE for IgA vasculitis, at an unspecified dose and frequency and SOTROVIMAB for Asymptomatic COVID-19, at an unspecified dose and frequency. At the time of the report, HENOCH-SCHONLEIN PURPURA (IgA vasculitis) was resolving and ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: Showed focally crescentic and necrotizing proliferative glomerulitis with IgA dominant deposits consistent with IgA vasculitis with renal involvement.. On an unknown date, Blood albumin: On follow up three months later serum albumin normalized. and 1.6 g/dL. On an unknown date, Endoscopy: showed esophagitis and small bowel ulcerations.. On an unknown date, Protein urine: proteinuria improved but remained in the nephrotic range. and 2.3 gram per 24 hour He continues to have subnephrotic range proteinuria with 2.3 grams/24 hours. On an unknown date, SARS-CoV-2 test: Positive. On an unknown date, Urinary sediment: active urinary sediment with dysmorphic red cells.. On an unknown date, Urine protein/creatinine ratio: 8.5.     mRNA-1273 (Spikevax) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Patient had no prior history of renal or autoimmune disease.  Patient was presented with a vasculitic rash, hematochezia and edema. Symptoms developed one week after first dose of Moderna mRNA-1273 vaccine.   He received pulse dose solumedrol followed by prednisone taper as a treatment. Cyclophosphamide was initiated but then stopped due to cytopenias. After several weeks Gastrointestinal (GI) bleeding was resolved spontaneously, and proteinuria improved but remained in the nephrotic range.  The course was further complicated by positive COVID testing prior to discharge patient was asymptomatic and received sotrovimab. On follow up three months later the patient's edema resolved. Patient remains on steroid taper with plan for repeat renal biopsy to inform decisions regarding further immune suppression. Patient had not been rechallenged with COVID vaccine.  Author highlighted by this case, unvaccinated or partially vaccinated patients are at increased risk for COVID infection. Thus, even in those with known glomerular disease, vaccination should still be recommended. Studies are needed to determine if patients with off target glomerulopathies can be safely re-challenged with COVID vaccine, whether the course of COVID vaccine associated disease glomerular lesions mimic the primary glomerular disease and how to optimally manage these patients.  Company comment: This regulatory authority case concerns a 24-year-old, male patient with no relevant medical history reported( no prior history of renal or autoimmune disease), who experienced the unexpected serious (hospitalization) event of Henoch-Schonlein purpura (IgA vasculitis) and asymptomatic COVID 19. The events occurred approximately one week after the first dose of mRNA-1273. As reported, the patient presented with a vasculitic rash, hematochezia and edema. Serum albumin was 1.6 g/dL and urine protein-creatinine ratio 8.5. Endoscopy showed esophagitis and small bowel ulcerations. Renal biopsy showed focally crescentic and necrotizing proliferative glomerulitis with IgA dominant deposits consistent with IgA vasculitis with renal involvement. Patient received pulse dose solumedrol followed by prednisone taper. Cyclophosphamide was initiated but then stopped due to cytopenias. After several weeks GI bleeding resolved spontaneously and proteinuria improved but remained in the nephrotic range, as reported. The course was further complicated by positive COVID testing prior to discharge-he was asymptomatic and received sotrovimab. On followup three months later the patient's edema resolved and serum albumin normalized but patient continues to have subnephrotic range proteinuria with 2.3 grams/24 hours and active urinary sediment with dysmorphic red cells. Patient has not been rechallenged with COVID vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 24-year-old, male patient with no relevant medical history reported( no prior history of renal or autoimmune disease), who experienced the unexpected serious (hospitalization) event of Henoch-Schonlein purpura (IgA vasculitis) and asymptomatic COVID 19. The events occurred approximately one week after the first dose of mRNA-1273. As reported, the patient presented with a vasculitic rash, hematochezia and edema. Serum albumin was 1.6 g/dL and urine protein-creatinine ratio 8.5. Endoscopy showed esophagitis and small bowel ulcerations. Renal biopsy showed focally crescentic and necrotizing proliferative glomerulitis with IgA dominant deposits consistent with IgA vasculitis with renal involvement. Patient received pulse dose solumedrol followed by prednisone taper. Cyclophosphamide was initiated but then stopped due to cytopenias. After several weeks GI bleeding resolved spontaneously and proteinuria improved but remained in the nephrotic range, as reported. The course was further complicated by positive COVID testing prior to discharge-he was asymptomatic and received sotrovimab. On followup three months later the patient's edema resolved and serum albumin normalized but patient continues to have subnephrotic range proteinuria with 2.3 grams/24 hours and active urinary sediment with dysmorphic red cells. Patient has not been rechallenged with COVID vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.