Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood albumin, Blood creatinine, Disease recurrence, Focal segmental glomerulosclerosis
Clinical narrative: Focal segmental glomerulosclerosis; recurrence of FSGS; This is a literature report for the following literature source(s):   The authors report a case of a 21-year-old male with a history of focal segmental glomerulosclerosis (FSGS) who underwent deceased donor KT at 13 years of age complicated by early disease recurrence requiring 6 months of plasmapheresis and rituximab therapy. He was then stable for the following 8 years, with serum creatinine 0.8 mg/dL and serum albumin 4.8 g/dL until 1 month after completion of mRNA COVID-19 two vaccination series when he presented with edema, nephrotic-range proteinuria (urine protein/creatinine ratio (UPCR)?>?6.21 mg/mg with?>?2500 mg/dL of protein), albumin of 1.7 g/dL, and peak sCr of 1.3 mg/dL. Kidney biopsy showed diffuse foot process effacement, concerning for recurrence of FSGS. He was treated with methylprednisolone, plasmapheresis, and rituximab (two 375 mg/m2 doses). His nephrotic syndrome resolved after 4 weeks of plasmapheresis. Now 10 months after recurrence, he remains in remission of nephrotic syndrome with a normal UPCR (0.18 mg/mg), sCr (0.66 mg/dL) and serum albumin (4.3 g/dL) on mycophenolate mofetil, tacrolimus (goal trough 4-6), and prednisone 5 mg daily. While there are isolated reports of new onset or recurrence of proteinuric kidney disease after mRNA COVID-19 vaccine, to their knowledge, this is the first report of FSGS recurrence in a kidney transplant recipient after COVID-19 vaccination. The pathogenesis of COVID-19 vaccine-related glomerular pathology remains poorly understood; though T-cells are hypothesized to play a prominent role given the rapid disease presentation in relationship to vaccine receipt. Although causality is not proven, the temporal relationship of this case strongly suggests an association between vaccination and disease recurrence. While the risk-benefit ratio of COVID-19 vaccination for kidney transplant recipients remains favorable and vaccination is encouraged by national clinical guidelines, close monitoring for disease recurrence after vaccination in kidney transplant patients at risk is warranted.; Sender's Comments: This 21-year-old male had a history of focal segmental glomerulosclerosis (FSGS) and underwent deceased donor kidney transplant (KT) at 13 years of age complicated by early disease recurrence requiring 6 months of plasmapheresis and rituximab therapy.  There are many factors which may have impacted the recurrence of FSGS.  Considering temporal relationship, a possible contribution role of COVID-19 vaccination to the recurrence of FSGS cannot be excluded in this case.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.