Sex: M
Vaccine: COVID19
Symptoms: Protein urine, SARS-CoV-2 test, Urine output, Urine protein/creatinine ratio
Clinical narrative: FSGS recurrence; This is a literature report.  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "FSGS" (not ongoing), notes: 8 years status post deceased donor kidney transplant; "kidney transplant" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: FOCAL SEGMENTAL GLOMERULOSCLEROSIS (medically significant), outcome "recovering", described as "FSGS recurrence". The patient underwent the following laboratory tests and procedures: biopsy: revealed foot process effacement without definitiv, notes: revealed foot process effacement without definitive evidence of segmental sclerosis; blood albumin: 4.8 g/dl, notes: Routine labs 1 day prior to COVID 19 mRNA vaccine series were stable; 1.7 g/dl, notes: hypoalbuminemia. Thirty-one days after the second COVID 19 vaccine, routine labs were significant for nephrotic range; 3.5 g/dl, notes: concurrent with prednisone taper, the patient appeared clinically well with noted improvement in labs; blood creatinine: 0.8 mg/dl, notes: Routine labs 1 day prior to COVID 19 mRNA vaccine series were stable; 1.3 mg/dl, notes: Thirty-one days after the second COVID 19 vaccine, routine labs were significant for nephrotic range; 0.57 mg/dl, notes: concurrent with prednisone taper, the patient appeared clinically well with noted improvement in labs; physical examination: periorbital and lower extremity edema, notes: have periorbital and lower extremity edema; protein urine: increased; sars-cov-2 test: negative; urine output: decreased; urine protein/creatinine ratio: 0.42, notes: 0.42 mg/mg. 65 mg/dL of protein. Routine labs 1 day prior to COVID 19 mRNA vaccine series were stable; greater than 6.21, notes: >6.21 mg/mg (>2500 mg/dL of protein),; 0.55, notes: 0.55 mg/mg. concurrent with prednisone taper, the patient appeared clinically well with noted improvement in labs. Therapeutic measures were taken as a result of focal segmental glomerulosclerosis. He was currently undergoing wean of PP and steroids. Other than one prior FSGS recurrence early post-transplant, which responded to plasmapheresis (PP) and rituximab, he maintained normal allograft function with stable, low-level proteinuria on losartan 12.5 mg daily. The patient remained asymptomatic until 2 days prior to labs. He received methylprednisolone 1g IV for 3 days, thrice-weekly PP, rituximab 375 mg/m2 weekly x2, and an oral prednisone taper. During week 4 of PP concurrent with prednisone taper, the patient appeared clinically well with noted improvement in labs.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event FSGS recurrence and suspect drug BNT162B2 cannot be excluded.   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.