Sex: M
Vaccine: COVID19
Symptoms: Light chain analysis, Microscopy, Protein urine, Tubulointerstitial nephritis, Urine protein/creatinine ratio
Clinical narrative: recurrent glomerulonephritis; acute tubulointerstitial nephritis; This is a literature report.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLE", start date: 2000 (unspecified if ongoing), notes: without renal involvement; "Hypothyroidism" (unspecified if ongoing); "Valvular heart disease" (unspecified if ongoing); "Aortic valve replacement", start date: 2015, stop date: 2015. The patient's concomitant medications were not reported. Past drug history included: Hydroxychloroquine for SLE, notes: for greater than 5 years as his SLE was quiescent; Prednisone for SLE, notes: for greater than 5 years as his SLE was quiescent. The following information was reported: TUBULOINTERSTITIAL NEPHRITIS (hospitalization, medically significant) with onset 21Mar2021, outcome "unknown", described as "acute tubulointerstitial nephritis"; GLOMERULONEPHRITIS (hospitalization, medically significant) with onset 21Mar2021, outcome "unknown", described as "recurrent glomerulonephritis". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: (unspecified date) Negative; Antinuclear antibody: (unspecified date) Negative; (unspecified date) Positive; (unspecified date) Positive; Biopsy kidney: (unspecified date) showed focal mild mesangial, notes: hypercellularity but no endocapillary hypercellularity, fibrinoid necrosis, crescent formation, or segmental sclerosis There were prominent protein droplets within cytoplasm of tubular epithelial cells. No significant IFTA was seen; (unspecified date) findings were consistent with lupus podocytopathy; (26Mar2021) Severe podocytopathy without significant immune-, notes: complex activity or glomerular hyper cellularity. There were prominent protein droplets within cytoplasm of tubular epithelial cells. No significant IFTA was seen; Blood albumin: (unspecified date) 3.6 g/dl; (unspecified date) 2.5 g/dl, notes: hypoalbuminemia; Blood creatinine: (unspecified date) 0.9-1.2 mg/dl, notes: Pre-vaccine; (unspecified date) 0.72 mg/dl; (unspecified date) 1.2 mg/dl; (unspecified date) 1.2 mg/dl; (unspecified date) 2.1 mg/dl, notes: Post-vaccine; Blood immunoglobulin A: (unspecified date) 1+; Blood immunoglobulin G: (unspecified date) 1+; Blood immunoglobulin M: (unspecified date) 1+; Blood potassium: (unspecified date) 2+; Complement factor: (unspecified date) Low; Double stranded DNA antibody: (unspecified date) Negative; Immune complex assay: (unspecified date) 1-2+; Immunology test: (unspecified date) showed weak segmental granular mesangial staining, notes: IgG (1+), IgA (1+), IgM (1+), C1q (1-2+). C3 (2+), k (2+), and ? (1+); anti-Smith antibodies: (unspecified date) Positive; (unspecified date) 2+; Light chain analysis: (unspecified date) 1+; Microscopy: (unspecified date) severe foot process, notes: effacement with mild microvillous transformation was observed Scattered mesangial but no subepithelial or subendothelial EDD were seen; Protein urine: (unspecified date) 100 mg/g; Protein urine: (unspecified date) 11.6 g, notes: 24-hour urine (Post-vaccine); Urine protein/creatinine ratio: (unspecified date) less than or equal to 0.5, notes: Unit: g/g (Pre-vaccine); (unspecified date) 0.1, notes: Unit: g/g. Therapeutic measures were taken as a result of glomerulonephritis, tubulointerstitial nephritis. Patient  received his second dose of the vaccine in May 2021. After 4 months of treatment, his UPCR was 0.1 g/g, serumalbumin 3.6 g/dL, and serum creatinine1.2 mg/dL. Prednisone was tapered down to5 mg/day, and MMF is being slowly tapered off as well.; Sender's Comments: Based on the currently available information the possibility of causal association between the events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.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.,Linked Report(s) : US-PFIZER INC-202200944528 Same article/ drug/event and different patient;