Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Urine protein/creatinine ratio
Clinical narrative: IgA Vasculitis; exacerbated a pre-existing, otherwise quiescent IgA nephropathy; exacerbated a pre-existing, otherwise quiescent IgA nephropathy; This is a literature report for the following literature source(s).  A 69-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "longstanding microscopic hematuria" (ongoing); "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HENOCH-SCHONLEIN PURPURA (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "IgA Vasculitis"; IGA NEPHROPATHY (medically significant), CONDITION AGGRAVATED (medically significant), all with latency 3 weeks after the suspect product(s) administration, outcome "unknown" and all described as "exacerbated a pre-existing, otherwise quiescent IgA nephropathy". The patient underwent the following laboratory tests and procedures: Biopsy skin: was consistent with leukocytoclastic vasculitis; Histology: revealed mild mesangial, notes: hypercellularity; Immunology test: showed IgA dominant mesangial staining; Microscopy: showed mesangial deposits; Protein urine: less than 200, notes: proteinuria; Renal function test: normal; preservation; Serology test: Negative; Urine analysis: there was newly identified proteinuria, notes: and redemonstrated microscopic hematuria; Urine protein/creatinine ratio: 1.6, notes: Unit: g/g. Therapeutic measures were taken as a result of henoch-schonlein purpura, iga nephropathy, condition aggravated.  Clinical course: A 69 year old female with hypertension and longstanding microscopic hematuria received Pfizer BioTech SARS-COV-2 vaccine. Three weeks post vaccination, the patient developed diffuse abdominal and a palpable, right lower extremity purpuric rash. Methods: Skin biopsy was consistent with leukocystoclastic vasculitis. Serologic workup was negative. Kidney function was normal, but there was newly identified proteinuria on urinalysis and redemonstrated microscopic hematuria. Urine protein/creatinine ratio was 1.6 g/g. Histopathologic examination revealed mild mesangial hypercellularity and immunofluoroscense showed IgA dominant mesangial staining. Electron microscopy showed mesangial deposits. The constellation of symptoms and biopsy findings were consistent with an IgA Vasculitis, suspected to be associated with recent SARS-CoV-2 vaccination. The patient was treated with ace inhibition and sglt2 inhibition, resulting in reduction in proteinuria to less than 200 mg/g and preservation of renal function. The rash resolved with no additional intervention. Results: Development of abdominal pain, purpric rash and sub-nephrotic proteinuria after vaccination raises possibility that SARS-CoV-2 vaccination may have triggered as de-novo IgA vasculitis or, given the longstanding, unexplained microscopic hematuria, may have exacerbated a pre-existing, otherwise quiescent IgA nephropathy. Conclusion: In susceptible individuals, an aberrant immune response triggered by vaccination my result in production and deposition of galactose deficient-IgA1 in glomeruli, activating an inflammatory cascade leading to glomerular injury and possibly a systemic vasculitis. However, despite the temporal association, both a causative link between, and pathogenic mechanisms underlying SARS-CoV-2 vaccination and IgA vasculitis remain incompletely elucidated.; Sender's Comments: Based on the temporal relationship, the association between the events IgA vasculitis and excacerbation of pre-existing IgA nephropathy with BNT162b2 can not be fully 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.