Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood albumin, Condition aggravated, IgA nephropathy, Investigation
Clinical narrative: De novo IgA Nephropathy Following mRNA COVID-19 Vaccine; recurrent GH and SNRP; This is a literature report for the following literature source(s):  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster dose), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1 SINGLE), for COVID-19 vaccination, reaction(s): "mild COVID-19 infection", "mild COVID-19 infection", "De novo IgA Nephropathy Following mRNA COVID-19 Vaccine"; Bnt162b2 (DOSE 2 SINGLE/asymptomatic SNRP), for COVID-19 vaccination, reaction(s): "mild COVID-19 infection"; Bnt162b2 (DOSE 2 SINGLE /asymptomatic GH), for COVID-19 vaccination, reaction(s): "mild COVID-19 infection"; Bnt162b2 (DOSE 2 SINGLE), for COVID-19 vaccination, reaction(s): "asymptomatic GH (gross hematuria)/ sub-nephrotic range proteinuria (SNRP)", "IgA Nephropathy". The following information was reported: IGA NEPHROPATHY (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "De novo IgA Nephropathy Following mRNA COVID-19 Vaccine"; CONDITION AGGRAVATED (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "recurrent GH and SNRP". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed IgAN; Blood albumin: Normal; kidney function: Normal; M1E0S1T0C0; Laboratory studies: showed normal kidney function and serum albumin; Microscopy: continued to have persistent microscopic hematuria; Protein urine: continued to have subnephrotic proteinuria; Protein urine: 976 mg/24h; 2063 mg/24h, notes: Increased 2 days after the booster vaccine; Rheumatological examination: Negative; Urine analysis: revealed proteinuria, dysmorphic red blood cells, notes: and rare granular casts; Urine protein/creatinine ratio: 14, notes: Unit: g/g. Therapeutic measures were taken as a result of iga nephropathy.  Case article: A 23-year-old female with recent mild COVID-19 infection developed asymptomatic GH with SNRP 2 days after receiving the first and the second dose of Pfizer-BioNTech vaccine. Laboratory studies showed normal kidney function and serum albumin. Negative rheumatologic workup. Urinalysis revealed proteinuria, dysmorphic red blood cells, and rare granular casts. Urine protein-creatinine ratio (UPr/Cr) was 1,4g/g. Within 1 week the GH self-resolved, however, she continued to have persistent microscopic hematuria and sub nephrotic proteinuria. Kidney biopsy showed IgAN. The Oxford MEST-C score was M1E0S1T0C0. She was started on Lisinopril. Upr was 976mg/24h. Subsequently, 2 days after the booster vaccine she developed GH, Upr increased to 2063mg/24h and was started on Dapagliflozin. This is the first reported case of de novo IgAN following each dose of COVID-19 vaccine and booster presenting with recurrent GH and SNRP. This case illustrates the need and whether we should use non-mRNA or a different vaccine schedule in this vulnerable population. The new-onset and recurrence of GH shortly after the COVID-19 vaccines suggests a potential association with the development of IgAN and relapses. Further studies are needed to understand the pathophysiology of the vaccine-associated glomerular diseases, optimize vaccine strategies and guide optimal therapeutic management.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely 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. Linked Report(s) : PFIZER INC-PV202200130613 Same article/event/drug/patient.