Sex: F
Vaccine: COVID19
Symptoms: Renal function test, Rheumatological examination, Urinary casts, Urine analysis, Urine protein/creatinine ratio
Clinical narrative: mild COVID-19 infection; mild COVID-19 infection; De novo IgA Nephropathy Following mRNA COVID-19 Vaccine; This is a literature report.  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "mild COVID-19 infection". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed IgAN; Blood albumin: Normal; MEST-C score: 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; Red blood cells urine: dysmorphic; Renal function test: Normal; Rheumatological examination: Negative; Urinary casts: rare; Urine analysis: revealed proteinuria, dysmorphic red blood cells, notes: and rare granular casts; Urine protein/creatinine ratio: 1.4, notes: Unit: g/g. Therapeutic measures were taken as a result of iga nephropathy.  Clinical course: A 23-year-old White 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 for pharmacovigilance 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) : US-PFIZER INC-202201393053 Same article/event/drug/patient; Different Dose;US-PFIZER INC-202201393052 Same article/event/drug/patient; Different Dose;