Sex: M
Vaccine: COVID19
Symptoms: Respiratory rate, SARS-CoV-2 test, Treponema test, Ultrasound abdomen, Urine albumin/creatinine ratio
Clinical narrative: Nephrotic syndrome/ longstanding minimal change disease which shows exacerbation following a third dose of an mRNA vaccine for SARS-CoV-2; Nephrotic syndrome/ longstanding minimal change disease which shows exacerbation following a third dose of an mRNA vaccine for SARS-CoV-2; This is a literature report for the following literature source(s).  A 33-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "smoking" (not ongoing), notes: quit about 22 months prior to his symptoms; "alcohol use" (ongoing); "denied any illicit drug use" (unspecified if ongoing); "tobacco use" (ongoing); "Minimal Change Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: GLOMERULONEPHRITIS MINIMAL LESION (medically significant), CONDITION AGGRAVATED (medically significant), all with latency 10 days after the suspect product(s) administration, outcome "recovered" and all described as "Nephrotic syndrome/ longstanding minimal change disease which shows exacerbation following a third dose of an mRNA vaccine for SARS-CoV-2". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: Provided no significant findings; Provided no significant findings; Antinuclear antibody: Provided no significant findings; Antiphospholipid antibodies: Provided no significant findings; Biopsy: compatible with a diffuse, notes: podocytopathy with a minimal change disease phenotype and provided an anatomic etiology for the nephrotic syndrome. The low grade mesangial deposits likely were latent IgA deposits or possibly a very low-grade IgA nephropathy, and provided an anatomic explanation for the hematuria. The presence of a delicate punctate IgG podocyte staining pattern raised the possibility of anti nephrin antibodies as the mechanism of podocyte injury (commercial serologic testing for confirmation is currently unavailable); Biopsy kidney: showed a cortex containing, notes: 33 glomeruli (3 globally sclerotic). The glomeruli were normal by light microscopy, without lesions of segmental sclerosis.There was minimal acute tubular epithelial cell injury and minimal interstitial fibrosis/tubular atrophy (<5%).There was no interstitial inflammation. Arteries and arterioles were unremarkable; Blood albumin: 2.2 g/dl; Blood creatinine: 0.85 mg/dl; Blood pressure measurement: 167/107 mmHg; Blood urea: 14 mg/dl; Body mass index: 32.56, notes: unit: kg/m2; Body temperature: 36.7 Centigrade; Complement factor: Provided no significant findings; Creatinine urine: 0.8 mg/dl, notes: in 4 weeks; Heart rate: 95, notes: unit: bpm; Hepatitis viral test: Provided no significant findings; HIV test: Provided no significant findings; Immunology test: Provided no significant findings; were significant for diffuse global weak, notes: punctate IgG, kappa and lambda podocyte cytoplasmic staining, and low-grade segmental granular mesangial staining for IgA (1+), IgM (1-2+), C3 (1+), and kappa and lambda light chains (both trace); Microscopy: demonstrated complete podocyte foot process, notes: effacement associated with variable microvillous transformation of podocytes, as well as small electron-dense deposits in segmental mesangial regions. There were no tubuloreticular inclusions. No deposits displayed any substructure; Oxygen saturation: 96 %, notes: on room air; physical examination: consistent with bilateral lower extremity edema.; Protein total: 5.2 g/dl; Protein urine: 7.5 g; Renal function test: Normal, notes: in 4 weeks; Respiratory rate: 18, notes: unit: bpm; SARS-CoV-2 test: Provided no significant findings; Treponema test: Provided no significant findings; Ultrasound abdomen: confirmed mildly hyperechoic kidneys,, notes: suggestive of mild renal parenchymal disease, with no hydronephrosis, and a small non-obstructing right renal calculus; Urine albumin/creatinine ratio: less than 30; Urine analysis: showed 3+ protein and 1+ blood; Urine protein/creatinine ratio: 9.3, notes: unit: g/g; 1.8, notes: unit: g/g, After 24 weeks of remission, the disease relapsed with increasing UPC; 0.2, notes: unit: g/g, in 4 weeks; Viral test: Provided no significant findings. Therapeutic measures were taken as a result of glomerulonephritis minimal lesion, condition aggravated  Clinical information: The patient with a past medical history of nephrotic syndrome at age 11 presented to our clinic with bilateral lower extremity swelling and frothy urine 10 days after receiving his third dose of the BNT162b2 mRNA COVID-19 vaccine. The patient had mild edema in the bilateral lower extremities and sacrum. He also reported bilateral leg numbness and lower back pain. He had no recent history of trauma or falls, and no bowel or bladder incontinence was noted. He ambulated safely and had no recent changes in urine output. He reported no fevers or chills, nausea, vomiting, chest pain, shortness of breath, or abdominal pain, and had no prior history of similar symptoms. He had no recent travel history, no sick contacts, and no family history of autoimmune disease, coagulopathy, or neurologic disorders. The patient quit smoking about 22 months prior to his symptoms, with his current tobacco use limited to chewing. He also reported current alcohol use and denied any illicit drug use. He was not taking any prescription or over-the-counter medications and had no history of nonsteroidal anti-inflammatory drug use. The patient was started on 80 mg oral prednisone, which led to complete remission of disease in 4 weeks, with improvement of leg swelling and resolution of proteinuria. The dosage was tapered from 80 mg (47 days) to 60 mg (30 days), 40 mg (7 days), 30 mg (7 days), 20 mg (10 days), 10 mg (45 days), and 5 mg (60 days), and it was discontinued over the course of 28 weeks. After 24 weeks of remission, the disease relapsed, with UPC increasing to 1.8 g/g; therefore, he was restarted on 60 mg of prednisone. Remission was achieved in 4 weeks with Alb/Cr <30 mg/g, UPC of 0.2 g/g, and normal kidney function with Cr=0.8 mg/dl in 4 weeks. Prednisone was tapered within 2 months after achieving remission with resolution of proteinuria and complete remission to normal kidney function. Treatment was tapered off over the course of 28 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between  the events Glomerulonephritis minimal lesion and condition aggravated and the use of suspect product cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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