Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Blood pressure measurement, C-reactive protein, Cardiolipin antibody
Clinical narrative: developed cSLE with class V lupus nephritis two days after SARS-CoV-2 mRNA Pfizer-BioNTech vaccination; developed cSLE with class V lupus nephritis two days after SARS-CoV-2 mRNA Pfizer-BioNTech vaccination; The initial case was missing the following minimum criteria: [Unspecified product]. Upon receipt of follow-up information on (28Dec2022), this case now contains all required information to be considered valid.  This is a literature report for the following literature source(s):   A 14-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant, life threatening), 2 days after the suspect product(s) administration, outcome "recovering", LUPUS NEPHRITIS (medically significant, life threatening), outcome "recovering" and all described as "developed cSLE with class V lupus nephritis two days after SARS-CoV-2 mRNA Pfizer-BioNTech vaccination". The patient underwent the following laboratory tests and procedures: Angioscopy: had capillary loop dilatation; Antibody test (normal high range 1.0): 2.7, notes: found to be high-titer positive; Antinuclear antibody: Positive, notes: ANA 1:80 titer, nuclear speckled pattern; Positive, notes: with a titer of 1:1280 (nuclear speckled pattern) and positive anti-dsDNA, anti-Smith, anti-RNP, and anti-Ro antibodies; Positive; Positive; Antiphospholipid antibodies: Negative; Autoantibody test: Positive, notes: against double-stranded deoxyribonucleic acid (dsDNA), Ro, Smith and ribonucleoprotein (RNP); Beta-2 glycoprotein antibody: Negative; Biopsy kidney: revealed class V lupus nephritis; Blood albumin: 2.6 g/dl, notes: hypoalbuminemia; Blood creatinine: 0.46 mg/dl; Blood immunoglobulin A: Positive; Blood immunoglobulin G (500-1590): 1806 mg/dl, notes: elevated; Blood immunoglobulin M: Positive; Blood pressure measurement: 115/63, notes: which is mildly elevated for age, sex and height; Cardiolipin antibody: Negative; Chest X-ray: normal; Complement factor C1: Positive; Complement factor C3: Positive; Coombs direct test: Negative; C-reactive protein: normal; Double stranded DNA antibody: Positive; Echocardiogram: normal; Glomerular filtration rate: 155, notes: unit: ml/min/1.73 m2; Haemoglobin: 14.1 g/dl; Immunology test: demonstrated full house staining, notes: he was  positive for IgA, IgG, IgM, C3, and C1q; anti-Smith: Positive; Microscopy: revealed numerous subepithelial immune, notes: complex deposits with minimal basement membrane remodeling and extensive foot process effacement; glomeruli had a mild increase in, notes: mesangial matrix and cells; the basement membranes  appeared intact; physical exam: Positive, notes: positive physical exam findings included arthritis of bilateral elbows, palatal erythema, maculopapular malar rash on face with fat, violaceous lesions on extremities; Platelet count: 140000 /mm3; Red blood cell sedimentation rate: elevated; 126, notes: elevated unit: mm/hour; Urine analysis: had 3 plus protein, notes: and no red blood cells; Urine protein/creatinine ratio (normal high range 0.2): 13.5, notes: unit: mg/mg; 0.8, notes: improved unit: mg/mg; White blood cell count: 3500 /mm3, notes: leucopenia. Therapeutic measures were taken as a result of systemic lupus erythematosus, lupus nephritis.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "SYSTEMIC LUPUS ERYTHEMATOSUS " and "LUPUS NEPHRITIS ". The impact of this report on the benefit/risk profile of the Pfizer drug 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.