Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Anti-glomerular basement membrane antibody negative, Antibody test negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Asthenia
Clinical narrative: Pauci-immune crescentic glomerulonephritis involving 40% of glomeruli with cellular crescents; Membranous nephropathy stage I/IV with PLA2R positive staining; Orange colored urine; Night sweats; Serum creatinine on presentation was 2.54 mg/dL / Serum creatinine rapidly increased to 6.53 mg/dL within one week; Generalized weakness; This Literature - Spontaneous case, initially received on 21-May-2024, was reported by a health professional and concerns an adult male patient.  This case report describes a case of an adult male patient with two de novo glomerulonephritides (GNs) following simultaneous SARS CoV-2 vaccine and influenza vaccine.  Past medical history included medical history of treated Human immunodeficiency virus (HIV) with undetectable viral load.  Administration of company suspect drug(s): On an unknown date, the patient received Influenza virus vaccine (brand not specified) for unreported Indication, Lot number: Not reported.  Non-company suspect drugs: On an unknown date, the patient received unspecified 'SARS CoV-2 vaccine', Indication: Not reported.  No additional suspect drugs.  Adverse reactions/events and outcomes:  On an unknown date, reported as 'one week after receiving SARS-CoV-2 vaccine along with influenza vaccine', the patient presented for evaluation of orange colored urine, night sweats and generalized weakness. Serum creatinine on presentation was 2.54 mg/dL (baseline of 0.89 mg/dL one month prior) and rapidly increased to 6.53 mg/dL within one week. Urinalysis demonstrated one to four course granular casts/low-power field (LPF), more than 50 red blood cells (RBC)/high-power field (HPF), more than 600 mg/dL protein with urine protein/creatinine ratio of 2.22 (unit not reported). Work-up demonstrated normal complement levels, negative antinuclear antibody (ANA), antineutrophil cytoplasmic antibodies (ANCA), anti-glomerular basement membrane antibody (anti-GBM), phospholipase A2 receptor (PLA2R) hepatitis panel. The patient underwent renal biopsy which was consistent with pauci-immune crescentic glomerulonephritis involving 40% of glomeruli with cellular crescents as well as membranous nephropathy stage I/IV with PLA2R positive staining. The patient was treated with pulse dose steroids along with cyclophosphamide with improvement in renal function. Following finding of positive PLA2R staining on kidney biopsy, the patient was later transitioned to rituximab and continued to have improvement in renal function. A diagnosis of de novo rather than relapsed disease was favoured given prior normal kidney function without proteinuria or hematuria. The pathologic features on biopsy suggested an early membranous lesion and cellular crescents and lack of significant tubulointerstitial fibrosis point to a new GN.   At the time of initial reporting, the patient was recovering from the events as treatment with steroids, cyclophosphamide, and rituximab showed improvement in renal function.   Non-drug treatment/Other action taken:  Influenza virus vaccine action taken: Not Applicable Treatment medication: Steroids, Cyclophosphamide, Rituximab   Reporter's assessment: The authors considered the events as related to combination of COVID and influenza vaccine. It was postulated that the added immunologic effect of combined COVID and influenza vaccines might have further provoked these two distinct glomerulonephritides. Membranous nephropathy with positive PLA2R staining on biopsy as well as pauci-immune crescentic GN have individually been described as rare complications associated with COVID immunization, however never concurrently. While GN associated with vaccines is rare, clinicians should be mindful of the potential risk.; Reporter's Comments: Causality for asthenia, increased blood creatinine, night sweats, chromaturia, membranous glomerulonephritis, and rapidly progressive glomerulonephritis is unassessable based on the information provided. The patient received a co-suspect SARS-CoV-2 vaccine a week before the onset of symptoms, alongside the suspect vaccine. Despite the plausible temporal relationship for both vaccines, the patient's pre-existing human immunodeficiency virus (HIV) condition complicates the clinical picture, making it difficult to attribute the symptoms directly to the suspect vaccine. Furthermore, membranous glomerulonephritis and rapidly progressive glomerulonephritis are rarely associated with vaccination. Additional information is required in order to make a definitive causality assessment.