BNT-162b1

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A 39-year-old man developed worsening of minimal change disease (MCD) and nephrotic syndrome following treatment with BNT162b1 for prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection).

The man had a history of biopsy-proven minimal change disease with nephrotic syndrome (at the age of one year). After 6 months of unspecified steroid treatment, he had no recurrence, and he had been on regular follow-up for 37 years. On current presentation, he presented with fatigue, weakness and lower limb oedema. Three days prior to the presentation, he received his first dose of vaccination with BNT162b1 [dosage and route not stated] for prevention of SARS-CoV-2 infection. After 8 days of vaccination, he admitted to the nephrology unit at a hospital in Italy with acute kidney injury, full-blown nephrotic syndrome, albuminaemia and generalised peripheral oedema. The other common causes (dehydration, nephrotoxic agents, autoimmune and infectious diseases) of renal failure were excluded. The abdominal ultrasonography was also found to be unremarkable. However, a renal biopsy confirmed the diagnosis of worsening of MCD and nephrotic syndrome secondary to the BNT162b1 vaccination.

The man was treated with prednisone. As a result, the clinical picture rapidly improved with complete regression of proteinuria. At the follow-up visit (at the end of therapy), his renal function was found to be normal. Subsequently, prednisone therapy was stopped after standard tapering. At the time of report, he had not received his second dose of vaccination. However, he had been vaccinated against seasonal influenza (split inactivated vaccine) 6 months previously with no associated side effects.