Tozinameran

Author Information

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

Author Information

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 34-year-old woman developed scleroderma renal crisis secondary to tozinameran vaccine.

The woman was referred to the nephrology department for acute kidney injury and hypertensive emergency. She had history of asthma with annual exacerbations, uncomplicated pregnancy, Raynaud phenomenon from the age of 18 years and an episode of pericarditis 5 years previously. One week prior to the admission, she had received injection of first dose of tozinameran [BNT162b2, by Pfizer; route and dosage not stated] vaccine. Twenty-four hours after the injection, she developed nausea and persistent headaches. Then, she developed acute vision loss. In the ophthalmic emergency ward evidence of stage I hypertensive retinopathy and high blood pressure were noted. Chest CT scan and brain MRI excluded posterior reversible encephalopathy syndrome, aortic dissection, pulmonary lesions and cerebral venous thrombosis. On admission, BP was 210/120mm Hg. Physical examination showed thickened skin on the face and the back of both hands, oral telangiectasia and wrist sclerodactyly. Laboratory tests showed acute kidney injury, thrombocytopenia, anemia, increased lacticodehydrogenase and under detected haptoglobin. ADAMTS 13 activity was noted to be 97%. Proteinuria was noted. Anti-RNA polymerase III antibodies were positive. SARS-CoV-2 anti-spike IgG antibody level was noted to be 475 AU/mL. Renal biopsy showed 50 glomeruli, including two globally sclerotic glomeruli, predominant medium size artery changes with mucoid intimal thickening leading to severe narrowing of the vascular lumen. Secondary ischemic glomerular changes were noted. On basis of clinical and biological findings, she was diagnosed with scleroderma renal crisis with preexisting diffuse cutaneous systemic sclerosis.

The woman was treated with unspecified ACE-inhibitors. One week after the initiation of ACE-inhibitors, she was discharged with normal BP, with sign of stable biological haemolysis and renal function. No second dose of the tozinameran vaccine was planned.