The Italian Medicines Agency would like to inform you of the following:

• Very rare cases of capillary leak syndrome (CLS) have been reported in the first days after vaccination with Vaxzevria. A history of CLS was apparent in some of the cases. A fatal outcome has been reported.
• Vaxzevria is now contraindicated in individuals who have previously experienced episodes of CLS.

CLS is characterised by acute episodes of oedema mainly affecting the limbs, hypotension, haemoconcentration and hypoalbuminaemia. Patients with an acute episode of CLS following vaccination require prompt recognition and treatment. Intensive supportive therapy is usually warranted.