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

Immune thrombocytopenia (ITP):

• Cases of ITP, some with very low platelet levels (<20,000 per μL), have been reported very rarely, usually within the first four weeks after receiving COVID-19 Vaccine Janssen. This included cases with bleeding and cases with a fatal outcome. Some of these occurred in individuals with a history of ITP. 
• If an individual has a history of ITP, the risks of developing low platelet levels should be considered before vaccination, and platelet monitoring is recommended after vaccination.
• Individuals should be alert to signs and symptoms of ITP, such as spontaneous bleeding, bruising or petechiae.
• Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with COVID-19 Vaccine Janssen should be actively investigated for signs of thrombosis to assess a potential diagnosis of thrombosis with thrombocytopenia syndrome (TTS) that requires specialised clinical management.

Venous thromboembolism (VTE):

• Venous thromboembolism has been observed rarely following vaccination with COVID-19 Vaccine Janssen.
• The risk of VTE should be considered for individuals with increased risk for thromboembolism.
• Healthcare professionals should be alert to the signs and symptoms of VTE. Those vaccinated should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg pain, leg swelling, or persistent abdominal pain following vaccination.
• Individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia to assess a potential diagnosis of thrombosis with thrombocytopenia syndrome (TTS) that requires specialised clinical management.