Italian Medicines Agency Agenzia Italiana del Farmaco

COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia - COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia

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COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia

Summary

  • A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with COVID-19 Vaccine Janssen. A causal relationship with the vaccine is considered plausible. 
  • These cases occurred within the first three weeks following vaccination, and mostly in women under 60 years of age.
  • No specific risk factors have been identified at this stage.
  • Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia.
  • Those being vaccinated should be instructed to seek immediate medical attention if they develop symptoms of thromboembolism and, or thrombocytopenia following vaccination.
  • Thrombosis in combination with thrombocytopenia requires specialised clinical management.  Consult applicable guidance and/or specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.


Published on: 26 April 2021

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