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Health Canada is updating the labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines

Issued November 9, 2021
Issue
Health Canada is informing Canadians and healthcare professionals about changes to the product labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines. The Department is updating the label of the Janssen COVID-19 Vaccine to provide additional information about the very rare risk of immune thrombocytopenia (ITP), an autoimmune condition, and the rare risk of venous thromboembolism (VTE) following vaccination. Health Canada is also updating the label of the Vaxzevria (AstraZeneca) COVID-19 vaccine to provide additional information about the very rare risk of thrombocytopenia, including the very rare risk of ITP, following vaccination.
Hazard description
Product safety - COVID
What to do
If you have received the Janssen or Vaxzevria COVID-19 vaccine: Seek prompt medical attention immediately if you have any of the following symptoms after vaccination: unexplained bleeding unexplained bruising small purplish spots beyond the site of vaccination shortness of breath chest pain leg pain and/or swelling persistent abdominal pain Talk to your healthcare professional if you have any questions about the Janssen or Vaxzevria COVID-19 vaccines. Report any adverse events after immunization to your healthcare professional. If you are a healthcare professional: Be alert to the signs and symptoms of thromboembolism and thrombocytopenia to promptly treat these conditions according to available evidence and clinical guidelines . Inform people receiving the vaccine to seek medical attention if they develop any of the following symptoms: ITP symptoms include spontaneous bleeding, unusual bruising or small red, purple or brown spots that appear under the skin. VTE symptoms include shortness of breath, chest pain, leg pain, leg swelling, or persistent abdominal pain following vaccination. Consider consultation with a specialist if you suspect the patient has post-vaccine thrombosis. If an individual has a history of a thrombocytopenic disorder, such as immune thrombocytopenia, the risk of developing low platelet levels should be considered before administering the vaccine and platelet monitoring is recommended after vaccination.
Product
Product name
Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines
Reference
ID
RA-78102