Home/Recalls/CANADA-78102
Health CanadaGeneral Alert

Health Canada is updating the labels of the Janssen and Vaxzevria (AstraZeneca) ...

Published: November 9, 2021Recall ID: 78102Category: generalCountry: Canada

Reason for Recall / Hazard

Product safety - COVID

Product Description & Identification

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 bleedingunexplained bruisingsmall purplish spots beyond the site of vaccination shortness of breathchest painleg pain and/or swellingpersistent abdominal painTalk 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.

Affected Products

Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines

Additional Source Details

FieldValue
N I D78102
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/health-canada-updating-labels-janssen-and-vaxzevria-astrazeneca-covid-19-vaccines
IssueProduct safety - COVID
TitleHealth Canada is updating the labels of the Janssen and Vaxzevria (AstraZeneca) COVID-19 vaccines
ProductJanssen and Vaxzevria (AstraZeneca) COVID-19 vaccines
Archived0
CategoryBiologic or vaccine
Last updated2021-11-09
OrganizationCommunications and Public Affairs Branch
What you should doIf 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 bleedingunexplained bruisingsmall purplish spots beyond the site of vaccination shortness of breathchest painleg pain and/or swellingpersistent abdominal painTalk 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.

Overview

  • Recalling FirmCommunications and Public Affairs Branch
Official Agency Alert