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Publication Type: Safety Information
Single or Multiple Incident: Multiple
Date: 5/23/2021 12:00:00 AM
Country: Australia

This Safety Information alert addresses the need to report adverse events following immunization with vaccines to prevent COVID-19. Serious adverse events following immunisation include any illness that: • results in death • is life threatening • requires hospitalisation • results in persistent or significant disability or incapacity • is an unexpected reaction for that vaccine. Any serious adverse event following any immunisation is notifiable. NSW Health provides these reports to the TGA. The alert provides resources and guidelines for assessment of possible thrombosis with thrombocytopenia syndrome after COVID-19 immunisation, reporting and investigating anaphylaxis after COVID-19 immunisation, and reporting other serious conditions. A flow chart providing guidance on reporting of adverse events following COVID-19 vaccination is provided as are suggested actions to address this issue. In addition, contraindications and precautions to immunization with COVID-19 vaccines are provided.

Additional Details

Medication/Gas/Fluid:
vaccine, Astra Zeneca COVID-19 Vaccine, Pfizer COMINARTY® Vaccine


Reporting Adverse Events Following Immunisation