Specific clotting condition reported after COVID-19 vaccination

On behalf of the Australian Government Department of Health, please find below statements published regarding a specific clotting condition being reported after COVID-19 vaccination:

Acting Chief Medical Officer and Head of the TGA

Joint statement from acting Australian Government Chief Medical Officer, Professor Michael Kidd and Head of the Therapeutic Goods Administration Adj. Professor John Skerritt.

ATAGI statement for health providers

The Australian Technical Advisory Group on Immunisation (ATAGI) released a statement to support health professionals in responding to any instances of clotting disorders following vaccine administration. This provides more information on clinical management and raises awareness of the potential for this condition.

Summary of current recommendations

• Rare cases of thrombosis associated with thrombocytopenia were reported following administration of COVID-19 Vaccine AstraZeneca overseas.
• The onset of reported cases was between 4 to 20 days after vaccination.
• Providers should be aware of warning signs of a severe condition associated with thrombosis and thrombocytopenia. This has presented as either central venous sinus thrombosis (CVST) or thrombosis in other sites, such as intra-abdominal venous systems. CVST may present as a new onset persistent headache not settling with analgesia, features of raised intracranial pressure (including acute severe headache, vomiting, confusion), focal neurological deficits, and/or seizures.
• If CVST or another severe thrombotic complication with thrombocytopenia is suspected in a patient who has received COVID-19 Vaccine AstraZeneca, refer them to an emergency department for further assessment and haematology consultation.
• Clinical investigations should include a full blood count (to look for thrombocytopenia), a D-dimer test and radiological imaging.
• Patients suspected to have this condition should NOT receive any heparin or platelet transfusions.
• The TGA has received one report of a case of thrombosis and thrombocytopenia following COVID-19 Vaccine AstraZeneca in Australia. The clinical details of this case are currently under review by the TGA.

ATAGI statement for consumers

A statement from ATAGI for consumers on a specific clotting condition being reported after COVID-19 vaccination.

Additional statement from ATAGI statement

An ATAGI statement on COVID-19 vaccination and a reported case of thrombosis.

TGA statement

The TGA's assessment is that the benefits of vaccination against COVID-19 continue to outweigh any risks.

Useful documents

The Australian Government Department of Health revised the four documents below on 4 April 2021, with updates from ATAGI regarding a specific clotting condition:

• Provider guide for obtaining informed consent
• Consent form for COVID-19 vaccination
• Consumer information on the AstraZeneca vaccine
• Information for after your AstraZeneca vaccine