Reporting suspected side effects associated with a COVID-19 vaccine

This page provides information for consumers and health professionals on how to report suspected side effects (adverse events) associated with a COVID-19 vaccine.

Importance of reporting

Once a COVID-19 vaccine is approved, the Therapeutic Goods Administration (TGA) continues to monitor its safety and effectiveness. Australia has robust procedures to quickly detect and respond to vaccine safety concerns.

Vaccines, like any medication, can have side effects. Side effects to vaccines, if they occur, are usually minor and temporary. Common ones include low-level fever and pain or redness where the injection was given. More serious side effects, like allergic reactions, are very rare. You can find information about the possible side effects of COVID-19 vaccines on the Health Direct website or in the relevant Consumer Medicine Information for the specific vaccine.

If you are a consumer and are worried about a suspected side effect, seek advice from a health professional. If you or your doctor think a COVID-19 vaccine has caused a side effect, especially it is unexpected or significant, we encourage you to report it.

Every report is valuable, as they help to maintain and improve the safety of vaccines.

How to report

There are many ways to report, so you can pick the option that is best for you.

Report to your health professional

Consumers can report adverse events to their health professional and ask them to report on their behalf.

Report to your state or territory health department

Reports can be made directly to the relevant state or territory health department (see details below). Health professionals in NSW, Western Australia, Queensland, Northern Territory or ACT, are required under public health legislation to notify adverse events following immunisation to their state or territory health department. These reports are then submitted to the TGA and entered into our Adverse Event Management System (AEMS).

Report to the 1300 MEDICINE Adverse Medicine Events line

Consumers can make a report and obtain advice from a pharmacist by calling the 1300 MEDICINE Adverse Medicine Events line on 1300 633 424 (9am-5pm AET, Monday to Friday) or visit www.1300medicine.com.au.

Report directly to the TGA

Anyone can submit reports directly to the TGA. Visit www.tga.gov.au/reporting-problems for further details.

Sharing information

To make sure that stakeholders have the most up-to-date information on AEFIs occurring in Australia, the TGA meets weekly with Jurisdictional Immunisation Coordinators (JICs) from each state and territory, as well as representatives from the National Centre for Immunisation Research and Surveillance (NCIRS) and Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC). During these meetings, we discuss particularly serious or clinically significant AEFI reports and related information (such as the state or territory where the AEFI occurred and the age and gender of the patient).