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COVID-19 vaccine safety monitoring and reporting

9 February 2021

The Therapeutic Goods Administration (TGA) is responsible for monitoring the safety of all vaccines approved for use in Australia. We closely assess safety data prior to approval, and continue to monitor the safety of vaccines after they are registered in Australia so that we can detect and respond to any safety concerns. This is known as 'pharmacovigilance'.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Understand potential side effects from COVID-19 vaccines

Like other medicines, all vaccines can cause side effects. Most side effects are mild and temporary (lasting 1 or 2 days). Common side effects include low-level fever and pain or redness where the injection was given.

Even when the suspected side effect is serious, it is possible - even likely - that it may not have been caused by the vaccine. The timing may be coincidental. There is an expected 'background rate' of coincidental adverse events. This is why the TGA investigates the reports it receives to determine if there is a genuine safety concern related to the vaccine.

If you have any questions or concerns about potential side effects of COVID-19 vaccines, please speak to your doctor.

For further information, visit the Health Direct website.

Reporting suspected side effects

If you think you may be experiencing a significant side effect (also known as an adverse event) to a COVID-19 vaccine, you should seek advice from your doctor.

The TGA encourages health professionals and consumers to report suspected side effects following immunisation with COVID-19 vaccines. Every report is valuable and contributes to our safety monitoring.

Further information about how to report suspected side effects to a COVID-19 vaccine.

COVID-19 vaccine safety updates

The TGA will be open and transparent about safety information relating to COVID-19 vaccines, including any suspected side effects or potential safety issues.

We will be publishing a regular safety report, including information about reported suspected side effects, as well as other safety alerts as required.

Find out more about how we will be communicating COVID-19 safety information.

Australia's vaccine safety monitoring system

The TGA's safety monitoring processes for vaccines are robust and well established. They include collaboration with Australian stakeholders, including state and territory health departments and professional bodies, and international regulators. This enables us to rapidly detect, investigate and respond to any emerging safety issues.

Find out more about how we are monitoring the safety of COVID-19 vaccines.

Enhanced monitoring for COVID-19 vaccines

We are further enhancing the TGA vaccine safety monitoring system so that we can rapidly detect, investigate and respond to any emerging safety issues related to COVID-19 vaccines.

COVID-19 vaccine safety monitoring plan
9 February 2021
The plan outlines five key strategies to strengthen Australia's vaccine vigilance system.