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'.
COVID-19 vaccine safety reports
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.
Safety Alerts
A safety alert tells you about a possible risk or action you need to take for a health product. This alert doesn't always mean a medicine or medical device product is unsafe.
Find out more about Safety Alerts
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.
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.