We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. Millions of people have received COVID-19 vaccines under the most intense safety monitoring ever conducted in Australia.
Two COVID-19 vaccines are currently in use in Australia – Vaxzevria (AstraZeneca) and Comirnaty (Pfizer). The Spikevax (Moderna) vaccine will also be available shortly. To be registered for use, these vaccines have met the TGA’s high standards for quality, safety and effectiveness.
Like all medicines, COVID-19 vaccines may have some side effects (also known as adverse events). The overwhelming majority of these side effects are mild and resolve within a few days. More serious side effects can occur after vaccination but are very rare.
The TGA closely monitors reports of suspected side effects and provides regular updates on vaccine safety in this report. Find out how the TGA identifies and responds to a safety concern.
Importantly, suspected adverse events reported to the TGA are often not caused by the vaccines. Learn more about causality and the TGA’s COVID-19 vaccine safety monitoring and reporting activities.
Summary
-
The protective benefits of vaccination against COVID-19 continue to far outweigh the potential risks of vaccination.
-
To 12 September 2021, approximately 22.8 million vaccine doses have been given in Australia – 14 million first doses and 8.8 million second doses.
-
The most frequently reported side effects suspected to be associated with the vaccines reflect what was seen in the clinical trials. They include injection-site reactions such as a sore arm, and more general symptoms such as headache, muscle pain, fever and chills.
-
We are closely monitoring rare reports of blood clots with low blood platelets (also called thrombosis with thrombocytopenia syndrome or TTS) linked to the Vaxzevria (AstraZeneca) vaccine.
-
In the last week, an additional 5 reports of blood clots and low blood platelets have been assessed as confirmed or probable TTS. None of these cases were fatal.
Reported side effects for COVID-19 vaccines
The most frequently reported side effects suspected to be associated with the vaccines reflect what was seen in the clinical trials. They include injection-site reactions such as a sore arm, and more general symptoms such as headache, muscle pain, fever and chills.
Large scale vaccination means that coincidentally some people will experience a new illness or die within a few days or weeks of vaccination.
The TGA reviews all deaths reported in people who have been vaccinated. As the number of vaccinated people has increased, so has reporting of fatal events with a coincidental association with vaccination. This does not indicate a link between vaccination and the fatalities reported. Review of individual reports and patterns of reporting does not suggest the vaccines played a role in these deaths.
Since the beginning of the vaccine rollout to 12 September 2021, over 22.8 million doses of COVID-19 vaccines have been given. So far, the TGA has found that 9 reports of deaths were linked to immunisation from 535 reports received and reviewed. These deaths occurred after the first dose of the Vaxzevria (AstraZeneca) vaccine – 8 were TTS cases and one was a case of immune thrombocytopenia (ITP). The overwhelming majority of deaths reported to the TGA following vaccination occurred in people aged 65 years and older.