Four main COVID-19 vaccines are approved for use in Australia – Comirnaty (Pfizer), Spikevax (Moderna), Vaxzevria (AstraZeneca), and Nuvaxovid (Novavax). However, Vaxzevria (AstraZeneca) is no longer available. Bivalent vaccines for both mRNA vaccines are also registered in Australia. These cover the Omicron BA.1 and BA.4-5 variants. All of these COVID-19 vaccines have met the TGA’s high standards for quality, safety and effectiveness.
The TGA closely monitors reports of suspected side effects (also known as adverse events) to the COVID-19 vaccines. This is the most intensive safety monitoring ever conducted of any vaccines in Australia.
We encourage people to report suspected side effects, even if there’s only a very small chance a vaccine was the cause. Learn more about causality and our COVID-19 vaccine safety monitoring and reporting activities.
Summary
- Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination far outweigh the potential risks. Read the latest statement from medicine regulators around the world confirming the good safety profile of COVID-19 vaccines.
- Like all medicines, COVID-19 vaccines may cause some side effects. The most frequently reported include injection-site reactions (such as a sore arm) and more general symptoms, like headache, muscle pain, fever and chills. This reflects what was seen in the clinical trials.
- The most up-to-date recommendations for use of the COVID-19 vaccines are available from the Australian Technical Advisory Group on Immunisation (ATAGI).
- Reporting rates of adverse events following COVID-19 vaccination are very stable. More detail on vaccine safety in children, adolescents and adults following vaccination is available in a previous vaccine safety report.
- Reporting rates of myocarditis and pericarditis (inflammation of the heart or membrane around the heart) following vaccination are very stable. We will continue to monitor and review these adverse effects and will communicate any updated safety advice if needed.
- Myocarditis is reported in around 1-2 in every 100,000 people who receive Comirnaty (Pfizer), around 2 in every 100,000 of those who receive Spikevax (Moderna) and 3-4 in every 100,000 people who receive Nuvaxovid (Novavax). Detailed information about our analysis of myocarditis and pericarditis following vaccination with an mRNA vaccine or Nuvaxovid (Novavax) is available in a previous vaccine safety report.
- Similarly, our analyses of thrombosis with thrombocytopenia syndrome (TTS), Guillain-Barre syndrome (GBS) and immune thrombocytopenia (ITP) following the Vaxzevria (AstraZeneca) vaccine are available in a previous vaccine safety report. This vaccine is no longer available in Australia.
Total adverse event reports following immunisation to 3 September 2023
- 2.0
Reporting rate per 1,000 doses
- 139461
Total adverse event reports
- 68623071
Total doses administered
- 48848
Total reports for Vaxzevria
- 81848
Total reports for Comirnaty
- 7607
Total reports for Spikevax
- 1020
Total reports for Nuvaxovid
- 777
Total reports for brand not specified
Reported side effects for COVID-19 vaccines
The most frequently reported side effects suspected to be associated with the vaccines include headache, muscle pain, fever, fatigue and nausea. Skin reactions at the site of the injection are also common and can include pain, swelling, redness and an itchy rash. These are recognised side effects of vaccination and are usually transient and mild.
Vaccine safety in children and adolescents
The most up-to-date vaccine recommendations for children are available from ATAGI.
The TGA is closely monitoring adverse event reports in people aged under 18 years. Reporting rates of adverse events following COVID-19 vaccination, including those for children and adolescents, are very stable. More detail on vaccine safety in children and adolescents following vaccination is available in the safety report published on 15 December 2022.
Booster doses
The most up-to-date vaccine recommendations for booster doses are available from ATAGI.
The TGA continues to monitor the safety of booster vaccine doses in adults. A booster dose is an additional vaccine dose given after the primary vaccine course. In people who have recently had COVID-19, a 6-month interval is recommended before having their next scheduled dose.
Reporting rates of adverse events following booster doses are very stable. A small number of myocarditis and pericarditis cases have been reported for booster doses. We are closely monitoring these events. So far, reports of myocarditis after a booster dose are very rare, occurring in less than 1 in every 100,000 doses administered.
Information on vaccine safety following booster doses is available in the safety report published on 15 December 2022.
Reports of death in people who have been vaccinated
Vaccines can lead to death in extremely rare instances. However, most deaths that occur after vaccination are not caused by the vaccine. In large populations in which a new vaccine is given, there are people with underlying diseases who may die from these diseases. When a vaccine is given in that same population, the link between the vaccine and death is usually coincidental – not caused by the vaccine. These deaths are carefully reviewed to assess whether vaccines could be the cause and for the vast majority that is not the case.
