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COVID-19 vaccine safety report - 07-09-2023

Published

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.

Report a suspected side effect

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 - external site 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

  • 1,952

    Total adverse event reports

  • 960,722

    Total doses administered

  • 683

    Total reports for Vaxzevria

  • 1,145

    Total reports for Comirnaty

  • 106

    Total reports for Spikevax

  • 14

    Total reports for Nuvaxovid

  • 10

    Total reports for brand not specified

Reported side effects for COVID-19 vaccines

Learn more about how the TGA identifies and responds to safety issues.

Anyone can report a suspected side effect, either:

You can report anonymously.

Learn more about how to report a suspected side effect to a COVID-19 vaccine.

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 - external site 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 - external site 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.

The TGA closely reviews all deaths reported in the days and weeks after COVID-19 vaccination. Read more about this process in a previous report. Since the beginning of the vaccine rollout to 3 September 2023, more than 68 million doses of COVID-19 vaccines have been given in Australia. The TGA has identified 14 reports where the cause of death was linked to vaccination from 997 reports received and reviewed. There have been no new vaccine-related deaths identified since 2022.

The 14 deaths likely to be related to vaccination occurred in people aged 21-81 years old. There have been no deaths in children or adolescents determined to be linked to COVID-19 vaccination. More detail on these deaths is available in the safety report published on 15 December 2022.

If we identify a new death likely to be related to vaccination, we will publish this information promptly, as we have for all other cases since the start of the vaccine roll-out.

Beware of vaccine misinformation

It is important when looking for information about COVID-19 vaccines to consider whether the source of the information is credible and trustworthy. Websites such as COVID vaccines - is it true? - external site and COVID-19 vaccines: Frequently asked questions - external site help to debunk false claims and misleading rumours.

Comirnaty (Pfizer) mRNA vaccines

The original Comirnaty (Pfizer) vaccine is provisionally approved for adults and children aged 5 years and over. Two bivalent vaccines are available from Pfizer for use as booster doses - Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5.

To 3 September 2023, more than 44 million doses have been administered in Australia, as well as more than 2.7 million doses of the bivalent booster vaccines.

The TGA continues to monitor reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines.

Rates of these side effects are very stable. Myocarditis is reported in around 1-2 in every 100,000 people who receive Comirnaty (Pfizer). More detail on our analysis of myocarditis and pericarditis following vaccination is available in a previous vaccine safety report.

Go to the Comirnaty (Pfizer) information page - external site to find out more about these vaccines.

Up-to-date information for Comirnaty (Pfizer), including details of potential side effects , can be found in the Consumer Medicine Information - external site (for consumers) and Product Information - external site (for health professionals).

Spikevax (Moderna) mRNA vaccines

The Spikevax vaccine is fully approved for adults and children aged 6 years and over. Two bivalent vaccines are available from Moderna for use as booster doses - Spikevax Original/Omicron BA.1 and Spikevax Original/Omicron BA.4-5 vaccine.

To 3 September 2023, more than 5 million doses have been administered in Australia, as well as more than 1.3 million doses of the bivalent booster vaccines.

The TGA continues to monitor reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines.

Rates of these side effects are very stable. Myocarditis is reported in around 2 in every 100,000 of those who receive Spikevax (Moderna). More detail on our analysis of myocarditis and pericarditis following vaccination is available in a previous vaccine safety report.

Go to the Spikevax (Moderna) information page - external site to find out more about these vaccines.

Up-to-date information for Spikevax (Moderna), including details of potential side effects, can be found in the Consumer Medicine Information - external site (for consumers) and Product Information - external site (for health professionals).

Nuvaxovid (Novavax) vaccine

The Nuvaxovid (Novavax) vaccine is provisionally approved for adults. To 3 September 2023, almost 266,000 doses of Nuvaxovid (Novavax) have been administered in Australia.

The TGA continues to monitor reports of myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) following vaccination.

Rates of these side effects are very stable. Myocarditis is reported in around 3-4 in every 100,000 people who receive the Nuvaxovid (Novavax) vaccine. More detail on our analysis of myocarditis and pericarditis following vaccination with Nuvaxovid (Novavax) is available in a previous vaccine safety report.

Go to the Nuvaxovid (Novavax) information page - external site to find out more about this vaccine.

More information for Nuvaxovid (Novavax), including details about its ingredients and potential side effects, can be found in the Consumer Medicine Information - external site (for consumers) and Product Information - external site (for health professionals).

Vaxzevria (AstraZeneca) vaccine

The Vaxzevria (AstraZeneca) vaccine is no longer available for use in Australia. Almost 14 million doses of Vaxzevria (AstraZeneca) were administered when it was in use.

Go to the Vaxzevria (AstraZeneca) information page - external site to find out more about this vaccine.

More general information for Vaxzevria (AstraZeneca), including details of potential side effects can be found in the Consumer Medicine Information - external site (for consumers) and Product Information - external site (for health professionals).

Watch this video to find out how the TGA monitors and reports the safety of COVID-19 vaccines - external site

COVID-19 vaccines: Frequently asked questions - 26 July 2023 - external site

COVID vaccines - is it true? - 8 May 2023 - external site

ATAGI clinical recommendations for COVID-19 vaccines in Australia - 24 August 2023 - external site

Latest advice on COVID-19 vaccination for pregnant and breastfeeding women - external site

TGA COVID-19 vaccines hub

Australian Government Department of Health COVID-19 vaccines hub - external site

COVID vaccine information in your language - external site

Database of Adverse Event Notifications (DAEN)

AusVaxSafety - a national survey on COVID-19 vaccine safety - external site

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