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Three COVID-19 vaccines are currently in use in Australia – Comirnaty (Pfizer), Spikevax (Moderna) and Vaxzevria (AstraZeneca). These vaccines meet 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 intense safety monitoring ever conducted in Australia.
We encourage people to report suspected side effects, even if there’s only a very small chance a vaccine was the cause. This provides valuable data that helps us identify trends or spikes that might reveal potential safety issues. Often, however, these events are not caused by the vaccines. Learn more about causality and our COVID-19 vaccine safety monitoring and reporting activities.
Summary
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Vaccination against COVID-19 is the most effective way to reduce deaths and severe illness from infection. The protective benefits of vaccination continue to far outweigh the potential risks.
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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.
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We are carefully monitoring and reviewing reports of:
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myocarditis and pericarditis following mRNA vaccines, particularly in younger age groups
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thrombosis with thrombocytopenia syndrome (TTS) following Vaxzevria (AstraZeneca)
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Guillain-Barre Syndrome (GBS) following Vaxzevria (AstraZeneca)
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immune thrombocytopenia (ITP) following Vaxzevria (AstraZeneca)
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Myocarditis is a known but very rare side effect of Comirnaty (Pfizer) and Spikevax (Moderna). It is usually temporary with most people getting better within a few days. Myocarditis is reported in about one in of every 100,000 people who receive Comirnaty (Pfizer), although it is more common in young men and teenage boys after the second dose (3–7 cases per 100,000 doses).
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To 31 October 2021, the TGA has received 253 reports which have been assessed as likely to be myocarditis from about 21.9 million doses of Comirnaty (Pfizer). This is an increase of 18 cases of likely myocarditis since last week.
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Thrombosis with thrombocytopenia syndrome (or TTS) is a very rare but serious side effect of Vaxzevria (AstraZeneca). Our analysis shows it is reported in about 2 in every 100,000 people following vaccination, although the risk is slightly higher in people under 60 years. The risk of TTS is much lower after the second vaccine dose.
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One new case of TTS was reported this week, taking the total to 158 cases from about 13.1 million doses of Vaxzevria (AstraZeneca).
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