COVID-19 vaccine safety report - 20-04-23

Published

20 April 2023

Four main COVID-19 vaccines are provisionally approved for use in Australia – Comirnaty (Pfizer), Spikevax (Moderna), Vaxzevria (AstraZeneca), and Nuvaxovid (Novavax). However, Vaxzevria (AstraZeneca) is not currently available, as existing batches have expired. Bivalent vaccines for both mRNA vaccines are also now 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.
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 the safety report published on 15 December 2022.
We are carefully monitoring and reviewing reports of myocarditis and pericarditis (inflammation of the heart or membrane around the heart) following vaccination. These are usually temporary conditions, with most people getting better within a few days.
Myocarditis is a known but very rare side effect of the mRNA vaccines. It is reported in around 1-2 in every 100,000 people who receive Comirnaty (Pfizer) and around 2 in every 100,000 of those who receive Spikevax (Moderna). It occurs in males and females but is more common after the second dose in boys aged 12-17 years (13 cases per 100,000 Comirnaty doses and 24 cases per 100,000 Spikevax doses) and men under 30 (9 cases per 100,000 Comirnaty doses and 20 cases per 100,000 Spikevax doses).
We are also closely monitoring reports of thrombosis with thrombocytopenia syndrome (TTS), Guillain-Barre syndrome (GBS) and immune thrombocytopenia (ITP) following Vaxzevria (AstraZeneca) in adults. However, since the end of 2021 very few doses of this vaccine are being used. Detailed information of our analysis of these adverse effects is available in a previous vaccine safety report.

Total adverse event reports following immunisation to 16 April 2023

2.1
Reporting rate per 1,000 doses
138307
Total adverse event reports
65991753
Total doses administered
48773
Total reports for Vaxzevria
81448
Total reports for Comirnaty
7508
Total reports for Spikevax
998
Total reports for Nuvaxovid
752
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:

directly to the TGA
through a health professional
by calling 1300 Medicine (1300 633 424) or visiting www.1300medicine.com.au.

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 and joint pain, fever, chills 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 3-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. This is a recognised risk with the Comirnaty (Pfizer) and Spikevax (Moderna) vaccines and 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 16 April 2023, nearly 66 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 985 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 in a vaccine safety report, 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? and COVID-19 vaccines: Frequently asked questions 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 is approved for adults and Comirnaty Original/Omicron BA.4-5 is approved for those aged 12 years and over.

To 16 April 2023, more than 44 million doses have been administered in Australia, as well as about 951,000 doses of the bivalent booster vaccines.

The TGA is actively investigating reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines. We continue to work with international regulators on this safety signal. See below for reporting rates of myocarditis and pericarditis associated with the Comirnaty (Pfizer) vaccines.

Go to the Comirnaty (Pfizer) information page 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 (for consumers) and Product Information (for health professionals).

Spikevax (Moderna) mRNA vaccines

The original Spikevax vaccine is provisionally approved for adults and children aged 6 years and over. A paediatric formulation of the original vaccine is available for children aged from 6 months to 5 years (or less than 6 years). Two bivalent vaccines are available from Moderna for use as booster doses – Spikevax Original/Omicron BA.1 is approved for adults and Spikevax Original/Omicron BA.4-5 vaccine is approved for those aged 12 years and over.

To 16 April 2023, more than 5 million doses have been administered in Australia, as well as about 632,000 doses of the bivalent booster vaccines.

The TGA is actively investigating reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines. We continue to work with international regulators on this safety signal. See below for reporting rates of myocarditis and pericarditis associated with the Spikevax (Moderna) vaccine.

Go to the Spikevax (Moderna) information page 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 (for consumers) and Product Information (for health professionals).

Nuvaxovid (Novavax) vaccine

The Nuvaxovid (Novavax) vaccine is provisionally approved for adults. To 16 April 2023, more than 251,000 doses of Nuvaxovid (Novavax) have been administered in Australia.

The TGA is actively investigating reports of myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) following vaccination.

Myocarditis is reported in around 3-4 in every 100,000 doses of Nuvaxovid. Overall, pericarditis is reported in 13 in every 100,000 doses but is more common in men aged 18-49 years (estimated at 27 per 100,000* doses).

To date, there have only been about 2,000 Nuvaxovid doses administered in people aged 12-17 years and no adverse events following immunisation have been reported.

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

* This reporting rate for pericarditis is less certain than for Comirnaty and Spikevax vaccines due to the low number of Nuvaxovid vaccine doses given.

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

Vaxzevria (AstraZeneca) vaccine

The Vaxzevria (AstraZeneca) vaccine is provisionally approved for adults, however it is not currently available for use as existing batches have expired. To 16 April 2023, just under 14 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. Very few doses of this vaccine have been used since 2021.

Update to the Product Information

The Product Information (Section 4.8) for Vaxzevria (AstraZeneca) has been updated to include decreased appetite as a potential adverse reaction.

Go to the Vaxzevria (AstraZeneca) information page 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 (for consumers) and Product Information (for health professionals).

Myocarditis and pericarditis after COVID-19 vaccination

Myocarditis and pericarditis have been reported for the mRNA vaccines and Nuvaxovid (Novavax) vaccine. For more details about what these adverse effects are, their severity and what symptoms to look out for, please refer to the vaccine safety report published on 15 December 2022.

ATAGI continues to emphasise that the protective benefits of the vaccines far outweigh the rare risk of these side effects.

ATAGI has advised that people who have had suspected vaccine-related myocarditis or pericarditis should defer further COVID-19 vaccine doses until at least 6 weeks after their symptoms have resolved. They should also discuss future vaccine doses with their treating doctor. Refer to expert Guidance on myocarditis and pericarditis after COVID-19 vaccines for more information.

What does the TGA know about myocarditis and pericarditis in Australia?

Reports of suspected myocarditis and pericarditis received by the TGA have been reviewed against internationally accepted criteria to classify if they are likely to be related to vaccination.

Tables 1–3 summarise the most up-to-date reporting rates of likely myocarditis and pericarditis for the mRNA vaccines to the 2 April 2023. Rates for the Nuvaxovid (Novavax) vaccine are given above.

Reporting rates of likely myocarditis

Table 1. Rates of likely myocarditis cases following Comirnaty (Pfizer)‡
Age (years)	All doses		Second doses
	*Rate per 100,000 doses**		*Rate per 100,000 doses**
		Male	Female	Male	Female
5-11	0.3	0.1	0.2	0
12-17	8.1	1.7	13.2	2.8
18-29	5.1	1.6	9.3	2.9
30-39	2.4	0.9	3.2	1.0
40-49	1.0	1.0	1.5	1.9
50-59	0.8	0.4	0.8	0.4
60-69	0.4	0.3	0.4	0.4
70+	0.1	0.3	0	0.4
All ages*	2.4	0.9	4.8	1.6

Table 2. Rates of likely myocarditis cases following Spikevax (Moderna) †
Age (years)	All doses		Second doses
	*Rate per 100,000 doses**		*Rate per 100,000 doses**
		Male	Female	Male	Female
12-17	12.1	2.9	23.6	5.0
18-29	9.8	1.7	20.2	4.7
30-39	3.3	0.7	5.0	0
40-49	1.7	1.1	3.2	2.0
50-59	0.9	1.5	2.0	2.5
60-69	0	0.2	0	0
70+	0.1	0.1	0	0
All ages*	3.2	1.0	11.2	2.6

Notes for Table 1 and Table 2

* The rate includes cases of myocarditis that occurred after vaccination but may not be vaccine related.

‡ To 16 April 2023, from about 2.4 million vaccine doses given, 4 likely cases of myocarditis have been reported in children aged 5-11 years following vaccination with Comirnaty (Pfizer).

† The rates for Spikevax (Moderna) are less certain due to low numbers of cases overall and small changes in case number can lead to fluctuations in the rates for different groups.

Reporting rates of likely pericarditis

Table 3. Rates of likely pericarditis cases following the mRNA vaccines
Age (years)
	*Rate per 100,000 doses**
		Comirnaty (Pfizer)	Spikevax (Moderna)
5-11‡	0.3	-
12-17	2.4	2.3
18-29	4.4	5.3
30-39	4.5	5.0
40-49	2.9	2.9
50-59	1.7	1.4
60-69	0.8	0.4
70+	0.2	0.2
All ages*	2.7	2.5

Notes for Table 3

* The rate includes cases of pericarditis that occurred after vaccination but may not be vaccine related.

‡ To 16 April 2023, from about 2.4 million Comirnaty (Pfizer) vaccine doses given, one probable and 7 possible cases of pericarditis have been reported in children aged 5-11 years. No cases of pericarditis have been reported following Spikevax (Moderna) in this age group.

† The rates are less certain in some age groups due to low numbers of cases overall. This means small changes in case number can lead to fluctuations in the rates.

For more information, see guidance on myocarditis and pericarditis developed by ATAGI and the Cardiac Society of Australia and New Zealand (CSANZ).