COVID-19 vaccine weekly safety report - 09-06-2022

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. More information about what to expect and how to manage any symptoms after you receive your vaccine are available from NPS MedicineWise.

Launch of a new trial version of the TGA’s public adverse event database

Our publicly available Database of Adverse Event Notifications (DAEN) for medicines and vaccines is being upgraded. A trial (beta) version of DAEN is now available on the TGA website alongside the existing database.

Due to the pandemic, we saw unprecedented public interest in the safety of medicines and vaccines. Consequently, the number of adverse event reports listed in the database, and the number of people searching it, has grown significantly. This led to some performance issues and complaints from users.

We have created a trial (beta) version of the database with improved usability and performance. In the new trial version, you can now search more easily for information and interact with your results through dynamic tables, filters and graphs. Users can also export search results in .csv and .xls formats, which is a function medicine sponsors, academics, media and the public have asked for.

It is important to remember that adverse events listed in the database only reflect the observations of the person who reported them (consumer or healthcare professional) and do not necessarily mean that the adverse event was caused by the vaccine. The TGA does not assess adverse event reports for a causal link with a medicine or vaccine before they are published in the database.

Vaccine safety in children and adolescents

The TGA is closely monitoring adverse event reports in people aged under 18 years. Although we continue to receive a small number of reports, this is decreasing each week and is not impacting overall reporting rates in this age group.

To 5 June 2022, we have received about 4,180 reports from approximately 3.7 million doses of Comirnaty (Pfizer) and Spikevax (Moderna) in 12-17 year olds. The most commonly reported reactions are chest pain, headache, dizziness, nausea and fever.

The TGA is also closely monitoring adverse event reports in 5-11 year olds. To 5 June 2022, we have received about 1,470 reports from approximately 2.2 million Comirnaty (Pfizer) doses administered in this age group. The most common reactions reported included chest pain, vomiting, fever, headache and abdominal pain. We have received 35 reports of suspected myocarditis and/or pericarditis in this age group. Following review of information in the reports, 4 were likely to represent myocarditis and another 6 reports were likely to represent pericarditis.

Survey data from AusVaxSafety survey show that:

• children aged 5-11 years report fewer side effects following a second COVID-19 vaccine dose than older Australians
• children and adults are more likely to experience side effects after a second COVID-19 vaccine dose, but most reactions are mild and temporary.

These observations are consistent with what was reported in the clinical trials and from overseas experiences.

More information and frequently asked questions about COVID-19 vaccines in children are available on the National Centre for Immunisation Research and Surveillance website. A decision aid is now available for parents and carers who may be hesitant to get their children vaccinated.

Booster doses

The TGA is monitoring the safety of booster vaccine doses in adults. A booster dose is an additional vaccine dose given after the primary vaccine course. In Australia, the booster dose is most commonly a third dose of an mRNA vaccine. A fourth dose has also been recommended for people over 65 years of age, and a winter booster dose is now recommended for people aged 16-64 years who have:

• a medical condition that increases their risk of severe COVID-19 illness
• a disability with significant or complex health needs or multiple comorbidities that increase the risk of poor outcomes from COVID-19.

In this report, we refer to a booster dose as either a third or fourth dose.

To 5 June 2022, approximately 13.7 million boosters have been administered in Australia. We have received approximately 8,400 reports of suspected adverse events identified as a booster dose. These reports do not suggest any emerging safety concerns with use of a booster dose that are different to the first and second vaccine doses received.

Our booster or third dose reports include a small number of cases of myocarditis and pericarditis (inflammation of the heart). This is a recognised risk with the Comirnaty (Pfizer) and Spikevax (Moderna) vaccines and we are closely monitoring these events. So far, reports after booster doses are very rare with myocarditis reported in less than 1 in every 100,000 people after they receive a booster dose.

The most common adverse events reported to the TGA following a booster dose are headache, swollen lymph nodes (also called lymphadenopathy), chest pain, fatigue and muscle pain. Swollen lymph nodes are a normal and known side effect of vaccines and occur when the immune system is stimulated and were seen in the clinical trials. More detail about this potential side effect is given in a previous vaccine safety report on the 6 January 2022.

Reports of death in people who have been vaccinated

Large scale vaccination means that some people will experience a new illness or die within a few days or weeks of vaccination. These events are often coincidental, rather than being caused by the vaccine. As the number of people being vaccinated has increased, so has reporting of fatal events with a temporal association with vaccination. Review of these individual reports and patterns of reporting does not suggest that the vaccines played a role in the vast majority of these deaths.

The TGA closely reviews all adverse events after COVID-19 vaccination where a fatal outcome is reported. Read more about this process in a previous report. Since the beginning of the vaccine rollout to 5 June 2022, about 59.4 million doses of COVID-19 vaccines have been given. The TGA has identified 11 reports where the cause of death was linked to vaccination from 885 reports received and reviewed. The deaths linked to vaccination occurred after the first dose of Vaxzevria (AstraZeneca) – 8 were thrombosis with thrombocytopenia syndrome (TTS) cases, 2 were linked to Guillain-Barre syndrome (GBS) and one was a case of immune thrombocytopenia (ITP).

The 11 deaths likely to be related to vaccination occurred in people aged 34–81 years old. There have been no deaths in children, adolescents or younger adults determined to be linked to COVID-19 vaccination.

AusVaxSafety - a national survey on COVID-19 vaccine safety

AusVaxSafety has collected responses from over 6 million Australians about adverse events after they have received a COVID-19 vaccine. Survey results largely reflect what was seen in the clinical trials, with injection-site reactions, fatigue, headache, and muscle and joint pain being the most common reactions.

On the AusVaxSafety website, survey results are presented for each COVID-19 vaccine:

• Comirnaty (Pfizer) adult formulation and paediatric formulation (5-11 years)
• Spikevax (Moderna)
• Vaxzevria (AstraZeneca)
• Nuvaxovid (Novavax)

For each vaccine, survey results are given for different age groups and different populations, such as Aboriginal and Torres Strait Islander people, those affected by cancer or who have received a transplant, and pregnant women.

Comirnaty (Pfizer) mRNA vaccine

The Comirnaty (Pfizer) vaccine has been provisionally approved for adults and children aged 5 years and over. To 5 June 2022, about 41 million doses have been administered in Australia.

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).

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 vaccine

The Spikevax (Moderna) vaccine has been provisionally approved for adults and children aged 6 years and over. To 5 June 2022, about 4.5 million doses have been administered in Australia.

The TGA is actively investigating reports of myocarditis (inflammation of the heart muscle) 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).

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 has been provisionally approved for adults. To 5 June 2022, about 150,300 doses of Nuvaxovid (Novavax) have been administered in Australia.

The TGA has received a small number of reports of suspected myocarditis and/or pericarditis in people who have received the Nuvaxovid (Novavax) vaccine. After assessing these against a set of internationally accepted criteria, 3 cases were likely to represent myocarditis and 11 were likely to represent pericarditis. We are closely monitoring these reports and investigating whether there is an association between the Nuvaxovid (Novavax) vaccine and myocarditis and pericarditis. We will provide more information on this when the investigation is finalised.

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 has been provisionally approved for adults. To 5 June 2022, about 13.8 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. However, since the end of 2021 very few doses are now being used.

The TGA is closely monitoring rare reports of blood clots with low blood platelets (also called thrombosis with thrombocytopenia syndrome or TTS) linked to this vaccine, immune thrombocytopenia (ITP) and Guillain-Barre Syndrome (GBS). These are rare but serious side effects, with TTS reported in about 2 in every 100,000 people after receiving Vaxzevria (AstraZeneca) and ITP and GBS reported in about one in every 100,000 people. Detailed information of our analysis of these adverse effects is available in a previous vaccine safety report.

With only limited use of the Vaxzevria (AstraZeneca) vaccine now in Australia, we have not received any new reports of confirmed or probable TTS this year. However, new information on an older case that occurred in 2021 in a 79-year-old woman from Victoria indicates that it now fits the criteria for probable TTS related to a first dose of Vaxzevria (AstraZeneca). The total number of TTS cases reported in Australia is 173. Of these, 149 (83 confirmed, 66 probable) were related to a first dose of Vaxzevria (AstraZeneca) and 24 (5 confirmed, 19 probable) to a second dose. There has been no change in the reporting rates for ITP, GBS or TTS this year but we continue to monitor for reports to identify new information about these risks.

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 with mRNA vaccines

ATAGI continues to emphasise that the protective benefits of the mRNA vaccines far outweigh the rare risk of these side effects in all eligible age groups.

Current evidence tells us the risk of myocarditis and other heart effects is much higher after COVID-19 infection than after COVID-19 vaccination.

ATAGI has advised that people who develop myocarditis attributed to their first vaccine dose should defer further doses of an mRNA COVID-19 vaccine and discuss this with their treating doctor.

For those with suspected pericarditis after a first dose, future dose recommendations depend on test results and the person's age and sex. Refer to expert Guidance on myocarditis and pericarditis after mRNA COVID-19 vaccines for more information.

What are myocarditis and pericarditis?

Myocarditis is inflammation of the heart, and pericarditis is inflammation of the membrane around the heart. They can occur as rare adverse events after vaccination with the mRNA vaccines Comirnaty (Pfizer) and Spikevax (Moderna).

When do myocarditis and pericarditis occur?

Cases typically occur within 10 days, with symptom onset often within 5 days of vaccination. Some published evidence found pericarditis symptoms may occur later, commonly 2-3 weeks after vaccination. Our analysis indicates that most of the patients with likely myocarditis experienced symptoms within 3 days of vaccination.

Who is at risk of these heart problems?

Myocarditis is more commonly reported after the second dose in 12-17 year-old boys (13 cases per 100,000 Comirnaty doses and 21 cases per 100,000 Spikevax doses) and men under 30 (8 cases per 100,000 Comirnaty doses and 19 cases per 100,000 Spikevax doses). However, even in this population it remains rare.

Do myocarditis and pericarditis occur after a booster dose?

Myocarditis and pericarditis can occur after a booster dose but this is rare. Australian and international data indicate that myocarditis and pericarditis are reported less commonly after a booster dose than after a second dose. The rate of reporting of myocarditis and pericarditis is less than 1 in every 100,000 people after a booster dose. There is no indication that these events are more serious than after earlier doses.

To 5 June 2022, from approximately 13.7 million booster doses, we have received 36 reports of likely myocarditis and 77 reports of likely pericarditis for Comirnaty (Pfizer) and 20 reports of likely myocarditis and 17 reports of likely pericarditis for Spikevax (Moderna). The median age of affected individuals was 31 years old.

How serious are myocarditis and pericarditis?

Myocarditis is often mild, and cases usually resolve after a few days with treatment and rest. Some cases are more serious and need to be treated in hospital.

Our analysis has found about half of the patients with suspected myocarditis or pericarditis were admitted to hospital. Nine people with likely myocarditis or pericarditis were treated in intensive care. This represents less than 1% of all likely cases. Most patients admitted to hospital were discharged within 4 days.

What myocarditis and pericarditis symptoms should I look out for?

We encourage people to seek medical attention if they experience symptoms that could suggest myocarditis or pericarditis. This includes chest pain, palpitations (irregular heartbeat), fainting or shortness of breath, particularly if they occur within 1–5 days of vaccination.

What does the TGA know about Australian myocarditis and pericarditis cases?

Reports received by the TGA of suspected myocarditis and pericarditis for the 2 mRNA vaccines are provided in Table 1. We have reviewed these reports against an internationally accepted criteria to classify the likelihood of myocarditis. This assessment does not determine whether cases have been caused by vaccination.

Reporting rates of likely myocarditis and pericarditis appear similar to overseas rates and are given in Tables 2 and 3.

Table 1. Reports of suspected myocarditis and pericarditis received by the TGA to 5 June 2022 ^¥

		Comirnaty (Pfizer) (41 million doses given)		Spikevax (Moderna) (4.5 million doses given)
		All cases	Cases in adolescents (12-17 years)	All cases	Cases in adolescents (12-17 years)
Suspected myocarditis cases*		1,323	219	185	33
Likely myocarditis†‡	Level 1	38	7	2	0
	Level 2	423	136	79	22
	Level 3	116	12	16	3
Unlikely myocarditis		398	34	45	4
Insufficient information		348	29	43	4
Suspected pericarditis cases		2,717	285	285	15
Likely pericarditis£		947	71	90	3

* Cases reporting both myocarditis and pericarditis are included in suspected myocarditis cases.

^¥ The total number of reports can fluctuate slightly over time as duplicate reports may be identified and deleted and cases may be reclassified after receiving additional information.

^‡ Cases classified as level 1 are confirmed to be myocarditis based on strong clinical evidence including the patient’s symptoms, and results of tests and imaging indicating a diagnosis of myocarditis. Level 2 cases are probably myocarditis based on a combination of symptoms and routine tests for heart conditions. Level 3 cases are possibly myocarditis based on symptoms and a doctor's report that myocarditis is the most likely diagnosis in the absence of medical tests and investigations. For all cases of suspected myocarditis, where possible, other known causes of the patient’s symptoms or test results are ruled out before cases are classified.

^† The youngest case classified as 'likely myocarditis' to date is 6 years old.

^£ Classification of likely pericarditis is based on the patient's symptoms and test results and the absence of other known causes of pericarditis.

Table 2. Rates of likely myocarditis cases following the mRNA vaccines^‡ A. 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	7.8	1.5	12.8	2.4
18-29	4.5	1.3	8.2	2.3
30-39	2.0	0.7	2.5	0.8
40-49	0.6	0.7	1.0	1.2
50-59	0.4	0.3	0	0.4
60-69	0.2	0.3	0	0.4
70+	0.1	0.1	0	0.4
All ages*	2.2	0.7	4.2	1.3

B. Spikevax (Moderna)

Age (years)	All doses		Second doses
	Rate* per 100,000 doses		Rate* per 100,000 doses
	Male	Female	Male	Female
12-17	11.2	3.0	21.4	5.1
18-29	9.6	1.6	18.6	3.6
30-39	3.2	0.6	5.1	0
40-49	1.6	0.3	1.6	0
50-59	0.9	1.5	2.0	5.0
60-69	0	0.3	0	0
70+	0	0.2	0	0
All ages*	3.7	1.0	10.1	2.4

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

^‡ To 5 June 2022, from about 2.2 million vaccine doses given, 4 likely cases of myocarditis have been reported in children aged 5-11 years.

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	2.1	0.9
18-29	3.5	4.2
30-39	3.9	4.3
40-49	2.4	1.9
50-59	1.3	0.8
60-69	0.7	0.3
70+	0.3	0
All ages*	2.4	2.1

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

^‡ To 5 June 2022, from about 2.2 million Comirnaty vaccine doses given, 1 probable and 5 possible cases of pericarditis have been reported in children aged 5-11 years. No cases of pericarditis have been reported following Spikevax in this age group.

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

Useful links

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COVID-19 vaccines: Frequently asked questions - 24 May 2022

COVID vaccines - is it true? - 17 February 2022

ATAGI update following weekly COVID-19 meeting - 23 May 2022

Expanded ATAGI recommendations on winter COVID-19 booster doses for people at increased risk of severe COVID-19 - 25 May 2022

Should my child get a COVID-19 vaccine? A decision aid for parents and carers

AusVaxSafety: Children experience fewer side effects from COVID-19 vaccine

AusVaxSafety: Pfizer COVID-19 vaccine safety data - Child participants

COVID-19 vaccines do not cause infertility - 21 April 2022

Latest advice on COVID-19 vaccination for pregnant and breastfeeding women - 18 August 2021

TGA COVID-19 vaccines hub

Australian Government Department of Health COVID-19 vaccines hub

COVID vaccine information in your language

Database of Adverse Event Notifications (DAEN)