COVID-19 vaccine weekly safety report - 10-02-2022

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 the NPS MedicineWise Adverse Medicine Events phone line for consumers.

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 injection-site reactions, such as a sore arm, headache, muscle and joint pain, fever and chills.

Dizziness and fainting

Dizziness, feeling faint and fainting (also known as syncope) are also quite commonly reported with vaccination. These are well-recognised stress-related reactions that sometimes occur following procedures involving an injection, including vaccination. For example, fainting was commonly reported in teenagers following the human papillomavirus vaccine Gardasil. These side effects are usually mild and get better relatively quickly.

It is important to make sure you or your child has had enough to eat and drink before getting vaccinated as fainting may be more common when someone has an empty stomach or is not adequately hydrated. If you (or your child) start to feel faint before, during or after receiving the vaccine, make sure you are sitting or lying down to avoid falling and injuring yourself, and let the healthcare professional know.

Vaccine safety in children and adolescents

The TGA is closely monitoring reports in people aged under 18 years. To 6 February 2022, we have received about 3,400 reports from approximately 3.3 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 Comirnaty (Pfizer) vaccine is now being given to 5–11 year olds in Australia. This follows provisional approval by the TGA and a recommendation by the Australian Technical Advisory Group on Immunisation (ATAGI) - external site.

The TGA is also closely monitoring adverse event reports in 5-11 year olds. To 6 February 2022, we have received 523 reports from approximately 1 million Comirnaty doses administered in this age group. The most common reactions reported included chest pain, vomiting, fainting, nausea and fever. We have received 10 reports of suspected myocarditis and/or pericarditis in this age group. Following review of information in the reports, none were likely to represent myocarditis. One report in a 10-year-old boy possibly represented mild pericarditis when assessed against internationally accepted criteria for this condition.

Evidence from clinical trials and real-world experience from overseas indicate that side effects most commonly seen in this age group were mild and temporary similar to the safety profile in older populations. In clinical trials - external site of over 2000 children, most side effects were reported in the first 2-3 days after vaccination with the most common being a sore arm (70% of children), headache (25%) and tiredness (25%).

In the US, over 8 million doses of the vaccine have already been given to children aged 5-11 from 3 November to 19 December 2021. A review of active and passive vaccine surveillance data - external site published by the US Centers for Disease Control and Prevention (CDC) found similar safety findings to the clinical trial with most side effects being mild. A survey conducted shortly after vaccination found that about 5% of children missed school (usually only a single day or less) after a first dose and 7% after a second dose.

Reports of more serious effects following vaccination in children in the US were extremely rare with 100 reports from 8.7 million vaccine doses - the most common were fever, vomiting and in some cases seizures. Importantly, reports of myocarditis were also very rare in the US, with 11 confirmed reports from over 8 million doses - these were all mild cases.

New safety data from the AusVaxSafety survey indicates that the Comirnaty (Pfizer) vaccine is well tolerated in children aged 5-11 years - external site, with less adverse reactions reported after vaccination than in older Australians. The most frequently reported side effects include local reactions at the injection site such as pain, swelling, redness and itching. Headache and fatigue were also common.

More information and frequently asked questions about COVID-19 vaccines in children are available on the National Centre for Immunisation Research and Surveillance website - external site.

Vaccination errors in children

Children aged 5-11 years old receive a smaller dose of the Comirnaty (Pfizer) vaccine compared with older children and adults. Therefore, there is a potential for age-related vaccine mix-ups to occur. Unlike other medicines, the Comirnaty (Pfizer) vaccine dosage does not vary according to the child’s weight, but depends on the age of the child on the day of vaccination.

Since the beginning of the rollout of Comirnaty (Pfizer) in this age group, the TGA has received 42 reports of vaccination errors in 5-11 year olds. Most of these are dosing errors in children aged 10 or 11 years old who received an adult dose of the vaccine by mistake, but there are also a few reports in younger children. For the majority these reports, no adverse events were associated with receiving an incorrect dose. However, 4 reports contained an adverse event - these were common and expected reactions including fever, headache and injection-site reactions.

To reduce the likelihood of children receiving the wrong dose, the Australian Technical Advisory Group on Immunisation (ATAGI) recommend using the paediatric version of the Comirnaty (Pfizer) vaccine. This is specifically formulated for the 5-11 year age group and comes in a vial with an orange top. Formulations for adolescents and adults have a purple or grey top and need to be diluted differently before use. When taking your child for vaccination, make sure you clearly communicate your child's age to help ensure the correct formulation is used.

All health professionals administering COVID-19 vaccines must have completed specific training on vaccination procedures - external site to minimise the risk of errors. More information on recommendations for COVID-19 vaccination in children (pdf,280kb) - external site are provided by ATAGI.

Booster doses

The TGA is monitoring the safety of booster vaccine doses. It is not expected that the types of side effects will be different to first and second vaccine doses based on the results of clinical trials - external site, and observations from regulators overseas - external site where more booster doses have been given.

In Australia, the Comirnaty (Pfizer) vaccine is now recommended for use as a booster dose for those aged 16 years and over - external site. Spikevax (Moderna) is recommended as a booster for those aged 18 and over. For people who are immunocompromised, a third dose is given as part of their primary vaccine course. This is not considered to be a 'booster'. The latest vaccination recommendations are available from ATAGI - external site.

To 6 February 2022, approximately 9 million boosters or third doses have been administered in Australia. We have received approximately 2,840 reports of suspected adverse events identified as a third or booster dose.

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 and there is no indication that these events are more serious than after earlier doses.

To 6 February 2022, we have received 5 reports of likely myocarditis and 20 reports of likely pericarditis where the third or booster dose was Comirnaty (Pfizer). There has also been 4 reports of likely myocarditis and 7 reports of likely pericarditis where the third or booster dose was Spikevax (Moderna). The median age of affected individuals was 33 years old.

Myocarditis following COVID-19 vaccination is most likely to be reported in adolescents and young men, whereas the median age of people who have received a third or booster dose of a COVID-19 vaccine to date is 55 years. The TGA will continue to closely monitor the occurrence of myocarditis and pericarditis following booster or third doses as the booster roll-out extends to younger age groups, who have a higher risk of myocarditis.

The most common adverse events reported to the TGA following a booster dose are swollen lymph nodes (also called lymphadenopathy), headache, fatigue, muscle pain and fever. 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. There was more information about this potential side effect in the 6 January 2022 report.

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 6 February 2022, about 51.1 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 762 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).

AusVaxSafety - a national survey on COVID-19 vaccine safety

AusVaxSafety actively collects responses from Australians about adverse events after they have received a COVID-19 vaccine. It tells us what proportion of people experience an adverse event and what the most common reactions are. It also measures how frequently people go to the doctor or miss work or study because of an adverse event. Reassuringly, 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.

Results are given for everyone who has taken the survey, which is almost 6 million Australians so far. Data is presented for each vaccine and for the first, second and third or booster doses. Vaccine safety data is also given for subgroups of the population including:

• children aged 5–11 age years - external site
• adolescents - external site
• Aboriginal and Torres Strait Islander people - external site
• people affected by cancer or who have received a transplant - external site
• pregnant women - external site

For more details and results of the survey, go to the AusVaxSafety website - external site.

Comirnaty (Pfizer) mRNA vaccine

To 6 February 2022, about 34.2 million doses of Comirnaty (Pfizer) 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 - external site (for consumers) and Product Information - external site (for health professionals).

Spikevax (Moderna) mRNA vaccine

To 6 February 2022, about 3.2 million doses of Spikevax (Moderna) 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 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).

Vaxzevria (AstraZeneca) vaccine

In total, about 13.7 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. However, very few doses are now being used, particularly since the end of 2021.

The TGA continues to monitor 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). Detailed information of our analysis of these adverse effects is available in the 27 January 2022 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 a case reported late last year, in a 20-year-old woman from Queensland, indicates that it now fits the criteria of probable TTS related to a second dose of Vaxzevria. This takes the total number of TTS cases to 172. Of these, 148 (83 confirmed, 65 probable) were related to a first dose of Vaxzevria (AstraZeneca) and 24 to a second dose (5 confirmed, 19 probable).

Both ITP and GBS are very rare but serious side effects that can occur in about one in every 100,000 people after receiving the Vaxzevria (AstraZeneca) vaccine.

We continue to monitor the safety of Vaxzevria (AstraZeneca) and any new or emerging safety issues will be included in future weekly updates. All reports of suspected side effects to Vaxzevria will continue to be listed in the publicly available Database of Adverse Event Notifications (DAEN).

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).

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 - external site.

ATAGI advises 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 - external site 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 - external site 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.

How common are myocarditis and pericarditis?

In some countries, higher rates of myocarditis and pericarditis have been reported with Spikevax (Moderna) than with Comirnaty (Pfizer). In Australia, we are seeing slightly higher estimated rates of myocarditis for Spikevax - 1.6 cases per 100,000 Spikevax doses versus 1.3 cases per 100,000 Comirnaty doses. This difference is smaller than that reported overseas, including in the UK and Canada.

Pericarditis has been reported in 2-3 in every 100,000 people who receive an mRNA vaccine. Preliminary analysis of Australian data indicates pericarditis following vaccination occurs most commonly in people aged under 50 years, with a trend to a higher rate in the 18-39 year old group. It remains a rare adverse event.

Who is at risk of these heart problems?

Myocarditis is more commonly reported after the second dose in teenage boys (11 cases per 100,000 Comirnaty doses and 15 cases per 100,000 Spikevax doses) and men under 30 (7 cases per 100,000 Comirnaty doses and 13 cases per 100,000 Spikevax doses). However, even in this population it remains rare.

A European review of myocarditis and pericarditis data in teenage boys and young men (12-29 years old) - external site found for Comirnaty, there were 2-6 extra cases of myocarditis per 100,000 vaccinated individuals after a second dose compared to unvaccinated individuals. For Spikevax, there were 13-19 extra cases of myocarditis per 100,000 vaccinated individuals compared to unvaccinated individuals. A study by the Centers for Disease Control and Prevention (CDC) (pdf,606kb) - external site in the US found in 18-39 years olds there was approximately 2 extra cases of myocarditis and pericarditis reported per 100,000 Comirnaty (Pfizer) second doses and 3 extra cases per 100,000 Spikevax (Moderna) second doses.

The Australian data does not show as large a difference in incidence of myocarditis as this review between Comirnaty (Pfizer) and Spikevax (Moderna). In Australia the rates of pericarditis are similar between the mRNA vaccines.

Emerging Australian and international data indicate that pericarditis is more common in people under 50 years of age than in older people.

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 need to be treated in hospital. Our analysis has found about half of the patients with suspected myocarditis 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.

Evidence from a US surveillance survey (pdf,1.1Mb) - external site of patients who had myocarditis following vaccination indicates that most patients fully recover without lasting impacts on their quality of life or ability to work. The survey, which was conducted 3 months after the initial myocarditis diagnosis, involved mostly men under 30 years after their second vaccine dose (and their treating doctors). There were no deaths from myocarditis reported in these patients.

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.

Initial tests for those presenting with symptoms include ECG, troponin levels and chest X-ray. Brief guidance on the initial assessment of children and adolescents with symptoms has been published by the Paediatric Research in Emergency Departments International Collaborative (PREDICT) network - external site.

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. Tables 2 and 3 present the rates of myocarditis and pericarditis.

We have received a small number of reports of myocarditis and pericarditis after a third or booster dose. The reports after booster doses are very rare and there is no indication that these events are more serious than after earlier doses.

Table 1. Reports of suspected myocarditis and pericarditis received by the TGA to 6 February 2022

		Comirnaty (Pfizer) (34.2 million doses given)		Spikevax (Moderna) (3.2 million doses given)
		All cases	Cases in adolescents (12-17 years)	All cases	Cases in adolescents (12-17 years)
Suspected myocarditis cases*		1,058	183	122	25
Likely myocarditis†‡	Level 1	37	7	0	0
	Level 2	329	102	40	14
	Level 3	80	11	10	3
Unlikely myocarditis		250	21	29	2
Insufficient information		362	42	43	6
Suspected pericarditis cases		2,233	148	200	10
Likely pericarditis£		800	61	63	3

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

^‡ 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 was 12 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.

Rates of myocarditis by age, sex and dose are given for Comirnaty (Pfizer) and Spikevax (Moderna) in Table 2. The estimated reporting rates in Australia appear similar to overseas rates. The rates for Spikevax (Moderna) are less certain due to low numbers of cases overall. Rates of pericarditis by age are given for Comirnaty (Pfizer) and Spikevax (Moderna) in Table 3.

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
12-17	6.6	1.4	10.7	2.4
18-29	4.0	1.2	6.7	2.0
30-39	1.5	0.6	1.8	0.5
40-49	0.7	0.6	1.2	1.0
50-59	0.4	0.3	0.1	0.4
60-69	0.1	0.2	0.0	0.0
70+	0	0.1	0	0.4
All ages*	2.0	0.7	3.6	1.2

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	8.4	1.9	15.2	2.7
18-29	6.0	0.8	12.6	0.0
30-39	3.2	0.4	5.4	0.0
40-49	0.8	0.4	0.0	0.0
50-59	0.4	0.8	0.0	0.0
60-69	0.0	0.0	0.0	0.0
70+	0.0	0.0	0.0	0.0
All ages*	2.6	0.6	7.0	0.6

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

^‡ To 6 February 2022, from about 1 million vaccine doses given, no 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)
12-17	2.0	0.9
18-29	3.3	4.2
30-39	3.7	4.3
40-49	2.2	1.9
50-59	1.3	0.6
60-69	0.5	0.0
70+	0.2	0.0
All ages*	2.3	1.9

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

^‡ To 6 February 2022, from about 1 million vaccine doses given, one possible case of mild pericarditis has been reported in children aged 5-11 years. As this number is so low, we are unable to estimate reliable rates of pericarditis in this age group.

We continue to monitor Australian reports on myocarditis and pericarditis and will provide regular updates in this report as more information becomes available. We are also working closely with international medicines regulators to share emerging safety information.

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

Useful links

Tested positive for COVID-19? Find out what you need to do - external site

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

Top 3 COVID-19 vaccine questions - Vaccines and child immunisation schedules, RAT false positives and Novavax - 3 February 2022 - external site

ATAGI update following weekly COVID-19 meeting - 2 February 2022 - external site

ATAGI recommendations for use of Pfizer COVID-19 vaccine as a booster dose in adolescents aged 16-17 years - 3 February 2022 - external site

ATAGI statement on the use of Novavax COVID-19 vaccine (Nuvaxovid) - 24 January 2022 - external site

Myocarditis and pericarditis following COVID-19 mRNA vaccines - Melbourne Vaccine Education Centre - 18 January 2022 - external site

COVID-19 vaccines: Frequently asked questions - 25 January 2022 - external site

COVID vaccines - is it true? - 17 December 2021 - external site

RMIT ABC Fact Check - external site

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

Coronavirus (COVID-19) case numbers and statistics - external site

Australia's COVID-19 vaccine rollout - 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)

Comirnaty (Pfizer) vaccine - phase III clinical trial - external site

Comirnaty (Pfizer) vaccine - clinical trials in children under 12 years - external site

Vaxzevria (AstraZeneca) vaccine - phase III clinical trial - external site

Spikevax (Moderna) vaccine - phase III clinical trial - external site