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Myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) are rare effects on the heart that may occur after vaccination with the Pfizer and Moderna vaccines.

The Therapeutic Goods Administration Covid-19 vaccine weekly safety report released on Thursday revealed there have been 235 reports to October 24 assessed as likely to be myocarditis from about 21 million doses of Pfizer – an increase of 60 reports since last week.

“Our analysis of Australian data indicates there is a higher than expected number of cases of myocarditis in vaccinated compared to unvaccinated individuals Pfizer. This is similar to findings from other drug regulators overseas,” the TGA says.

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COVID-19 vaccine weekly safety report – 28-10-2021

Release date

Thursday, 28 October 2021

Previous reports

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, but often these events are not caused by the vaccines. 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 continue to 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. 
  • We are carefully monitoring and reviewing reports of: 
  • 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 approximately 1 in of every 100,000 people who receive Comirnaty (Pfizer), although it is more common in teenage boys after the second dose (6.7 cases per 100,000 doses). 
    • To 24 October, the TGA has received 235 reports which have been assessed as likely to be myocarditis from approximately 21 million doses of Comirnaty (Pfizer). This is an increase of 60 reports since last week.
  • Thrombosis with thrombocytopenia syndrome (or TTS) is a very rare but serious side effect of Vaxzevria (AstraZeneca). Our analysis shows it occurs in approximately 2 in every 100,000 people following vaccination, although the risk appears higher in people under 60 years. The risk is much lower after the second dose.
    • One new case of probable TTS was reported this week, taking the total to 157 cases from approximately 12.9 million doses of Vaxzevria (AstraZeneca).

Total adverse event reports to 24 October 2021

2.2Reporting rate per 1000 doses74,380Total AEFI reports received34,364,950Total doses administered39,496Total reports for Vaxzevria33,878Total reports for Comirnaty670Total reports for Spikevax

To 24 October 2021, the total number of adverse event reports received where the brand of the COVID-19 vaccine was not specified was 397.

Reported side effects for COVID-19 vaccines

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

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.

The TGA is closely monitoring reports in people aged under 18 years as vaccination continues in this age group. To 24 October 2021, we have received 1255 reports after vaccination with Comirnaty (Pfizer) and Spikevax (Moderna). The most commonly reported reactions are:

  • dizziness
  • nausea 
  • chest pain 
  • fainting (syncope) and feeling faint (pre-syncope)
  • headache. 

For more information on side effects reported in adolescents, check out the AusVaxSafety survey results for those aged under 20 years old(link is external).

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.

Side effects reported for Aboriginal and Torres Strait Islander people

Since the beginning of the vaccine rollout to 24 October 2021, the TGA has received 796 adverse event reports for Aboriginal and Torres Strait Islander people. During this time approximately 629,000 vaccine doses have been given in this population, giving a reporting rate of 1.3 suspected adverse events per 1000 doses.

The side effects reported for Aboriginal and Torres Strait Islanders are similar to the total population with the most common being headache, muscle pain, fever, fatigue and nausea. 

Further information on adverse event reports in Aboriginal and Torres Strait Islander people is published in the ongoing AusVaxSafety survey(link is external). 

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.

The TGA reviews all deaths reported in people who have been recently vaccinated. As the number of people being vaccinated has increased, so has reporting of fatal events with a coincidental association with vaccination. Our review of individual reports and patterns of reporting does not suggest that the vaccines played a role in the vast majority of these deaths.

Since the beginning of the vaccine rollout to 24 October 2021, approximately 34.4 million doses of COVID-19 vaccines have been administered. The TGA has found 9 reports of death that were linked to immunisation from 629 reports received and reviewed. The overwhelming majority of deaths reported occurred in people aged 65 years and older. The deaths linked to immunisation occurred after the first dose of Vaxzevria (AstraZeneca) – 8 were TTS cases and one was a case of immune thrombocytopenia (ITP).

Comirnaty (Pfizer) mRNA vaccine

To 24 October 2021, approximately 21 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 (for consumers) and Product Information (for health professionals).

Spikevax (Moderna) mRNA vaccine

To 24 October 2021, approximately 500,000 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 (for consumers) and Product Information (for health professionals).

Vaxzevria (AstraZeneca) vaccine

To 24 October 2021, approximately 12.9 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. 

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. We are also monitoring reports of immune thrombocytopenia (ITP) and Guillain-Barre Syndrome (GBS). See below for more details.

The prescribing information for Vaxzevria (AstraZeneca) has recently been updated to include warnings about ITP and GBS. This is a cautious approach, as a clear relationship between GBS and Vaxzevria (AstraZeneca) has not been established, and vaccine-related ITP is very rare and frequently occurs due to other causes.

Up-to-date information, including details of these and other 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

Myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) are rare effects on the heart that may occur after vaccination with the mRNA vaccines Comirnaty (Pfizer) and Spikevax (Moderna). Cases typically occur within 10 days, and usually resolve after a few days following treatment and rest. In Australia, myocarditis is reported in approximately 1 out of every 100,000 people after receiving the Comirnaty vaccine. While it is more commonly reported in young men and teenage boys after the second dose (6.7 cases in 100,000 people) it remains rare.

Myocarditis is seen much more commonly in people who become infected with COVID-19 than in people who are vaccinated. The Australian Technical Advisory Group on Immunisation (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(link is external).

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 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(link is external). 

ATAGI advises that people who develop myocarditis or pericarditis attributed to their first dose of Comirnaty (Pfizer) should defer further doses of an mRNA COVID-19 vaccine and discuss this with their treating doctor.