Guidance on Myocarditis
and Pericarditis after
mRNA COVID-19 Vaccines
The following guidance has been developed jointly by the
Australian Technical Advisory Group on Immunisation (ATAGI) and
the Cardiac Society of Australia and New Zealand (CSANZ).
Version 1.0 – 30 July 2021
Key Points
• A risk of myocarditis and pericarditis has been observed in people who have received
mRNA COVID-19 vaccines in overseas studies, particularly in males under 30 years of age
after the second vaccine dose.
• This association is based on data from the USA and Europe, where these mRNA vaccines
have been extensively used.
• ATAGI and CSANZ emphasise that the overwhelming benefits of vaccination in protecting
against COVID-19 greatly outweigh the rare risk of these conditions, and Comirnaty (Pfizer
mRNA vaccine) continues to be recommended for all people ≥ 16 years of age who do not
have any contraindications to the vaccine, in those aged 12-15 with specific medical
conditions that increase their risk of severe illness from COVID-19, and in Aboriginal and
Torres Strait Islanders aged 12-15.
• COVID-19 Vaccine AstraZeneca is not associated with an increased risk of
myocarditis/pericarditis. Cases have been reported after this vaccine, however have not
been reported more frequently than what is expected in the absence of vaccination (the
‘background rate’).
• Most myocarditis and pericarditis cases linked to mRNA vaccination have been mild and
patients have recovered quickly. Longer-term follow-up of these cases is ongoing.
• Symptoms typically appear within 1-5 days of vaccination and include chest pain,
palpitations (irregular heartbeat), syncope (fainting) or shortness of breath. People who
experience any of these symptoms after having an mRNA COVID-19 vaccine should seek
prompt medical attention. Initial investigations for people presenting with symptoms or signs
of myocarditis or pericarditis should include ECG, troponin, chest X-ray, and other
investigations for other differential diagnoses as clinically indicated.
• Most pre-existing cardiac conditions are not regarded as contraindications to vaccination.
Comirnaty is a recommended vaccine for people with a history of heart conditions: this
includes coronary artery disease, myocardial infarction, stable heart failure, arrhythmias,
rheumatic fever, rheumatic heart disease (RHD), Kawasaki Disease, most congenital heart
disease and people with implantable cardiac devices
• People with a history of any of the following conditions can receive an mRNA vaccine (e.g.
Comirnaty) but should consult a cardiologist about the best timing of vaccination and
whether any additional precautions are recommended:
o Inflammatory cardiac illness e.g., myocarditis, pericarditis, endocarditis
o Current acute rheumatic fever
o People aged 12-29 years with dilated cardiomyopathy
o Complex or severe congenital heart disease including single ventricle (Fontan)
circulation
o Acute decompensated heart failure
o Cardiac transplant recipients.
• People who develop myocarditis or pericarditis attributed to their first dose of Comirnaty are
advised to defer further doses of an mRNA COVID-19 vaccine and to discuss this with their
treating doctor.
health.gov.au/covid19-vaccines 2
Background
Myocarditis refers to inflammation of the heart muscle, and pericarditis refers to inflammation of
the thin sac that surrounds the heart. These conditions can occur separately or together
(myopericarditis). Myocarditis and/or pericarditis have been reported as rare side effects after
mRNA COVID-19 vaccines (including Comirnaty (Pfizer) and Spikevax (Moderna)) in adults,
particularly young adults, in several countries including the USA, Israel, UK and Italy.1–6 Cases
have also been reported in adolescents.7,8 As of 25 July 2021, 84 cases of myocarditis and/or
pericarditis have been reported in Australia to the Therapeutic Goods Administration following
Comirnaty (Pfizer) vaccine.9 It is important to note these are not all necessarily caused by the
vaccine as myocarditis and pericarditis occur in the absence of vaccination, e.g. for people
aged 18-34 years the estimated incidence in females is 16 per million (95% prediction interval
8-32), and for males is 37 (16 – 88).10
COVID-19 Vaccine AstraZeneca has not been associated with an increased risk of
myocarditis/pericarditis. Cases have been reported after the COVID-19 Vaccine AstraZeneca,
however, cases have not been reported more frequently than what is expected in the absence
of vaccination (the ‘background rate’)
Most myocarditis and pericarditis cases linked to mRNA vaccination have required
hospitalisation, however most have responded well to standard treatment with a mild and self-
limiting course.1,6 Symptoms typically appear within 1- 5 days (median 2 days) after
vaccination.11 In an analysis of myocarditis cases reported after mRNA vaccines in the US
Vaccine Adverse Events Reporting System (VAERS), 76% of cases were in males, and the
median age of the 323 reported cases meeting US CDC’s case definition was 19 years
(range = 12-29 years).10
The risk of myocarditis or pericarditis appears to be higher following the second dose of an
mRNA COVID-19 vaccine, but cases have also been reported after the first dose. 76% of cases
reported to the US VAERS occurred after a second dose.11 The crude reporting rate in males
aged 12-29 years was 40.6 cases per million second doses of an mRNA COVID-19 vaccine,
and in females aged 12-29 years was 4.2 cases per million. The rate in males aged 30 years or
older was 2.4 cases per million second doses, and in females of the same age was 1.0 case
per million second doses. Further analysis of rates and risks after vaccination is ongoing.
Myocarditis and pericarditis, due to a variety of causes, are also commonly seen in the general
population. Importantly, myocarditis is also a possible complication of COVID-19.12
Recommendations
ATAGI and CSANZ emphasise that the overwhelming benefits of vaccination using an mRNA
vaccine in protecting individuals against COVID-19 and its serious outcomes such as
hospitalisation and death as well as the wider benefits of reducing spread of the disease in the
community, greatly outweigh the rare risk of myocarditis or pericarditis after vaccination.
Comirnaty continues to be recommended for all people ≥ 16 years of age who do not have any
contraindications to the vaccine, for those aged 12-15 with specific medical conditions that
increase their risk of severe illness from COVID-19 and for all Aboriginal and Torres Strait
Islanders aged 12-15. For further information refer to the Clinical guidance on use of COVID-19
vaccine in Australia in 2021.
Advice for people with a history of cardiac conditions
Comirnaty continues to be one of the recommended vaccines to prevent COVID-19 in people
with a history of most chronic cardiovascular conditions, including coronary artery disease,
health.gov.au/covid19-vaccines 3
myocardial infarction, stable heart failure, arrhythmias, rheumatic heart disease (RHD),
Kawasaki Disease, most congenital heart disease and people with implantable cardiac devices.
No specific precautions are recommended for people in these groups. There is no current data
suggesting that their risk of developing myocarditis or pericarditis after vaccination is any higher
than for the general population.
People with a history of any of the following conditions can receive an mRNA vaccine (e.g.
Comirnaty) but should consult a cardiologist* about the best timing of vaccination and whether
any additional precautions are recommended:
• Inflammatory cardiac illness e.g., myocarditis, pericarditis, endocarditis
• Current acute rheumatic fever
• People aged 12-29 years with dilated cardiomyopathy
• Complex or severe congenital heart disease including single ventricle (Fontan)
circulation
• Acute decompensated heart failure
• Cardiac transplant recipients
There is a theoretical concern that patients with these conditions may be at increased risk of
developing myocarditis and/or pericarditis after a dose of an mRNA COVID-19 vaccine,
although there is no evidence to confirm this at present. Pericarditis is more frequently recurrent
than myocarditis. These patients should be counselled about the symptoms to look out for after
vaccination, and some may be advised by their cardiologist to schedule a routine visit with their
general practitioner a few days after vaccination to screen for any concerning symptoms or
signs. Vaccination should be deferred in people with ongoing cardiac inflammation, or
an alternative vaccine (e.g. COVID-19 Vaccine AstraZeneca) considered in people aged ≥ 60
years.
*If no local cardiology service is available, this advice may be given via phone or telehealth, or
by the primary care provider.
Advice for people who experience myocarditis/pericarditis attributed to an
mRNA COVID-19 vaccine
People who experience myocarditis and/or pericarditis after an mRNA COVID-19 vaccine
should be referred to a cardiologist for further assessment and management, to investigate for
possible causes other than vaccination, and for follow-up.
Currently, ATAGI advises people who have had myocarditis or pericarditis attributed to an
mRNA COVID-19 vaccine where other causes have been excluded, to defer future doses of
mRNA COVID-19 vaccine, and to discuss this with their treating doctor. It should be noted that
Spikevax (Moderna) is also an mRNA vaccine and therefore not recommended for people who
have experienced myocarditis and/or pericarditis after Comirnaty.
Additional advice on second dose vaccination in this context will be provided in the near future.
For further advice on mixed schedules, refer to ATAGI clinical advice on use of a different
COVID-19 vaccine as the second dose in special circumstances.
health.gov.au/covid19-vaccines 4
What to look out for after vaccination
During the consent process, all people who receive Comirnaty should be advised of the very
rare risk of myocarditis and/or pericarditis after vaccination, and should be advised of possible
symptoms, which include:
• chest pain, pressure or discomfort
• palpitations (irregular heartbeat, skipped beats or ‘fluttering’).
• syncope (fainting)
• shortness of breath
• pain with breathing.
Symptoms typically start within a few days after vaccination (median 2 days).11 People who
experience any of these symptoms after receiving Comirnaty should seek prompt medical
attention. People who feel well and do not have any of these symptoms after vaccination can
continue with their usual physical activity and do not routinely need to avoid physical exertion.
People who already have underlying heart dysfunction should seek medical attention for new
onset or worsening of pre-existing symptoms following vaccination.
Assessment of suspected myocarditis or pericarditis
People presenting with any of the above symptoms within the first 2 weeks of receiving
Comirnaty should be assessed by a healthcare professional, and those who appear unwell
should be referred immediately to an emergency department. Initial investigations should
include:
• a 12-lead ECG
• troponin
• chest X-ray
• other tests for other differential diagnoses as clinically indicated.
Findings consistent with pericarditis include a pericardial rub on auscultation, widespread ST-
elevation or PR depression on ECG, and pericardial effusion on imaging.
Findings consistent with myocarditis are varied and may include:
• elevated troponin
• ECG showing ST or T-wave abnormalities, premature atrial or ventricular complexes
• abnormal echocardiogram or cardiac MRI.
Brighton Collaboration case definitions of myocarditis and pericarditis are available at
https://brightoncollaboration.us/myocarditis-case-definition-update/.
If the ECG and/or troponin are abnormal, patients will require further assessment, including an
echocardiogram and other investigations or imaging as deemed necessary by their treating
physician. It is important to assess for the presence of other causes of myocarditis/pericarditis,
and for other more common causes of the patient's symptoms, including acute coronary
syndrome.
If patients who are investigated for myocarditis and/or pericarditis after Comirnaty have a
normal ECG and troponin, they should be advised to avoid high-intensity exercise or
competitive sports until symptoms have subsided, and to return for assessment in 1-2 days if
symptoms are ongoing. If clinical suspicion of myocarditis or pericarditis is high, a cardiologist
should be consulted even if investigation results are normal.
health.gov.au/covid19-vaccines 5
Management
Patients with established myocarditis should be admitted to hospital for cardiac monitoring
(ideally continuous ECG monitoring), until the cardiac biomarker levels have peaked and
symptoms have resolved. Treatment is determined on a case-by-case basis and often
supportive treatment is all that is required.13
People who have had confirmed myocarditis attributed to Comirnaty should be followed up by a
cardiologist. A repeat echocardiogram and ECG are likely to be required.
People who have had confirmed myocarditis or pericarditis should be advised to avoid high
intensity exercise or competitive sports until resolution of symptoms and ECG changes, and
normalisation of cardiac function.
Prognosis and long term follow up
There are currently no available data on the long-term outcomes of people who have had
myocarditis and/or pericarditis after an mRNA COVID-19 vaccine. A number of large studies
monitoring outcomes are currently being undertaken in the United States and Canada.
Importantly, most people who have had myocarditis and/or pericarditis due to other causes
recover completely and have no ongoing impairment of cardiac function, and early data suggest
this is likely for those after Comirnaty.
Patients with myocarditis and/or pericarditis after an mRNA COVID-19 vaccine whose
symptoms resolve quickly, who do not have any arrhythmia associated with the acute
myocarditis, and who have not had prolonged impairment of ventricular systolic function, should
be followed up by a specialist for at least 12 months.
For any patient who is found to have a persisting abnormality, e.g. heart block or ventricular
tachycardia, persisting ventricular dysfunction, or persisting abnormalities on a cardiac MRI,
follow-up should be extended in consultation with their treating specialist.
Reporting adverse events
Suspected cases of myocarditis or pericarditis following a COVID-19 vaccine should be
reported to your jurisdiction vaccine safety service, with details available at the Therapeutic
Goods Administration website.
More information
• CSANZ: www.csanz.edu.au/
• Australian Product Information on Comirnaty COVID-19 Vaccine, available on the TGA
website.
• Department of Health: www.health.gov.au/covid19-vaccines
health.gov.au/covid19-vaccines 6
References
1. Montgomery J, Ryan M, Engler R, et al. Myocarditis Following Immunization With
mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiol. Published online
June 29, 2021. doi:10.1001/jamacardio.2021.2833
2. Kim HW, Jenista ER, Wendell DC, et al. Patients With Acute Myocarditis Following
mRNA COVID-19 Vaccination. JAMA Cardiol. Published online June 29, 2021.
doi:10.1001/jamacardio.2021.2828
3. Abu Mouch S, Roguin A, Hellou E, et al. Myocarditis following COVID-19 mRNA
vaccination. Vaccine. 2021;39(29):3790-3793. doi:10.1016/j.vaccine.2021.05.087
4. Rosner CM, Genovese L, Tehrani BN, et al. Myocarditis Temporally Associated with
COVID-19 Vaccination. Circulation. 0(0). doi:10.1161/CIRCULATIONAHA.121.055891
5. Larson KF, Ammirati E, Adler ED, et al. Myocarditis after BNT162b2 and mRNA-1273
Vaccination. Circulation. 0(0). doi:10.1161/CIRCULATIONAHA.121.055913
6. Medicines and Healthcare Regulatory Agency. Coronavirus vaccine - weekly summary
of Yellow Card reporting. Published July 9, 2021.
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-
reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
7. Marshall M, Ferguson ID, Lewis P, et al. Symptomatic acute myocarditis in seven
adolescents following Pfizer-BioNTech COVID-19 vaccination. Pediatrics. Published online
2021:2.
8. Snapiri O, Rosenberg Danziger C, Shirman N, et al. Transient Cardiac Injury in
Adolescents Receiving the BNT162b2 mRNA COVID-19 Vaccine. Pediatr Infect Dis J.
Published online June 2, 2021. doi:10.1097/INF.0000000000003235
9. Therapeutic Goods Administration. COVID-19 vaccine weekly safety report. Published
July 22, 2021. https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-29-07-
2021
10. Gargano JW. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among
Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United
States, June 2021. MMWR Morb Mortal Wkly Rep. 2021;70. doi:10.15585/mmwr.mm7027e2
11. Daniels CJ, Rajpal S, Greenshields JT, et al. Prevalence of Clinical and Subclinical
Myocarditis in Competitive Athletes With Recent SARS-CoV-2 Infection: Results From the Big
Ten COVID-19 Cardiac Registry. JAMA Cardiol. Published online May 27, 2021.
doi:10.1001/jamacardio.2021.2065
12. Tschöpe, Carsten, Enrico Ammirati, Biykem Bozkurt, Alida L. P. Caforio, Leslie T.
Cooper, Stephan B. Felix, Joshua M. Hare, et al. ‘Myocarditis and Inflammatory
Cardiomyopathy: Current Evidence and Future Directions’. Nature Reviews Cardiology 18, no.
3 (March 2021): 169–93. https://doi.org/10.1038/s41569-020-00435-x.
1. Montgomery J, Ryan M, Engler R, et al. Myocarditis Following Immunization With
mRNA COVID-19 Vaccines in Members of the US Military. JAMA Cardiol. Published online
June 29, 2021. doi:10.1001/jamacardio.2021.2833
2. Kim HW, Jenista ER, Wendell DC, et al. Patients With Acute Myocarditis Following
mRNA COVID-19 Vaccination. JAMA Cardiol. Published online June 29, 2021.
doi:10.1001/jamacardio.2021.2828
health.gov.au/covid19-vaccines 7
3. Abu Mouch S, Roguin A, Hellou E, et al. Myocarditis following COVID-19 mRNA
vaccination. Vaccine. 2021;39(29):3790-3793. doi:10.1016/j.vaccine.2021.05.087
4. Rosner CM, Genovese L, Tehrani BN, et al. Myocarditis Temporally Associated with
COVID-19 Vaccination. Circulation. 0(0). doi:10.1161/CIRCULATIONAHA.121.055891
5. Larson KF, Ammirati E, Adler ED, et al. Myocarditis after BNT162b2 and mRNA-1273
Vaccination. Circulation. 0(0). doi:10.1161/CIRCULATIONAHA.121.055913
6. Medicines and Healthcare Regulatory Agency. Coronavirus vaccine - weekly summary
of Yellow Card reporting. Published July 9, 2021.
https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-
reactions/coronavirus-vaccine-summary-of-yellow-card-reporting
7. Marshall M, Ferguson ID, Lewis P, et al. Symptomatic acute myocarditis in seven
adolescents following Pfizer-BioNTech COVID-19 vaccination. Pediatrics. Published online
2021:2.
8. Snapiri O, Rosenberg Danziger C, Shirman N, et al. Transient Cardiac Injury in
Adolescents Receiving the BNT162b2 mRNA COVID-19 Vaccine. Pediatr Infect Dis J.
Published online June 2, 2021. doi:10.1097/INF.0000000000003235
9. Therapeutic Goods Administration. COVID-19 vaccine weekly safety report. Published
July 22, 2021. https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-29-07-
2021
10. Li, Xintong, Anna Ostropolets, Rupa Makadia, Azza Shoaibi, Gowtham Rao, Anthony G.
Sena, Eugenia Martinez-Hernandez, et al. ‘Characterising the Background Incidence Rates of
Adverse Events of Special Interest for Covid-19 Vaccines in Eight Countries: Multinational
Network Cohort Study’. BMJ 373 (14 June 2021): n1435. https://doi.org/10.1136/bmj.n1435.
11. Gargano JW. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among
Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United
States, June 2021. MMWR Morb Mortal Wkly Rep. 2021;70. doi:10.15585/mmwr.mm7027e2
12. Daniels CJ, Rajpal S, Greenshields JT, et al. Prevalence of Clinical and Subclinical
Myocarditis in Competitive Athletes With Recent SARS-CoV-2 Infection: Results From the Big
Ten COVID-19 Cardiac Registry. JAMA Cardiol. Published online May 27, 2021.
doi:10.1001/jamacardio.2021.2065
13. Tschöpe, Carsten, Enrico Ammirati, Biykem Bozkurt, Alida L. P. Caforio, Leslie T.
Cooper, Stephan B. Felix, Joshua M. Hare, et al. ‘Myocarditis and Inflammatory
Cardiomyopathy: Current Evidence and Future Directions’. Nature Reviews Cardiology 18, no.
3 (March 2021): 169–93. https://doi.org/10.1038/s41569-020-00435-x.
health.gov.au/covid19-vaccines 8
