Australia’s active vaccine safety system
Since the COVID-19 vaccination program commenced in Australia, more than 62 million doses have been administered to individuals aged 5 years and older. While AusVaxSafety data from more than 6.4 million doses show that expected short-term side effects such as a sore arm and headache are common, in rare instances, myocarditis (inflammation of the heart muscle) has been seen in individuals following vaccination with mRNA COVID-19 vaccines Pfizer and Moderna.
As COVID-19 vaccines are relatively new, there are limited long-term safety data in Australia and internationally on individuals with myocarditis following COVID-19 vaccination. To help us gain a greater understanding of characteristics, progress and outcomes of those affected, AusVaxSafety is conducting long-term follow-up surveillance of individuals who experienced myocarditis following COVID-19 vaccination.
AusVaxSafety is actively engaging with individuals in Australia diagnosed with myocarditis after COVID-19 vaccination and following them up over an 18-month period to monitor their health progress and outcomes. The collection and analysis of clinical data from these individuals will provide important information for clinicians treating myocarditis, and will help inform future vaccination policies in Australia.
Any individual who has confirmed myocarditis as per the Centers for Disease Control and Prevention (CDC) definition with symptom onset within 42 days after mRNA COVID-19 vaccination can participate.
Where possible, eligible individuals will be identified and contacted by a nurse or doctor from their respective state/territory health department. Individuals who have had confirmed myocarditis following COVID-19 vaccination can also participate by completing the eligibility form.
Click here to complete the eligibility form
Participation in the myocarditis long-term follow-up surveillance program is voluntary. All individuals affected by myocarditis will receive the best possible care whether they participate in this program or not.
Participants will be contacted and asked questions by a research nurse at different time points over an 18-month period. These questions relate to general and psychological health following diagnosis and relevant follow-up tests. With permission, the treating specialists of participants will also provide additional information regarding their care and progress.
Data collected from participants will be de-identified and analysed by clinical specialists, including cardiologists and epidemiologists. Results, highlighting key findings and recommendations for the future, will be published.
Learn more about the adverse event of special interest long-term follow-up program
AusVaxSafety receives fundingfrom the Australian Government
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We acknowledge that the National Centre for Immunisation Research and Surveillance (NCIRS) is on the land of the traditional owners the Aboriginal and Torres Strait Islander peoples, the First Australians, and recognise their culture, history, diversity and their deep connection to the land. Together, through research and partnership, we aim to move to a place of equity for all. NCIRS also acknowledges and pays respect to other Aboriginal and Torres Strait Islander nations from which our research, staff and community are drawn.
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We acknowledge that the National Centre for Immunisation Research & Surveillance (NCIRS) is on the land of the traditional owners the Aboriginal and Torres Strait Islander peoples, the First Australians, and recognise their culture, history, diversity and their deep connection to the land. Together, through research and partnership, we aim to move to a place of equity for all. NCIRS also acknowledges and pays respect to other Aboriginal and Torres Strait Islander nations from which our research, staff and community are drawn.