Safety of COVID-19 vaccines

In Australia COVID-19 vaccines registered for use are required to undergo the Therapeutic Goods Administration’s (TGA’s) rigorous assessment and approval process to ensure compliance with our country’s strict standards on safety and effectiveness. The TGA releases a COVID-19 vaccine weekly safety report (external site) with updated reporting on side effects and adverse events.

Clinical guidance on COVID-19 vaccine in Australia

See the Australian Technical Advisory Group (ATAGI) clinical guidance for COVID-19 immunisation providers and program staff COVID-19 vaccination – ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021 (external site).

See the Australasian Society of Clinical Immunology and Allergy (ASCIA) guide for health professionals on allergy and COVID-19 vaccination – Guide: Allergy and COVID-19 vaccination (external site).

Common side effects from COVID-19 vaccines

Most side effects are mild and transient. Reactions at the injection site such as redness, swelling, pain and systemic symptoms, like headaches, fever, muscle aches and fatigue, are very common within the first 48 hours. Serious adverse events attributable to vaccination are very rare.

Of note, respiratory symptoms (e.g. cough, runny nose etc.) are not side effects of the vaccine. People with respiratory symptoms should be tested for COVID-19.

Rare side effects after COVID-19 Vaccine Comirnaty (Pfizer) or SpikeVax (Moderna)

Myocarditis and/or pericarditis have been reported as rare sides effects after mRNA COVID-19 vaccines (i.e. Comirnaty/Pfizer or Spikevax/Moderna). Overseas studies have reported cases particularly in males under 30 years of age after the second vaccine dose, with most cases being mild, self-limiting and recovering quickly.

The Australian Technical Advisory Group on Immunisation released a joint statement (external site) with the Cardiac Society of Australia and New Zealand on myocarditis and pericarditis and the use of mRNA COVID-19 vaccines. The WA Department of Health has accordingly advised the following:

  • Pre-existing cardiac conditions are not regarded as a contraindication to vaccination.
  • People with a history of any of the following conditions can receive an mRNA vaccine (e.g. Comirnaty or Spikevax) but should consult a GP, immunisation specialist service or cardiologist about the best timing of vaccination and whether any additional precautions are recommended:
    • Recent myocarditis or pericarditis (within the last 3 months)
    • Acute rheumatic fever or acute rheumatic heart disease (i.e., with evidence of active inflammation)
    • Acute decompensated heart failure
  • See more information about guidance on myocarditis and pericarditis after mRNA COVID-19 vaccines (external site)

Adverse events after COVID-19 vaccine Vaxzevria (AstraZeneca)

People who have had the first dose of AstraZeneca without any serious adverse effects can safely be given the second dose, including adults under 60 years.

Mixed dosing

It is recommended people have the same vaccine brand for the first and second dose.

However, an alternative vaccine can be offered for the second dose in some circumstances, including:

  • Severe side effects after the first dose - there are medical contraindications or precautions to a vaccine,
  • Overseas vaccines - the original vaccine is not available in Australia,
  • Lack of access - a person is unable to access a particular vaccine
  • Personal preference - a person is not accepting of a second dose of the same brand

If you have questions about switching brands between your first and second dose of COVID vaccine you should discuss it with your health care provider.

For further information, see COVID-19 vaccination – ATAGI Clinical advice on the use of a different COVID-19 vaccine as the second dose (external site).

Reporting adverse events following immunisation (AEFI)

Healthcare providers should report:

  • any significant (or rare and unexpected) AEFIs in both children and adults
  • any vaccine reaction that requires assessment by a doctor or nurse
  • any vaccine reaction that has affected a family’s confidence in future immunisation.

You can report adverse events even if you are not sure whether the vaccine caused the event.

Health care providers and members of the public can report possible AEFI using the online portal at SAFEVAC-WAVSS (external site).

For further information see adverse events following immunisation in WA.

Clinical guidance on COVID-19 vaccine in Australia

See the Australian Technical Advisory Group (ATAGI) clinical guidance for COVID-19 immunisation providers and program staff COVID-19 vaccination – ATAGI clinical guidance on COVID-19 vaccine in Australia in 2021 (external site).

See the Australasian Society of Clinical Immunology and Allergy (ASCIA) guide for health professionals on allergy and COVID-19 vaccination – Guide: Allergy and COVID-19 vaccination (external site).

Last reviewed: 10-11-2021