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:

  • Vaccination should be deferred in people with ongoing cardiac inflammation or who develop myocarditis/pericarditis after their first dose.
  • People with a history of myocarditis, pericarditis, or endocarditis more than 6 months ago can be vaccinated without any additional precautions
  • People who have precautions (listed in the joint statement (external site) to vaccination can consult a GP, immunisation specialist, or cardiologist before vaccination.

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.

People who have had the first dose and are pregnant, have a qualifying medical condition or were impacted by a severe adverse event attributable to the vaccine are eligible for switching for their second dose vaccination. Please see Requests for alternative COVID-19 vaccine.

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 and specialist immunisation clinics in WA

Doctors and nurses who report a significant AEFI will receive advice by phone, email or letter from Western Australian Vaccine Safety Surveillance (WAVSS) staff to help clinically manage the future care and immunisation needs of these patients. If required, the patient will be contacted by WAVSS staff to arrange an appointment for the Specialist Immunisation Clinic (external site). A separate referral is not required.

If you require assistance in submitting an AEFI report following first or second dose of COVID-19 vaccination via the online portal, or further information relating to the progress of an AEFI report, contact WAVSS staff by:

  • phone on (08) 6456 0208 (Monday to Friday, 08:00 to 16:30, except public holidays)
  • email wavss@health.wa.gov.au

If your patients have medical queries/conditions that require consideration prior to vaccination, or you require assistance in advice regarding investigation and management of suspected AEFIs, you can:

  • seek advice from public health staff on current guidelines and referral pathways by:
  • request referral to a specialist clinic via Central Referral Services (CRS)(non-WA Health providers) or via e-referral (WA health providers) to:
    • SCGH Immunology Specialist Immunisation Clinic for adults or
    • PCH Infectious Diseases Specialist Immunisation Clinic for children.

After hours support should be reserved for advice on the immediate investigation and management of serious AEFI. Clinicians may contact the on-call adult immunologist through the Sir Charles Gairdner Hospital switchboard on 08 6457 3333 for urgent after-hours clinical support.

Last reviewed: 21-09-2021