Vaccine reaction reporting: Adverse event following immunisation

Vaccines, like any medication or natural therapy, can have side effects. An adverse event following immunisation (AEFI) refers to any untoward medical occurrence that follows immunisation, whether expected or unexpected, and whether triggered by the vaccine or only coincidentally occurring after receipt of a vaccine (Australian Immunisation Handbook). Most reactions, such as low grade fever and pain at the injection site, are mild and are usually short lasting, and do not require special treatment.

SA Health offers individualised advice to members of the public and health professionals.

When to report adverse reactions

As of 13 April 2021, an adverse event following immunisation is a notifiable condition in South Australia. All immunisation providers are expected to notify serious or unexpected AEFI, or any AEFI resulting in healthcare attendance to SA Health. See below for how to report an AEFI to SA Health's Immunisation Section.

All uncommon, unexpected or serious adverse reactions or reactions resulting in healthcare attendance must be reported to SA Health.

On very rare occasions a severe allergic reaction may occur. Anaphylaxis is the most severe form of allergic reaction and is potentially life threatening. Anaphylaxis is an allergic reaction involving more than one body system (for example skin, respiratory, gastro-intestinal and cardiovascular systems).

Why report an adverse event following

Reporting an AEFI is an essential part of ensuring ongoing vaccine safety monitoring. Being able to identify and respond quickly to any issues relating to vaccine safety is an essential part of maintaining public trust and confidence.

The South Australian Vaccine Safety Surveillance (SAVSS) is a passive surveillance system designed for timely detection of signals suggestive of an increase in adverse events following immunisation associated with a particular vaccine. Reporting suspected adverse events following immunisation to SAVSS enhances SA Health's ability to provide advice and make recommendations about the safety of vaccines.

SAVSS enables the safe monitoring of immunisation programs in South Australia.

How to report an adverse event following immunisation to SA Health

The preferred method to submit a report to SA Health is by completing the online Vaccine Reaction Report Form using the South Australian Vaccine Safety Surveillance System (SAVSS). SAVSS SA Vaccine Safety Surveillance Report reaction here

On completion of the online report form, a lodgement number will be issued. If you have provided an email address, the option to receive confirmation including your lodgement number by email, is available. There is also an option to print a copy of your report.

If you are unable to complete an online report you can phone 1300 232 272 during business hours.

What happens next?

Each report received by SA Health is assessed and triaged according to urgency. A specialist team provides appropriate advice and follow up for individuals who have experienced an adverse event following immunisation. Unexpected or unusual reactions in children may be referred to the Specialist Immunisation Service (SIS).

SA Health submits all reports to the Therapeutic Goods Administration (TGA). These reports contribute to national vaccine safety surveillance.

Are vaccines tested for safety?

Yes. Before a vaccine can be used in Australia it must be licensed by the TGA. The TGA extensively assess each vaccine for safety and effectiveness, with assessment being based on scientific evidence. This testing is required by law and is usually undertaken over many years during the vaccine’s development. The TGA continues to monitor the safety of vaccines once they are registered .

Further information

For more information about immunisations, advice on future vaccinations or to discuss any concerns you may have, contact your doctor, immunisation provider or SA Health's Immunisation Section.