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. It does not necessarily have a causal relationship with the 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. 

Who needs to report adverse reactions

A notifiable AEFI is a notifiable condition in South Australia and is a not a very common or common AEFI.

As of 2021, notifiable AEFI became a notifiable condition on an ongoing basis after it was added to the list of notifiable conditions in the South Australian Public Health (Notifiable and Controlled Notifiable Conditions) Regulations 2012.

The following groups are now required to notify AEFI

  • medical practitioners
  • pathology services
  • registered nurses, midwives and pharmacists who are authorised to vaccinate independently as per the Vaccine Administrative Code.

Health practitioners will be exempt from notifying an AEFI if they know or reasonably believe that the notification has already been made by another health practitioner who is required to notify. The general public will still be able to report AEFI to SA Health on a voluntary basis (a report by the general public does not remove the requirement for a health practitioner to also notify).

What types of adverse reactions require notification

All AEFI need to be notified except for very common or common adverse events. 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.

For further detail on what is considered a very common or common adverse event refer to the Australian Immunisation Handbook (the Handbook) or Australian Technical Advisory Group on Immunisation (ATAGI) clinical advce. The Handbook has information on adverse events in a number of sections including the 'adverse events' section in each vaccine preventable disease chapter and in a table entitled 'Common side effects following immunisation for vaccines used in the National Immunisation Program schedule'.

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).

Managing immediate AEFIs including vasovagal and anaphylaxis episodes

Immunisation providers must be able to distinguish between a vasovagal episode (faint), convulsion and anaphylaxis. The following resources will assist providers in managing these episodes and with preparing an anaphylaxis kit.

Why report an adverse event following immunisation

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 AEFI associated with a particular vaccine. Reporting suspected AEFI 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 lodgment number will be issued. If you have provided an email address, the option to receive confirmation including your lodgment 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).

Adults identified as at risk of AEFI may need to be referred to a specialist for further assessment.

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

How to refer your patient to the SIS

Referring patients to the SIS is done either through: 

  • Medical Practitioners can refer by directly contacting the SIS at the Women’s and Children’s Hospital. A referral letter addressed to one of the SIS consultants will be required, or
  • by reporting an AEFI to SA Health. When SA Health is notified of any unwanted or unexpected event occurring post immunisation, the Immunisation Section assesses the report and if criteria are met, will refer your patient to the SIS.

For more information on referring patients to the SIS contact SA Health's Immunisation Section or to discuss individual referrals, please contact the Allergy and Immunology Department at the Women’s and Children’s Hospital at 8161 8638.

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.