What is an adverse event following immunisation
An adverse event following immunisation (AEFI) is any negative reaction that follows vaccination. It is not necessarily caused by the vaccine.
It can be expected or unexpected, and can happen immediately after you give the vaccine, or some time later.
Most AEFIs are mild and short-lived, such as pain, redness or swelling at the injection site, or a low-grade fever. Serious adverse events are rare.
Reporting and recording adverse events
Most reactions to vaccines are mild and do not require special treatment or reporting.
You should report an adverse event following immunisation (AEFI) to your state and territory contacts if you have concerns about a reaction that:
- seems to be getting worse
- does not fit the common reactions known for that vaccine
- is serious or unexpected.
You can also report an AEFI or a problem with a vaccine directly to the Therapeutic Goods Administration (TGA) using the adverse event reporting tool.
Reporting AEFI helps the TGA assess the possible role of the vaccine in causing the adverse event. It helps with:
- identifying or understanding safety issues with newly introduced vaccines
- monitoring AEFI rates and trends across Australia
- identifying problems with manufacture, storage, delivery or administration of vaccines.
Reported adverse events are reviewed as part of Australia’s vaccine safety monitoring system. This information helps identify potential safety concerns and supports ongoing monitoring of vaccine safety.
Find your state or territory AEFI contact or use the TGA adverse event reporting tool to make a report. You can also read more about safety monitoring and information.
Managing adverse events
Managing adverse events includes:
- explaining potential adverse events to your patient before giving the vaccine – this is part of the consent process
- observing the patient for at least 15 minutes after giving the vaccine, as most adverse events start within 10 minutes
- providing immediate treatment in the case of an adverse reaction like anaphylaxis, febrile convulsions or fainting (vasovagal episode).
Serious adverse events following immunisation are rare, but vaccination providers should be prepared to recognise and manage them promptly.
Common AEFIs include:
- pain, redness, swelling or itching at the injection site
- low-grade fever
- mild tiredness or discomfort.
These reactions are generally self-limiting and resolve without treatment.
The Australian Immunisation Handbook details the different types of adverse events following immunisation and how to manage them, including information about rare adverse events associated with specific vaccines.
Vaccination after a past serious adverse event
If a patient previously had anaphylaxis following a vaccine, or in response to one of its ingredients, you should not give them that vaccine again.
Patients who have had other serious AEFIs to a vaccine may get it again under close medical supervision.
Depending on the circumstances, referral to a specialist immunisation service, immunisation clinic or other specialist provider may be appropriate to assess future vaccination options.
For advice about specialist immunisation services in your jurisdiction, contact your state or territory health department or visit the Specialist immunisation services page on the National Centre for Immunisation Research and Surveillance website.
Next steps
Read the:
- National Immunisation Program vaccines page on our website
- Australian Immunisation Handbook.
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