Any immunisation service provider who becomes aware of an adverse event following immunisation must notify the Department of Health.
What is an AEFI?
The international definition of an AEFI is an unwanted or unexpected event following the administration of a vaccine.
An AEFI may be caused by a vaccine or may occur by coincidence (that is it would have occurred regardless of vaccination).
The statutory requirement to notify adverse events after immunisation is specified in Regulation 4 of the Health (Notification of Adverse Event After Immunisation) Regulations 1995 (external site).
Who is responsible for reporting an AEFI?
Any immunisation provider who becomes aware of an AEFI has a statutory obligation to make sure the Department is notified.
It is far better for an AEFI to be reported by more than one person than not at all.
Who must be notified
Under the Health (Notification of Adverse Event After Immunisation) Regulations 1995, the Executive Director, Public Health must be notified.
Notifications are sent to the Director of the Communicable Disease Control Directorate Department of Health via the adverse event reporting system.
How do I report an AEFI in WA?
Notification should be made to the Department of Health using the WA Vaccine Safety Surveillance (WAVSS) system.
Please report an AEFI by one of the following methods:
Should all AEFIs be reported?
You should report:
- any significant event following immunisation
- any vaccine reaction which requires assessment by a doctor or nurse, or which has affected a family’s confidence in future immunisation.
You do not need to report reactions such as redness or a small lump at the injection site or a temperature that has resolved after a few hours.