All vaccines registered for use in Australia and included in the National Immunisation Program must pass stringent pre-licensure vaccine clinical trials before they are approved. The Therapeutic Goods Administration (TGA) continuously monitors the safety of vaccines once they are registered.
An adverse event following immunisation (AEFIs) is defined in The Australian Immunisation Handbook as “any untoward medical occurrence that follows immunisation. It does not necessarily have a causal relationship with the vaccine”.
Health professionals are required to report all uncommon, serious or unexpected AEFI or any event felt to be significant following immunisation to the relevant health authorities. All AEFIs or suspected AEFIs must be reported to both the Therapeutic Goods Administration (TGA) and the Public Health Unit (PHU).
Anaphylaxis following any vaccination must be reported to both the TGA and the PHU.
Anaphylaxis Resources
Vaccination administration errors can occur as a result of errors in vaccine preparation, handling, storage or administration and can be associated with immunisation error-related reactions. Identification and follow-up of vaccine administration errors can identify and correct immunisation error-related reactions in a timely manner.
It is the responsibility of the immunisation provider to manage vaccine administration errors.