Adverse event following immunisation
An Adverse Event Following Immunisation (AEFI) as described by the online Australian Immunisation Handbook is any negative reaction that follows vaccination. It does not necessarily have a causal relationship with the vaccine.
The adverse event may be any:
- unfavourable or unintended sign
- unfavourable or unintended symptom
- abnormal laboratory finding
These events may be caused by the vaccine(s) or may occur by chance (that is, the event would have occurred regardless of vaccination).
Mild events, such as fever, pain or redness at the site of injection, tiredness and aches and pains commonly occur after vaccination with some vaccines and should be anticipated.
Under the Public Health Act 2005, events following immunisation are a notifiable condition. It is very important that all AEFI are reported, particularly if serious or unexpected, as this will enable vaccine safety issues to be identified and managed appropriately as soon as possible.
Notify all AEFI to Queensland Health by completing an Adverse Events Following Immunisation Reporting Form (PDF 390 kB).
You do not need to complete a Therapeutic Goods Administration (TGA) form. Queensland Health will notify the TGA to enable national monitoring and reporting of AEFI in Australia.
Vaccine administration errors
Vaccination administration errors (VAEs) can occur because of errors in vaccine preparation, handling, storage or administration and can be associated with immunisation error-related reactions. Identification and follow-up of VAEs can identify and correct immunisation error-related reactions in a timely manner, and essential to ensuring the quality and safety of a vaccination service.
It is the responsibility of the immunisation provider to manage VAEs and should seek advice from their Public Health Unit if required. VAEs that result in a suspected adverse event following immunisation, must be reported to Queensland Health.
Please note: you will need to tick the Vaccine Administration Error box in the Adverse event details section on page 2 of the AEFI reporting form.
VAEs that may pose a safety risk to the patient, regardless of whether an adverse event following immunisation has occurred, must also be reported to Queensland Health using the Adverse Events Following Immunisation Reporting Form (PDF 390 kB). This includes VAEs such as,
- Inadvertent administration of a vaccine contraindicated in pregnancy or giving a live attenuated viral vaccine during pregnancy or shortly before pregnancy due to the potential risk to the fetus
- Inadvertent administration of live vaccines to an immunocompromised patient due to the risk of disseminated disease from the vaccine itself.
Contact your local public health unit.