Adverse event and administration error reporting

What is an adverse event?

An Adverse Event Following Immunisation (AEFI) as described by the online Australian Immunisation Handbook is any negative reaction that follows immunisation. 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
• disease
• abnormal laboratory finding

These events may be caused by the vaccine(s)/immunisations or may occur by chance (that is, the event would have occurred regardless of immunisation).

Mild events, such as fever, pain or redness at the site of injection, tiredness and aches and pains commonly occur after immunisation 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 839 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 due to errors in product 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 are essential to ensure the quality and safety of a vaccination service.

It is the responsibility of the immunisation service provider to manage VAEs by completing and submitting a VAE form (PDF 584 kB). Providers should seek advice from their Public Health Unit if required.

VAEs that result in a suspected or confirmed adverse event following immunisation, must be reported to Queensland Health using the Adverse Events Following Immunisation Reporting Form (PDF 839 kB). This includes VAEs such as:

• Inadvertent administration of an immunisation contraindicated in pregnancy or giving a live attenuated viral vaccine during pregnancy or shortly before pregnancy due to the potential risk to the foetus
• Inadvertent administration of live vaccines to an immunocompromised patient due to the risk of disseminated disease from the vaccine itself.

Reporting Adverse Events Following Immunisation (AEFI) and vaccination errors

Under the Public Health Act 2005, adverse events following immunisation (AEFI) are a notifiable condition. It is 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).

Vaccine administration errors (VAEs) can occur because of errors in 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 an immunisation service.

It is the responsibility of the immuniser provider to manage VAEs and they should seek advice from their Public Health Unit if required. VAEs that result in a suspected AEFI, must be reported to Queensland Health.

For more information, visit Adverse event following immunisation | Queensland Health webpage.

Need more information?

Contact your local Public Health Unit.