Reporting side effects after immunisation

An adverse event following immunisation (AEFI) is an unwanted or unexpected event occurring after the administration of a vaccine.

Such an event may be caused by the vaccine or occur by chance after vaccination (that is, it would have occurred regardless of vaccination).

Most vaccines cause minor adverse events such as low-grade fever, pain or redness at the injection site.

Read more about immunisation safety.

Health professionals involved in the care of a person who has an AEFI have a statutory requirement to notify AEFIs to the WA Department of Health.

You can also report an AEFI if you or someone you care for has experienced an AEFI and needed medical assessment or treatment.

It doesn’t matter if more than one person reports the AEFI. It is far better that an AEFI is reported by more than one person than not at all.

You do not need to report common/minor reactions that are mild and short lasting. You can read more about the possible side effects of vaccination.

You should report:

• any significant event following immunisation.
• any reaction to a vaccine which requires assessment by a doctor or nurse
• any reaction that has affected you or your family’s confidence in future immunisation.

The Western Australian Vaccine Safety Surveillance (WAVSS) is the central reporting service in WA for any significant adverse events following immunisation (AEFI).

Although significant AEFIs are rare, WAVSS was established to help healthcare providers and the public to report potential AEFIs and to make sure that people who have experienced a significant AEFI receive the appropriate clinical follow-up.

The WAVSS reporting system is now part of the national reporting hub SAFEVAC - an Australian database for reporting of adverse events following immunisation (AEFI) and associated clinical visits. There are no changes in services or management of WAVSS and all WA reports will be followed up as usual by WA Health staff.

Health care providers and members of the public can report possible AEFI using the online portal at SAFEVAC-WAVSS (external site). 

Please use the AEFI-CAN reporting guide (PDF 1.3MB) to assist with reporting the AEFI online.

The WAVSS system provides timely feedback to patients and service providers who report a significant AEFI.

Feedback to members of the public will depend on the severity of the reaction. Where significant events have occurred after immunisation a nurse will call the patient and request further details.

Whilst WAVSS can provide advice to clinicians regarding AEFI assessment, it cannot provide acute management advice to patients. Patients who require medical advice due to ongoing symptoms should seek clinical assessment and management with their GP, or at their local Hospital Emergency Department.

All AEFIs will be reported daily to the Therapeutic Goods Administration (TGA) by WAVSS staff.

Timely reporting of AEFI results in:

• early detection of serious reactions
• appropriate and quick response for management of adverse reactions
• reducing the negative impact upon the health of individuals and the WA immunisation program.\

The WAVSS system provides:

• a user-friendly way for both immunisation providers and patients to report AEFIs
• support for patients and immunisation providers
• individualised assessment of the suspected adverse event and options regarding future vaccinations
• access to specialised immunisation clinics for people with a history of a significant AEFI.

The clinical follow-up service provided by WAVSS seeks to increase the confidence of patients and immunisation providers to continue with the immunisation schedule even after an AEFI has been experienced and reported.

Whilst WAVSS can provide advice to clinicians regarding AEFI assessment, it cannot provide acute management advice to patients. Patients who require medical advice due to ongoing symptoms should seek clinical assessment and management with their GP, or at their local Hospital Emergency Department.

If you reported a significant AEFI, you may be contacted by WAVSS staff to arrange an appointment for the specialist immunisation clinic.

For people who have had significant AEFIs, specialised clinical services are available where they can discuss and receive further vaccinations under medical supervision. Members of the public needing a referral to specialist immunisation services must discuss this with their medical practitioner.