Adverse event following immunisation (AEFI)

• The medical or nurse practitioner who becomes aware of an AEFI has a statutory responsibility to notify the WA Department of Health within 72 hours of diagnosis as specified in the Public Health Act 2016 (external site) and the Public Health Regulations 2017 (external site).
• Other immunisation providers and healthcare professionals involved in the care of a vaccinated person who experiences an AEFI should also report significant. events.
• Members of the public can also report an AEFI if they or someone they care for has experienced an AEFI and needed medical assessment or treatment.
• It is far better for an AEFI to be reported by more than one person than not at all.

AEFIs are classified as 'common/minor' or 'significant'.

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 (Healthy WA).

Healthcare providers should report:

• any significant (or rare and unexpected) AEFIs in both children and adults
• any vaccine reaction that requires assessment by a doctor or nurse
• any vaccine reaction that has affected a family’s confidence in future immunisation.

You can report adverse events even if you are not sure whether the vaccine caused the event.

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

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.

Additionally, if after-hours clinical support is required, including advice on immediate investigation and management of serious AEFI, health professionals can contact the on-call adult Immunologist through Sir Charles Gairdner Hospital switchboard on 6457 3333.

For guidance and advice around AEFI reporting, WAVSS staff can be contacted at:

Email: wavss@health.wa.gov.au
Phone: 08 6456 0208 (Monday to Friday, 08:00 to 16:30, except public holidays).

Monitoring of vaccine safety occurs through a combination of passive and active surveillance systems.

Passive vaccine safety surveillance is the spontaneous reporting of Adverse Events Following Immunisation (AEFI) by individuals, including the patient, GPs, specialist doctors, immunisation providers or the vaccine manufacturer. The is done through the Western Australian Vaccine Safety Surveillance system (WAVSS).

Active vaccine safety surveillance entails contacting vaccine recipients within the week after vaccination via SMS with a brief survey to collect data on any symptoms they may have experienced following the immunisation. WA participates in a national active adverse events surveillance system called AusVaxSafety (external site).

WAVSS system provides:

• a user-friendly way for both immunisation providers and patients to report AEFIs
• clinical support to patients and immunisation providers
• access to specialised immunisation clinics for individuals with a history of a significant AEFI
• individualised assessment of the suspected adverse event and options regarding future vaccinations
• improved knowledge of AEFI through systematic surveillance
• improved reporting levels of AEFI’s to the Therapeutic Goods Administration (TGA) (external site). All AEFIs will be reported to the TGA by WAVSS staff.

WAVSS annual reports

• Western Australia Vaccine Safety Surveillance Annual Report 2019 (PDF 338KB)
• Western Australia Vaccine Safety Surveillance Annual Report 2018 (PDF 388KB)
• Western Australia Vaccine Safety Surveillance Annual Report 2017 (PDF 225KB)
• Western Australia Vaccine Safety Surveillance Annual Report 2016 (PDF 277KB)
• Western Australia Vaccine Safety Surveillance Annual Report 2015 (PDF 739KB)
• Western Australia Vaccine Safety Surveillance Annual Report 2014 (PDF 965KB)
• Western Australia Vaccine Safety Surveillance Annual Report 2013 (PDF 807KB)
• Western Australia Vaccine Safety Surveillance Annual Report 2012 (PDF 377KB)
• Western Australia Vaccine Safety Surveillance Annual Report 2011 (PDF 343KB)

Western Australia Vaccine Safety Advisory Committee (WAVSAC) provides independent expert advice to the Department of Health on the surveillance of AEFI and responding to potential safety signals. Members of WAVSAC include clinical immunologists, adult and paediatric subspecialists, and invited experts in fields relevant to vaccine safety surveillance.

Post vaccination

Doctors and nurses who report a significant AEFI for a patient will receive advice by phone, email or letter from WAVSS to help clinically manage the future care and immunisation needs of these patients. If required, the patient will be contacted by WAVSS staff to arrange an appointment for the Specialist Immunisation Clinic (external site). A separate referral is not required.

If you require further information relating to the progress of an AEFI report, contact WAVSS staff by:

• phone on (08) 6456 0208 (Monday to Friday, 08:00 to 16:30, except public holidays)
• email wavss@health.wa.gov.au

After hours support should be reserved for advice on the immediate investigation and management of serious AEFI. Clinicians may contact the on-call adult immunologist through the Sir Charles Gairdner Hospital switchboard on 08 6457 3333 for urgent after-hours clinical support.

Prior to vaccination

If your patients have medical queries/conditions that require consideration prior to vaccination, you can

• seek advice from the WAVSS staff by:
• phone on (08) 6456 0208 (Monday to Friday, 08:00 to 16:30, except public holidays)
• email wavss@health.wa.gov.au
• For non-WA health providers submit a referral via Central Referral Services (CRS) or for WA health providers via e-referral to:
• SCGH Immunology Specialist Immunisation Clinic for adults or
• PCH Infectious Diseases Specialist Immunisation Clinic for children.

For people who have had significant AEFIs, specialised clinical services are available where they can discuss and receive further vaccinations under medical supervision. On rare occasions, there are adverse events that prevent patients from having further specific vaccinations. For many others re-vaccination is possible.

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 clinical follow-up service provided by WAVSS will increase the confidence of patients and their immunisation providers to continue the immunisation schedule, even if they have experienced an AEFI.

Visit the Australian Immunisation Handbook (external site) for key concepts in vaccine safety and effectiveness, and information about adverse events.