Adverse event following immunisation (AEFI)

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 (WAVSS) system.

Active vaccine safety surveillance entails contacting vaccine recipients within the week after vaccination via SMS or email 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).

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.

Western Australia Vaccine Safety Expert Clinical Review Group (ECRG) is a group of clinical experts that assesses referred reports of severe adverse events following immunisation, examines relevant clinical information and reports these data to WAVSAC and, where relevant, the TGA.

WAVSS system provides:

• a user-friendly way for both immunisation providers and patients to report AEFIs
• 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.

Whilst the WAVSS system can provide advice to healthcare providers 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.

• Anyone can report an AEFI in WA.
• 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).
• Pharmacists administering vaccines are required under their Structured Administration and Supply Arrangement (SASA) to report all adverse events following immunisation to the WAVSS system and the patient’s nominated healthcare provider.
• 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.

AEFI 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 healthcare provider
• 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 (WAVSS) system 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 SAFEVAC-WAVSS reporting guide (PDF 642KB) 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, healthcare providers 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).

Information provided in AEFI reports may be:

• provided to a WAVSS clinician for assessment;
• investigated for any potential vaccine or immunisation system problems;
• forwarded to the Therapeutic Goods Administration (TGA) who closely monitor and assess vaccine safety in Australia;
• combined with information from other reports, and the combined, de-identified information made available as vaccine safety data for the general public, immunisation policy makers, national vaccine surveillance networks and researchers of ethically approved studies.

For further information about how WA Health collects, discloses and uses the personal information of people who report an AEFI, see the WAVSS Privacy Policy (PDF 180KB).

Post vaccination

Healthcare providers 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 at the Specialist Immunisation Clinic (external site) at Perth Children’s Hospital for paediatric patients, or the Vaccine Safety Clinic at Sir Charles Gairdner Hospital for adult patients. A separate referral is not required.

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

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

Prior to vaccination

If your patient has a medical history that requires consideration prior to vaccination, you can:

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

Telehealth

Patients and doctors in rural, regional or outer metropolitan areas in Western Australia can have an online video consultation with specialist immunisation services using a web-based system similar to Skype.

WAVSS annual reports from 2011 onwards can be accessed below.

• Western Australia Vaccine Safety Surveillance Annual Report 2022 (PDF 1.3MB)
• Western Australia Vaccine Safety Surveillance Annual Report 2021 (PDF 1.3MB)
• Western Australia Vaccine Safety Surveillance Annual Report 2020 (PDF 844KB)
• 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)