Adverse events reporting
Page contents: SAEFVIC |How do I report AEFI in Victoria? | What does SAEFVIC provide? | What is an AEFI? | Should all AEFI be reported? | How can immunisation providers refer a patient to an adult or children's specialist immunisation clinic? | TeleHealth | Do immunisation providers still have to report a significant AEFI to ASCOM? | Why is it important to collect information about AEFI? | Download factsheet
In Victoria adverse events following immunisation (AEFI) should be notified to SAEFVIC – the Surveillance of Adverse Events Following Vaccination in the Community.
This specialist service helps immunisation providers and the community manage children and adults who have had an AEFI.
Please report an AEFI at any time (24 hours and 7 days a week) by:
Online report via: www.saefvic.org.au
1300 882 924 or 03 9345 4143 between 10am and 4pm, Monday to Friday. All other times, please leave contact details on the answering machine and the SAEFVIC nurses will return your call as soon as possible.
Email, fax or post:SAEFVIC form for reporting an adverse event following immunisation
Fax: 03 9345 4163 (24 hours)
SAEFVIC, Murdoch Children's Research Institute
c/- Royal Children's Hospital
Parkville Vic 3052
- Rapid clinical support and information to patients and immunisation providers
- Specialised immunisation clinics for children and adults with a history of a significant AEFI
- Vaccine safety TeleHealth consultations for clients in regional Victoria
- Improved knowledge of AEFI by systematic surveillance and investigation of vaccine safety signals
- Improved levels of reporting of AEFIs to the Therapeutic Goods Administration (TGA), as all our reports are forwarded to the national Australian Committee on the Safety of Medicine (ACSOM).
The international definition of an AEFI is 'an unwanted or unexpected event following the administration of a vaccine(s). AEFI may be caused by a vaccine(s) or may occur by coincidence (ie it would have occurred regardless of vaccination)'. AEFIs also include conditions that may occur following the incorrect handling and/or administration of a vaccine(s).We welcome reports even if you are unsure whether the vaccine caused the event.
Currently AEFI are classified as 'common/minor' or 'significant'. Please report all significant (or rare and unexpected) AEFI in both children and adults to SAEFVIC. It is not a requirement to report common/minor AEFI, but if uncertain SAEFVIC staff are happy to discuss any vaccine safety queries. Immunisation providers should refer to the current edition of the Australian Immunisation Handbook for more information regarding significant AEFI.
How can immunisation providers refer a patient to an adult or children's specialist immunisation clinic?
SAEFVIC offers individualised assessment on the suspected adverse event and provides options regarding future vaccinations. Although some adverse reactions contraindicate further vaccine doses, in most who require it, revaccination is possible. Revaccination plans are provided to providers and patients. If needed, subsequent vaccines be administered under medical supervision at one of the hospital-based clinics (as an out-patient or, if required, as an in-patient).
A GP referral is required for patients to attend any of the SAEFVIC clinics. The immunisation clinics are located at the Royal Children's and Monash Medical Hospitals (for children), and Monash Medical Centre and the Royal Melbourne Hospital (for adults). SAEFVIC can provide immunisation providers with more information regarding these clinics and TeleHealth.
More information is available at http://www.rch.org.au/telehealth contact SAEFVIC on 9345 4143.
Do immunisation providers still have to report a significant AEFI to ACSOM (the Advisory Committee on the Safety of Medicines)?
No. They only need to report to the SAEFVIC Unit. The SAEFVIC Unit report all AEFI they receive directly to ACSOM. The TGA lists an anonymised summary of all adverse event reports national on its website.
The early detection of AEFI, and appropriate and quick response to any vaccine safety signals, protects our community and lessens any negative impact immunisation program.
The clinical back-up and individualised support provided by SAEFVIC increases the confidence of patients and their immunisation providers to continue the immunisation schedule, even if they have experienced an AEFI.SAEFVIC-Information for all immunisation providers