Adverse events following immunisation reporting

An adverse event following immunisation (AEFI) is an unwanted or unexpected event following the administration of a vaccine(s). AEFIs may be caused by a vaccine(s) or may occur by coincidence (that is, the event would have occurred regardless of vaccination). AEFIs also include conditions that may occur following the incorrect handling or administration of a vaccine.

Adverse events and vaccine error – report to SAEFVIC

All AEFIs in Victoria should be reported to SAEFVIC (the Surveillance of adverse events following vaccination in the community) for assessment and expert advice. Any event felt to be significant following immunisation should be reported. You do not need to report common/minor/expected reactions, however any vaccine reaction which has affected a vaccinee's confidence can and should be reported.

AEFIs can be reported via the SAEFVIC website 24 hours a day, 7 days a week.

Alternatively, you can call SAEFVIC on 1300 882 924 (Option 1). Hours of operation are Monday - Friday 9.00am - 4.00pm.

For further information about SAEFVIC please refer to Melbourne vaccination education centre - SAEFVIC.

About SAEFVIC

SAEFVIC is a specialist service that helps immunisation providers and the community manage people who have had an AEFI.

Early detection of AEFI, and appropriate and quick response to any vaccine safety signals protects our community and lessens any negative impact on the immunisation program.

SAEFVIC provides clinical back-up and individualised support to manage future vaccination, which increases the confidence of patients and their immunisation providers.

What to report to SAEFVIC

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

Report all significant (or rare and unexpected) AEFIs in both children and adults to SAEFVIC. You do not need to report common/minor/expected AEFIs.

If you are unsure, contact SAEFVIC for advice or refer to the current edition of The Australian immunisation handbook. You can report adverse events even if you are not sure whether the vaccine caused the event.

SAEFVIC reports all notifications to the Australian Adverse Drug Reactions System (ADRS) at the Therapeutic Goods Administration.

Vaccine errors

Vaccine errors can occur when a vaccine is incorrectly stored, prepared or given outside the current clinical guidelines, potentially resulting in an AEFI. Examples include administration of an expired vaccine, diluent component of a vaccine, vaccine compromised by a cold chain breach or the administration of a vaccine that is contraindicated for an individual or outside recommended age.

Refer to the vaccine error management webpage for details on how to prevent and manage vaccine error, including when to report vaccine error to SAEFVIC.

SAEFVIC services

SAEFVIC provides:

• rapid clinical support and information to patients and immunisation providers
• specialised immunisation clinics for children and adults with a history of significant AEFI
• vaccine safety telehealth consultations for clients in regional Victoria
• systematic surveillance and investigation of vaccine safety signals
• reports on AEFIs to the ADRS.

Specialist immunisation clinics

SAEFVIC provides individualised assessment on the suspected adverse event and options for future vaccinations. Most people can be revaccinated after an AEFI.

If needed, vaccines can be given under medical supervision at a specialist immunisation clinic. A General Practitioner/Specialist referral is required. Clinics are located at:

• Royal Children’s Hospital Melbourne (for children)
• Monash Children’s Hospital (for children)
• Monash Medical Centre (for adults).

Telehealth

Patients and doctors in rural, regional or outer metropolitan areas in Victoria can have an online video consultation with SAEFVIC, using a web-based system similar to Skype. Consultations are bulk-billed and there are no costs to the patient or the doctor.