SAFEVAC Reporting

An adverse event following immunisation is any untoward medical occurrence that happens following administration of a vaccine. It can be coincidentally associated with immunisation, without necessarily being caused by the vaccine.

Most side effects from vaccines (adverse events) are mild and short-lasting. A vaccine error is also considered an AEFI and may be related to the way a vaccine was stored, prepared or administered. Severe side effects from vaccines are rare.

You should report:

• Any event felt to be significant following immunisation, regardless of whether you think the symptoms were related to the vaccine or not
• Any expected symptoms that have not gone away after a few days
• Any side effects following an immunisation which requires assessment by a doctor or nurse
• Any vaccine administration errors

You do not need to routinely report: Minor, common or expected side effects

Any adverse events (as outlined in the criteria above) should be reported by first registering, and then logging in using the buttons at the top of the page. The vaccinee (person who received the vaccine) may receive follow up clinical advice (email or telephone) for these reports.

For more information on how to report an AEFI please see the Reporting Guide.

Any vaccinated individual, parents/guardians, immunisation providers or treating medical practitioner can report an AEFI to SAEFVIC by first registering, and then logging in with the buttons at the top of the page.

SAEFVIC forwards all adverse event reports to the Australian Therapeutic Goods Administration (TGA) who use this information to assist in the identification of any possible vaccine safety signal or 'flag' for concern. If a safety signal is identified, it is thoroughly investigated to determine the possible role that the vaccine or system played in causing the event.

When requested or deemed appropriate, SAEFVIC will offer advice to the immunisation provider and/or reporter. SAEFVIC does not provide acute management advice to patients. Consent to contact must be obtained if you would like SAEFVIC to follow up with the vaccinee. Not all reports will receive follow up.

Timely reporting to SAEFVIC enables us to quickly detect any potential vaccine safety or system problems. This helps to ensure Victoria has a safe immunisation program and maintains community confidence.

To find out more about why this data is collected and what it is used for click here.

Data is securely stored in the SAEFVIC clinical quality registry managed by Murdoch Children's Research Institute(MCRI). MCRI uses secure environment and regularly tests its systems to maintain data security.

The data may be shared with:

• The Therapeutic Goods Administration (TGA) for vaccine safety monitoring
• Clinicians (in the case of serious adverse events) for expert review and follow up
• Researchers, policy makers and vaccine surveillance networks in de-identified form
• The general public, also in de-identified form as part of vaccine safety data releases

The data is used to:

• Identify potential vaccine safety concerns or patterns
• Investigate and respond to vaccine or immunisation issues
• Monitor and improve vaccine safety at local and national levels

• The TGA uses the data to monitor and assess vaccine safety nationwide
• Clinicians use it to review and follow up significant cases
• Researchers and surveillance networks use the combined data to study vaccine safety trends and improve immunisation programs
• Policy makers use the findings to guide vaccine policy and safety standards

Where consent is given, you may be contacted for a further discussion of the adverse event. Not all reports will receive follow up.