How AusVaxSafety works

AusVaxSafety sends a short online survey via SMS or email to vaccine recipients in the days after vaccination at participating AusVaxSafety clinics across Australia – including general practices, pharmacies, hospitals, schools, community clinics and Aboriginal Controlled Community Health Organisations.

The survey allows participants to report any side effects (adverse events) they may have experienced following vaccination. 

De-identified survey response data undergo analysis and signal detection. The results of these analyses are reported to the Australian Government Department of Health, Disability and Ageing – including the Therapeutic Goods Administration (TGA) – and state and territory health departments and contribute to Australian vaccine safety surveillance investigations of any potential safety concerns.

Vaccine safety data are published online.

How does AusVaxSafety monitor vaccine safety?

Safety signal detection

AusVaxSafety also uses survey data to look for potential safety signals. A vaccine safety signal occurs when a known or new adverse event following immunisation (AEFI) may be happening more often than expected.

AusVaxSafety uses two signal detection methods – posterior predictive analysis and first initial response cumulative summation – to monitor if more people than expected seeking medical attention (i.e. visiting a doctor or hospital) or having a fever (in children less than 5 years of age) after vaccination, either during the latest analysis period or across the whole surveillance period.

Safety signal investigation

When a safety signal is identified, steps are taken to confirm that the signal is true and not due to a data error. 

The cause of the signal is then investigated. This includes looking at:

• the strength of the safety signal (i.e. level above normal)
• the AEFI reporting pattern over time
• if the reporting is concentrated in a specific population, area of Australia or to a batch of vaccine
• the reasons for visiting a doctor or hospital. 

Experts then investigate possible reasons behind the patterns. These may include: 

• other illnesses circulating in the community at the same time
• recent news stories and international safety alerts about the vaccine
• changes in how the vaccine is made
• other reasons that may not be related to the vaccine itself. 

Findings are then shared with the TGA and state and territory health departments to determine whether a similar pattern is emerging in the other surveillance systems. Where appropriate, the results may inform regulatory decisions and policy updates.