User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version

Closed 26 Oct 2022

Opened 28 Sep 2022

Feedback updated 3 Feb 2023

We asked

We asked for feedback on your experience searching for adverse events using the DAEN – medicines beta version. We developed this beta version to improve the performance and useability for users

You said

There were 34 responses to the survey. Users self-identified as sponsors, health professionals, consumers, academic researchers and other stakeholders.

Most users (70%) preferred the beta version. They commented that it looks nicer, was faster to search for products and easier to find the desired information. Many users (60%) also found the graphs useful. They said the graphs give a simple picture of the results and help to understand the prevalence of adverse events.

Users told us their challenges while using the beta version:

  • using the date selector
  • limit on the number of rows available for data export
  • some cases do not include age
  • not able to locate the number cases where death was the reported outcome
  • searching for cases without a trade name reported
  • Sponsor needs for access to additional information not displayed in the DAEN – medicines to fulfil their pharmacovigilance responsibilities.

We did

The beta testing period for the new DAEN – medicines is complete. The older version of the database has increasingly experienced performance issues and we have now removed links to that interface from the TGA website. This means that the new beta version of the DAEN – medicines is the only version available on the TGA website.

We have also updated our user guidance on the TGA website with search tips and information about search results, for example where cases may be missing details such as age. The DAEN – medicines shows cases where death was the reported outcome in the Search summary counter and the Medicines summary. We also provide information on deaths following COVID‑19 vaccination in our COVID-19 vaccine safety reports.

To support sponsors accessing information needed for their medicine safety responsibilities, we are also developing a secure, self-serve portal where they can access deidentified data related to their medicines. You can find more information on this at Improving access to medicine adverse event data.

We noted that some researchers and academic users seek to download more data than the 150,000 export limit. The complete data set can now be exported using filters to split the data into separate export files.


The Database of Adverse Event Notifications (DAEN) – medicines is the TGA’s public database displaying information about reports of suspected adverse events received in relation to medicines (including vaccines) and biological therapies in Australia.

The TGA have created a trial (beta) version of the DAEN – medicines with updated technology to improve its performance, reliability and user experience.

The beta version was created to address a decline in the older database's performance and reliability, including longer response times and time-out issues for users. Many of these issues were due to unprecedented interest in the safety of medicines and vaccines, leading to increased adverse event reporting to the TGA and more people searching the DAEN - medicines.

About medicine adverse event reports

Adverse events are unintended and sometimes harmful occurrences associated with the use of a therapeutic good, such as a medicine or vaccine. The therapeutic good may have caused the event, or it may be a coincidence that the event occurred after its use. Adverse events can also be reported for other types of therapeutic good, including medical devices.

Adverse events can range in severity – from mild, expected reactions such as the headache, nausea and body aches associated with a medicine or vaccine, to more severe events that can result in birth defects or lead to a fatal outcome. 

We encourage people to report adverse events even when it is not clear that a medicine was the cause. Adverse event reports reflect the observations of the person who reported them. Publishing adverse event reports does not mean that the details of the event have been confirmed, or that the event has been determined to be related to a medicine.

Why your views matter

We are seeking feedback on your experience of the beta version of the DAEN – medicines, currently available on the TGA website alongside the older version.

Your feedback will help to inform possible future user experience improvements.

What happens next

A summary of the feedback we recieve will be published on this page and shared with relevant stakeholders.

We are continually reviewing how we can better communicate about adverse events with consumers, health professionals and industry and are actively working on improvements. Future improvements may include expanding the level of information in the DAEN - medicines, consistent with international best practice, while still safeguarding personal privacy.


  • Non-government organisations
  • Health professionals
  • General public
  • Prescription medicines
  • Complementary medicines
  • Over-the-counter medicines
  • Biologicals


  • Regulatory policy