Dear Mr Cummins,

Thank you for your email below dated 16 September 2021 in which you make the following request under the Freedom of Information Act 1982 (FOI Act):

"1) Tally (total count) of adverse events reported to DAEN for each month from 01/01/2020 until 31/08/2021
2) Tally (total count) of adverse events where the outcome was death to DAEN for each month from 01/01/2020 until 31/08/2021"

At the outset, I note that the information you have requested is publicly available. While the TGA webpage you are seeking to access recently experienced technical issues, we are happy to advise that the TGA has resolved the issues and the webpage is once again accessible. While the TGA is not required to create documents or make copies of information which is publicly available, in order to assist you further, I have included some guidance on how to access and utilise the publicly available information below.

The TGA is committed to the transparent and accurate reporting of adverse events. All reports submitted to the TGA are evaluated, duplicate reports are rejected, and the information contained therein is uploaded to the Database of Adverse Event Notifications – medicines (DAEN). The DAEN contains information on all adverse events reported following administration of a medicine.

As of 19 August 2021, the TGA has reduced the time between adverse event reports being accepted into our database and published on the DAEN from 90 days to 14 days. This decision was made in response to the strong public interest in adverse event reports relating to COVID-19 vaccinations and allows reports for vaccines publicly available more quickly.

You can search the DAEN for reports related to specific medicines. You can search for the name of the medicine in the medicines report section, available here: https://apps.tga.gov.au/PROD/DAEN/daen-r.... Once you have typed the first three letters of a medicine name, a list of trade names will appear with the active ingredients shown in brackets. Where the reporter has only provided the TGA with the active ingredient name, the database will display 'Tradename not specified'. Select the medicines you want to search for by ticking or unticking the boxes. For example, to conduct a search by active ingredient, tick the box for each trade name containing the active ingredient.

There are two types of results shown in two tabs: medicine summary (this summary groups reported adverse events together) and list of reports (this lists all relevant reports in chronological order). In the “list of reports” tab, the results table provides the case number, report entry date, the age of the person, gender, medicines reported as being taken and the reaction.

I trust that this information assists you. The TGA apologises for any inconvenience caused by the recent technical issues and encourages you to check the DAEN for the most up-to-date safety information. As the information you have requested is publicly available, I consider your request dated 16 September 2021 to be withdrawn.

Freedom of Information

Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [email address]
PO Box 100, Woden ACT 2606, Australia
Web: www.tga.gov.au

Important: This transmission is intended only for the use of the addressee and may contain confidential or legally privileged information. If you are not the intended recipient, you are notified that any use or dissemination of this communication is strictly prohibited. If you receive this transmission in error please notify the author immediately and delete all copies of this transmission.

The Department of Health acknowledges the Traditional Custodians of Australia and their continued connection to land, sea and community. We pay our respects to all Elders past and present.

From: Timothy Cummins <[FOI #7869 email]>
Sent: Thursday, 16 September 2021 8:21 PM
To: FOI <[email address]>
Subject: Freedom of Information request - DAEN Database total submissions per month from 2020 to 2021

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Dear Therapeutic Goods Administration,

I am requesting the following information.

1) Tally (total count) of adverse events reported to DAEN for each month from 01/01/2020 until 31/08/2021
2) Tally (total count) of adverse events where the outcome was death to DAEN for each month from 01/01/2020 until 31/08/2021

Yours faithfully,
Timothy Cummins.

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