TGA database of adverse event notification following covid-19 vaccine injection
This request for information is made in accordance with the FOI Act.
Please refer to the TGA database of adverse event notifications. At 23/10/2021 the database recorded 71, 529 adverse events following injection of one of four covid-19 vaccines. The administration has disabled the database's PDF generator. The public is unable to export the data for review and analysis.
Please provide a printed copy of the database's report recording all adverse events reported following injection of the covid-19 vaccines as at 23/10/2021. Please also provide this information in an excel spreadsheet form if possible.
Yours faithfully,
Jaay-H
Dear Jaay,
Thank you for your correspondence dated 6 November 2021 in which you request the following under the Freedom of Information Act 1982 (the FOI Act):
“Please provide a printed copy of the database's report recording all adverse events reported following injection of the covid-19 vaccines as at 23/10/2021. Please also provide this information in an excel spreadsheet form if possible.”
We note that the purpose of the FOI Act is to provide access to documents held by the TGA. The information you have requested, being the Database of Adverse Events Notifications (DAEN) is already publicly available and capable of being extracted into other formats.
We also note that the DAEN is an online database which is updated live, as new information emerges. Therefore, we advise that the optimum method of ensuring that you are accessing the most up-to-date and accurate information regarding adverse events is by accessing the DAEN online.
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. To improve performance for the large number of users searching DAEN Medicines, PDF generation of search results has temporarily been disabled.
Notwithstanding, you can extract the information currently contained on the DAEN by copying and pasting the List of Reports table into your desired form. You can do this by setting the number of ‘Records to display’ to the highest value, ‘500’, and then copying the List of Reports table into an Excel spreadsheet.
This will preserve the information you have requested, including all hyperlinks contained in the table.
I trust that this information assists you. As the information you have sought is in the public domain, and as I have provided you with guidance on accessing and downloading it, I consider your request dated 6 November 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
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