Australia's Database of Adverse Event Notifications (DAEN)

Underreported, 93.9% reports lodged by "approved" authorities, HCW not required to report

Blanket Accusation: "Stop exaggerating anecdotal adverse events of COVID Vaccines. You are an anti-vaxxer, anti-science conspiracy theorist & a threat to the health and safety of Australians."

Let’s break it down

Accusation-1:

“You are making up the number of Covid-19 vaccine victims in Australia.”

Facts:

Number of COVID-19 vaccine Adverse Events and Deaths reported to the Australian Government’s Therapeutic Goods Administration (TGA) Database on Adverse Events Notification (DAEN) until 31 October 2021:

Number of reports (cases): 77599

Number of cases with a single suspected medicine: 76316

Number of cases where death was a reported outcome: 633

Source:

<https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx>

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Accusation-2:

“These adverse events are anecdotal reports. Anybody can report vaccine adverse events to the Database of Adverse Events Notification.”

Facts:  

As per the TGA, over a period of 30 years (until very recently on 14 September 2019), 93.9% of ALL vaccine injuries and deaths reports to the DAEN were lodged by "approved" / "authorised" sources. Patients very rarely lodge these reports -- rarer than even the pharmaceutical companies who have a vested interest in their vaccines.

Analysis of the sender type of DAEN adverse event reports for vaccines as held in AEMS (Adverse Event Management System) from 1 Jan 1989 to 14 Sep 2019:

Reporter Type  and  Percentage of Reports:

State and Territory Health Department -- 62%

Health Professional -- 25%

Pharmaceutical Company -- 6.9%

Patient / Consumer -- 6.1%

Other (Distributor, other organisation, unknown) -- < 0.1%

Source:

Australian Government Therapeutic Goods Administration document released on 14 November 2019 under Section 11C of the Freedom of Information Act 1982.

Link to the FOI listing: <https://www.tga.gov.au/documents-released-under-section-11c-freedom-information-act-1982-jul-2019-jun-2020>

This document (FOI 1327) shows the sender type of DAEN reports on vaccine injury or death.

Link to the document: <https://www.tga.gov.au/sites/default/files/foi-1327-document-01.pdf>

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Accusation-3:

“There is over-reporting of Adverse Events.”

Facts:

There is under-reporting of Adverse Events.

TGA states:

“Adverse event reports from consumers and health professionals to the TGA are voluntary, so there is under-reporting by these groups of adverse events related to therapeutic goods in Australia. This is the same around the world.”

Source:

<https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx>

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Accusation-4:

“Most of these Adverse Event reports in the DAEN are very minor issues. People exaggerate.”

Facts:

Health Care Professionals are under no obligation to report any serious adverse events to the TGA. Only the sponsors are. Health Care Professionals and Sponsors gain nothing by taking their time to report exaggerated symptoms.

TGA states:

"It is mandatory under the Therapeutic Goods Act 1989 for sponsors to report to the TGA all serious adverse events suspected of being related to their medicines. As a result, the search results in the DAEN - medicines may reflect a higher ratio of serious to non-serious adverse event reports."

In fact, in the case of COVID-19 Vaccines, Health Care Professionals are dismissing vaccine victims and their families despite the serious nature of the adverse events.

Source:

<https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx>