Dear Dee Mo,

Thank you for your email below dated 1 September 2021 in which you make the following request under the Freedom of Information Act 1982 (FOI Act) asked the following:

“Can i please have a copy of the latest TGA Adverse Event Reports and Deaths since The jab rollout - January 2021.
Last time I checked it was over 50,000 Adverse Events and over 400 deaths!! Why isnt the Nation being told about this? After all the government supposed to be "transparent"

The current US VAERS report states 85,000 serious adverse events/deaths to date and who knows how many other countries in the world have.

If the jabs are still in Emergency Use Approval - why is the government mandating these on people. This could be considered crimes against humanity. Pfizer (cominarty) is still not fully approved until they provide the FDA witb a full list of ingredients.

Can you please explain why you are trying to force these medical experiments (going against Section 50 xxiiiA of our Australian constitution - may I remind you that the Constitution trumps any federal or state law) on healthy young adults and children when this virus has a 99.9% recovery and we have an immune system to heal us? Why isnt informed consent being advertised, after all that is our right, jt says so in the Vaccinaction Act??”

At the outset, I note that your query is not a valid request under the FOI Act. The TGA is not required under the FOI Act to create a document, make copies of information which is publicly available or answer specific questions. Notwithstanding that the TGA is not required to answer your questions, I would like to provide you publicly available information which is relevant to your request.

Publicly available information regarding Adverse Event Reports and Deaths

You can access information about all adverse events reported following vaccination with the COVID-19 vaccines in Australia via the Database of Adverse Event Notifications (DAEN), available on the TGA website.

The DAEN contains information from reports of adverse events that the TGA has received in relation to medicines, including vaccines, used in Australia. If you are interested in this information, we refer you to: https://apps.tga.gov.au/PROD/DAEN/daen-e....

You can search the DAEN for “COVID” in the medicines report section, available here: https://apps.tga.gov.au/PROD/DAEN/daen-r.... 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 and list of reports. In the “list of reports” tab when you search for the COVID-19 vaccine, the results table provides the case number, report entry date, the age of the person, gender, medicines reported as being taken and the reaction.

Reporting of an adverse event and publication of an adverse event in the DAEN does not mean the event was related to the vaccine. There might be no relationship between the adverse event and the medicine or vaccine - it may be a coincidence that the adverse event occurred when the medicine or vaccine was taken, and the symptom may be related to the underlying illness or to other factors. Expert analysis and review of adverse event reports is needed to determine whether there may be a link between reported events and vaccination.

The TGA analyses adverse event report data and reviews individual reports to identify possible safety issues for investigation. If these investigations confirm a safety signal, the TGA takes appropriate action. There is not a predefined number of adverse event reports that leads to removal of a product from the market because the type of action depends on the nature of the safety issue identified, including its likelihood and severity and the potential to mitigate the risk (such as through patient selection or monitoring), and the impact of the safety issue on the balance of benefits and risks for the product.

I also note that AusVaxSafety is an active vaccine safety surveillance system that complements the TGA’s enhanced safety surveillance activities. Active vaccine safety surveillance uses SMS and a short survey to collect reports of AEFI directly from a subset of people receiving the vaccines. AusVaxSafety is an Australian Government-funded system that shares its findings with the TGA to assist safety investigations and responses. Please see details of AusVaxSafety’s latest COVID-19 safety data available here: https://www.ausvaxsafety.org.au/safety-d....

The TGA also publishes a weekly safety report for COVID-19 vaccines. Any deaths causally linked to any of the COVID-19 vaccines in Australia will be reported on in these updates. All weekly safety reports remain available on the TGA website at this address: https://www.tga.gov.au/periodic/covid-19....

To date, over 19 million doses of COVID-19 vaccines have been given. So far, the TGA has found that 9 reports of deaths were linked to immunisation from 495 reports received and reviewed. These deaths occurred after the first dose of the Vaxzevria (AstraZeneca) vaccine – 8 were TTS cases and 1 was a case of immune thrombocytopenia (ITP). This information is contained in the most recent TGA safety report, which can be found here: https://www.tga.gov.au/periodic/covid-19....

Publicly available information regarding COVID-19 vaccine approval

Application for registration of COVID-19 vaccines using the provision approval pathway is consistent with the mechanisms being used by other international regulators to assess and evaluate COVID-19 vaccine applications. It is important to note that an evaluation under the provisional pathway is still a full review, and the TGA does not have a mechanism for emergency use authorisations. The TGA provisionally approved the relevant COVID-19 vaccines after a complete assessment of all the available data. For more information on the approval process for the COVID-19 vaccines, we refer you to: https://www.health.gov.au/initiatives-an....

Please also note that as part of the provisional approval process, the TGA requires that a full list of the ingredients found in COVID-19 vaccines be made publicly available for healthcare professionals and consumers. This can be found within the comprehensive Product Information (PI) document and Consumer Medicine Information (CMI) leaflets for each vaccine.

The PI and CMI documents are available on the TGA’s website at: www.tga.gov.au/covid-19-vaccines. To access these documents, click on the ‘Provisional Registrations’ heading and then select the name of each vaccine. In the CMI, the ingredients are listed under section 7 ‘Product Details’. Ingredients are also listed on the TGA website at: https://www.tga.gov.au/covid-19-vaccine-...

Please see the TGA’s Disclosure Log at www.tga.gov.au/foi-disclosure-log and the documents released in response to FOI 2389 (FOI documents 1 – 7). I note that similar documents with respect to the AstraZeneca vaccine are the subject of a separate FOI request, and these documents may be available on the disclosure log in due course.

These documents outline the TGA’s evaluation and assessment of data submitted by the relevant sponsors – that is, the documents provide a useful summary and analysis of the data submitted to the TGA for the purposes of considering the provisional approval of the COVID-19 vaccines.

Please also note that the Pfizer (COMIRNATY) vaccine has received full approval from the FDA in the USA. Further information is available at: https://www.fda.gov/vaccines-blood-biolo....

Publicly available information regarding vaccination in Australia

The TGA is not responsible for the roll-out of the COVID-19 vaccines. Nonetheless, I wish to assure you that vaccination for COVID-19 remains voluntary. Further information on being vaccinated is available from the Department of Health at: https://www.health.gov.au/initiatives-an...

I trust that this information assists you. Whilst the TGA is not required under the FOI Act to answer your specific questions, to assist you, we have provided you with the publicly available information in relation to your queries. As the information you have requested does not amount to a valid request, I consider your request dated 1 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: Dee Mo <[FOI #7794 email]>
Sent: Wednesday, 1 September 2021 10:40 PM
To: FOI <[email address]>
Subject: Freedom of Information request - TGA weekly Adverse Events

REMINDER: Think before you click! This email originated from outside our organisation. Only click links or open attachments if you recognise the sender and know the content is safe.
Dear Department of Health,

Can i please have a copy of the latest TGA Adverse Event Reports and Deaths since The jab rollout - January 2021.
Last time I checked it was over 50,000 Adverse Events and over 400 deaths!! Why isnt the Nation being told about this? After all the government supposed to be "transparent"

The current US VAERS report states 85,000 serious adverse events/deaths to date and who knows how many other countries in the world have.

If the jabs are still in Emergency Use Approval - why is the government mandating these on people. This could be considered crimes against humanity. Pfizer (cominarty) is still not fully approved until they provide the FDA witb a full list of ingredients.

Can you please explain why you are trying to force these medical experiments (going against Section 50 xxiiiA of our Australian constitution - may I remind you that the Constitution trumps any federal or state law) on healthy young adults and children when this virus has a 99.9% recovery and we have an immune system to heal us? Why isnt informed consent being advertised, after all that is our right, jt says so in the Vaccinaction Act??

Yours faithfully,

Dee Mo

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"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."

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