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Covid-19 Comirnaty/Pfizer vacination associated "brain fog" and similar effects

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Dear Department of Health,

I seek access to all Government held documents, including but not limited to electronic messages, recorded voice calls, memos, dossiers, reports, or advice, that contains the terminology "brain fog", "cognitive", "memory" or "confusion" related to the Comirnaty Pfizer vaccination.

I make this Freedom of information request pursuant to the 1982 Freedom of Information Act.

Yours sincerely,

Michael Betts

FOI, Department of Health

Attention: Michael Betts

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT AND REQUEST FOR AN EXTENSION OF TIME

I am writing to notify you that the Department of Health (department) received your request on 25 October 2021 for access to documents under the Freedom of Information Act 1982 (Cth) (FOI Act) being:

"all Government held documents, including but not limited to electronic messages, recorded voice calls, memos, dossiers, reports, or advice, that contains the terminology "brain fog", "cognitive", "memory" or "confusion" related to the Comirnaty Pfizer vaccination"

The statutory timeframe for processing your request is 30 calendar days within which a decision on access to the requested documents is to be notified. The department may impose a charge for the work involved in providing access to the documents. If this request attracts a charge you will be notified in writing.

Unless you advise otherwise, duplicate documents and Commonwealth employee names and contact details below Senior Executive Service level and mobile telephone numbers of all staff will be excluded from the scope of your request under s22(1)(a)(ii) of the FOI Act.

Request for extension of time

As a result of the ongoing coronavirus pandemic, the department is dealing with a very high volume of FOI requests. To ensure the department can process your request in accordance with the requirements of the FOI Act, including locating and providing access to all relevant documents, the department would be grateful if you would agree to an extension of 30 calendar days for processing your request. If you agree, the department will endeavour to provide a decision to you by 24 December 2021.

Next Steps

Please contact the department by 27 October 2021 with your decision to the 30 day extension of processing time.

You can contact the FOI Unit on via email at [email address], should you have any questions.

Kind regards
FOI Officer

Freedom of Information Section
Legal & Assurance Division |  Corporate Operations Group
Legal Advice & Legislation Branch
Australian Government Department of Health
E: [Health request email] 
GPO Box 9848, Canberra ACT 2601, Australia

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. 

If you receive this email in error, please delete it and contact the sender immediately.

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TGA FOI, Department of Health

Dear Mr Betts

Thank you for your email below dated 25 October 2021 in which you make the following request under the Freedom of Information Act 1982 (FOI Act):

At the outset, I note that your query is not a valid request under the FOI Act. Subsection 15(2)(b) of the FOI Act states that a request must “provide such information concerning the document as is reasonably necessary to enable a responsible officer of the agency, or the Minister, to identify it”.

Your request for "all Government held documents, including but not limited to electronic messages, recorded voice calls, memos, dossiers, reports, or advice, that contains the terminology "brain fog", "cognitive", "memory" or "confusion" related to the Comirnaty Pfizer vaccination" does not provide sufficient information to allow TGA officers to identify relevant documents. Notwithstanding that I am not required under the FOI Act to assist you, I would like to provide you with some publicly available information which may be relevant to your request.

The TGA has published a range of regulatory documents relating to the provisional approval of each COVID-19 vaccine, which provides detailed information regarding the evaluation process and the data that were considered. These include the Australian Public Assessment Report (AusPAR), the Product Information (PI) and the Consumer Medicine Information (CMI), and they are available at: www.tga.gov.au/covid-19-vaccines. The approved PIs and CMIs for each of the COVID-19 vaccines contain information about the recognised side effects of COVID-19 vaccines and are updated as new information becomes available. You can find these documents on our website at: https://www.tga.gov.au/covid-19-vaccine-....

Furthermore, all adverse event reports submitted to the TGA are evaluated, duplicate reports are rejected, and the information in those reports is uploaded to the Database of Adverse Event Notifications (DAEN). The DAEN contains information on all adverse events reported following administration of a medicine, including the COVID-19 vaccines. You can search the DAEN for “COVID” in the medicines report section, available here: https://apps.tga.gov.au/PROD/DAEN/daen-r.... As at 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.

In addition to the vaccine safety monitoring conducted by the TGA, AusVaxSafety, which is led by the NCIRS and funded by the Australian Government Department of Health, conducts active vaccine safety surveillance of the COVID-19 vaccines in use in Australia to ensure their ongoing safety. This information is updated regularly and is accessible here: https://www.ausvaxsafety.org.au/safety-d....

I trust that this information assists you. As your request is not valid, and as I have provided you with publicly available information, I consider your query dated 25 October 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: Michael Betts <[FOI #8008 email]>
Sent: Monday, 25 October 2021 10:53 AM
To: FOI <[email address]>
Subject: TRIM: Freedom of Information request - Covid-19 Comirnaty/Pfizer vacination associated "brain fog" and similar effects

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,

I seek access to all Government held documents, including but not limited to electronic messages, recorded voice calls, memos, dossiers, reports, or advice, that contains the terminology "brain fog", "cognitive", "memory" or "confusion" related to the Comirnaty Pfizer vaccination.

I make this Freedom of information request pursuant to the 1982 Freedom of Information Act.

Yours sincerely,

Michael Betts

-------------------------------------------------------------------

Please use this email address for all replies to this request:
[FOI #8008 email]

Is [Health request email] the wrong address for Freedom of Information requests to Department of Health? If so, please contact us using this form:
https://www.righttoknow.org.au/change_re...

This request has been made by an individual using Right to Know. This message and any reply that you make will be published on the internet. More information on how Right to Know works can be found at:
https://www.righttoknow.org.au/help/offi...

Please note that in some cases publication of requests and responses will be delayed.

If you find this service useful as an FOI officer, please ask your web manager to link to us from your organisation's FOI page.

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Dear Department of Health,

Firstly please let me be clear, my FOI request is to the Department of Health not directly to the TGA.

I disagree with your decision and request an internal review of my request.
The points of relevance relate to my allegation that the Department of Health is being in possession of documents (inter alia) that contain the terminology "brain fog", "cognitive", "memory" or "confusion" related to the Comirnaty Pfizer vaccination"
Since this information concerns public health (including mine) I say that I and the Australian People have a right to access this information.
Document word searches are simple methods to extract these data.
Seeking such documents from Ministerial Offices which encompass my request have not been actioned and as such, I reserve my right to make complaint with the Office of the Australian Information Commissioner and/or seek Order of the Federal Circuit Court of Australia.

Sincerely,
Michael Betts

TGA FOI, Department of Health

6 Attachments

Dear Mr Betts

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

As set out in the attached correspondence, we seek your response within 14
days, being 2 December 2021.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

[3][IMG][4][IMG][5][IMG]

 

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.

 

"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."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...

TGA FOI, Department of Health

5 Attachments

Dear Mr Betts

 

I refer to the TGA’s request consultation letter (attached) that was sent
to you on 18 November 2021.

 

As noted in paragraph 34 of our letter, and, in accordance with subsection
24AB(7) of the FOI Act, as we have not received any correspondence from
you within the 14 days as stipulated in the letter, your request is now
taken to have been withdrawn.

 

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

[3][IMG][4][IMG][5][IMG]

 

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: TGA FOI <[email address]>
Sent: Thursday, 18 November 2021 5:38 PM
To: [FOI #8008 email]
Cc: TGA FOI <[email address]>
Subject: Request consultation - FOI 3252

 

Dear Mr Betts

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

As set out in the attached correspondence, we seek your response within 14
days, being 2 December 2021.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [6][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [7]www.tga.gov.au

 

[8][IMG][9][IMG][10][IMG]

 

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.

 

"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."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
6. mailto:[email address]
7. http://www.tga.gov.au/
8. https://www.facebook.com/TGAgovau/
9. https://twitter.com/TGAgovau
10. https://www.youtube.com/channel/UCem9INJ...

We don't know whether the most recent response to this request contains information or not – if you are Michael Betts please sign in and let everyone know.