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Information regarding AEFI's reported after MMR vaccine

Shanna Miller made this Freedom of Information request to Department of Health

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From: Shanna Miller

Delivered

Dear Department of Health,

I hereby request the release of documents held by the Therapeutic Goods Association for the purposes of Freedom of Information Act 1982.

Documents requested:

1. A list of reports of Adverse Reactions Following Immunisation reported to the TGA after administration of the MMR 11, Priorix, Priorix Tetra and Proquad vaccines, that were not transferred to the Database of Adverse Events Notifications. Please include reports from the beginning of 2010 until the most current reports available.
2. All information detailing the reasons that the AEFI was not transferred to the DAEN.

Yours faithfully,
Shanna Miller

Link to this

From: TGA FOI
Department of Health


Attachment image006.png
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Dear Ms Miller

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act) for:

“…Documents requested:

 

1.       A list of reports of Adverse Reactions Following Immunisation
reported to the TGA after administration of the MMR 11, Priorix, Priorix
Tetra and Proquad vaccines, that were not transferred to the Database of
Adverse Events Notifications. Please include reports from the beginning of
2010 until the most current reports available.

2.       All information detailing the reasons that the AEFI was not
transferred to the DAEN.”

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 18 August 2019.

However, where there is requirement to undertake consultation with
affected third parties, this timeframe is extended by a further 30 days.
It may also be extended in certain circumstances, including with your
agreement or where the Department applies to the Office of the Australian
Information Commissioner for an extension.

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

PROCESSING YOUR REQUEST

To assist us to streamline the processing of your request we ask you to
consider and respond to the following questions.

 

1.       Personal Information

Documents containing personal information, (e.g. the names and contact
details of any individuals, or any information that could reasonably
identify an individual) may require the Department to consult with the
identified individuals or parties. This consultation is likely to add to
the time taken to process your request, and potentially increase the
charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal information in the documents (e.g. names, contact
details, addresses) relating to:

·         third parties; and

·         Commonwealth staff (please note that unless you advise
otherwise, we will assume that you do not seek access to personal
information of Commonwealth employees below Senior Executive Service
level).

 

If you are not seeking access to any personal information, you can simply
reply: 'no personal information requested'.

 

If you are seeking access to specific types of personal information,
please specify the type of personal information you require.

 

2.       Duplicate Documents

Under section 4(1) of the FOI Act, the definition of a document includes
‘any copy, including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

We look forward to hearing from you by COB Friday 26 July 2019.

If you have any queries, please contact the FOI team on (02) 6232 8806, or
via email at [1][email address].

Kind regards

 

Freedom of Information
(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [2][email address]

 

[3]cid:image001.png@01D1D5D9.7DDEADA0

 

show quoted sections

Link to this

From: TGA FOI
Department of Health


Attachment image001.png
3K Download


Dear Ms Miller

 

Thank you for your FOI request regarding adverse event reports for MMR 11,
Priorix, Priorix Tetra and Proquad vaccines, which was received by the
Therapeutic Goods Administration on 19 July 2019.

 

I am writing to seek clarification regarding the scope of your request.

 

In its current form, the scope may be too voluminous for the TGA to
process.

 

Prior to June 2018, the reason for a case not being included in the DAEN
was not systematically recorded within the database. For some cases the
reason may be available if it was recorded in a free text field of the
database. A preliminary review of some of the database entries relating to
AEFIs prior to June 2018 indicates that a reason is not always readily
apparent for each AEFI. Nonetheless, if you do seek access to such
information, a manual search of all records relating to each AEFI prior to
June 2018 would be necessary to determine the existence of otherwise of
such documents, which is likely to add significantly to the time taken to
process your request, and potentially increase the amount of any charge
that may be imposed on you. In addition, these documents may include
personal information, and release of this information may require third
party consultation, which may also increase time and associated charges.

 

We would be grateful if you could you please revise the scope by:

 

1.       advising what you mean by “a list of reports” – could you please
indicate if you require:

o   a list of individual reports with the level of detail like the public
view of the Database of Adverse Event Notifications (DAEN) or

o   the view as reports appear in the Adverse Event Management System
(TGA’s internal adverse event database) but not to the level of detail
provided on the DAEN in the ‘list of reports’ view.

 

2.       indicating if you require personal information - Documents
containing personal information, (e.g. the names and contact details of
any individuals, or any information that could reasonably identify an
individual such as personal medical information) may require the
Department to consult with the identified individuals or parties. This
consultation is likely to add to the time taken to process your request,
and potentially increase the charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal information in the documents (e.g. names, contact
details, addresses) relating to:

o   third parties; and

o   Commonwealth staff (please note that unless you advise otherwise, we
will assume that you do not seek access to personal information of
Commonwealth employees below Senior Executive Service level).

 

If you are not seeking access to any personal information, you can simply
reply: 'no personal information requested'.

 

3.       indicating if you require duplicate information - Under section
4(1) of the FOI Act, the definition of a document includes ‘any copy,
including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Furthermore, to ensure we are providing what you request, I would like to
advise that the TGA’s internal database may contain reports from more than
one source in relation to an adverse event. These are termed ‘duplicate
reports’, and the information may differ slightly between reports due to
differences in how the reporter described the reactions.  These differ
from ‘duplicate copies’ which refers to a reproduction or replica of a
document (e.g. where the same report has been stored in two locations, it
would be a duplicate copy).

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

Alternatively, you may wish to consider submitting the following scope:

 

“…I hereby request the release of documents held by the Therapeutic Goods
Association for the purposes of Freedom of Information Act 1982.

 

Documents requested:

 

1.                   A list of reports of Adverse Reactions Following
Immunisation (AEFI) reported to the TGA after administration of the MMR
11, Priorix, Priorix Tetra and Proquad vaccines, that were not transferred
to the Database of Adverse Events Notifications. Please include reports
from the beginning of 2010 until the most current reports available.
Personal information and duplicate copies of documents are not requested,
and the information provided should be to the same level as that included
in the ‘list of reports’ public view of the DAEN.

 

2.                   For cases entered after June 2018, the reasons that
the AEFI was not transferred to the DAEN. For cases reported prior to June
2018, the reasons that the AEFI was not transferred to the DAEN if it is
available within the database”

 

Please note that at this early stage, this scope is a sample only, and the
TGA is unable to advise on how many documents (if any) would be returned
if a search and retrieval was conducted.

 

We would be grateful for your response by 5pm on Wednesday 31 July 2019.

 

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

 

Kind regards

 

Freedom of Information
+61 (0)2 6232 8806

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

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.

 

show quoted sections

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From: TGA FOI
Department of Health


Attachment image001.png
3K Download


Dear Ms Miller

 

I am writing to follow up a request for scope clarification (see email
below), which was sent on 29 July 2019.

 

As the due date for your response has now passed, I would be very grateful
if you could please provide a response by COB 2 August 2019.

 

Please note that if a response from you is not received by this time, the
TGA will continue to process your request using your original scope.

 

Thank you for your cooperation.

 

Kind regards

 

Freedom of Information
+61 (0)2 6232 8806

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

 

From: TGA FOI
Sent: Monday, 29 July 2019 1:03 PM
To: '[FOI #5523 email]'
Cc: TGA FOI
Subject: FOI 1231 - Scope clarification [SEC=OFFICIAL]

 

Dear Ms Miller

 

Thank you for your FOI request regarding adverse event reports for MMR 11,
Priorix, Priorix Tetra and Proquad vaccines, which was received by the
Therapeutic Goods Administration on 19 July 2019.

 

I am writing to seek clarification regarding the scope of your request.

 

In its current form, the scope may be too voluminous for the TGA to
process.

 

Prior to June 2018, the reason for a case not being included in the DAEN
was not systematically recorded within the database. For some cases the
reason may be available if it was recorded in a free text field of the
database. A preliminary review of some of the database entries relating to
AEFIs prior to June 2018 indicates that a reason is not always readily
apparent for each AEFI. Nonetheless, if you do seek access to such
information, a manual search of all records relating to each AEFI prior to
June 2018 would be necessary to determine the existence of otherwise of
such documents, which is likely to add significantly to the time taken to
process your request, and potentially increase the amount of any charge
that may be imposed on you. In addition, these documents may include
personal information, and release of this information may require third
party consultation, which may also increase time and associated charges.

 

We would be grateful if you could you please revise the scope by:

 

1.       advising what you mean by “a list of reports” – could you please
indicate if you require:

o   a list of individual reports with the level of detail like the public
view of the Database of Adverse Event Notifications (DAEN) or

o   the view as reports appear in the Adverse Event Management System
(TGA’s internal adverse event database) but not to the level of detail
provided on the DAEN in the ‘list of reports’ view.

 

2.       indicating if you require personal information - Documents
containing personal information, (e.g. the names and contact details of
any individuals, or any information that could reasonably identify an
individual such as personal medical information) may require the
Department to consult with the identified individuals or parties. This
consultation is likely to add to the time taken to process your request,
and potentially increase the charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal information in the documents (e.g. names, contact
details, addresses) relating to:

o   third parties; and

o   Commonwealth staff (please note that unless you advise otherwise, we
will assume that you do not seek access to personal information of
Commonwealth employees below Senior Executive Service level).

 

If you are not seeking access to any personal information, you can simply
reply: 'no personal information requested'.

 

3.       indicating if you require duplicate information - Under section
4(1) of the FOI Act, the definition of a document includes ‘any copy,
including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Furthermore, to ensure we are providing what you request, I would like to
advise that the TGA’s internal database may contain reports from more than
one source in relation to an adverse event. These are termed ‘duplicate
reports’, and the information may differ slightly between reports due to
differences in how the reporter described the reactions. These differ from
‘duplicate copies’ which refers to a reproduction or replica of a document
(e.g. where the same report has been stored in two locations, it would be
a duplicate copy).

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

Alternatively, you may wish to consider submitting the following scope:

 

“…I hereby request the release of documents held by the Therapeutic Goods
Association for the purposes of Freedom of Information Act 1982.

 

Documents requested:

 

1.                   A list of reports of Adverse Reactions Following
Immunisation (AEFI) reported to the TGA after administration of the MMR
11, Priorix, Priorix Tetra and Proquad vaccines, that were not transferred
to the Database of Adverse Events Notifications. Please include reports
from the beginning of 2010 until the most current reports available.
Personal information and duplicate copies of documents are not requested,
and the information provided should be to the same level as that included
in the ‘list of reports’ public view of the DAEN.

 

2.                   For cases entered after June 2018, the reasons that
the AEFI was not transferred to the DAEN. For cases reported prior to June
2018, the reasons that the AEFI was not transferred to the DAEN if it is
available within the database”

 

Please note that at this early stage, this scope is a sample only, and the
TGA is unable to advise on how many documents (if any) would be returned
if a search and retrieval was conducted.

 

We would be grateful for your response by 5pm on Wednesday 31 July 2019.

 

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

 

Kind regards

 

Freedom of Information
+61 (0)2 6232 8806

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

show quoted sections

Link to this

From: Shanna Miller

Delivered

Dear TGA FOI,

I hereby request the release of documents held by the Therapeutic Goods
Association for the purposes of Freedom of Information Act 1982.

Documents requested:

1. A list of reports of Adverse Reactions Following
Immunisation (AEFI) reported to the TGA after administration of the MMR
11, Priorix, Priorix Tetra and Proquad vaccines, that were not transferred
to the Database of Adverse Events Notifications. Please include reports
from the beginning of 2010 until the most current reports available.
Personal information and duplicate copies of documents are not requested,
and the information provided should be to the same level as that included
in the ‘list of reports’ public view of the DAEN.

2. For cases entered after June 2018, the reasons that
the AEFI was not transferred to the DAEN. For cases reported prior to June
2018, the reasons that the AEFI was not transferred to the DAEN if it is
available within the database”

Yours sincerely,

Shanna Miller

Link to this

From: Shanna Miller

Delivered

Dear TGA FOI,

In addition to my previous response today, I would like to request that this includes any previous versions (since 2010) of any Measles vaccine that may not be currently on the NIP.

Yours sincerely,

Shanna Miller

Link to this

From: TGA FOI
Department of Health


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3K Download


Dear Ms Miller

 

I am writing to confirm that as of 13 August 2019 the TGA has accepted
your revised scope (below), and confirms a practical refusal reason no
longer exists. As such, the TGA will continue to process your request.

 

“…Documents requested:

 

1.       A list of reports of Adverse Reactions Following Immunisation
(AEFI) reported to the TGA after administration of the MMR 11, Priorix,
Priorix Tetra and Proquad vaccines that were not transferred to the
Database of Adverse Events Notifications. Please include reports from the
beginning of 2010 until the most current reports available.

 

Personal information and duplicate copies of documents are not requested,
and the information provided should be to the same level as that included
in the ‘list of reports’ public view of the DAEN.

 

2.       For cases entered after June 2018, the reasons that the AEFI was
not transferred to the DAEN. For cases reported prior to June 2018, the
reasons that the AEFI was not transferred to the DAEN if it is available
within the database.

 

….I would [also] like to request that this includes any previous versions
(since 2010) of any Measles vaccine that may not be currently on the NIP.”

 

Currently, a decision on your request is due to you on or before 18 August
2019. However, this timeframe may be affected by the requirement to
undertake consultation with affected third parties and if the agency
determines you are liable to pay a charge in relation to your request.

 

You will be notified by the TGA if charges are applicable or if third
party consultation is required.

 

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

 

Kind regards

 

Freedom of Information
+61 (0)2 6289 4630

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

 

 

show quoted sections

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From: Shanna Miller

Delivered

Dear TGA FOI,

Thank you for your response.

I have one last addition to my requests.

Please make it very clear which AEFI's on the report resulted in death.

Yours sincerely,

Shanna Miller

Link to this

From: TGA FOI
Department of Health


Attachment image001.png
3K Download


Dear Ms Miller

 

The TGA is currently in the process of finalising a search in relation to
the release of documents for your request FOI 1231 relating to MMR
vaccines.

 

Given that the scope of your request was recently revised on 14 August
2019 and a full search and retrieval is still underway, it has become
apparent that the TGA will be unable to meet the current deadline for your
request, which is 18 August 2019.

 

I would be grateful if you could please consider agreeing to an extension
(under section 15AA) of ten (10) days for the processing of your request.
If you agree to this extension the decision on your request would then be
due on or before 28 August 2019.

 

Could you please respond advising whether you agree to this extension by
Noon Monday 19 August 2019.

 

Thank you for your consideration of this matter.

 

Please do not hesitate to contact the FOI team if you have any questions.

 

Kind regards

 

Freedom of Information
+61 (0)2 6289 4630

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

 

 

 

show quoted sections

Link to this

From: Shanna Miller

Delivered

Dear TGA FOI,

Yes I agree to a 10 day extension.

Yours sincerely,

Shanna Miller

Link to this

From: TGA FOI
Department of Health


Attachment image001.png
3K Download

Attachment FOI 1231 Estimate of Charges Notice.pdf
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Attachment credit card payment authorisation.pdf
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Dear Ms Miller

 

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

 

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

 

Kind regards

 

Freedom of Information
+61 (0)2 6289 4630

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

 

 

show quoted sections

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