COVID Immunisation Register adverse reaction statistics

Paul Jones made this Official Information request to Ministry of Health

The request was successful.

From: Paul Jones

Dear Ministry of Health,

Concerning the COVID Immunisation Register (CIR) the following URL lists the details recorded in this database.

https://www.health.govt.nz/our-work/dise...

One of the details is a record of "any reactions you have to the vaccine".

Under the Official Information Act would you please;

1) Confirm that the CIR databases is separate to the CARM (Centre for Adverse Reactions Monitoring) database?

2) Are there any other databases being used to record adverse reactions to the Covid vaccine? If so then please provide a list of them.

3) For the CIR database please provide a list of all "reactions" recorded and a total count for each reaction.

Yours faithfully,

Paul Jones

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From: OIA Requests

Kia ora Paul,
Thank you for your request for official information received 28 August
2021. The Ministry's reference number for your request is: H202111267.
As required under the Official Information Act 1982 we will endeavour to
respond to your request no later than 20 working days after the day your
request was received.  
If we are unable to respond to your request within this time frame, we
will notify you of an extension of that time frame.
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]

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This is an Official Information request made via the FYI website.

Please use this email address for all replies to this request:
[FOI #16546 email]

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References

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1. https://www.health.govt.nz/our-work/dise...
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From: OIA Requests


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Kia ora Paul

Thank you for your request for official information, received on 28 August
2021 requesting:

 

1) Confirm that the CIR databases is separate to the CARM (Centre for
Adverse Reactions Monitoring) database?

 

2) Are there any other databases being used to record adverse reactions to
the Covid vaccine? If so then please provide a list of them.

 

3) For the CIR database please provide a list of all "reactions" recorded
and a total count for each reaction.

 

The Ministry of Health has decided to extend the period of time available
to respond to your request under section 15A of the Official Information
Act 1982 (the Act) as further collation is required.

You can now expect a response to your request on, or before, 8 October
2021.  

You have the right, under section 28 of the Act, to ask the Ombudsman to
review my decision to extend the time available to respond to your
request.

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [email address]

 

 

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From: Paul Jones

Dear OIA Requests,

We note that the deadline for your extension to the 8th October has now been reached. Please update us with the requested information.

Yours sincerely,

Paul Jones

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Paul Jones left an annotation ()

A complaint has been made to the ombudsman due to the OIA request being overdue and lack of acknowledgement from the Ministry.

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From: Paul Jones

Dear OIA Requests,

A further week has passed since the deadline of 8th October and our follow up email from 9th October has gone unacknowledged.

A case has been opened with the Ombudsman, but would rather you responded promptly with the request information.

Yours sincerely,

Paul Jones

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From: OIA Requests


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Attachment H202111267 response letter.pdf
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Attachment H202111267 Appendix 1.pdf
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Kia ora Paul,

 

Please find attached a letter regarding your request for information. We
apologise for the delay and any inconvenience this may have caused.

 

Ngā mihi,

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [email address]

 

 

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From: Paul Jones

Dear OIA Requests,

Thanks for your response. The results aren't quite what I was expecting.

In the OIA request with reference number H202101370 with released documents here https://fyi.org.nz/request/14693/respons... it provides details about how the adverse reactions are reported. There are two methods;

1) During the 30 minute observation period after administration of the vaccine, an adverse event must be recorded in the CIR, the CARM will then conduct further investigation.

2) Events after the observation period are to be reported to CARM.

As the CARM data is readily available, I was in fact requesting the CIR data which records the adverse events which occurred during the 30 minute observation period.

Therefore would you please update us with a list of events and totals for the observation period and exclude those reported outside of the observation period.

Yours sincerely,

Paul Jones

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From: OIA Requests

Kia ora,

 

Thank you for your Official Information Act (the Act) request. This is
an automatic reply to let you know we received it.

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. We
will endeavour to acknowledge your request as soon as possible. Further
information about COVID-19 can be found on our
website: [1]https://www.health.govt.nz/our-work/dise...

 

In accordance with the Act, we'll let you know our decision within no more
than 20 working days. If you'd like to calculate the timeframe, you can
use the Ombudsman's online calculator
here: [2]http://www.ombudsman.parliament.nz/

If you have any questions while we're processing your request, please let
us know via [3][email address]

 

Ngā mihi  

OIA Services Team  

   

[4]Ministry of Health information releases  

[5]Unite against COVID-19 

 

 

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References

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1. https://www.health.govt.nz/our-work/dise...
2. http://scanmail.trustwave.com/?c=15517&a...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/

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From: OIA Requests


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Kia ora Paul,

 

Thank you for your request for official information. The Ministry's
reference number for your request is: H202114970

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/

 

Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. If
we are unable to respond to your request within this time frame, we will
notify you of an extension of that time frame.

 

If you have any queries related to this request, please do not hesitate to
get in touch.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [2][email address]

 

 

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From: Paul Jones

Dear OIA Requests,

Further more in addition to the statistics for each adverse reaction event during the 30 minute observation period. As a single patient can have one or more event recorded, would you also provide a total count for the number of patients it represents.

Yours sincerely,

Paul Jones

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From: OIA Requests


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Kia ora Paul,

 

Thank you for your request or information to the Ministry of health (the
Ministry) on 27 October 2021 for information regarding CARM reporting. A
response to each part of your request is below:

 

1) During the 30 minute observation period after administration of the
vaccine, an adverse event must be recorded in the CIR, the CARM will then
conduct further investigation.

2) Events after the observation period are to be reported to CARM.

As the CARM data is readily available, I was in fact requesting the CIR
data which records the adverse events which occurred during the 30 minute
observation period.

Therefore would you please update us with a list of events and totals for
the observation period and exclude those reported outside of the
observation period.

 

CARM data can consist of CIR reports, webform reports, and manually
entered reports. Only the data from the CIR was provided in the previous
response to the previous request and we therefore complied with your
request.

 

Further more in addition to the statistics for each adverse reaction event
during the 30 minute observation period. As a single patient can have one
or more event recorded, would you also provide a total count for the
number of patients it represents.

 

The number of reports from CIR can be found on the Medsafe report
“Reported AEFIs by reporter type” and is publicly available here:
[1]www.medsafe.govt.nz/COVID-19/safety-report-32.asp.

 

Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [2][email address] or by calling 0800
802 602.     

 

Nga mihi,

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [email address]

 

 

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References

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1. http://www.medsafe.govt.nz/COVID-19/safe...
2. mailto:[email address]

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