Kia ora,

 

Thank you for your Official Information Act (the Act) request. This is
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[4]Ministry of Health information releases  

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Kia ora John,

 

Thank you for your request for official information. The Ministry's
reference number for your request is: H202114849.

 

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]

 

-----Original Message-----
From: John <[FOI #17310 email]>
Sent: Saturday, 23 October 2021 11:35 am
To: OIA Requests <[email address]>
Subject: Official Information request - CARM Reports by group and AESI
Follow ups

 

Dear Ministry of Health,

 

1. Could you please provide a breakdown of numbers of CARM reports by who
entered them

 

The first page of the online entry questions requests - Member of the
Public, Health Professional, Other. Medsafe's reports detail how many
adverse reactions have been entered but does not give a breakdown of by
whom. We are told to take these numbers with a grain of salt but how many
reports have been entered by Health professionals and Other and are they
included in the Medsafe totals.

 

2. Is it mandatory for a health professional to enter a report for a
suspected (or confirmed) reaction to the covid Vaccine and if not why

 

3.  Who/What is regarded as "Other" in the above form

 

4. To date how many of the AESI have been followed up for further analysis
and studies and which Government organization has been tasked with this

 

Medsafe's report  mentions numbers of "Adverse Event Of Special Interest
(AESI)" and offers the explanation that "AESIs need to be carefully
monitored and any potential association to vaccination confirmed by
further analysis and studies."

 

Yours faithfully,

 

John

 

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

 

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Tçnâ koe John,

 

Thank you for your request under the Official Information Act 1982 (the
Act) to the Ministry of Health (the Ministry) on 23 October 2021. Please
find a response to each part of your request below.

 

“1. Could you please provide a breakdown of numbers of CARM reports by who
entered them

Reporter type is now available in the weekly AEFI reports found on
Medsafe’s website from safety report 31 onwards:
[1]www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp.

2. Is it mandatory for a health professional to enter a report for a
suspected (or confirmed) reaction to the covid Vaccine and if not why

It is not mandatory for a healthcare professional to enter a report for
suspected reaction to the vaccine, however they are encouraged and
expected to do so. Any member of the public is able to report an adverse
reaction themselves too via this link:
[2]https://report.vaccine.covid19.govt.nz/s/.

3. Who/What is regarded as "Other" in the above form

 

Others include hospital doctors, Healthline, midwives, dentists etc.

4. To date how many of the AESI have been followed up for further analysis
and studies and which Government organization has been tasked with this

 

To date around 300 cases have been actively followed for further details
on the individual case, this is done by the Centre for Adverse Reactions
Monitoring (CARM) with help from Medsafe and the Immunisation Advisory
Centre (IMAC). The case is then reassessed by the Medical Assessor. If a
signal is raised an investigation of the signal occurs – the list of
signals investigated is in the weekly AEFI report linked above.

 

I trust this information fulfils your request. 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:
[3][email address] or by calling 0800 802 602.

 

Ngâ mihi

 

OIA Services Team

[4]www.health.govt.nz

[5]Ministry of Health information releases

[6]Unite against COVID-19

 

 

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References

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2. https://report.vaccine.covid19.govt.nz/s/
3. mailto:[email address]
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5. https://www.health.govt.nz/about-ministr...
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