133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
11 June 2021
Ross Francis
By email:
[FYI request #15522 email]
Ref:
H202106608
Dear Ross Francis
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 27 May 2021
regarding reactions to the COVID-19 vaccine in New Zealand.
Please find a response to each part of your request below.
“1. What are the 10 severest reactions to the COVID-19 vaccine (excluding death) in New
Zealand?”
Please note severity is considered an opinion. It can apply to any event including a headache.
Medsafe therefore does not systematically collect information on reaction severity to the COVID-
19 vaccine. With it being an opinion, some people may provide this in their adverse events
following immunisation (AEFI) reports, however it is unclear if severity information is provided by
everyone and in the same way. There are also no internationally accepted criteria to define
severity. We are therefore unable to provide you with such information. As such, this part of your
request is refused under section 18(e) as the information requested does not exist.
Medsafe however does publish some information on serious AEFI reports as an overview which
are included in the Weekly COVID-19 Vaccine Reports. These reports can be accessed here:
www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp.
An AEFI is considered serious if it is:
-
A medically important event or reaction
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Requires hospitalisation or prolongs an existing hospitalisation
-
Causes persistent or significant disability or incapacity
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Is life threatening
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Causes a congenital anomaly/birth defect
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Results in death
Please note it is possible for different people to have experienced the same event but for the
report to be serious for one person and non-serious for another person.
To find additional information on the top 10 AEFI reactions in New Zealand please see here:
www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-
vaccines/covid-19-vaccine-safety-and-approval/covid-19-vaccine-side-effects-and-reactions.
“2. How many reports have there been of each of the 10 severest reactions to the COVID-
19 vaccine (excluding death) in New Zealand?”
As aforementioned, the Ministry does not collect data based on severe reactions therefore this
part of your request is refused under 18(e) of the Act as the information requested does not exist.
“3. Does CARM keep records of each individual severe reaction to the vaccine? If so,
where is such information published?”
Reports to the Centre for Adverse Reactions Monitoring (CARM) are kept in a database.
Information is publicly published and accessed here
: www.medsafe.govt.nz/COVID-19/vaccine-
report-overview.asp.
“4. Are vaccine recipients provided with any information about the 10 severest reactions
before they are vaccinated?”
Known adverse reactions are recorded in the data sheet. This can be publicly accessed and
searched here:
www.medsafe.govt.nz/Medicines/infoSearch.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:
[email address] or by calling 0800 802 602.
Yours sincerely
Chris James
Group Manager
Medsafe
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