MINISTRY OF
HEALTH
MANATU liAUORA
133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
Ron Law
By email:  [FYI request #14693 email]
Ref:
H202101370
Dear Ron Law
Response to your request for official information
Thank you for your request under the Official  Information Act 1982 (the Act) to the Ministry of
Health (the Ministry) on 16  February 2021 for:
"1.  Can you please provide copies of information that is required to be given to recipients
of COVID-19/SARS/CoV-2 vaccines so that they can make an informed choice before
deciding whether to have the vaccine or not.
2. Can you please provide a copy of the informed consent form to be given to recipients of
COVID-19/SARS/CoV-2 vaccines in New Zealand.
3. Can you please provide instructions to vaccinators administering COVID-
19/SARS/CoV-2 vaccines regarding the reporting of any adverse effects following
injection fo the vaccine into the recipient? Please include details of any forms or
information systems being used to report such adverse events."
Five documents have been identified within scope of your request. These are itemised in
Appendix One to this letter, and copies of the documents are enclosed.
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: [email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website at: www.health.govt.nz/about-ministry/information-releases/responses-official-
information-
uests.
Mathew Parr
Programme Director, COVID-19 Immunisation
COVID-19 Health System Response

Appendix One: List of documents for release

#  Date
Title
Decision on release
1  19 February 2021
COVID-19 vaccination
Released in full
consent form

2  15 February 2021
COVID-19 vaccine: what  Released in full
to expect

3  16 February 2021
After your immunisation  Released in full

4  19 February 2021
Privacy Statement
Released in full

5  N/A
Information provided to
Released in full
vaccinators about

obtaining informed
consent

Page 2 of 2

Document 1
COVID-19 vaccination
consent form
Patient
Surname ……………………………………………….................    First name ……………………………………………...................
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Phone ………………………………………………
Date of birth ………  / ………  / ……… NHI ……………………………..
Address ………………………………………………………………………………………………………………………………………………................
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Medical Centre/GP .............................................................................................
Guardian
Name of guardian (if applicable) ………………………………………………………………………………
Guardian’s relationship to patient ………………………………………………
Please let the vaccinator know:
•  If you are unwell
Information
•  If you’ve had a previous severe allergic reaction to any vaccine or injection in the past
•  If you’re on blood-thinning medications or have a bleeding disorder
•  If you’ve had any vaccines in the past four weeks
•  If you are pregnant or breastfeeding
•  If you are currently receiving the cancer drugs Keytruda, Opdivo, Yervoy, or Tecentriq or have done
Official
so in the past six months

the
I have read the COVID-19 information pamphlet on “What to Expect”, and/or have had explained to me
information about the COVID-19 vaccine.
I have had a chance to ask questions and they were answered to my satisfaction.
I believe I understand the benefits and risks of COVID-19 vaccination.
under
I understand it is my choice to get the COVID-19 vaccination.
Signature ……………………………………………………………….   Date ………  / ………  / ………
Released
HP7565 | 19 February 2021

Document 1
Information for Vaccinator

Details confirmed
Positive answer to any screening questions?   Yes No

Record information and advice given:

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Informed consent obtained?   Yes No

Date ………  / ………  / …….   Time ………...............
Act

If deferred, declined or not medical fit for vaccine record detail .............................................
................................................................................................................................................................................
Vaccine
Diluent
Name of vaccine
Date
Time
Dose
Site
Batch
Expiry
Batch
Expiry
Time of
reconstitution
Information
Pfizer/BioNTech
0.3ml
COVID-19
Vaccine
  Dose 1
Dose 2
Official
the
Post vaccination information given
Signature of vaccinator ……………………………….......
Name of vaccinator   …………………………………………..
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Observation area information
Signature ………………………………………………………………
Details of any AEFI or observations recorded
Departure time   ………...............
CARM Report completed
Released

Document 2
Getting your COVID-19
vaccine: what to expect
Vaccines are one of the ways we can fight the 1982
COVID-19 pandemic and protect the welfare
and wellbeing of our communities.
Act
Protection
Safety
COVID-19 vaccines are free and available to
Medsafe only grants consent for a vaccine to be
everyone in New Zealand.
used in New Zealand once they are satisfied it’s
safe and effective enough to use. All COVID-19
Vaccines protect your health and prevent disease
vaccines will go through the same safety test and
by working with your body’s natural defences so
must meet the same robust standards.
you are ready to fight the virus, if you are exposed.
Information
The COVID-19 vaccine works by triggering your
Pfizer vaccine
immune system to produce antibodies and blood
This vaccine will not give you COVID-19. You’ll
cells that work against the COVID-19 virus.
need two doses, three weeks apart. To ensure
Getting a COVID-19 vaccine is an important step
you have the best protection, make sure you get
you can take to protect yourself from the effects
both doses of the vaccine. If you can’t make your
Official
of the virus. However, we don’t yet know if it will
appointment, reschedule as soon as possible.
stop you from catching and passing on the virus.
Things to consider before getting
Once you’ve been vaccinated, continue to take
the
precautions to prevent the spread of COVID-19.
your vaccine
Thoroughly wash and dry your hands. Cough or
If you have had a severe or immediate allergic
sneeze into your elbow and stay home if you feel
reaction to any vaccine or injection in the past,
unwell. This will help you protect yourself, your
please discuss this with your vaccinator.
whānau and others.
If you are on blood-thinning medications or have
under
Continue using the COVID tracer app, turn on
a bleeding disorder, please let your vaccinator
your phone’s Bluetooth function, and you may
know.
wish to wear a face covering or mask.
If you are pregnant or breastfeeding, please talk
to your vaccinator, GP or midwife.
Released
HP7557 | 15 February 2021

Document 2
If you are receiving the cancer drugs Keytruda,
Opdivo, Yervoy, or Tecentriq, talk with your
Further support and information
specialist about whether you should receive the
vaccine.
If you experience symptoms that could be
COVID-19 related, such as a new continuous
We are not currently offering the Pfizer vaccine
cough, a high temperature/fever or a loss or
to those under 16 years of age until further data is
change in your normal sense of taste or smell,
available.
stay home and get a COVID-19 test.
If you have symptoms of COVID-19, get a test and
If you are unsure about your symptoms or if they
stay at home until you get your results. You can be
get worse, call Healthline on 0800 358 5453. 1982
vaccinated once you have a negative test.
If you have an immediate concern about your
What happens after my
safety, call 111, and make sure you tell them
you’ve had a COVID-19 vaccination so that they
Act
vaccine?
can assess you properly.
You’ll need to wait 30 minutes after your
vaccination so medical staff can check you do
www.health.govt.nz/covid-vaccine
not have a serious allergic reaction.
Potential side effects
The most common reported reactions are pain at
the injection site, a headache and feeling tired or
fatigued.
Information
Muscle aches, feeling generally unwell, chills,
fever, joint pain and nausea may also occur. This
shows that the vaccine is working.
Like all medicines, the vaccine may cause side
effects in some people. These are common, are
Official
usually mild and don’t last long and won’t stop
you from having the second dose or going about
your daily life.
the
Some side effects may temporarily affect your
ability to drive or use machinery.
Serious allergic reactions do occur but are
extremely rare. Our vaccinators are trained to
manage these.
under
Released

Document 3
After your immunisation
Like all medicines, the vaccine may cause side effects in some people. This is
the body’s normal response and shows the vaccine is working. Side effects are
usually mild, don’t last long and won’t stop you from having the second dose or
going about your daily life.
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What you may feel
What can help
When this could start
Act
Pain at the injection site, a
Place a cold, wet cloth, or ice
Within 6 to 24 hours
headache and feeling tired
pack on the injection site for a
and fatigued. These are the
short time.
most commonly reported side
effects.
Do not rub or massage the
injection site.
Muscle aches, feeling generally
Rest and drink plenty of fluids
Within 6 to 48 hours
unwell, chills, fever, joint pain
Information
and nausea may also occur.
Paracetamol or ibuprofen
can be taken, follow the
manufacturer’s instructions.
Seek advice from your health
professional if your symptoms
worsen. Official
Serious allergic reactions can occur but are
You can also report any unexpected reactions
the
extremely rare. New Zealand vaccinators are
direct by emailing CARM or using their online
trained to manage these. Some side effects
reporting form on the CARM website
may temporarily affect the ability to drive or use
otago.ac.nz/carm.
machinery. In the unlikely event this happens,
please discuss it with your employer.
If you are unsure about your symptoms or they
get worse, talk to your GP or call Healthline on
under
If you experience symptoms that could be
0800 358 5453.
COVID-19 related, such as new continuous cough,
a high temperature/fever, or a loss of or change
If you have an immediate concern about your
in your normal sense of taste or smell, stay home
safety, call 111 and make sure you tell them you’ve
and get a COVID-19 test.
had a COVID-19 vaccination so that they can
assess you properly.
If you have an unexpected reaction to your
COVID-19 vaccination, your vaccinator or health
professional should report it to the Centre for
Released
Adverse Reactions Monitoring (CARM).
HP7558 | 16 February 2021

Document 4
Privacy
1982

Act
All the information you provide today will be
used to help run the COVID-19 vaccination
programme. Information from the consent form
and details of each immunisation given or turned
down will be recorded by the Ministry of Health in
the COVID-19 Immunisation Register.
This information will be treated with care
to ensure the Ministry of Health meets its
obligations under the Privacy Act 2020 and the
Information
Health Information Privacy Code 2020.
The information collected as part of the
Sharing information with employers
vaccination process may be used for:
Your employer may request confirmation of you
•  managing your health
receiving a vaccine. They should email COVID-19.
Official
•  keeping you and others safe
[email address] to request access.
•  planning and funding health services
Further information
the
•  carrying out authorised research
•  training health care professionals
For more information about how the Ministry
of Health protects your information, visit the
•  preparing and publishing statistics
Ministry website at health.govt.nz/covid-
•  improving government services.
vaccine-privacy or email COVID-19.privacy@
health.govt.nz
under

Some information, such as information about
reactions to the vaccine, will be shared with other
organisations who provide health services such
as the Centre for Adverse Reactions Monitoring.
Released
HP7568 | 19 February 2021

Document 5
Information provided to vaccinators about obtaining informed consent
(over and above whatever is available in the Immunisation Handbook)
The vaccinator (or vaccinator support person) must obtain the consumer’s informed consent to receive
the vaccine prior to the administering of the vaccine.
Use the COVID-19 Vaccination form to obtain the consumer’s written consent. Where appropriate,
consent may be given by a proxy such as a guardian or person with power of attorney. See below for
instructions on managing the written consent forms.
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Written consent must be obtained for Tier 1 consumers.
Note: IPC guidance must be observed when dealing with hard-copy consent forms and obtaining
consent. This may include, for example, the provision of single-use pens or encouraging consumers to
Act
bring along their own pen.
The vaccinator or an administrative support person must record the consumer’s consent to receive the
vaccine in COVID Immunisation Register (CIR). If the person does not wish to receive the vaccine,
record their decline in CIR.

Information provided to vaccinators about reporting adverse events
Information
1.1.1  Adverse Events During Observation Period
If the consumer has an adverse event during the 30-minute observation period at the vaccination site,
appropriate medical attention must be provided. The on-site adverse event must be recorded in CIR
to enable reporting on adverse reactions to the vaccine.
For more information on managing medical emergencies and anaphylaxis, please see section 2.3 of
Official
the Immunisation Handbook.
Adverse events should be notified to the site clinical lead, who can then undertake a clinical review
the
and determine appropriate actions with the site manager (e.g. pausing vaccinations for a time if
needed).
The adverse event must be recorded in CIR. The Centre for Adverse Reaction Monitoring (CARM) will
then undertake further investigation and provide any additional guidance to the consumer and site as
appropriate.
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1.1.2  Adverse Events After Observation Period
If the consumer has an adverse event after the observation period/when they’ve left the vaccination
site, they will be advised (in the ‘After your immunisation’ flyer) to contact Healthline and submit an
adverse reaction report to the Centre for Adverse Reaction Monitoring (CARM). A dedicated COVID-19
Vaccine Adverse Event Report is available on the CARM website. This may be completed by the
consumer or a health practitioner.
Released

Document Outline