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COMIRNATY™ COVID-19 VACCINE
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about receiving this vaccine, speak to your doctor or
pharmacist.
1. Why am I being given COMIRNATY?
COMIRNATY is a vaccine given to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in adults and adolescents from 12 years of age and older. COMIRNATY contains the active ingredient
BNT162b2 [mRNA]. For more information, see Section 1. Why am I being given COMIRNATY? in the full CMI.
2. What should I know before I am given COMIRNATY?
You should not be given COMIRNATY if you have had an allergic reaction to any of the ingredients in COMIRNATY. See list at the
end of the CMI.
Check with your doctor if you have had: a severe allergic reaction or breathing problems after any other vaccine or after being
given COMIRNATY in the past; fainted following any needle injection; a severe illness or infection with high fever; a weakened
immune system or are on a medicine that affects your immune system; a bleeding disorder, bruise easily or are on a blood
thinning medicine.
As with any vaccine, COMIRNATY may not fully protect all those who receive it and it is not known how long you will be
protected.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
COMIRNATY should not be given to children under 12 years. For more information, see Sectio
n 2. What should I know before I
am given COMIRNATY? in the full CMI.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you
buy without a prescription. Tell your doctor or pharmacist if you have recently received any other vaccine. For more information,
see Section
3. What if I am taking other medicines? in the full CMI.
4. How will I be given COMIRNATY?
COMIRNATY will be given as an injection into the muscle of your upper arm by a doctor, nurse or pharmacist. You will be given
one dose followed by a second dose at least 21 days later. It is very important that you receive your second dose. A doctor, nurse
or pharmacist will observe you for at least 15 minutes after being given COMIRNATY. For more information, see Sectio
n 4. How
will I be given COMIRNATY? in the full CMI.
5. What should I know while being given COMIRNATY?
Things you
• If you receive one dose of COMIRNATY, you should receive a second dose of the same vaccine 21
should know
days later to complete the vaccination schedule.
• You may not be protected against COVID-19 disease until at least seven days after your second dose.
• You may not be protected if you only receive one dose, so a second dose is important.
Driving or using
• Be careful before you drive or use any machines or tools until you know how COMIRNATY affects
machines
you. Some of the side effects of COMIRNATY may temporarily affect your ability to drive or use
machines.
For more information, see Section
5. What should I know while being given COMIRNATY? in the full CMI.
6. Are there any side effects?
Very common side effects of COMIRNATY include pain/swelling at injection site, tiredness, headache, muscle pain, chills, joint
pain and fever. For more information, including what to do if you have any side effects, see Section
6. Are there any side effects?
in the full CMI.
COMIRNATY™
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COMIRNATY™ COVID-19 VACCINE Active ingredient: BNT162b2 [mRNA]
• a bleeding disorder, bruise easily or are on a blood
Consumer Medicine Information (CMI)
thinning medicine.
This leaflet provides important information about using
During treatment, you may be at risk of developing certain
COMIRNATY.
You should also speak to your doctor or
side effects. It is important you understand these risks and
pharmacist if you would like further information or if you
how to monitor for them. See additional information
have any concerns or questions about receiving
under Section
6. Are there any side effects?
COMIRNATY.
Very rare cases of myocarditis (inflammation of the heart
Where to find information in this leaflet:
muscle) and pericarditis (inflammation of the lining
outside the heart) have been reported after vaccination
1.
Why am I being given COMIRNATY?
with COMIRNATY. The cases have mostly occurred within
2.
What should I know before I am given COMIRNATY?
two weeks following vaccination, more often after the
3.
What if I am taking other medicines?
second vaccination, and more often occurred in younger
4.
How will I be given COMIRNATY?
men. Following vaccination, you should be alert to signs of
5.
What should I know while being given COMIRNATY?
myocarditis and pericarditis, such as breathlessness,
6.
Are there any side effects?
palpitations and chest pain, and seek immediate medical
1.
Why am I being given COMIRNATY?
attention should these occur.
2.
What should I know before I am given COMIRNATY?
You may develop a temporary, stress-related response
3.
What if I am taking other medicines?
associated with the process of receiving your injection.
4.
How will I be given COMIRNATY?
This may include dizziness, fainting, sweating, increased
5.
What should I know while being given COMIRNATY?
heart rate and/or anxiety.
6.
Are there any side effects?
7.
Product details
As with any vaccine, COMIRNATY may not fully protect all
those who receive it and it is not known how long you will
1. Why am I being given COMIRNATY?
be protected.
COMIRNATY contains the active ingredient BNT162b2
Pregnancy and breastfeeding
[mRNA]. COMIRNATY is an mRNA (messenger ribonucleic
If you are pregnant or breast-feeding, think you may be
acid) vaccine.
pregnant or are planning to have a baby, ask your doctor
COMIRNATY is a vaccine given to prevent COVID-19
or pharmacist for advice before you receive this vaccine.
disease caused by SARS-CoV-2 virus in adults and
Children and adolescents
adolescents from 12 years of age and older.
COMIRNATY works by triggering your immune system to
COMIRNATY should not be given to children under 12
produce antibodies and blood cells that work against the
years.
virus, to protect against COVID-19 disease.
3. What if I am taking other medicines?
2. What should I know before I am given
Tell your doctor or pharmacist if you are taking, have
COMIRNATY?
recently taken or might take any other medicines,
including any medicines, vitamins or supplements that you
Warnings
buy without a prescription from your pharmacy,
COMIRNATY should not be given:
supermarket or health food shop.
Tell your doctor or pharmacist if you have recently
1. if you are allergic to BNT162b2 [mRNA] or any of the
received any other vaccine.
ingredients listed at the end of this leaflet.
Check with your doctor or pharmacist if you are not sure
Check with your doctor if you have:
about what medicines, vitamins or supplements you are
•
taking and if these affect, or are affected by,
had a severe allergic reaction or breathing problems
after any other vaccine or after being given
COMIRNATY.
COMIRNATY in the past.
• fainted following any needle injection.
4. How will I be given COMIRNATY?
• a severe illness or infection with high fever. However,
• COMIRNATY will be given as an injection into the
you can have your vaccination if you have a mild fever
muscle of your upper arm by a doctor, nurse or
or upper airway infection like a cold.
pharmacist.
• a weakened immune system, such as due to HIV
• You will be given one dose followed by a second dose
infection or are on a medicine that affects your
at least 21 days later. If you miss the second dose, ask
immune system.
your doctor for advice.
COMIRNATY™
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• A doctor, nurse or pharmacist will observe you for at
Common side effects
least 15 minutes after being given COMIRNATY.
Common side effects
What to do
5. What should I know while being given
• redness at injection site
Speak to your
COMIRNATY?
• nausea
doctor if you
•
have any of
Things you should know
these common
•
side effects and
If you receive one dose of COMIRNATY, you should
they worry you.
receive a second dose of the same vaccine at least 21
days later to complete the vaccination schedule.
Uncommon side effects
• You may not be protected against COVID-19 disease
until at least seven days after your second dose.
Uncommon side effects
What to do
• You may not be protected if you only receive one
• enlarged lymph nodes
Speak to your
dose, so a second dose is important.
• feeling unwell
doctor if you
Driving or using machines
• insomnia
have any of
• decreased appetite
these side
Be careful before you drive or use any machines or tools
• excessive sweating
effects and
until you know how COMIRNATY affects you.
• night sweats
they worry you.
Some of the side effects of COMIRNATY may temporarily
• physical weakness and/or lack of
affect your ability to drive or use machines.
energy
•
Storage of the vaccine
COMIRNATY is stored at -90 °C to -60 °C. It must be kept in
Rare side effects
the original package in order to protect from light.
Rare side effects
What to do
A doctor, nurse or pharmacist will prepare the injection for
you before you are given it.
• temporary one-sided facial
Call your doctor
drooping
straight away,
Getting rid of any unwanted vaccine
•
or go straight
A doctor, nurse or pharmacist will dispose of any unused
to the
vaccine.
Emergency
Department at
6. Are there any side effects?
your nearest
hospital if you
All medicines can have side effects. If you do experience
notice this side
any side effects, most of them are minor and temporary.
effect.
However, some side effects may need medical attention.
See the information below and, if you need to, ask your
Other side effects (frequency unknown)
doctor or pharmacist if you have any further questions
Other side effects (frequency
What to do
about side effects.
unknown)
Very common side effects
• severe allergic reaction
Call your doctor
• allergic reactions such as rash,
straight away,
Very common side effects
What to do
itching, hives or swelling of the
or go straight
• pain/swelling at injection site
Speak to your
face
to the
• tiredness
doctor if you
• inflammation of the heart
Emergency
• headache
have any of
muscle (myocarditis) or
Department at
• muscle pain
these very
inflammation of the lining
your nearest
• chills
common side
outside the heart (pericarditis)
hospital if you
• joint pain
effects and
which can result in chest pain,
notice this
• fever
they worry you.
breathlessness and/or
serious side
palpitations
effect.
• diarrhoea
Speak to your
• vomiting
doctor if you
• pain in arm
have any of
these side
effects and
they worry you.
COMIRNATY™
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Tell your doctor or pharmacist if you notice anything else
that may be making you feel unwell.
Other side effects not listed here may occur in some
people.
7. Product details
What COMIRNATY contains
Active
• BNT162b2 [mRNA]
ingredient
(main
ingredient)
Other
• ((4-hydroxybutyl)azanediyl)bis(hexane-
ingredients
6,1-diyl)bis(2-hexyldecanoate) (ALC-
(inactive
0315)
•
ingredients)
2-[(polyethylene glycol)-2000]-N,N-
ditetradecylacetamide (ALC-0159)
• Distearoylphosphatidylcholine (DSPC)
• Cholesterol
• Potassium chloride
• Monobasic potassium phosphate
• Sodium chloride
• Dibasic sodium phosphate dihydrate
• Sucrose
• Water for injections
Do not receive this vaccine if you are allergic to any of
these ingredients.
What COMIRNATY looks like
COMIRNATY is a white to off-white suspension provided in
a multidose clear glass vial.
After dilution, each vial contains 6 doses of vaccine.
Who distributes COMIRNATY
Pfizer New Zealand Limited
PO Box 3998
Auckland
Toll Free Number: 0800 736 363
This leaflet was prepared in July 2021.
© Copyright
COMIRNATY™
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