COMIRNATY- covid-19 vaccine, mrna injection, suspension 
COMIRNATY- covid-19 vaccine, mrna injection, suspension 
Pfizer Laboratories Div Pfizer Inc
Reference Label Set Id: ddd7c1e5-1098-481a-9d9c-e1359f8dde86


Patient Package Insert

COMIRNATY (2023-2024 Formula) is made the same way as Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, but it encodes the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).


COMIRNATY (Cuh-mir'-na-tee)


(2023-2024 Formula)

This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.


COMIRNATY is a vaccine for use in people 12 years of age and older to protect against COVID-19.

COMIRNATY may not protect all people who receive the vaccine.

COMIRNATY does not contain SARS-CoV-2, the virus that causes COVID-19. COMIRNATY cannot give you COVID-19.

Who should not get COMIRNATY?

You should not get COMIRNATY if you had:

a severe allergic reaction after a previous dose of COMIRNATY or any Pfizer-BioNTech COVID-19 vaccine*
a severe allergic reaction to any ingredient in these vaccines (see What are the ingredients in COMIRNATY?).

Before getting COMIRNATY, tell your vaccination provider about all of your medical conditions, including if you:

have any allergies
had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection

How is COMIRNATY given?

COMIRNATY is given as an injection into the muscle.

What are the possible risks of COMIRNATY?

There is a remote chance that COMIRNATY could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

Difficulty breathing
Swelling of your face and throat
A fast heartbeat
A bad rash all over your body
Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following COMIRNATY have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:

Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include:

Severe allergic reactions
Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
Myocarditis (inflammation of the heart muscle)
Pericarditis (inflammation of the lining outside the heart)
Injection site reactions: pain, swelling, redness, arm pain
General side effects: tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness
Fainting in association with injection of the vaccine

These may not be all the possible side effects of COMIRNATY. Ask your healthcare provider about any side effects that concern you.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to

In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or

What if you are pregnant or breastfeeding?

If you are pregnant or breastfeeding, discuss your options with your healthcare provider.

What are the ingredients in COMIRNATY?

COMIRNATY contains the following ingredients:

messenger ribonucleic acid (mRNA)
lipids (((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol)
tromethamine hydrochloride

COMIRNATY does not contain preservatives.

This Information for Recipients and Caregivers may have been updated. For the most recent Information for Recipients and Caregivers, please visit

If you have questions, talk to your healthcare provider or visit or call 1-877-VAX-CO19 (1-877-829-2619).


Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany


Manufactured by
Pfizer Inc., New York, NY 10001


US Govt. License No. 2229

Revised 09/2023

Revised: 10/2023
Document Id: 4baf2a1c-1557-4aae-9524-9c51d5d76e82
Set id: 48c86164-de07-4041-b9dc-f2b5744714e5
Version: 8
Effective Time: 20231023
Pfizer Laboratories Div Pfizer Inc