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COVID-19 (coronavirus 2019, tris-sucrose) vaccine, Pfizer

Generic name: COVID-19 (coronavirus 2019, tris-sucrose) vaccine, Pfizer [ KOE-vid-19 koe-ROE-na-vye-rus-VAX-een ]
Brand names: Comirnaty (Do Not Dilute) PF, Pfizer-BioNTech COVID-19 Vaccine (Do Not Dilute) PF
Dosage form: intramuscular suspension (30 mcg/0.3 mL)

What is the COVID-19 vaccine?

COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.

COVID-19 can affect your lungs or other organs. Symptoms may be mild or serious and include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

The COVID-19 vaccine is used to help prevent severe disease and death from COVID-19 caused by SARS-CoV-2.

The US Food and Drug Administration (FDA) has fully approved the Pfizer vaccine for use in people who are at least 16 years old.

The FDA has authorized emergency use of the Pfizer vaccine in people who are 6 months to 15 years old.

COVID-19 vaccine does not contain coronavirus and cannot give you COVID-19. This vaccine will not treat an active COVID-19 infection.

Like any vaccine, COVID-19 vaccine may not provide protection in every person.

This vaccine side effects

Get emergency medical help if you have signs of an allergic reaction: hives, rash; dizziness, weakness, fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat.

Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine.

You should not receive this vaccine again if the first shot caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive another COVID-19 vaccine.

Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if you have:

Common side effects of COVID-19 (coronavirus 2019, tris-sucrose) vaccine, Pfizer may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

You may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health problems you have after receiving a COVID-19 vaccine: www.cdc.gov/vsafe.

Warnings

The Centers for Disease Control and Prevention (CDC) does not recommend the administration of monovalent COVID-19 vaccines.

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Before taking this medicine

You should not receive this vaccine if you've ever had a severe allergic reaction to a Pfizer COVID-19 vaccine.

If you are infected with COVID-19, are waiting for testing results, or are exposed to someone infected with COVID-19: You may not be able to receive this vaccine until you have no symptoms and/or your required quarantine period has ended. Receiving this vaccine will not make you less contagious to other people if you are infected with COVID-19 but you have no symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you received.

Tell your vaccination provider if:

COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but this vaccine is likely to be less harmful than becoming infected with COVID-19 during pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of COVID-19 vaccine on the baby.

How is this vaccine given?

The Centers for Disease Control and Prevention (CDC) does not recommend the administration of monovalent COVID-19 vaccines.

Read all vaccine information sheets provided to you.

The Pfizer COVID-19 vaccine is given as an injection (shot) into a muscle, in a series of 2 shots given 3 to 8 weeks apart.

The Pfizer COVID-19 vaccine is fully approved for people at least 16 years old. The Pfizer vaccine is authorized for emergency use in people who are 6 months to 15 years old.

The Pfizer vaccine is also authorized for emergency use in a series of 3 shots for people 6 months and older who have received an organ transplant or have certain types of immunosuppression. The first 2 shots are given 3 to 8 weeks apart and the third shot is given 4 to 8 weeks after the second shot.

Your doctor or vaccination provider will determine whether you need a booster dose.

You will receive a reminder card showing the date and type of each injection. Take this card with you each time you receive a COVID-19 vaccine.

Keep using infection control methods when you are in public or around others who may not have been vaccinated. This includes social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Receiving a COVID-19 vaccine will not cause you to test positive on a coronavirus test. However, once your body develops immunity to COVID-19, you could test positive on an antibody test (a test to detect immunity in your body from previous exposure to coronavirus).

It is not known how long this vaccine will protect you from infection with COVID-19. It also is not known how long immunity will last in a person who's been infected with and recovered from COVID-19. COVID-19 vaccine is still being studied and all of its risks are not yet known. Updated federal public health recommendations may be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

What happens if I miss a dose?

Be sure to receive all recommended doses of COVID-19 vaccine or you may not be fully protected. Contact your vaccination provider or health department if you miss your second dose.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid while receiving this vaccine?

Avoid receiving other vaccines without first seeking medical advice.

What other drugs will affect this vaccine?

Before receiving this vaccine, tell your vaccination provider about all other vaccines you have received and all medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.