Pfizer-BioNTech COVID-19 Vaccine

Generic name: COVID-19 (coronavirus 2019) vaccine, Pfizer (KOE vid-19 koe ROE na vye rus VAX een)
Brand name: Pfizer-BioNTech COVID-19 Vaccine PF, Comirnaty
Drug class: Viral vaccines

COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Serious 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 US Food and Drug Administration (FDA) has authorized emergency use of COVID-19 vaccine to help prevent infection with SARS-CoV-2. The Pfizer vaccine is for use in people who are at least 12 years old.

This vaccine may help your body develop immunity to SARS-CoV-2. However, this vaccine has not been approved to prevent or treat coronavirus or COVID-19.

COVID-19 vaccine is experimental and all of its risks are not yet known. The COVID-19 vaccine does not contain coronavirus and cannot give you COVID-19.

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

Warnings

The FDA has authorized emergency use of this vaccine as it may help prevent infection with COVID-19. This vaccine has not been approved to prevent or treat coronavirus or COVID-19.

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

If you have a certain type of reaction after the first dose of this vaccine, your healthcare provider will determine if you can safely receive the second dose.

Before taking this medicine

You should not receive this vaccine if you've ever had an allergic reaction to a COVID-19 vaccine. Your healthcare provider will determine whether any reaction you have would prevent you from safely getting the second dose.

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.

If you had COVID-19 and were treated with monoclonal antibodies or convalescent plasma: You should wait 90 days before getting a COVID-19 vaccine. Ask your doctor if you are unsure about any COVID-19 treatments you received.

Tell your vaccination provider if:

  • you have a fever;
  • you have any allergies;
  • you have had inflammation in or around your heart (myocarditis or pericarditis);
  • you have bleeding problems, or if you use a blood thinner (warfarin, Coumadin, Jantoven);
  • you have a weak immune system caused by disease or by using certain medicine;
  • you are pregnant or breastfeeding;
  • you've received any other COVID-19 vaccine; or
  • you have fainted after receiving an injection.

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.

How is this vaccine given?

Read all vaccine information sheets provided to you.

COVID-19 vaccine is given as an injection (shot) into a muscle. The Pfizer vaccine is given in a series of 2 shots given 3 weeks apart. You may need 3 shots if you have a weak immune system or have had an organ transplant. The third dose should be given at least 1 month after the second dose.

Be sure to receive only the Pfizer type of COVID-19 vaccine for each dose.

The Pfizer COVID-19 vaccine is transported and stored at ultra-cold temperatures. However, this vaccine will be at room temperature when it is injected into your arm.

You will receive a reminder card showing the date and type of each injection. Take this card with you when you get your second or third shot.

You will be "fully vaccinated" if it has been at least 2 weeks since you received your last dose of this vaccine. You may become infected with COVID-19 if the vaccine has not had enough time to provide protection.

Receiving this vaccine will not make you less contagious to other people if you are already infected with COVID-19 but you have no symptoms. Keep using infection control methods such as self-isolation, 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 after receiving this vaccine?

Avoid receiving other vaccines without first seeking medical advice.

This vaccine side effects

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

You will be treated quickly if you have a reaction.

You should not receive this vaccine again if the first shot caused an allergic reaction. Your healthcare provider will determine if you can safely receive a second or third dose.

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:

  • chest pain;
  • shortness of breath; or
  • fast or pounding heartbeats or fluttering in your chest.

Common side effects may include:

  • fever, chills, swollen glands, not feeling well;
  • pain, redness, or swelling where the shot was given;
  • pain in your arm;
  • nausea, vomiting, diarrhea;
  • rash, itching;
  • feeling tired; or
  • headache, muscle pain, joint pain.

Other side effects, mild or serious, may occur with more widespread use of COVID-19 vaccine.

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.

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.

Generic name: sars-cov-2 (covid-19) mrna bnt-162b2 vaccine

Note: This document contains side effect information about sars-cov-2 (covid-19) mrna bnt-162b2 vaccine. Some of the dosage forms listed on this page may not apply to the brand name Pfizer-BioNTech COVID-19 Vaccine.

Applies to sars-cov-2 (covid-19) mrna bnt-162b2 vaccine: intramuscular suspension

Warning

The FDA has authorized emergency use of this vaccine as it may help prevent infection with COVID-19. This vaccine has not been approved to prevent or treat coronavirus or COVID-19.

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

If you have a certain type of reaction after the first dose of this vaccine, your healthcare provider will determine if you can safely receive the second dose.

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

You will be treated quickly if you have a reaction.

You should not receive this vaccine again if the first shot caused an allergic reaction. Your healthcare provider will determine if you can safely receive a second or third dose.

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:

  • chest pain;
  • shortness of breath; or
  • fast or pounding heartbeats or fluttering in your chest.

Common side effects may include:

  • fever, chills, swollen glands, not feeling well;
  • pain, redness, or swelling where the shot was given;
  • pain in your arm;
  • nausea, vomiting, diarrhea;
  • rash, itching;
  • feeling tired; or
  • headache, muscle pain, joint pain.

Other side effects, mild or serious, may occur with more widespread use of COVID-19 vaccine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.