Vaccine Safety Information & FAQs
Allergic Reaction Information
If you have a severe allergic reaction to a COVID-19 Vaccine:
“If you have had a severe allergic reaction to any ingredient in an mRNA COVID-19 vaccine, you should not get either of the currently available mRNA COVID-19 vaccines. If you had a severe allergic reaction after getting the first dose of an mRNA COVID-19 vaccine, CDC recommends that you should not get the second dose.”
If you have a non-severe allergic reaction to a COVID-19 Vaccine:
“If you have had an immediate allergic reaction—even if it was not severe—to any ingredient in an mRNA COVID-19 vaccine, CDC recommends that you should not get either of the currently available mRNA COVID-19 vaccines. If you had an immediate allergic reaction after getting the first dose of an mRNA COVID-19 vaccine, you should not get the second dose. Your doctor may refer you to a specialist in allergies and immunology to provide more care or advice”.
Source: Pfizer BioNTech
What is the Pfizer-BioNTech COVID-19 Vaccine?
The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA).
What should you tell your provider before you get the Pfizer-BioNTech COVID-19 Vaccine?
Tell the vaccination provider about all of your medical conditions, including if you:
- have any allergies
- 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
Who should get this vaccine?
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older.
Who should NOT get this vaccine?
You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
- had a severe allergic reaction after a previous dose of this vaccine
- had a severe allergic reaction to any ingredient of this vaccine.
What are the ingredients in this vaccine?
The Pfizer-BioNTech COVID-19 Vaccine includes the following ingredients: 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), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
How is the vaccine given?
The Pfizer-BioNTech COVID-19 Vaccine will be given to you as an injection into the muscle. The Pfizer-BioNTech COVID-19 Vaccine vaccination series is 2 doses given 3 weeks apart. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.
Has this vaccine been used before?
The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 20,000 individuals 16 years of age and older have received at least 1 dose of the Pfizer-BioNTech COVID-19 Vaccine.
What are the benefits of being vaccinated?
In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.
What are the risks of this vaccine?
Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include:
- injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy)
- There is a remote chance that the Pfizer-BioNTech COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 Vaccine.
- 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 and/or dizziness and weakness
These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Vaccine is still being studied in clinical trials.
What should I do about side effects?
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. 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 https://vaers.hhs.gov/reportevent.html. Please include “Pfizer-BioNTech COVID-19
Vaccine EUA” in the first line of box #18 of the report form.
What do I do if I decide not to get this vaccine?
It is your choice to receive or not receive the Pfizer-BioNTech COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.
Can I receive this vaccine with other vaccines?
There is no information on the use of the Pfizer-BioNTech COVID-19 Vaccine with other vaccines.
What if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
Will the vaccine give me COVID-19?
No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.
Keep your information card
When you get your first dose, you will get a vaccination card to show you when to return for your second dose of Pfizer-BioNTech COVID-19 Vaccine. Remember to bring your card when you return.
How can I learn more?
- Ask the vaccination provider.
- Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
- Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization.
- Contact your local or state public health department.
Where will my vaccination information be recorded?
The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for the second dose. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.
What is an Emergency Use Authorization (EUA)?
The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.