AUTHORIZED USE
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12+ Years of Age
Authorized Use
Indication & Authorized Use
Important Safety Information
Important Safety Information
Important Safety Information
Do not administer
Management of Acute Allergic Reactions
Appropriate medical treatment to manage immediate allergic reactions
must be immediately available in the event an acute anaphylactic
reaction occurs following administration of
Monitor
Myocarditis and Pericarditis
Postmarketing safety data with
Postmarketing data with authorized or approved monovalent mRNA
The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html)
Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence
Immunocompromised persons, including individuals receiving
immunosuppressive therapy, may have a diminished response to
Limitation of Vaccine Effectiveness
Adverse Reactions
The safety of
-
safety data from clinical trials which evaluated primary and booster vaccination with
Pfizer-BioNTech COVID-19 Vaccine (monovalent formulation is no longer authorized for use in the United States), - safety data from clinical trials which evaluated booster vaccination with Pfizer-BioNTech COVID-19 Vaccine, Bivalent,
- safety data from a clinical study which evaluated a booster dose of bivalent vaccine (Original and Omicron BA.1), [not authorized or approved in the U.S., hereafter referred to as bivalent vaccine (Original and Omicron BA.1)] and
-
postmarketing safety data with
Pfizer-BioNTech COVID-19 Vaccine (monovalent formulation is no longer authorized for use in the United States) andPfizer-BioNTech COVID-19 Vaccine, Bivalent
Solicited adverse reactions include:
-
6 months through 23 months of age:
Injection site redness, swelling, and tenderness; decreased appetite, drowsiness, fever, irritability. -
2 years of age and older:
Injection site pain, redness, and swelling; chills, diarrhea, fatigue, fever, headache, new or worsened joint pain, new or worsened muscle pain, vomiting.
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors and all serious adverse events to the Vaccine Adverse Event Reporting System (VAERS) by submitting online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer‑BioNTech COVID‑19 Vaccine, Bivalent EUA” in the description section of the report. To the extent feasible, report adverse events to Pfizer 1-800-438-1985 or provide a copy of the VAERS form to Pfizer www.pfizersafetyreporting.com
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