Do not administer Pfizer‑BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer‑BioNTech COVID-19 Vaccine.
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer‑BioNTech COVID-19 Vaccine.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer‑BioNTech COVID-19 Vaccine.
The Pfizer‑BioNTech COVID-19 Vaccine may not protect all vaccine recipients.
In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), and lymphadenopathy (0.3%). Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer‑BioNTech COVID-19 Vaccine.
Severe allergic reactions (2 cases in the U.K.) have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
Available data on Pfizer BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
Data are not available to assess the effects of Pfizer BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
There are no data available on the interchangeability of the Pfizer BioNTech COVID 19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer BioNTech COVID-19 Vaccine should receive a second dose of Pfizer BioNTech COVID-19 Vaccine to complete the vaccination series
Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
Vaccination Providers should review the Fact Sheet for mandatory requirements and Information to Provide to Vaccine Recipients/Caregivers and the Full EUA Prescribing Information for Requirements and Instructions for Reporting Adverse Events and Vaccine Administration Errors
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at https://www.cvdvaccine.com
Jasmina Alatovic- photo BioNTech