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Safety Data Sheet

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CDC=Centers for Disease Control and Prevention.

IMPORTANT SAFETY INFORMATION

Do not administer COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.

Management of Acute Allergic Reactions

Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of COMIRNATY.

Myocarditis and Pericarditis

Postmarketing data from use of authorized or approved mRNA COVID-19 vaccines, including COMIRNATY, have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week following vaccination. The observed risk has been highest in males 12 years through 24 years of age.

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to COMIRNATY.

Limitation of Vaccine Effectiveness

COMIRNATY may not protect all vaccine recipients.

Adverse Reactions

The most commonly reported adverse reactions (≥10%) after a dose of COMIRNATY were pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at
1-800-438-1985 or https://www.pfizersafetyreporting.com or VAERS at
1-800-822-7967 or https://vaers.hhs.gov

Please click for COMIRNATY Full Prescribing Information and Patient Information.

PP-CVV-USA-5217

INDICATION

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

Please click for COMIRNATY Full Prescribing Information and Patient Information.

PP-CVV-USA-5217

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Ordering available through Pfizer Prime*

Orders for 2024-2025 formula COVID-19 vaccines by BioNTech and Pfizer can be placed by eligible
healthcare professionals directly with Pfizer through Pfizer Prime online or by calling 1-800-533-4535.

Visit Pfizer Prime

*Eligible healthcare providers can order COVID-19 vaccines directly from
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Call 1-800-879-3477
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Pfizer Customer Service

Including General
Product Questions.

Call 1-800-879-3477

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Medical Information

Visit
PfizerMedicalInformation.com

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Shipment Support US Trade Customer Service

Call 1-800-666-7248

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