Comirnaty (2023-2024) PF (cvx 309) Side Effects

Generic name: sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 309)

Note: This document contains side effect information about sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 309). Some dosage forms listed on this page may not apply to the brand name Comirnaty (2023-2024) PF (cvx 309).

Applies to sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 309): intramuscular suspension.

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

Your vaccination provider may want to watch you for a short time after your shot, to make sure you don't have an allergic reaction. You will be treated quickly if you have a reaction right after you receive the vaccine.

You should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. Your doctor or vaccination provider will determine if you can safely receive this vaccine.

Not all possible side effects are known. 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 the first week 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;

• pain, bruising, swelling, or irritation where the shot was given;

• feeling tired; or

• headache, muscle pain, joint pain.

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.

For Healthcare Professionals

Applies to sars-cov-2 (covid-19) mrna-lnp vaccine (cvx 309): intramuscular suspension.

General

The most commonly reported side effects included injection site pain, fatigue, and headache.^[Ref]

Cardiovascular

Postmarketing reports: Myocarditis, pericarditis^[Ref]

Dermatologic

Frequency not reported: Hyperhidrosis, night sweats

Postmarketing reports: Pruritus, rash, urticaria^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 10.7%)

Common (1% to 10%): Vomiting

Frequency not reported: Nausea^[Ref]

Hematologic

Common (1% to 10%): Lymphadenopathy^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, angioedema, other hypersensitivity reactions (e.g., pruritus, rash, urticaria), severe allergic reactions^[Ref]

Local

Very common (10% or more): Injection site pain (up to 90.5%), injection site swelling (up to 10.6%), injection site redness (up to 10.4%)

Postmarketing reports: Extremity (arm) pain^[Ref]

Metabolic

Frequency not reported: Decreased appetite^[Ref]

Musculoskeletal

Very common (10% or more): Chills (up to 49.2%), muscle pain (up to 45.5%), new/worsened muscle pain (up to 39.3%), joint pain (up to 27.5%), new/worsened joint pain (up to 23.8%)^[Ref]

Nervous system

Very common (10% or more): Headache (up to 75.5%)

Frequency not reported: Lethargy

Postmarketing reports: Dizziness, syncope^[Ref]

Other

Very common (10% or more): Fatigue (up to 77.5%), use of antipyretic or pain medication (up to 50.8%), fever (up to 24.3%)

Frequency not reported: Asthenia, malaise^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer