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Pfizer-BioNTech COVID-10 (6m-4y) Vaccine PF Side Effects

Generic name: sars-cov-2 mrna (tozinameran 6m-4y) vaccine

Note: This document contains side effect information about sars-cov-2 mrna (tozinameran 6m-4y) vaccine. Some dosage forms listed on this page may not apply to the brand name Pfizer-BioNTech COVID-10 (6m-4y) Vaccine PF.

Applies to sars-cov-2 mrna (tozinameran 6m-4y) vaccine: intramuscular suspension.

Warning

Becoming infected with COVID-19 is much more dangerous to your child's health than receiving this vaccine.

Get emergency medical help if your child has signs of an allergic reaction: hives, rash; dizziness, weakness, fast heartbeats; difficult breathing; swelling of the face, lips, tongue, or throat.

The vaccination provider may want to watch your child for a short time after the shot, to make sure he or she doesn't have an allergic reaction. Your child will be treated quickly if he or she has a reaction right after receiving the vaccine.

Your child should not receive this vaccine again if the first shot caused an allergic reaction. The doctor or vaccination provider will determine if he or she can safely receive another COVID-19 vaccine.

Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your child's health than receiving this vaccine.

Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within a few days after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if your child has:

Common side effects may include:

  • fever, chills, swollen glands, not feeling well;

  • pain, redness, or swelling 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 the 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 your child has after receiving a COVID-19 vaccine: www.cdc.gov/vsafe.

For Healthcare Professionals

Applies to sars-cov-2 mrna (tozinameran 6m-4y) vaccine: intramuscular suspension.

General

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

Cardiovascular

Very rare (less than 0.01%): Myocarditis, pericarditis[Ref]

Dermatologic

Uncommon (0.1% to 1%): Hyperhidrosis, night sweats, rash, pruritus, urticaria

Frequency not reported: Angioedema, erythema multiforme[Ref]

Gastrointestinal

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

Common (1% to 10%): Nausea, vomiting[Ref]

Genitourinary

Frequency not reported: Heavy menstrual bleeding[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions

Frequency not reported: Anaphylaxis, facial swelling[Ref]

Local

Very common (10% or more): Injection site pain (up to 90%), injection site redness (up to 20%), injection site swelling (up to 20%), injection site tenderness (up to 20%)

Frequency not reported: Excessive swelling of vaccinated limb, injection site pruritus[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 30%)[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 40%), arthralgia (up to 20%)

Uncommon (0.1% to 1%): Extremity pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 70%), drowsiness (up to 40%)

Uncommon (0.1% to 1%): Dizziness, lethargy

Rare (0.01% to 0.1%): Acute peripheral facial paralysis/palsy

Frequency not reported: Hypoesthesia, paresthesia[Ref]

Other

Very common (10% or more): Fatigue (up to 70%), chills (up to 40%), fever/pyrexia (up to 20%)

Frequency not reported: Asthenia, malaise[Ref]

Psychiatric

Very common (10% or more): Irritability (up to 60%)

Uncommon (0.1% to 1%): Insomnia[Ref]

More about Pfizer-BioNTech COVID-10 (6m-4y) Vaccine PF (sars-cov-2 mrna (tozinameran 6m-4y) vaccine)

References

1. Product Information. Comirnaty Children 6 months - 4 years (SARS-CoV-2 mRNA (tozinameran 6m-4y) vaccine). Pfizer Ltd. 2022.

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.