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Sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 13, 2023.

Applies to sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine: intramuscular suspension.

Warning

Intramuscular route (Suspension)

Although the licensed vaccine (Comirnaty®) is FDA-approved in patients aged 16 or older for 2 doses , Pfizer-BioNTech COVID-19 vaccine is an unapproved product authorized for emergency use in individuals aged 12 through 15 years and to provide a third dose to individuals aged 12 years or older who are solid organ transplant recipients or have an equivalent level of immunocompromise.

Serious side effects

Along with its needed effects, sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine:

More common

Less common

Rare

Incidence not known

Other side effects

Some side effects of sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine: intramuscular suspension.

General

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

Cardiovascular

Postmarketing reports: Myocarditis, pericarditis[Ref]

Dermatologic

Postmarketing reports: Angioedema, erythema multiforme, pruritus, skin rash, urticaria[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 13.7%)

Common (1% to 10%): Vomiting

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

Hematologic

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

Hypersensitivity

Postmarketing reports: Anaphylaxis, severe allergic reactions[Ref]

Local

Very common (10% or more): Injection site pain (up to 79.4%)

Common (1% to 10%): Injection site redness, injection site swelling[Ref]

Metabolic

Uncommon (0.1% to 1%): Decreased appetite[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 33.7%), new/worsened muscle pain (up to 31.4%), arthralgia (up to 23.5%), new/worsened joint pain (up to 16.7%)

Common (1% to 10%): Extremity pain (arm)

Frequency not reported: Joint pain, muscle pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 47.6%)

Frequency not reported: Bell's palsy, facial paralysis

Postmarketing reports: Dizziness, hypoesthesia, paresthesia[Ref]

Bell's palsy was mild to moderate in severity, began 3 to 48 days after the last dose, included facial paralysis and facial paresis, and typically lasted 3 to 68 days. This side effect was reported in 4 participants who received the vaccine and 2 patients who received a placebo, but a causal relationship to the vaccine could not be made.[Ref]

Other

Very common (10% or more): Fatigue (up to 64.3%), use of antipyretic/pain medication (up to 46.7%), chills (up to 31.6%)

Common (1% to 10%): Fever (at least 38C)

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

Frequently asked questions

More about sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine

Patient resources

Professional resources

Related treatment guides

References

1. Product Information. Comirnaty Original and Omicron BA 4-BA 5 (SARS-CoV-2 (famtozinameran and tozinameran 12y+) bivalent booster). Pfizer Canada Inc. 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.