Sars-cov-2 (covid-19) mrna (tozinameran 12y+) bivalent booster vaccine Side Effects
Medically reviewed by Drugs.com. Last updated on Jan 2, 2024.
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
- Chills
- diarrhea
- fever
- headache
- irritability
- joint or muscle pain
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- unusual tiredness or weakness
Less common
- Nausea
- vomiting
Rare
- Decreased appetite
- general feeling of discomfort or illness
- pain in the arms
- rash
Incidence not known
- Anxiety
- blue or pale skin
- chest discomfort or tightness
- chest pain, possible moving to the left arm, neck, or shoulder
- cough
- difficulty swallowing
- dizziness
- fainting
- fast heartbeat
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- trouble breathing
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
- Pain, redness, or swelling at the injection site
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
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: viral vaccines
Patient resources
Professional resources
Related treatment guides
References
1. (2022) "Product Information. Comirnaty Original and Omicron BA 4-BA 5 (SARS-CoV-2 (famtozinameran and tozinameran 12y+) bivalent booster)." Pfizer Canada Inc
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.