Sars-cov-2 mrna (tozinameran) vaccine Side Effects
Medically reviewed by Drugs.com. Last updated on Apr 26, 2023.
Applies to sars-cov-2 mrna (tozinameran) 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 mrna (tozinameran) 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 mrna (tozinameran) 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
- fast heartbeat
- fainting
- 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 mrna (tozinameran) 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 mrna (tozinameran) vaccine: intramuscular suspension.
Local
Very common (10% or more): Pain at injection site (78.3% to 90.5%), injection site swelling (up to 10.5%)
Common (1% to 10%): Swelling, injection site redness/redness[Ref]
Nervous system
Very common (10% or more): Headache (43.5% to 75.5%)
Uncommon (0.1% to 1%): Lethargy
Rare (0.01% to 0.1%): Bell's palsy
Postmarketing reports: Dizziness, syncope[Ref]
Bell's palsy occurred in 4 patients in the treatment group versus 2 patients in the placebo group. Onset of facial paralysis occurred on day 37 after dose 1 (patient only received one dose), and days 3, 9, and 48 after dose 2 in the treatment group; onset of facial paralysis was day 30 and 102 in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine.[Ref]
Other
Very common (10% or more): Fatigue (49.4 to 77.5%), use of antipyretic or pain medication (27.8% to 45.2%), fever of 38C or higher (4.1% to 24.3%)
Uncommon (0.1% to 1%): Malaise, asthenia[Ref]
Musculoskeletal
Very common (10% or more): Chills (16.5% to 49.2%), new or worsened muscle pain (22.9% to 42.2%), new or worsened joint pain (11.8% to 24.3%)
Postmarketing reports: Pain in extremity (arm)[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (up to 11.7%)
Common (1% to 10%): Nausea, vomiting
Uncommon (0.1% to 1%): Decreased appetite[Ref]
Hypersensitivity
Postmarketing reports: Severe allergic reactions including anaphylaxis, other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)[Ref]
Cardiovascular
Postmarketing reports: Pericarditis, myocarditis[Ref]
Dermatologic
Uncommon (0.1% to 1%): Hyperhidrosis, night sweats[Ref]
Hematologic
Uncommon (0.1% to 1%): Lymphadenopathy[Ref]
Metabolic
Uncommon (0.1% to 1%): Decreased appetite[Ref]
Frequently asked questions
More about sars-cov-2 mrna (tozinameran) vaccine
- sars-cov-2 mrna (tozinameran) vaccine consumer information
- Check interactions
- Compare alternatives
- Reviews (17)
- Latest FDA alerts (1)
- Dosage information
- During pregnancy
- Drug class: viral vaccines
Patient resources
Other brands
Comirnaty, Pfizer-BioNTech COVID-19 Vaccine
Professional resources
- COVID-19 Vaccine, mRNA (Pfizer-BioNTech) monograph
- Covid-19 Vaccine Pfizer (FDA)
- Covid-19 Vaccine Pfizer, Monovalent, 6 mo-4 yr (FDA)
- Covid-19 Vaccine Pfizer, Monovalent,5 yr to 11 yr (FDA)
- Pfizer-BioNTech Vaccine (FDA)
Other brands
Related treatment guides
References
1. "Product Information. Pfizer-BioNTech COVID-19 Vaccine PF (SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vaccine)." Pfizer Inc., Madison, NJ.
2. (2022) "Product Information. Pfizer-BioNTech COVID-19 Vaccine PF (SARS-CoV-2 mRNA (tozinameran) vaccine)." Pfizer 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.