Moderna COVID-19 (6y+) Bivalent Booster Vaccine PF Side Effects
Generic name: sars-cov-2 (covid-19)mrna-1273(6y+ bivalent booster) vaccine
Note: This document contains side effect information about sars-cov-2 (covid-19)mrna-1273(6y+ bivalent booster) vaccine. Some dosage forms listed on this page may not apply to the brand name Moderna COVID-19 (6y+) Bivalent Booster Vaccine PF.
Applies to sars-cov-2 (covid-19)mrna-1273(6y+ bivalent booster) vaccine: intramuscular suspension.
General
The most commonly reported side effects included injection site pain, headache, fatigue, and myalgia.[Ref]
Cardiovascular
Postmarketing reports: Myocarditis, pericarditis[Ref]
Dermatologic
Frequency not reported: Rash, urticaria
Postmarketing reports: Acute urticaria, delayed urticaria, erythema multiforme[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 24%), vomiting (up to 24%)[Ref]
Hematologic
Common (1% to 10%): Lymphadenopathy[Ref]
Hypersensitivity
Common (1% to 10%): Hypersensitivity events/hypersensitivity
Frequency not reported: Facial swelling
Postmarketing reports: Anaphylaxis[Ref]
Immunologic
Common (1% to 10%): Acute otitis media[Ref]
Acute otitis media occurred more frequently in patients 6 to 23 months of age who received this vaccine compared to placebo.[Ref]
Local
Very common (10% or more): Injection site pain (up to 97.2%), localized swelling/hardness (up to 17%), injection site erythema (up to 13.5%), localized swelling/induration (up to 12.6%)
Common (1% to 10%): Delayed injection site reactions, injection site lymphadenopathy
Frequency not reported: Injection site pruritus, injection site rash, injection site swelling, injection site urticaria[Ref]
Delayed injection site reactions included at least 1 of the following: erythema, pain, and/or swelling.
Facial swelling occurred in 2 patients on Day 1 and Day 3 with a history of injection of dermatological fillers.[Ref]
Metabolic
Very common (10% or more): Appetite loss (up to 32.1%)[Ref]
Musculoskeletal
Very common (10% or more): Myalgia (up to 61.5%), chills (up to 49.1%), arthralgia (up to 41%)[Ref]
Nervous system
Acute peripheral facial paralysis/palsy was reported in 3 patients who received their second dose after 22 days, 28 days, and 32 days.[Ref]
Very common (10% or more): Headache (up to 78.4%), sleepiness (up to 37.3%)
Frequency not reported: Acute peripheral facial paralysis/palsy, Bell's palsy, febrile convulsion
Postmarketing reports: Dizziness, facial paralysis, hypoesthesia, paresthesia[Ref]
Other
Axillary swelling and tenderness included localized axillary swelling or tenderness ipsilateral to the vaccinated arm and lymphadenopathy.[Ref]
Very common (10% or more): Pain (up to 91%), fatigue (up to 75.2%), use of antipyretic/pain medication (up to 57.3%), axillary swelling (up to 28%), axillary tenderness (up to 28%), fever (up to 23.9%)
Common (1% to 10%): Axillary/groin swelling or tenderness[Ref]
Psychiatric
Very common (10% or more): Irritability/crying (up to 67.6%)[Ref]
More about Moderna COVID-19 (6y+) Bivalent Booster Vaccine PF (sars-cov-2 (covid-19)mrna-1273(6y+ bivalent booster) vaccine)
References
1. Product Information. Spikevax Bivalent (Original / Omicron BA.1) (SARS-CoV-2 (COVID-19) mRNA-1273 (bivalent booster) vaccine). Moderna Therapeutics Inc. 2023.
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.
