![]() Very common (10% or more): Fatigue (up to 75.2%), pain (up to 71.4%), use of antipyretic/pain medication (up to 57.3%), axillary swelling (up to 28%), axillary tenderness (up to 28%), fever (up to 23.9%)Ĭommon (1% to 10%): Axillary/groin swelling or tenderness Psychiatric ![]() Postmarketing reports: Dizziness, facial paralysis, hypoesthesia, paresthesia OtherĪxillary swelling and tenderness included localized axillary swelling or tenderness ipsilateral to the vaccinated arm and lymphadenopathy. Very common (10% or more): Headache (up to 78.4%), sleepiness (up to 37.3%)įrequency not reported: Acute peripheral facial paralysis/palsy, Bell's palsy, febrile convulsion Very common (10% or more): Myalgia (up to 61.5%), chills (up to 45.4%), arthralgia (up to 41%) Nervous systemĪcute peripheral facial paralysis/palsy was reported in 3 patients who received their second dose after 22 days, 28 days, and 32 days. Very common (10% or more): Appetite loss (up to 32.1%) Musculoskeletal 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%)Ĭommon (1% to 10%): Delayed injection site reactions, injection site lymphadenopathyįrequency not reported: Injection site pruritus, injection site rash, injection site swelling, injection site urticaria Metabolic Localĭelayed injection site reactions included at least 1 of the following: erythema, pain, and/or swelling.įacial swelling occurred in 2 patients on Day 1 and Day 3 with a history of injection of dermatological fillers. Postmarketing reports: Anaphylaxis ImmunologicĬommon (1% to 10%): Acute otitis media Īcute otitis media occurred more frequently in patients 6 to 23 months of age who received this vaccine compared to placebo. Very common (10% or more): Nausea (up to 24%), vomiting (up to 24%) HematologicĬommon (1% to 10%): Lymphadenopathy HypersensitivityĬommon (1% to 10%): Hypersensitivity events/hypersensitivity Postmarketing reports: Acute urticaria, delayed urticaria, erythema multiforme Gastrointestinal Postmarketing reports: Myocarditis, pericarditis Dermatologic The most commonly reported side effects included injection site pain, headache, fatigue, and myalgia.
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