Fluzone High-Dose Side Effects

Generic name: influenza virus vaccine, inactivated

Medically reviewed by Drugs.com. Last updated on May 12, 2024.

Note: This document provides detailed information about Fluzone High-Dose Side Effects associated with influenza virus vaccine, inactivated. Some dosage forms listed on this page may not apply specifically to the brand name Fluzone High-Dose.

Applies to influenza virus vaccine, inactivated: intramuscular solution.

Other dosage forms:

• intramuscular emulsion
• suspension

Common side effects of Fluzone High-Dose

Some side effects of influenza virus vaccine, inactivated 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

• difficulty with moving
• headache
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• nausea
• pain at the injection site
• swollen joints

Less common

• chills
• redness, bruising, or swelling at the injection site

Serious side effects of Fluzone High-Dose

Along with its needed effects, influenza virus vaccine, inactivated (the active ingredient contained in Fluzone High-Dose) 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 influenza virus vaccine, inactivated:

Incidence not known

• cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• unusual tiredness or weakness

For Healthcare Professionals

Applies to influenza virus vaccine, inactivated: intradermal suspension, intramuscular solution, intramuscular suspension, nasal spray.

General

The most commonly reported side (inclusive of all age groups) were local injection site reactions, myalgia, headache, drowsiness/sleepiness, malaise, pain, and abnormal crying.^[Ref]

Cardiovascular

• Common (1% to 10%): Chest tightness
• Rare (0.01% to 0.1%): Flushing/vasodilation, hot flush
• Frequency not reported: Myocarditis
• Postmarketing reports: chest pain, extensive swelling of injected limb, Henoch-Schonlein purpura, pallor, tachycardia, vasculitis (with potential transient renal involvement)^[Ref]

Dermatologic

• Common (1% to 10%): Facial swelling, rash, sweating
• Rare (0.01% to 0.1%): Pruritus, night sweats, urticaria
• Frequency not reported: Cellulitis-like reactions, erythema multiforme
• Postmarketing reports: Angioedema, cellulitis, erythema, generalized rash, generalized skin reactions, localized rash, non-specific rash (local/generalized), Stevens-Johnson syndrome^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 25.6%), vomiting (up to 14.8%), nausea (up to 11%)
• Common (1% to 10%): Oropharyngeal pain, teething
• Uncommon (0.1% to 1%): Upper abdominal pain
• Frequency not reported: Gastroenteritis
• Postmarketing reports: Abdominal pain, dysphagia, swelling of the mouth, throat, and/or tongue^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Lymphadenopathy
• Postmarketing reports: Thrombocytopenia^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity
• Rare (0.01% to 0.1%): Allergic reactions
• Postmarketing reports: Anaphylactic shock, anaphylaxis, immediate hypersensitivity reactions, other allergic reactions, other hypersensitivity reactions, serum sickness, shock^[Ref]

Immunologic

• Common (1% to 10%): Influenza-like illness
• Frequency not reported: Influenza B infection (vaccine failure), Varicella^[Ref]

Local

• Very common (10% or more): Injection site tenderness (up to 89.4%), injection site pain (up to 66.6%), injection site swelling (up to 64.8%), injection site redness/erythema (up to 60.1%), injection site itching (up to 28%), injection site induration (up to 17.7%), injection site bruising/hematoma (up to 17.6%), injection site ecchymosis (up to 15.2%), injection site lump (up to 11%)
• Uncommon (0.1% to 1%): Injection site warmth
• Rare (0.01% to 0.1%): Injection site discomfort
• Postmarketing reports: Decreased injected limb mobility, injection site cellulitis-like reaction, injection site inflammation, injection site rash, injection site reaction, injection site sterile abscess, large injection site swelling^[Ref]

Metabolic

• Very common (10% or more): Loss of appetite (up to 33.3%), eating habit changes (up to 21%)^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia/musculoskeletal pain (up to 38.6%), muscle aches (up to 29%), arthralgia (up to 13%)
• Common (1% to 10%): Chills, shivering
• Uncommon (0.1% to 1%): Muscular/muscle weakness
• Frequency not reported: Myositis
• Postmarketing reports: Abnormal gait, arthritis, extremity pain^[Ref]

Nervous system

• Very common (10% or more): Drowsiness (up to 37.7%), sleepiness (up to 35.5%), headache (up to 30.3%)
• Uncommon (0.1% to 1%): Lethargy, vertigo
• Rare (0.01% to 0.1%): Dizziness, paresthesia, somnolence
• Frequency not reported: Febrile seizures
• Postmarketing reports: Brachial neuritis, convulsions/seizures, cranial nerve paralysis, encephalitis, encephalomyelitis, encephalopathy, facial nerve paralysis/facial palsy/Bell's palsy, febrile convulsions, Guillain-Barre syndrome (GBS), hypoesthesia, hypokinesia, limb paralysis, myelitis, neuralgia, neuritis, neuropathy, presyncope, syncope (shortly after vaccination), transverse myelitis, tremor^[Ref]

Ocular

• Common (1% to 10%): Otitis media, reddened eyes/eye redness
• Rare (0.01% to 0.1%): Ocular hyperemia
• Frequency not reported: Acute otitis media
• Postmarketing reports: Conjunctivitis, eye irritation, eye pain, eye swelling, eyelid swelling, optic neuritis/neuropathy, photophobia^[Ref]

Other

• Very common (10% or more): Pain (up to 59%), malaise (up to 38.1%), fatigue (up to 22%), fever/pyrexia (16%)
• Common (1% to 10%): Ear infection
• Rare (0.01% to 0.1%): Asthenia
• Frequency not reported: Death
• Postmarketing reports: Body aches, feeling hot^[Ref]

Psychiatric

• Very common (10% or more): Irritability (up to 54%), fussiness (up to 54%), abnormal crying (up to 41.2%)
• Uncommon (0.1% to 1%): Moaning, restlessness
• Postmarketing reports: Insomnia^[Ref]

Respiratory

• Very common (10% or more): Rhinorrhea (up to 11.2%), cough (up to 10.4%)
• Common (1% to 10%): Croup infections/croup, nasal congestion, nasopharyngitis, sore throat, upper respiratory tract infection
• Frequency not reported: Bronchitis, bronchiolitis, pneumonia, pulmonary congestion, shortness of breath
• Postmarketing reports: Asthma, bronchospasm, dyspnea, dysphonia, laryngitis, rhinitis, throat tightness, tonsillitis, wheezing^[Ref]

Frequently asked questions

• How and where is a flu shot injection given?
• What flu vaccine can I use with an egg allergy?
• How well does the flu vaccine work?
• How can I get a flu vaccine without a needle?
• Where can I get the flu vaccine right now?

Further information

Fluzone High-Dose side effects can vary depending on the individual. 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.

Medical Disclaimer