Fluzone High-Dose Quadrivalent Side Effects

Generic name: influenza virus vaccine, inactivated

Medically reviewed by Drugs.com. Last updated on Mar 31, 2025.

Note: This document provides detailed information about Fluzone High-Dose Quadrivalent 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 Quadrivalent.

Applies to influenza virus vaccine, inactivated: intramuscular emulsion.

Other dosage forms:

• intramuscular solution
• suspension

Precautions

Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or troubled breathing after you get the injection.

Fluad® Quadrivalent may not protect everyone who receives the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

Tell your doctor if you are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. However, your doctor may still want you to get the vaccine because it can give you some protection.

Other side effects

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:

Serious side effects

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

See also:

For healthcare professionals

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

General adverse events

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 (potentially associated with transient renal involvement)

Dermatologic

• Common (1% to 10%): Facial swelling, rash, sweating
• Rare (0.01% to 0.1%): Pruritus, night sweats, urticaria, hyperhidrosis
• 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

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 24.2%), 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

Hematologic

• Uncommon (0.1% to 1%): Lymphadenopathy
• Postmarketing reports: Thrombocytopenia

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

Immunologic

• Frequency not reported: Influenza B infection (vaccine failure)

Local

• Very common (10% or more): Injection site tenderness (up to 89.4%), injection site pain (up to 64.4%), 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 19%), 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: Injection site cellulitis-like reaction, injection site inflammation, injection site rash, injection site reaction, injection site sterile abscess, large injection site swelling

Metabolic

• Very common (10% or more): Loss of appetite (up to 32.3%), eating habit changes (up to 21%)

Musculoskeletal

• Very common (10% or more): Myalgia/musculoskeletal pain (up to 36.4%), 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, decreased injected limb mobility

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

Ocular

• Common (1% to 10%): Reddened eyes/eye redness
• Rare (0.01% to 0.1%): Ocular hyperemia
• Postmarketing reports: Conjunctivitis, eye irritation, eye pain, eye swelling, eyelid swelling, optic neuritis/neuropathy, photophobia

Other

• Very common (10% or more): Pain (up to 59%), malaise (up to 38.1%), fatigue (up to 22%)
• Common (1% to 10%): Ear infection/otitis media, influenza-like illness, fever/pyrexia
• Rare (0.01% to 0.1%): Asthenia
• Frequency not reported: Death
• Postmarketing reports: Body aches, feeling hot

Psychiatric

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

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 or congestion, pharyngolaryngeal pain, oropharyngeal pain
• Frequency not reported: Bronchitis, bronchiolitis, pneumonia, pulmonary congestion, shortness of breath
• Postmarketing reports: Asthma, bronchospasm, dyspnea, dysphonia, laryngitis, rhinitis, throat tightness, tonsillitis, wheezing

Frequently asked questions

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

Further information

Fluzone High-Dose Quadrivalent 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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