Afluria Preservative-Free Quadrivalent Side Effects

Generic name: influenza virus vaccine, inactivated

Medically reviewed by Drugs.com. Last updated on May 20, 2024.

Note: This document contains side effect information about influenza virus vaccine, inactivated. Some dosage forms listed on this page may not apply to the brand name Afluria Preservative-Free Quadrivalent.

Applies to influenza virus vaccine, inactivated: intramuscular emulsion. Other dosage forms:

• intramuscular solution
• suspension

Serious side effects

Along with its needed effects, influenza virus vaccine, inactivated (the active ingredient contained in Afluria Preservative-Free 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:

Less common

• Fever or chills

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• cough
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, or rash
• inability to move the arms and legs
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sudden numbness and weakness in the arms and legs
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness

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:

More common

• Headache
• joint or muscle pain
• pain at the injection site

Less common

• Diarrhea
• loss of appetite
• nausea or vomiting
• redness or swelling at the injection site

For Healthcare Professionals

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

General

The most common adverse events occurring in greater than 30% of patients (inclusive of all age groups) were local injection site reactions, myalgia, headache, drowsiness/sleepiness, malaise, pain, and abnormal crying.^[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Flushing, hot flush

Postmarketing reports: Vasculitis which may be associated with transient renal involvement, vasodilatation, pallor, tachycardia, Henoch-Schonlein purpura

Dermatologic

Common (1% to 10%): Sweating

Rare (0.01% to 0.1%): Pruritus, urticaria, night sweats, rash

Postmarketing reports: Stevens-Johnson syndrome, erythema multiforme, erythema, angioedema, cellulitis, local or generalized non-specific rash

Gastrointestinal

Very common (10% or more): Diarrhea (up to 23.2%), vomiting (up to 10.5%)

Common (1% to 10%): Nausea

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: Anaphylaxis/anaphylactoid reaction, allergic reactions, and other forms of hypersensitivity such as shock, serum sickness, and angioedema

Local

Very common (10% or more): Injection site pain (up to 66.6%), injection site tenderness (up to 54.1%), injection site erythema (up to 37.3%), injection site itching (up to 28%), injection site swelling/lump (up to 25.9%), injection site induration (up to 17.7%), injection site ecchymosis (up to 11.2%)

Common (1% to 10%): Injection site bruising

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 sterile abscess, injection site reaction^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 38.6%), muscle aches (up to 29%), arthralgia (up to 13%)

Uncommon (0.1% to 1%): Muscular weakness

Postmarketing reports: Arthritis

Nervous system

Very common (10% or more): Drowsiness (up to 37.7%), sleepiness (up to 35.5%), headache (up to 27.8%)

Uncommon (0.1% to 1%): Lethargy

Rare (0.01% to 0.1%): Dizziness, paresthesia, somnolence

Postmarketing reports: Guillain-Barre syndrome (GBS), convulsions/seizures, febrile convulsions, myelitis, encephalomyelitis, transverse myelitis, facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), hypoesthesia, hypokinesia, tremor, syncope, facial or cranial nerve paralysis, encephalopathy, limb paralysis

Ocular

Rare (0.01% to 0.1%): Ocular hyperemia

Postmarketing reports: Eye pain, photophobia, conjunctivitis, eye irritation, eye redness, eye swelling, eyelid swelling

Other

Very common (10% or more): Pain (up to 59%), abnormal crying (up to 41.2%), malaise (up to 38.1%), change of eating habits (21%), fatigue (up to 22%), loss of appetite (up to 16%)

Common (1% to 10%): Shivering, fever, influenza-like symptoms

Rare (0.01% to 0.1%): Vertigo, asthenia

Frequency not reported: Varicella

Postmarketing reports: Chest pain, chills, extensive swelling of injected limb, peripheral swelling, abnormal gait, pain in extremity, feeling hot, body aches

Psychiatric

Very common (10% or more): Irritability/fussiness (up to 54%)

Uncommon (0.1% to 1%): Moaning, restlessness

Postmarketing reports: Insomnia

Respiratory

Uncommon (0.1% to 1%): Cough, oropharyngeal pain

Rare (0.01% to 0.1%): Rhinorrhea

Postmarketing reports: Dyspnea, cough, wheezing, throat tightness, rhinitis, tonsillitis, laryngitis, dysphonia, bronchospasm, asthma, croup

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

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