Fluzone Preservative-Free 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 Preservative-Free Side Effects associated with influenza virus vaccine, inactivated. Some dosage forms listed on this page may not apply specifically to the brand name Fluzone Preservative-Free.

Applies to influenza virus vaccine, inactivated: suspension.

Other dosage forms:

• intramuscular emulsion
• intramuscular solution

In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.

It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, studies have shown that the risk of acquiring GBS from an influenza vaccine is very low (one out of every million people).

Serious side effects

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

More common

• bruising, hard lump, redness, or pain at the injection site
• cough
• diarrhea
• fever
• headache
• irritability
• large, flat, blue or purplish patches in the skin
• loss of appetite
• muscle aches
• redness of the eyes
• sneezing
• sore throat
• stuffy or runny nose
• vomiting

Less common

• body aches or pain
• chest tightness
• chills
• difficulty with breathing
• earache
• ear congestion
• loss of voice
• shivering
• swelling or puffiness of the face
• unusual tiredness or weakness

Rare

• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, lips, or tongue

Incidence not known

• agitation
• back pain, sudden and severe
• back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• chest pain
• clumsiness or unsteadiness
• confusion
• drowsiness
• dryness of the throat
• fainting
• feeling hot
• increased sensitivity of the eyes to sunlight
• inflammation, rash, swelling, or tenderness at the injection site
• lightheadedness
• nosebleeds
• pain, redness, soreness, swelling, tenderness, or warmth on the skin
• pinpoint red spots on the skin
• redness of the face, neck, arms, and occasionally, upper chest
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• sores, ulcers, or white spots in the mouth or on the lips
• sores, welts, or blisters
• stomach pain, soreness, or discomfort
• sweating
• trouble sleeping
• unusual bleeding or bruising
• voice changes
• weakness of the muscles in your face
• yellowing of the eyes or skin

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

• difficulty in moving
• joint pain
• muscle aches, cramping, pains, or stiffness
• swollen joints

Incidence not known

• sleepiness or unusual drowsiness

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 Preservative-Free 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