Fluad Preservative-Free Side Effects

Generic name: influenza virus vaccine, inactivated

Medically reviewed by Drugs.com. Last updated on Mar 21, 2025.

Note: This document provides detailed information about Fluad 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 Fluad 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 Fluad 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:

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:

Precautions

It is very important that your child return to your doctor’s office at the right time if your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the injection.

Children who have received a certain brand of the influenza vaccine (Afluria®, Afluria® Quadrivalent) have developed a fever and in some cases a fever with seizures. Talk with your doctor if you have concerns about this.

If you are very sick and have a high fever, you will probably need to wait until you are well before you receive this vaccine.

Influenza virus vaccine may not protect everyone who receives it. It will not also treat flu symptoms if you already have the virus.

The tip cap of the prefilled syringe for certain brands of the injection (Agriflu®, Flucelvax®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.

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

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 (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]

See also:

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?
• Where can I get the flu vaccine right now?
• How can I get a flu vaccine without a needle?
• Which flu vaccines are available?

Further information

Fluad 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.

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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