Fluzone Intradermal Side Effects

Generic name: influenza virus vaccine, inactivated

Note: This document contains side effect information about influenza virus vaccine, inactivated. Some of the dosage forms listed on this page may not apply to the brand name Fluzone Intradermal.

Some side effects of Fluzone Intradermal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to influenza virus vaccine, inactivated: intradermal suspension, intramuscular suspension

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side effects.

Get emergency medical help if you have any of these signs of an allergic reaction while taking influenza virus vaccine, inactivated (the active ingredient contained in Fluzone Intradermal) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);

• high fever;

• seizure (convulsions); or

• unusual bleeding.

Common side effects may include:

• low fever, chills;

• mild fussiness or crying;

• redness, bruising, pain, swelling, or a lump where the vaccine was injected;

• headache, tired feeling; or

• joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

Local

Local side effects have frequently included pain (54.7%), redness (17.5%), and swelling (9.3%). Ecchymosis, induration, injection site mass or abscess, injection site reaction or cellulitis, and warmth at the site of injection have also been reported.

Other

Other side effects have frequently included fatigue (19.7%), headache (19.3%), shivering (3.3%), and fever equal to/greater than 100.4 degrees Fahrenheit (1.7%). Malaise, sweating, vertigo, asthenia, chest pain, chills, and feeling hot have also been reported.

Musculoskeletal

Musculoskeletal side effects have frequently included muscle aches (23%) and arthralgia (6.4%). Pain in extremity has also been reported.

Hematologic

Hematologic side effects have included autoimmune hemolytic anemia, lymphadenopathy, and thrombocytopenia.

Cardiovascular

Cardiovascular side effects have included tachycardia, Henoch-Schonlein purpura, and vasculitis.

Ocular

Ocular side effects have included conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain or discomfort, nausea, swelling of the mouth, throat, and/or tongue.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, and serum sickness.

Nervous system

Nervous system side effects have rarely included convulsion, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barre syndrome, hypoesthesia, myelitis, neuritis, neuropathy, and paresthesia.

Respiratory

Respiratory side effects have included asthma, bronchospasm, cough, dyspnea, pneumonia, respiratory distress, stridor, pharyngitis, rhinitis, and tonsillitis.

Dermatologic

Dermatologic side effects have included angioneurotic edema, erythema, erythema multiforme, facial swelling, pruritus, rash, Stevens-Johnson syndrome, and urticaria.

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