Fluzone Side Effects

Please note - some side effects for Fluzone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Fluzone - for the Consumer

Fluzone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fluzone:

General body discomfort; headache; mild fever; mild pain, redness, swelling, or tenderness at the injection site; muscle aches.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); decreased movement of the face muscles; decreased movement or sensation in the arm or shoulder; muscle weakness; numbness or tingling of the hands or feet; severe or persistent headache or fever; vision changes.

Fluzone Side Effects - for the Professional

Fluzone

• Most common (≥10%) local reactions were soreness at injection site, tenderness, pain, and swelling. (6)
• Most common (≥10%) systemic events were malaise, headache, and myalgia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

Side Effects by Body System

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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