Influenza A Virus Vaccine, H1n1, Inactivated (Intramuscular Route)

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Side Effects

Along with its needed effects, a medicine 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 immediately if any of the following side effects occur:

• Difficulty with moving
• Fever
• General feeling of discomfort or illness
• Joint pain
• Muscle aching or cramping
• Muscle pains or stiffness
• Swollen joints
• Unusual tiredness or weakness

• Back pain, sudden and severe
• Black, tarry stools
• Bleeding gums
• Blindness
• Blistering, peeling, or loosening of the skin
• Blood in the urine or stools
• Blue-yellow color blindness
• Blurred vision
• Body aches or pain
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Burning, tingling, numbness or pain in the hands, arms, feet, or legs
• Chest pain
• Chills
• Congestion
• Convulsions
• Cough
• Decreased vision
• Diarrhea
• Difficult or labored breathing
• Difficulty with swallowing
• Dizziness
• Dryness or soreness of the throat
• Eye pain
• Fainting
• Fast heartbeat
• Feeling faint, dizzy, or lightheadedness
• Feeling of warmth or heat
• Flushing or redness of the skin, especially on the face and neck
• Headache
• Hives
• Hoarseness
• Itching
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Muscle weakness, sudden and progressing
• Pain in the arms or legs
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Red skin lesions, often with a purple center
• Redness of the face, neck, arms, and occasionally, upper chest
• Redness, soreness, or itching skin
• Runny nose
• Sensation of pins and needles
• Shortness of breath
• Skin rash
• Sneezing
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Sores, welting, or blisters
• Stabbing pain
• Stuffy nose
• Sweating
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin
• Tender, swollen glands in the neck
• Tightness in the chest
• Trouble with swallowing
• Unusual bleeding or bruising
• Voice changes
• Weakness of the muscles in your face
• Wheezing

Some side effects 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:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site

• Lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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