Influenza virus vaccine Intramuscular

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).

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 or nurse immediately if any of the following side effects occur:

• Cough
• diarrhea
• fever
• headache
• irritability
• loss of appetite
• muscle aches
• redness of the eyes
• sneezing
• sore throat
• stuffy or runny nose
• vomiting

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

• 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

• Agitation
• back pain, sudden and severe
• back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• bruising, inflammation, rash, redness, swelling, tenderness, or pain at the injection site
• 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
• 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
• 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

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:

• Sleepiness or unusual drowsiness

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.