Side Effects

Drug information provided by: Merative, Micromedex®

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:

More common

  1. Bruising, hard lump, redness, or pain at the injection site
  2. cough
  3. diarrhea
  4. fever
  5. headache
  6. irritability
  7. large, flat, blue or purplish patches in the skin
  8. loss of appetite
  9. muscle aches
  10. redness of the eyes
  11. sneezing
  12. sore throat
  13. stuffy or runny nose
  14. vomiting

Less common

  1. Body aches or pain
  2. chest tightness
  3. chills
  4. difficulty with breathing
  5. earache
  6. ear congestion
  7. loss of voice
  8. shivering
  9. swelling or puffiness of the face
  10. unusual tiredness or weakness

Rare

  1. Difficulty with swallowing
  2. dizziness
  3. fast heartbeat
  4. hives, itching, or skin rash
  5. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  6. noisy breathing
  7. puffiness or swelling of the eyelids or around the eyes, lips, or tongue

Incidence not known

  1. Agitation
  2. back pain, sudden and severe
  3. back, leg, or stomach pains
  4. blistering, peeling, or loosening of the skin
  5. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  6. burning, dry, or itching eyes
  7. chest pain
  8. clumsiness or unsteadiness
  9. confusion
  10. drowsiness
  11. dryness of the throat
  12. fainting
  13. feeling hot
  14. increased sensitivity of the eyes to sunlight
  15. inflammation, rash, swelling, or tenderness at the injection site
  16. lightheadedness
  17. nosebleeds
  18. pain, redness, soreness, swelling, tenderness, or warmth on the skin
  19. pinpoint red spots on the skin
  20. redness of the face, neck, arms, and occasionally, upper chest
  21. sensation of spinning
  22. shakiness in the legs, arms, hands, or feet
  23. sores, ulcers, or white spots in the mouth or on the lips
  24. sores, welts, or blisters
  25. stomach pain, soreness, or discomfort
  26. sweating
  27. trouble sleeping
  28. unusual bleeding or bruising
  29. voice changes
  30. weakness of the muscles in your face
  31. 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:

More common

  1. Difficulty in moving
  2. joint pain
  3. muscle aches, cramping, pains, or stiffness
  4. swollen joints

Incidence not known

  1. 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.