Fluzone Preservative-Free 2012-2013 Side Effects

Generic Name: influenza virus vaccine, inactivated

Note: This page contains information about the side effects of influenza virus vaccine, inactivated. Some of the dosage forms included on this document may not apply to the brand name Fluzone Preservative-Free 2012-2013.

Not all side effects for Fluzone Preservative-Free 2012-2013 may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to influenza virus vaccine, inactivated: solution, suspension

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).

In addition to its needed effects, some unwanted effects may be caused by influenza virus vaccine, inactivated (the active ingredient contained in Fluzone Preservative-Free 2012-2013). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking influenza virus vaccine, inactivated, check with your doctor or nurse immediately:

More common
  • Cough
  • diarrhea
  • fever
  • headache
  • irritability
  • loss of appetite
  • muscle aches
  • redness of the eyes
  • sneezing
  • sore throat
  • stuffy or runny nose
  • vomiting
Less common
  • 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
Incidence not known
  • 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 of the side effects that can occur with influenza virus vaccine, inactivated may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known
  • Sleepiness or unusual drowsiness

For Healthcare Professionals

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


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


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


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


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


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


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


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

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