Influenza a virus vaccine, h1n1, inactivated (Intramuscular)

Influenza virus vaccine, H1N1 is used to prevent infection from the influenza A (H1N1) 2009 virus. The vaccine helps your body make its own protection (antibodies) against the disease. It is also called a "flu shot".

Influenza is an infection caused by a virus that affects the throat, bronchial tubes, and lungs. Symptoms of influenza include fever, chills, cough, headache, muscle aches, and pain in your back, arms, and legs. Adults and children who are weakened by other diseases or medical conditions, as well as people aged 50 and older, even if they are healthy, may experience a much more serious illness that could require hospital treatment. Every year, thousands of people die from influenza infections.

This vaccine must be given only by or under the supervision of your doctor or another health care professional.

It is very important that your child returns to your doctor’s office at the right time for the second dose. Be sure to inform your doctor of any side effects that happen after you or your child receive this vaccine.

This vaccine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

Avoid contact with people who are sick or at higher risk of getting the infection after you receive this vaccine. Talk to your doctor about this if you have concerns.

Influenza a virus vaccine, h1n1, inactivated may not protect all persons who receive the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a vaccine, you and your doctor will weigh the risks of the vaccine against the benefits it may provide. Consider the following for this vaccine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how the influenza virus vaccine, H1N1 affects children. Safety and effectiveness have not been established for:

• Children below 4 years of age.
• Children below 6 months of age.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the usefulness of the influenza virus vaccine, H1N1.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may change the dose or take other precautions. Let your healthcare professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken near the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Be sure to inform your doctor if you have any other medical issues, especially:

• Allergy to eggs, egg products, or chicken products—Should not be used in patients with these allergies.

• Guillain-Barré syndrome, history of—May cause symptoms of this condition to return.

• Immune system problems (e.g., cancer, HIV)—This vaccine may not work as well if you have a weak immune system.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Difficulty moving
• fever
• general feeling of discomfort or illness
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• swollen joints
• unusual tiredness or weakness

Incidence not known

• Sudden and severe back pain
• 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 swallowing
• dizziness
• dryness or soreness of the throat
• eye pain
• fainting
• fast heartbeat
• feeling faint, dizzy, or lightheaded
• 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 genitals
• sudden and progressing muscle weakness
• 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 sometimes the upper chest
• redness, soreness, or itching of the 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 nodes in the neck, armpit, or groin
• tender, swollen glands in the neck
• tightness in the chest
• trouble 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. Your health care professional may also know 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

• 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 the injection site

Incidence not known

• Lack or loss of strength

Other side effects not listed may also happen 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.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles.

Some children who have not received the vaccine before should receive 2 doses at least 1 month apart.