Influenza virus vaccine (Intradermal, Intramuscular)

Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine helps your body create its own protection (antibodies) against the disease. It is also called a “flu shot.”

There are many types of influenza viruses, but not all will cause issues each year. Before producing the influenza vaccine each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses are most likely to cause influenza infections that year. The vaccine includes antigens, which are substances that trigger the immune system to make protective antibodies, for these viruses. Typically, the U.S. and Canada use the same influenza vaccine, but they are not required to do so.

You need to get an influenza vaccine injection every year because influenza infections are usually caused by different types of viruses, and the protection from the vaccine lasts for less than a year.

Influenza is a viral infection that affects the throat, bronchial tubes, and lungs. It can cause fever, chills, cough, headache, muscle aches, and pain in your back, arms, and legs. Additionally, adults and children who are weakened by other diseases or medical conditions, as well as people 50 years of age and older, even if they are healthy, may experience a much more serious illness that could require hospitalization. Each year, thousands of people die from influenza infections.

The best way to help prevent influenza infections is to get an influenza vaccination every year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and older, all children, and all adults (including those 65 years of age and older).

This vaccine must be given only by or under the direct 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 if a second dose of the vaccine is needed. Be sure to inform your doctor about any side effects that happen after you or your child receive this vaccine.

This vaccine can cause a serious allergic reaction known as anaphylaxis, which can be life-threatening and requires immediate medical help. Contact your doctor right away if you or your child experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or swelling of your hands, face, or mouth after the injection.

Children who have received a specific brand of the influenza vaccine (Afluria®, Afluria® Quadrivalent) have experienced fever, and in some cases, fever with seizures. Discuss any concerns with your doctor.

If you are very ill and have a high fever, you will likely need to wait until you are better before getting this vaccine.

The influenza virus vaccine may not protect everyone who receives it. It will not treat flu symptoms if you already have the virus.

The tip cap of the prefilled syringe for certain brands of the injection (Agriflu®, Flucelvax®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people sensitive to latex. Inform your doctor if you or your child have a latex allergy before receiving this vaccine.

Tell your doctor if you or your child are taking any medicine or treatment that weakens your immune system, including steroids, radiation, or cancer treatment. This vaccine may not be as effective if you are using these treatments. Your doctor may still recommend the vaccine as it can provide some protection.

In deciding to use a vaccine, you and your doctor will weigh the risks of the vaccine against its benefits. Here are some important considerations:

Allergies

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

Pediatric

There have not been suitable studies on how Agriflu®, Flulaval™, Fluzone® High-Dose, Fluzone® Intradermal, or Fluzone® Intradermal Quadrivalent affect children. Safety and effectiveness have not been established.

There have not been suitable studies on how Fluvirin® affects children younger than 4 years old. Safety and effectiveness have not been established.

There have not been suitable studies on how Fluarix® affects children younger than 3 years old. Safety and effectiveness have not been established.

There have not been suitable studies on how Afluria®, Afluria® Quadrivalent, Fluarix® Quadrivalent, Flucelvax® Quadrivalent, Flulaval® Quadrivalent, Fluzone®, or Fluzone® Quadrivalent affect children younger than 6 months old. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of the influenza virus vaccine.

There have not been suitable studies on how Fluzone® Intradermal or Fluzone® Intradermal Quadrivalent affect older adults. Safety and effectiveness have not been established.

Breast Feeding

There are no adequate studies in women about the risk to infants when using this vaccine while breastfeeding. Consider the potential benefits and risks before taking this vaccine if you are breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together even if an interaction may happen. In these situations, your doctor may adjust the dose or take other precautions. It is particularly important that your healthcare provider knows if you are taking any of the following medicines while receiving this vaccine, as they may increase the risk of certain side effects:

• Rituximab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use this vaccine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to eggs, egg products, or chicken proteins—This vaccine should not be used if you have this allergy.

• Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution, as there may be a higher risk of bleeding at the injection site.

• Guillain-Barré syndrome (a serious nerve and muscle issue), history of—Use with caution, as this may cause symptoms to return.

• Illness with fever, moderate or severe—You may need to wait until you recover before receiving the vaccine.

• Immune system problems due to a disease or medication—The vaccine may not work as well for patients with this condition.

• History of allergy to kanamycin, neomycin, or polymyxin—Only certain brands of the influenza vaccine can be used. Discuss this with your doctor.

In 1976, some people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), a disease that can cause paralysis. Most of these individuals were over 25 years old. Although only 10 out of every one million people who got the vaccine actually developed GBS, this was 6 times higher than what would normally be expected. Most people who experienced GBS fully recovered.

It is believed that the “swine flu” virus in the 1976 vaccine caused this issue, but this has not been proven. Since then, studies have shown that the risk of getting GBS from an influenza vaccine is very low (one out of every million people).

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects may occur, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Bruising, hard lump, redness, or pain at the injection site
• cough
• diarrhea
• fever
• headache
• irritability
• large, flat, blue or purplish patches on the skin
• loss of appetite
• muscle aches
• redness of the eyes
• sneezing
• sore throat
• stuffy or runny nose
• vomiting

Less common

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

Rare

• Difficulty 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
• sudden and severe back pain
• back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling sensations
• burning, dry, or itchy eyes
• chest pain
• clumsiness or unsteadiness
• confusion
• drowsiness
• dry throat
• fainting
• feeling hot
• increased sensitivity of the eyes to sunlight
• inflammation, rash, swelling, or tenderness at the injection site
• 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 sometimes, 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
• sores, welts, or blisters
• 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty moving
• joint pain
• muscle aches, cramping, pains, or stiffness
• swollen joints

Incidence not known

• 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Afluria 2015-2016 Formula
• Fluarix Quadrivalent 2013-2014 Formula
• Fluarix Quadrivalent 2015-2016 Formula
• Flucelvax 2015-2016 Formula
• Flulaval Quadravalent 2013-2014 Season
• FluLaval Quadrivalent 2015-2016 Formula
• Fluvirin 2015-2016 Formula
• Fluzone 2013-2014 Formula
• Fluzone 2015-2016 Formula
• Fluzone High Dose 2015-2016 Formula
• Fluzone Intradermal Quadrivalent 2014-2015 Formula
• Fluzone Intradermal Quadrivalent 2015-2016 Formula

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

A nurse or other trained health professional will give you or your child this vaccine. It is given as a shot into one of your muscles or into your skin, usually in the upper arm.

Sometimes there is not enough flu vaccine for everyone. If this happens and you are a healthy adult, you might need to wait until later in the flu season before getting your vaccination.

You need to get the flu vaccine every year to protect you from the flu.

Some children may need a second dose of the vaccine. If your child needs a second dose of the vaccine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as soon as possible.

Fluzone® Intradermal Quadrivalent and Fluzone® Quadrivalent come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

• How and where is a flu shot injection given?
• Flu Vaccines and Egg Allergy: Which Are Safe?
• Which flu vaccines are available this year?
• Where Can I Get a Flu Shot Near Me?
• How well does the flu vaccine work?
• How can I get a flu vaccine without a needle?
• What is the difference between Flublok and Flublok Quadrivalent?

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