FluLaval Quadrivalent is for use in adults and children at least 6 months old, to prevent infection caused by influenza virus. This vaccine helps your body develop immunity to the disease, but will not treat an active infection you already have.

FluLaval Quadrivalent is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year.

Influenza virus ("the flu") is a contagious disease caused by a virus that can spread from one person to another through the air or on surfaces. Flu symptoms include fever, chills, tiredness, aches, sore throat, cough, vomiting, and diarrhea. The flu can also cause sinus infections, ear infections, bronchitis, or serious complications such as pneumonia.

Influenza causes thousands of deaths each year, and hundreds of thousands of hospitalizations. Influenza is most dangerous in children, pregnant women, older adults, and people with weak immune systems or health problems such as diabetes, heart disease, or cancer.

Like any vaccine, FluLaval Quadrivalent may not provide protection from disease in every person.

FluLaval Quadrivalent vaccine is made from "killed viruses" and will not cause you to become ill with the flu virus.

Becoming infected with influenza is much more dangerous to your health than receiving this vaccine. However, like any medicine, FluLaval Quadrivalent can cause side effects but the risk of serious side effects is extremely low.

Before taking this medicine

You may not be able to receive FluLaval Quadrivalent if you are allergic to eggs, or if you have ever had a severe allergic reaction to a flu vaccine.

Tell your vaccination provider if you have:

• a weak immune system (caused by disease or by using certain medicine); or

• a history of Guillain-Barre syndrome (within 6 weeks after receiving a flu vaccine).

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving FluLaval Quadrivalent.

Tell your vaccination provider if you are pregnant or breastfeeding.

The Centers for Disease Control and Prevention recommends that pregnant women get a flu shot during any trimester of pregnancy to protect themselves and their newborn babies from flu. The nasal spray form of influenza vaccine is not recommended for use in pregnant women.

FluLaval Quadrivalent is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

You should receive a flu vaccine every year. Your immunity will gradually decrease over the 12 months after you receive the FluLaval Quadrivalent. Children receiving FluLaval Quadrivalent may need a booster shot one month after receiving the first vaccine.

The FluLaval Quadrivalent is usually given in October or November. Some people may need to have their vaccines earlier or later. Follow your doctor's instructions.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

You may not be able to receive FluLaval Quadrivalent if you are allergic to eggs, or if you have ever had a severe allergic reaction to a flu vaccine.

Tell your vaccination provider if you have:

• a weak immune system (caused by disease or by using certain medicine); or

• a history of Guillain-Barre syndrome (within 6 weeks after receiving a flu vaccine).

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving FluLaval Quadrivalent.

Tell your vaccination provider if you are pregnant or breastfeeding.

The Centers for Disease Control and Prevention recommends that pregnant women get a flu shot during any trimester of pregnancy to protect themselves and their newborn babies from flu. The nasal spray form of influenza vaccine is not recommended for use in pregnant women.

Call your doctor if you forget to receive your yearly flu shot in October or November, or if your child misses a booster dose.

An overdose of FluLaval Quadrivalent is unlikely to occur.

Follow your vaccination provider's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to FluLaval: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects you have. If you receive a FluLaval Quadrivalent in the future, you will need to tell the vaccination provider if the previous shot caused any side effects.

FluLaval Quadrivalent is made from "killed viruses" and will not cause you to become ill with the flu virus. You may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• severe weakness or unusual feeling in your arms and legs;

• numbness, pain, tingling, burning or prickly feeling;

• vision or hearing problems; or

• a fever higher than 101 degrees F.

Common FluLaval side effects may include:

• pain, redness, tenderness, swelling, bruising, or a hard lump where the shot was given;

• diarrhea, loss of appetite;

• muscle pain;

• headache, tiredness; or

• fussiness, crying, or drowsiness in a child.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished:

• steroid medicine;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

• medicines to treat or prevent organ transplant rejection.

This list is not complete. Other drugs may interact with FluLaval Quadrivalent, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.