VACCINE INFORMATION STATEMENT

Influenza Vaccine 2012 - 2013
	
Inactivated
What You Need to Know
Many Vaccine Information Statements are available in Spanish and other languages. 

See www.immunize.org/vis.
	
Hojas de Informacián Sobre Vacunas están disponibles en Español y en 

muchos otros idiomas. Visite http://www.immunize.org/vis
	
Why get vaccinated?1
Influenza (“flu”) is a contagious disease.
It is caused by the influenza virus, which can be spread
by coughing, sneezing, or nasal secretions.
Anyone can get influenza, but rates of infection are
highest among children. For most people, symptoms last
only a few days. They include:
• fever/chills • sore throat • muscle aches • fatigue
• cough • headache • runny or stuffy nose
Other illnesses can have the same symptoms and are
often mistaken for influenza.
Young children, people 65 and older, pregnant women,
and people with certain health conditions – such as heart,
lung or kidney disease, or a weakened immune system –
can get much sicker. Flu can cause high fever and
pneumonia, and make existing medical conditions worse.
It can cause diarrhea and seizures in children. Each year
thousands of people die from influenza and even more
require hospitalization.
By getting flu vaccine you can protect yourself from
influenza and may also avoid spreading influenza to
others.
Inactivated influenza vaccine2
There are two types of influenza vaccine:
1. Inactivated (killed) vaccine, the “flu shot,” is given
by injection with a needle.
2. Live, attenuated (weakened) influenza vaccine is
sprayed into the nostrils. This vaccine is described in a
separate Vaccine Information Statement.
A “high-dose” inactivated influenza vaccine is available
for people 65 years of age and older. Ask your doctor for
more information.
Influenza viruses are always changing, so annual
vaccination is recommended. Each year scientists try to
match the viruses in the vaccine to those most likely to
cause flu that year. Flu vaccine will not prevent disease
from other viruses, including flu viruses not contained in
the vaccine.
It takes up to 2 weeks for protection to develop after the
shot. Protection lasts about a year.
Some inactivated influenza vaccine contains a preservative
called thimerosal. Thimerosal-free influenza vaccine is
available. Ask your doctor for more information.
Who should get inactivated
3 influenza vaccine and when?
WHO
All people 6 months of age and older should get flu
vaccine.
Vaccination is especially important for people at higher
risk of severe influenza and their close contacts,
including healthcare personnel and close contacts of
children younger than 6 months.
WHEN
Get the vaccine as soon as it is available. This should
provide protection if the flu season comes early. You can
get the vaccine as long as illness is occurring in your
community.
Influenza can occur at any time, but most influenza
occurs from October through May. In recent seasons,
most infections have occurred in January and February.
Getting vaccinated in December, or even later, will still
be beneficial in most years.
Adults and older children need one dose of influenza
vaccine each year. But some children younger than 9
years of age need two doses to be protected. Ask your
doctor.
Influenza vaccine may be given at the same time as other
vaccines, including pneumococcal vaccine.
4
Some people should not get
inactivated influenza vaccine
or should wait.
• Tell your doctor if you have any severe (life-
threatening) allergies, including a severe allergy to
eggs. A severe allergy to any vaccine component may
be a reason not to get the vaccine. Allergic reactions to
influenza vaccine are rare.
5
• Tell your doctor if you ever had a severe reaction after
a dose of influenza vaccine.
• Tell your doctor if you ever had Guillain-Barré
Syndrome (a severe paralytic illness, also called GBS).
Your doctor will help you decide whether the vaccine
is recommended for you.
• People who are moderately or severely ill should usually
wait until they recover before getting flu vaccine. If you are
ill, talk to your doctor about whether to reschedule the
vaccination. People with a mild illness can usually get the
vaccine.
What are the risks from
inactivated influenza vaccine?
A vaccine, like any medicine, could possibly cause
serious problems, such as severe allergic reactions. The
risk of a vaccine causing serious harm, or death, is
extremely small.
Serious problems from inactivated influenza vaccine are
very rare. The viruses in inactivated influenza vaccine
have been killed, so you cannot get influenza from the
vaccine.
Mild problems:
• soreness, redness, or swelling where the shot was given
• hoarseness; sore, red or itchy eyes; cough
• fever • aches • headache • itching • fatigue
If these problems occur, they usually begin soon after the
shot and last 1-2 days.
Moderate problems:
Young children who get inactivated flu vaccine and
pneumococcal vaccine (PCV13) at the same time appear
to be at increased risk for seizures caused by fever. Ask
your doctor for more information.
Tell your doctor if a child who is getting flu vaccine has
ever had a seizure.
Severe problems:
• Life-threatening allergic reactions from vaccines are
very rare. If they do occur, it is usually within a few
minutes to a few hours after the shot.
• In 1976, a type of inactivated influenza (swine flu)
vaccine was associated with Guillain-Barré Syndrome
(GBS). Since then, flu vaccines have not been clearly
linked to GBS. However, if there is a risk of GBS
from current flu vaccines, it would be no more than 1
or 2 cases per million people vaccinated. This is much
lower than the risk of severe influenza, which can be
prevented by vaccination.
The safety of vaccines is always being monitored. For
more information, visit:
www.cdc.gov/vaccinesafety/Vaccine_Monitoring/Index.html and
www.cdc.gov/vaccinesafety/Activities/Activities_Index.html
One brand of inactivated flu vaccine, called Afluria,
should not be given to children 8 years of age or
younger, except in special circumstances. A related
vaccine was associated with fevers and fever-related
seizures in young children in Australia. Your doctor
can give you more information.
What if there is a severe
reaction?
6
What should I look for?
• Any unusual condition, such as a high fever or unusual
behavior. Signs of a serious allergic reaction can include
difficulty breathing, hoarseness or wheezing, hives,
paleness, weakness, a fast heart beat or dizziness.
What should I do?
•		Call a doctor, or get the person to a doctor right away.
•		Tell your doctor what happened, the date and time it
happened, and when the vaccination was given.
•		Ask your doctor, nurse, or health department to report
the reaction by filing a Vaccine Adverse Event
Reporting System (VAERS) form. Or you can file this
report through the VAERS web site at
www.vaers.hhs.gov, or by calling 1-800-822-7967.
VAERS does not provide medical advice.
The National Vaccine Injury
7 Compensation Program
The National Vaccine Injury Compensation Program
(VICP) was created in 1986.
People who believe they may have been injured by a
vaccine can learn about the program and about filing a
claim by calling 1-800-338-2382 or visiting the VICP
website at www.hrsa.gov/vaccinecompensation.
How can I learn more?8
• Ask your doctor. They can give you the vaccine
package insert or suggest other sources of information.
• Call your local or state health department.
• Contact the Centers for Disease Control and
Prevention (CDC):
- Call 1-800-232-4636 (1-800-CDC-INFO) or
- Visit CDC’s website at www.cdc.gov/flu
Vaccine Information Statement (Interim)
Influenza Vaccine
(Inactivated)	
7/2/2012

42 U.S.C. § 300aa-26
Office Use
Only

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Influenza vaccine

  • 1. VACCINE INFORMATION STATEMENT Influenza Vaccine 2012 - 2013 Inactivated What You Need to Know Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis. Hojas de Informacián Sobre Vacunas están disponibles en Español y en muchos otros idiomas. Visite http://www.immunize.org/vis Why get vaccinated?1 Influenza (“flu”) is a contagious disease. It is caused by the influenza virus, which can be spread by coughing, sneezing, or nasal secretions. Anyone can get influenza, but rates of infection are highest among children. For most people, symptoms last only a few days. They include: • fever/chills • sore throat • muscle aches • fatigue • cough • headache • runny or stuffy nose Other illnesses can have the same symptoms and are often mistaken for influenza. Young children, people 65 and older, pregnant women, and people with certain health conditions – such as heart, lung or kidney disease, or a weakened immune system – can get much sicker. Flu can cause high fever and pneumonia, and make existing medical conditions worse. It can cause diarrhea and seizures in children. Each year thousands of people die from influenza and even more require hospitalization. By getting flu vaccine you can protect yourself from influenza and may also avoid spreading influenza to others. Inactivated influenza vaccine2 There are two types of influenza vaccine: 1. Inactivated (killed) vaccine, the “flu shot,” is given by injection with a needle. 2. Live, attenuated (weakened) influenza vaccine is sprayed into the nostrils. This vaccine is described in a separate Vaccine Information Statement. A “high-dose” inactivated influenza vaccine is available for people 65 years of age and older. Ask your doctor for more information. Influenza viruses are always changing, so annual vaccination is recommended. Each year scientists try to match the viruses in the vaccine to those most likely to cause flu that year. Flu vaccine will not prevent disease from other viruses, including flu viruses not contained in the vaccine. It takes up to 2 weeks for protection to develop after the shot. Protection lasts about a year. Some inactivated influenza vaccine contains a preservative called thimerosal. Thimerosal-free influenza vaccine is available. Ask your doctor for more information. Who should get inactivated 3 influenza vaccine and when? WHO All people 6 months of age and older should get flu vaccine. Vaccination is especially important for people at higher risk of severe influenza and their close contacts, including healthcare personnel and close contacts of children younger than 6 months. WHEN Get the vaccine as soon as it is available. This should provide protection if the flu season comes early. You can get the vaccine as long as illness is occurring in your community. Influenza can occur at any time, but most influenza occurs from October through May. In recent seasons, most infections have occurred in January and February. Getting vaccinated in December, or even later, will still be beneficial in most years. Adults and older children need one dose of influenza vaccine each year. But some children younger than 9 years of age need two doses to be protected. Ask your doctor. Influenza vaccine may be given at the same time as other vaccines, including pneumococcal vaccine. 4 Some people should not get inactivated influenza vaccine or should wait. • Tell your doctor if you have any severe (life- threatening) allergies, including a severe allergy to eggs. A severe allergy to any vaccine component may be a reason not to get the vaccine. Allergic reactions to influenza vaccine are rare.
  • 2. 5 • Tell your doctor if you ever had a severe reaction after a dose of influenza vaccine. • Tell your doctor if you ever had Guillain-Barré Syndrome (a severe paralytic illness, also called GBS). Your doctor will help you decide whether the vaccine is recommended for you. • People who are moderately or severely ill should usually wait until they recover before getting flu vaccine. If you are ill, talk to your doctor about whether to reschedule the vaccination. People with a mild illness can usually get the vaccine. What are the risks from inactivated influenza vaccine? A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. The risk of a vaccine causing serious harm, or death, is extremely small. Serious problems from inactivated influenza vaccine are very rare. The viruses in inactivated influenza vaccine have been killed, so you cannot get influenza from the vaccine. Mild problems: • soreness, redness, or swelling where the shot was given • hoarseness; sore, red or itchy eyes; cough • fever • aches • headache • itching • fatigue If these problems occur, they usually begin soon after the shot and last 1-2 days. Moderate problems: Young children who get inactivated flu vaccine and pneumococcal vaccine (PCV13) at the same time appear to be at increased risk for seizures caused by fever. Ask your doctor for more information. Tell your doctor if a child who is getting flu vaccine has ever had a seizure. Severe problems: • Life-threatening allergic reactions from vaccines are very rare. If they do occur, it is usually within a few minutes to a few hours after the shot. • In 1976, a type of inactivated influenza (swine flu) vaccine was associated with Guillain-Barré Syndrome (GBS). Since then, flu vaccines have not been clearly linked to GBS. However, if there is a risk of GBS from current flu vaccines, it would be no more than 1 or 2 cases per million people vaccinated. This is much lower than the risk of severe influenza, which can be prevented by vaccination. The safety of vaccines is always being monitored. For more information, visit: www.cdc.gov/vaccinesafety/Vaccine_Monitoring/Index.html and www.cdc.gov/vaccinesafety/Activities/Activities_Index.html One brand of inactivated flu vaccine, called Afluria, should not be given to children 8 years of age or younger, except in special circumstances. A related vaccine was associated with fevers and fever-related seizures in young children in Australia. Your doctor can give you more information. What if there is a severe reaction? 6 What should I look for? • Any unusual condition, such as a high fever or unusual behavior. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness. What should I do? • Call a doctor, or get the person to a doctor right away. • Tell your doctor what happened, the date and time it happened, and when the vaccination was given. • Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967. VAERS does not provide medical advice. The National Vaccine Injury 7 Compensation Program The National Vaccine Injury Compensation Program (VICP) was created in 1986. People who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation. How can I learn more?8 • Ask your doctor. They can give you the vaccine package insert or suggest other sources of information. • Call your local or state health department. • Contact the Centers for Disease Control and Prevention (CDC): - Call 1-800-232-4636 (1-800-CDC-INFO) or - Visit CDC’s website at www.cdc.gov/flu Vaccine Information Statement (Interim) Influenza Vaccine (Inactivated) 7/2/2012 42 U.S.C. § 300aa-26 Office Use Only