Patient Information Sheet
Fluzone® Quadrivalent
Influenza Vaccine
Please read this information sheet before getting Fluzone Quadrivalent vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.
What is Fluzone Quadrivalent vaccine?
Fluzone Quadrivalent is a vaccine that helps protect against influenza illness (flu).
Fluzone Quadrivalent vaccine is for people who are 6 months of age and older.
Vaccination with Fluzone Quadrivalent vaccine may not protect all people who receive the vaccine.
Who should not get Fluzone Quadrivalent vaccine?
You should not get Fluzone Quadrivalent vaccine if you:
• ever had a severe allergic reaction to eggs or egg products.
• ever had a severe allergic reaction after getting any flu vaccine.
• are younger than 6 months of age.
Tell your healthcare provider if you or your child have or have had:
• Guillain-Barré syndrome (severe muscle weakness) after getting a flu vaccine.
• problems with your immune system as the immune response may be diminished.
How is the Fluzone Quadrivalent vaccine given?
Fluzone Quadrivalent vaccine is a shot given into the muscle of the arm.
For infants, Fluzone Quadrivalent vaccine is a shot given into the muscle of the thigh.
What are the possible side effects of Fluzone Quadrivalent vaccine?
The most common side effects of Fluzone Quadrivalent vaccine are:
• pain, redness, and swelling where you got the shot
• muscle aches
• tiredness
• headache
• fever
These are not all of the possible side effects of Fluzone Quadrivalent vaccine. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals.
Call your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy. Women who receive Fluzone Quadrivalent during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463.
What are the ingredients in Fluzone Quadrivalent vaccine?
Fluzone Quadrivalent vaccine contains 4 killed flu virus strains.
Inactive ingredients include formaldehyde and octylphenol ethoxylate. The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent vaccine.
Manufactured by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
