Fluzone High-Dose (Influenza Vaccine)

The most common side effects of Fluzone High-Dose Quadrivalent vaccine are:

• pain, redness, and swelling where you got the shot
• muscle ache
• tiredness
• headache

These are not all of the possible side effects of Fluzone High-Dose 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 https://vaers.hhs.gov.

Dose And Schedule

• Fluzone High-Dose Quadrivalent should be administered as a single 0.7 mL injection by the intramuscular route in adults 65 years of age and older.

Administration

• Inspect Fluzone High-Dose Quadrivalent visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists the vaccine should not be administered.
• Before administering a dose of vaccine, shake the prefilled syringe.
• The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
• Do not administer this product intravenously.
• Fluzone High-Dose Quadrivalent should not be combined through reconstitution or mixed with any other vaccine.

• Fluzone High-Dose Quadrivalent is not approved for use in persons <65 years of age.
• There are limited human data on Fluzone High-Dose and no animal data available on Fluzone High-Dose Quadrivalent to establish whether there is a vaccine-associated risk with use of Fluzone High-Dose Quadrivalent in pregnancy.
• Fluzone High-Dose Quadrivalent is not approved for use in persons <65 years of age.
• No human or animal data are available to assess the effects of Fluzone High-Dose Quadrivalent on the breastfed infant or on milk production/excretion.