Seasonal Influenza Vaccine Safety: A Summary for Clinicians
CDC and FDA monitor the safety of all vaccines licensed in the United States, including seasonal influenza vaccines. This summary provides information on:
- Safety of inactivated influenza vaccine (IIV), cell culture-based inactivated influenza vaccine (ccIIV3), recombinant influenza vaccine (RIV), and live attenuated influenza vaccine (LAIV), including adverse events following immunization, contraindications, and precautions.
- Adverse Event Following Immunization (AEFI): Adverse health events or health problems that occur following or during administration of a vaccine, that might be caused by the vaccine or might be coincidental and not related to vaccination.
- Contraindications: A condition in a vaccine recipient that increases the risk for a serious adverse reaction. A vaccine should not be administered when a contraindication is present.
- Precautions: A condition in a vaccine recipient that might increase the risk for a serious adverse reaction or that might compromise the ability of the vaccine to produce immunity.
- Safe vaccine administration.
- Reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS).
- Additional resources for clinicians about influenza vaccine safety .
Inactivated Influenza Vaccine (IIV)
Studies support the safety of annual IIV vaccination in children and adults. IIV is administered as an injection and may cause pain, redness, and swelling at the injection site, and may also cause fever, malaise and myalgias, which are usually mild and go away on their own. IIV contains inactivated virus and cannot cause influenza.
Cell Culture-based Inactivated Influenza Vaccine (ccIIV3)
Flucelvax (ccIIV3) is the first U.S.-licensed (trivalent inactivated) influenza vaccine manufactured using cell culture technology. It is indicated for use in individuals 18 years of age and older. ccIIV3 is administered as an injection and may cause pain, redness, and swelling at the injection site, and may also cause fever, malaise and myalgias which are usually mild and self-limited. ccIIV3 cannot cause influenza.
Recombinant Influenza Vaccine (RIV)
FluBlok (RIV) is a recombinant hemagglutinin influenza vaccine available as a trivalent formulation. RIV does not contain any egg protein. RIV is indicated for active immunization against disease caused by influenza virus subtypes A and type B and is approved for use in individuals 18 years of age and older. RIV is administered as an injection and may cause pain, redness, and swelling at the injection site, and may also cause fever, malaise and myalgias which are usually mild and self-limited. RIV cannot cause influenza.
Read more about how recombinant flu vaccines are made.
Live, Attenuated Influenza Vaccine (LAIV)
FluMist (LAIV) is administered as an intranasal vaccine. LAIV vaccine is a quadrivalent vaccine (protects against four types of flu viruses). It is indicated for use in individuals 2 to 49 years of age. LAIV contains attenuated viruses and cannot cause influenza.
Reporting Adverse Events
- There are three ways to submit a report to VAERS:
- Online: Complete a VAERS form online at: http://vaers.hhs.gov/
- By Fax: Fax a completed VAERS Form[98 KB, 2 pages] to (877) 721-0366.
- By Mail: Mail a completed VAERS Form[98 KB, 2 pages] to VAERS, P.O. Box 1100, Rockville, MD 20849-1100.
- Health care providers are encouraged to report all clinically significant adverse events after influenza vaccines and other vaccines to VAERS, even if you are not certain that the vaccine caused the event. Anyone may submit a report to VAERS.
- Anonymous VAERS data is publicly available through the CDC Wide-ranging Online Data for Epidemiologic Research (WONDER) database.
- Additional information about VAERS is available on the VAERS website.
The National Vaccine Injury Compensation Program
The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines.
Individuals 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. There is a time limit to file a claim for compensation.
Special Consideration Regarding Egg Allergy
The recommendations for vaccination of people with egg allergies have not changed since last season (2016-2017).
People with egg allergies can receive any licensed, recommended age-appropriate influenza vaccine and no longer have to be monitored for 30 minutes after receiving the vaccine. People who have severe egg allergies should be vaccinated in a medical setting and be supervised by a health care provider who is able to recognize and manage severe allergic conditions.
- Page last reviewed: August 25, 2016
- Page last updated: October 3, 2017
- Content source:
- Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases (NCIRD)
- Page maintained by: Office of the Associate Director for Communication, Digital Media Branch, Division of Public Affairs