Influenza Vaccine Live Intranasal

• Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would start a few minutes to a few hours after the vaccination.

• If you think it is a severe allergic reaction or other emergency that can't wait, call 9-1-1 and get the person to the nearest hospital. Otherwise, call your doctor.
• Reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS web site at http://www.vaers.hhs.gov, or by calling 1-800-822-7967.

VAERS does not give medical advice.

Live, attenuated virus vaccine.1 Seasonal influenza vaccine live intranasal (LAIV; LAIV4) contains live (cold-adapted) influenza virus types A and B representing influenza strains likely to circulate in the US during the upcoming season and is used to stimulate active immunity to influenza strains contained in the vaccine.1

Storage

Intranasal Spray

2–8°C; do not freeze.1

Does not contain thimerosal or any other preservatives.1

• Prior to administration of seasonal influenza vaccine live, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at ).1 20

• Advise patient and/or patient's parent or guardian of the risks and benefits of vaccine administration.1

• Advise patient and/or patient's parent or guardian that annual vaccination against seasonal influenza is necessary.100 Importance of receiving a 2016–2017 seasonal influenza vaccine, even if the individual received a 2015–2016 seasonal influenza vaccine.100 112

• Advise patient and/or patient's parent or guardian that a single dose of seasonal influenza vaccine is necessary each year in adults, adolescents, and children ≥9 years of age, but that 2 doses of seasonal influenza vaccine may be necessary in some children 2 through 8 years of age.1 100 112 (See Pediatric Patients under Dosage and Administration.)

• Ask patient and/or patient's parent or guardian if vaccinee has a history of asthma or recurrent wheezing or has had a recent wheezing episode (within the past 12 months).1 Advise patient's parent or guardian that a history of recurrent wheezing may be an asthma equivalent in children <5 years of age and that individuals of any age with asthma and children <5 years of age with recurrent wheezing may be at increased risk for wheezing after receiving the intranasal vaccine.1 (See Pediatric Use under Cautions.)

• Importance of informing clinicians of any severe or life-threatening allergies, including severe allergy to eggs, or any history of severe reaction after prior influenza vaccination.20

• Advise patient and/or patient's parent or guardian that seasonal intranasal influenza vaccine is a live, attenuated virus vaccine and that vaccine virus can be transmitted to close contacts.1 (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.)

• Importance of informing clinicians of adverse effects.1 Clinicians or individuals can report any adverse reactions that occur following vaccination to the manufacturer at 877-633-4411 or Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .1

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant medical problems (i.e., asthma, recurrent wheezing, GBS).1

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)