Influenza Virus Vaccine (Live / Attenuated)

For all patients taking influenza virus vaccine (live/attenuated):

• If you have an allergy to this medicine or any part of influenza virus vaccine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

Children:

• If your child is taking aspirin.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take influenza virus vaccine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all patients taking influenza virus vaccine (live/attenuated):

• Runny nose.
• Stuffy nose.
• Headache.
• Muscle pain.
• Feeling tired or weak.
• Not hungry.
• Fever.
• Sore throat.
• Cough.

Young children:

• Feeling fussy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Nasal [preservative free]:

FluMist Quadrivalent: (1 ea [DSC]) [latex free; contains egg white (egg protein), gelatin (pork)]

FluMist Quadrivalent: (1 ea [DSC]) [contains egg white (egg protein), gelatin (pork)]

≥6 to 8 months when vaccine is antigenically similar to circulating virus (CDC/ACIP [Grohskopf 2016]); response may be diminished in persons ≥65 years and limited evidence suggests titers may decline significantly 6 months following vaccination in this population (CDC/ACIP [Grohskopf 2016])

Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including egg protein, or to previous influenza vaccination; children and adolescents (2 to 17 years of age) receiving aspirin therapy or aspirin-containing therapy because of the association of Reye syndrome with aspirin and wild-type influenza infection.

Note: The ACIP does not consider an egg allergy to be a contraindication to influenza vaccination (CDC/ACIP [Grohskopf 2016]).

There are no dosage adjustments provided in the manufacturer's labeling.

There are no dosage adjustments provided in the manufacturer's labeling.

For intranasal administration only; do not inject. Half the dose (0.1 mL) is administered to each nostril; patient should be in upright position. A dose divider clip is provided to allow administration of 0.1 mL into each nostril. Place the tip of the sprayer inside the nostril and depress plunger as rapidly as possible to deliver the dose. Remove dose divider clip and repeat into opposite nostril. The patient does not need to inhale during administration (may breath normally). If recipient sneezes following administration, the dose should not be repeated (CDC/ACIP [Grohskopf 2016]). Defer immunization if nasal congestion is present which may impede delivery of vaccine (CDC/ACIP [Grohskopf 2013]).

US law requires that the date of administration, name of the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address and documentation of the vaccine information statement (VIS; date on VIS, and date given to patient) be entered into the patient's permanent medical record.

Frequency of events reported within 10 days.

>10%:

Central nervous system: Headache (adults: 40%; children: 3% to 9%), irritability (children: 12% to 21%), lethargy (children: 7% to 14%)

Gastrointestinal: Sore throat (adults: 28%; children: 5% to 11%), decreased appetite (children: 13% to 21%), abdominal pain (children: 2% to 12%)

Neuromuscular & skeletal: Fatigue (adults: ≤26%), weakness (adults: ≤26%), myalgia (adults: 17%; children: 2% to 6%)

Respiratory: Nasal congestion (children: ≤58%; adults: ≤44%), rhinorrhea (children: ≤58%; adults: ≤44%), cough (adults: 14%)

1% to 10%:

Central nervous system: Chills (adults: 9%; children: 2% to 4%)

Otic: Otitis media (children: 3%)

Respiratory: Wheezing (children: 6 to 23 months: 6%; 24 to 59 months: 2%), sinusitis (adults: 4%), sneezing (children: 2%)

Miscellaneous: Fever (children: 100°F to 101°F: 6% to 9%; >101°F: 1% to 4%)

<1%, postmarketing, and/or case reports: Anaphylaxis, Bell's palsy, diarrhea, encephalitis (vaccine-associated), epistaxis, exacerbation of asthma, facial edema, Guillain-Barre syndrome, hypersensitivity reaction, meningitis (including eosinophilic meningitis), nausea, pericarditis, skin rash, subacute necrotizing encephalomyelopathy (Leigh syndrome exacerbation), urticaria, vomiting