Important Safety Information for AFLURIA QUADRIVALENT

INDICATION

AFLURIA^® QUADRIVALENT (Influenza Vaccine) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older.

CONTRAINDICATIONS

• Severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

WARNINGS AND PRECAUTIONS

• If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
• Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
• Immunocompromised persons may have a diminished immune response to AFLURIA QUADRIVALENT.

ADVERSE REACTIONS

• In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when administered by needle and syringe was pain (≥40%). The most common systemic adverse events were myalgia and headache (≥20%).
• In adults 65 years of age and older, the most commonly reported injection-site adverse reaction when administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%).
• In children 5 through 8 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse event was headache (≥10%).
• In children 9 through 17 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥10%).
• In children 6 months through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥ 20%).The most common systemic adverse events were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).
• In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%).

The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions:

• In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions with AFLURIA (trivalent formulation) when administered by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥80%), swelling, pain, redness (≥60%), itching(≥20%) and bruising (≥10%). The most common systemic adverse events were myalgia, malaise (≥30%), and headache (≥20%).

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and http://vaers.hhs.gov.

Please see full prescribing information for AFLURIA QUADRIVALENT.

Important Safety Information for FLUAD QUADRIVALENT

Consumer

What is FLUAD QUADRIVALENT^® (Influenza Vaccine, Adjuvanted)?

FLUAD QUADRIVALENT is a vaccine that helps protect against the flu. FLUAD QUADRIVALENT is for people aged 65 years and older. Vaccination with FLUAD QUADRIVALENT may not protect all people who receive the vaccine.

Who should not get FLUAD QUADRIVALENT?

You should not get FLUAD QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine in the past, including egg protein, or a severe reaction to a previous influenza vaccine.

Who may not be able to get FLUAD QUADRIVALENT? Tell your health care provider if you:

• Have ever had Guillain-Barré syndrome (severe muscle weakness) after getting a flu shot. The decision to give FLUAD QUADRIVALENT should be made by your health care provider, based on careful consideration of the potential benefits and risks.

What if I have a weakened immune system?

Tell your health care provider if you have problems with your immune system, as your immune response to the vaccine may be reduced.

What are the most common side effects of FLUAD QUADRIVALENT?

• Pain or tenderness where you got the shot
• Muscle aches
• Headache
• Fatigue

These are not all of the possible side effects of FLUAD QUADRIVALENT. You can ask your health care provider for a complete list of possible side effects.

Ask your health care provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Events Reporting System (VAERS) by calling 1-800-822-7967 or by going to http://vaers.hhs.gov.

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and http://vaers.hhs.gov.

Please see full prescribing information for FLUAD QUADRIVALENT.

Important Safety Information for FLUCELVAX QUADRIVALENT

Consumer

What is FLUCELVAX^® QUADRIVALENT (Influenza Vaccine)?

FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 6 months and older from the flu. Vaccination with FLUCELVAX QUADRIVALENT may not protect all people who receive the vaccine.

Who should not get FLUCELVAX QUADRIVALENT?

You should not get FLUCELVAX QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine

Before receiving FLUCELVAX QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you:

• have ever had Guillain-Barré Syndrome severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give FLUCELVAX QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks.
• have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine
• have ever fainted after receiving an injection

What are the most common side effects of FLUCELVAX QUADRIVALENT?

• pain, redness, swelling, or a raised hardened area where the vaccine was given
• headache
• overtiredness with low energy
• muscle aches
• feeling unwell (malaise)

Additional side effects seen in children include:

• tenderness or bruising where vaccine was given
• sleepiness
• irritability
• diarrhea
• changes in eating habits

These are not all of the possible side effects of FLUCELVAX QUADRIVALENT. You can ask your healthcare provider for more information and for advice about any side effects that concern you.

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and http://vaers.hhs.gov. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

Please see full prescribing information for FLUCELVAX QUADRIVALENT.