Fluarix Vaccine

Fluarix is a flu shot for people who are at least 3 years old. It comes in Trivalent and Quadrivalent formulations. The most common side effects are reactions where the shot was given.

What is Fluarix?

Fluarix is an immunization against influenza (“the flu”) virus types A and B. It is made by GlaxoSmithKline and approved for people over 3 years old. There are two types of Fluarix:

• Fluarix Trivalent: Protects against 3 types of influenza viruses (two type A strains and one type B strain) and it was approved in 2005.
• Fluarix Quadrivalent: Protects against 4 types of influenza viruses (two type A strains and two type B strains) and it was approved in 2012.

How is Fluarix given?

For children between 3 years and 8 years old, Fluarix is given in one 0.5-mL dose. Children who have never received a flu shot should get two doses of the 0.5-mL Fluarix vaccine given at least 4 weeks apart.

Children over 9 years old and adults should get one 0.5mL dose of Fluarix. The preferred injection site is the upper arm (deltoid muscle).

Can Fluarix give you the flu?

No. Fluarix has inactivated (dead) influenza viruses that can’t cause infection with the flu. Some people do develop mild flu-like symptoms as their body develops immunity, but it is not the flu.

Who should NOT get Fluarix?

Fluarix is contraindicated in anyone with a history of severe allergic reaction (e.g., anaphylaxis) to egg protein, any previous flu shot, or any other ingredient in Fluarix (see below for a complete list).

Carefully consider the risks and benefits of Fluarix in anyone who developed Guillain-Barré Syndrome within 6 weeks of a flu shot.

What are minor side effects of Fluarix?

The following minor side effects have been linked to Fluarix Trivalent:

• Abdominal pain
• Back pain
• Cough
• Diarrhea
• Dizziness
• Drowsiness
• Enlarged lymph nodes
• Eye irritation, pain, redness, swelling
• Fatigue
• Fever
• Headache
• Influenza-like illness
• Injection-site pain, redness, swelling
• Irritability
• Itching where the shot was given
• Joint pain
• Malaise
• Menstrual cramps
• Muscle aches
• Nausea
• Nasal congestion
• Shivering
• Sweating
• Tiredness
• Vomiting

What are the most common side effects of Fluarix?

In adults, the most common side effects of Fluarix Trivalent were pain (55%), redness (18%), and swelling (9%) at the injection site, muscle aches (23%), fatigue (20%), headache (19%), joint pain (6%), and shivering (3%).

In children aged 3 to 4 years old, the most common side effects of Fluarix Trivalent were pain (35%), redness (23%), and swelling (14%) where the shot was given, irritability (21%), loss of appetite (13%), drowsiness (13%), and fever over 99.5ºF (7%).

In children and teenagers between the ages of 5 and 17 years old, the most common side effects of Fluarix Trivalent were pain (56%), redness (18%), and swelling (14%) where the shot was given, muscle aches (29%), fatigue (20%), headache (15%), joint pain (6%), and shivering (3%).

What is the risk of fever from Fluarix?

About 7% of children between 3 and 4 years old developed fevers over 99.5ºF after receiving Fluarix Trivalent.

About 4% of children and teenagers between 5 years old and 17 years old developed fevers over 99.5ºF after receiving Fluarix Trivalent.

About 2% of adult patients developed fever over 100.4ºF after receiving Fluarix Trivalent.

What are severe side effects of Fluarix?

The following severe side effects have been linked to Fluarix Trivalent:

• Abnormal heart rhythm
• Allergic reaction
• Anaphylactic shock
• Anaphylaxis
• Angioedema
• Asthma
• Bronchospasm
• Chest pain
• Conjunctivitis
• Convulsion
• Encephalomyelitis
• Erythema multiforme
• Facial palsy
• Facial paresis
• Facial swelling
• Fever
• Guillain-Barré syndrome
• Hematoma (blood pocket)
• Henoch-Schönlein purpura
• Hypersensitivity reaction
• Hyposthesia
• Injection-site mass, abscess, infection, or lump
• Migraine headache
• Musculoskeletal pain
• Myelitis
• Neck pain
• Neuritis
• Neuropathy
• Paresthesia
• Respiratory distress
• Seizure
• Serum sickness
• Shortness of breath
• Shoulder injury
• SIRVA
• Stevens-Johnson Syndrome (SJS)
• Tachycardia
• Tonic-clonic limb movements
• Tonsillitis
• Upper respiratory tract infection
• Vasculitis
• Vertigo
• Weakness

What ingredients are in Fluarix?

Each 0.5-mL dose of Fluarix Trivalent also contains octoxynol-10 (TRITON® X -100) ≤0.085 mg, α-tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0016 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process.

The tip caps and plungers of the pre-filled syringes of Fluarix Trivalent and Quadrivalent are NOT made with natural rubber latex.

Does Fluarix have thimerosal?

No. Fluarix Trivalent and Quadrivalent are both formulated without preservatives. They do not contain thimerosal, a mercury-based preservative.

Can Fluarix cause a Shoulder Injury Related to Vaccine Administration (SIRVA)?

Fluarix can potentially cause Shoulder Injury Related to Vaccine Administration (SIRVA) when the vaccine needle is accidentally injected too high or too deep into the shoulder

Can Fluarix cause Guillain-Barre Syndrome (GBS)?

Flu vaccines, including Fluarix, may slightly increase the risk of a rare side effect known as Guillain-Barré Syndrome (GBS).

Can I file a Fluarix lawsuit?

If you or your child was diagnosed with SIRVA or GBS after receiving Fluarix, you may be able to file a lawsuit and seek up to $250,000 from the Vaccine Injury Compensation Program (VICP).

Where can I get more information?

• Fluarix Lawsuit & Vaccine Injury Compensation Program
• Fluarix Quadrivalent Package Insert 2016-2017 Formula (PDF)
• Fluarix Trivalent Package Insert 2015-2016 Formula (PDF)
• Fluarix Quadrivalent FDA Product Information
• Fluarix Trivalent FDA Product Information

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