Fluzone Vaccine

Fluzone is a flu shot that comes in High-Dose, Intradermal, Trivalent, and Quadrivalent versions just for adults over 65.

Table of Contents

What is Fluzone?
What is Fluzone High-Dose?
How is Fluzone made?
How is Fluzone given?
Can Fluzone give you the flu?
How many shots do I need?
Who should NOT get Fluzone?
What are the most common side effects of Fluzone Quadrivalent?
What are severe side effects of Fluzone?
What ingredients are in Fluzone Trivalent?
What ingredients are in Fluzone Quadrivalent?
What ingredients are in Fluzone High Dose?
Can FluZone cause a Shoulder Injury Related to Vaccine Administration (SIRVA)?
Can FluZone cause Guillain-Barre Syndrome (GBS)?
Can I file a FluZone lawsuit?
Where can I get more information?

What is Fluzone?

Fluzone is an immunization against influenza (“the flu”) that is manufactured by Sanofi Pasteur. There are three versions of Fluzone:

Fluzone Trivalent: Vaccine against three strains of the flu virus (two type A and one type B) for people age 6 months and older. It was approved in 1980.
Fluzone Quadrivalent Vaccine against four strains of the flu virus (two type A and two type B) for people age 6 months and older. It was approved in 2013.
Fluzone High-Dose: Vaccine against three strains of the flu virus (two type A and one type B) for people age 65 years and older. It was approved in 2009.

What is Fluzone High Dose?

Fluzone High-Dose is a flu shot just for seniors. It contains about three-times the amount of hemagglutinin (HA) found in other flu shots. HA is the flu virus protein that causes the immune system to respond.

How is Fluzone made?

Fluzone contains flu viruses that are grown in fertilized chicken eggs.

How is Fluzone given?

Fluzone is given in a single 0.5-mL shot in the upper arm.

Can Fluzone give you the flu?

No. Fluzone is an inactivate flu vaccine that can’t cause an infection with the flu. However, many people develop mild flu-like symptoms as their body develops immunity to the vaccine.

How many shots do I need?

The CDC recommends a yearly flu shot in people over 6 months old.

Children between the ages of 6 months and 35 months can get one or two shots of Fluzone, 0.5-mL each, given at least 4 weeks apart. Two doses are recommended for children who have never had a flu shot.

Children between 35 months and 8 years old can also get one or two doses of Fluzone, 0.5-mL each, given at least 4 weeks apart. The number of shots depends on whether the child has ever had a flu shot.

People older than 9 years old can only get one shot of Fluzone.

Who should NOT get Fluzone?

Fluzone is not for anyone under 6 months old, or anyone who has had a severe allergic reaction (e.g. anaphylaxis) to a previous flu shot, egg or egg proteins, or other ingredients in Fluzone (see below for a list).

What are the most common side effects of Fluzone Quadrivalent?

In children 6 months through 35 months old, the most common side effects of Fluzone Quadrivalent were pain (57%), tenderness (54%), redness (37%), and swelling (22%) where the shot was given, irritability (54%), abnormal crying (41%), feeling unwell (38%), drowsiness (38%), appetite loss (32%), muscle aches (27%), vomiting (15%), and fever (14%).

In children 3 years through 8 years old, the most common side effects were pain (67%), redness (34%), and swelling (25%) where the shot was given, muscle aches (39%), feeling unwell (32%), headache (23%), and fever (7%).

In adults 18 years and older, the most common side effects were pain (47%) where the shot was given, muscle aches (24%), and feeling unwell (11%).

In adults aged 65 years and older, the most common side effects were pain (33%) where the shot was given, muscle aches (18%), headache (13%), feeling unwell (11%), and fever (1.3%).

What are severe side effects of Fluzone?

Allergic reaction
Anaphylaxis
Angioedema
Bell’s palsy
Blood and bleeding disorder
Brachial neuritis
Brain damage
Chest pain
Cough
Convulsions
Encephalomyelitis
Enlarged lymph nodes
Facial paralysis
Fainting
Fatigue
Febrile seizure
Fever-induced seizure
Guillain-Barré Syndrome (GBS)
Hypersensitivity reaction
Lymphadenopathy
Muscle weakness
Myelitis
Nerve damage
Neuropathy
Ocular hyperemia
Optic neuritis
Pain in extremities
Paralysis
Paresthesia
Rash
Seizures
Shoulder Injury Related to Vaccine Administration
SIRVA
Stevens-Johnson Syndrome (SJS)
Throat tightness
Thrombocytopenia
Transverse myelitis
Vasculitis
Vasodilation / flushing
Vomiting
Vision loss
Wheezing

What ingredients are in Fluzone Trivalent?

Fluzone Trivalent does not contain rubber latex.

Fluzone Trivalent is formulated to contain 45 micrograms (mcg) of hemagglutinin (HA), or 15 mcg for each of the three inactivated virus strains in the vaccine. HA is the flu virus protein that triggers an immune response.

Thimerosal is NOT added to the 0.5-mL pre-filled syringe, but thimerosal is added to the 5-mL multi-dose vials of Fluzone. There is 25 mcg of mercury in each 0.5-mL dose from the multi-dose vial.

The ingredients include egg protein, octylphenol ethoxylate (Triton X-100) ≤150 mcg, sodium phosphate-buffered isotonic sodium chloride solution, thimerosal (multi-dose vials), formaldehyde (≤100 mcg), and gelatin (≤0.05).

What ingredients are in Fluzone Quadrivalent?

Fluzone Quadrivalent does not contain latex.

Fluzone Quadrivalent has 60 micrograms (mcg) of hemagglutinin (HA), or 15 mcg for each of the four inactivated virus strains in the vaccine. HA is the flu virus protein that triggers an immune response.

Thimerosal is NOT added to the 0.5-mL single-dose pre-filled syringes, but thimerosal is added to the 5-mL multi-dose vials. There is 25 mcg mercury in each 0.5-mL dose from the multi-dose vial.

The other ingredients include egg protein (ovalbumin), formaldehyde (≤100 mcg), Octylphenol ethoxylate (≤250 mcg), and sodium phosphate-buffered isotonic sodium chloride solution.

What ingredients are in Fluzone High Dose?

Fluzone High Dose is not made with latex.

Fluzone High Dose contains 180 micrograms (mcg) of hemagglutinin (HA), or 60 mcg of HA for each of the three inactivated virus strains in the vaccine. HA is the flu virus protein that triggers an immune response. There is about 15 mcg of HA per flu virus in other flu shots.

Other ingredients include formaldehyde (≤100 mc) and Octylphenol ethoxylate (≤250 mcg).

There are no preservatives in Fluzone High Dose. It does not contain thimerosal, a mercury-based preservative.

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

FluZone is injected into the shoulder with a needle, so there is a possible risk of suffering a Shoulder Injury Related to Vaccine Administration (SIRVA) if the needle is injected too high or too deep. This can result in permanent shoulder pain or disability.

Can FluZone cause Guillain-Barre Syndrome (GBS)?

Like all flu shots, FluZone has been linked to a rare side effect called Guillain-Barré Syndrome (GBS). This side effect can cause permanent paralysis, nerve damage, or even death, but most people with GBS recover completely within a few months.

Can I file a FluZone lawsuit?

Our lawyers are evaluating FluZone lawsuits for adults and children who were diagnosed with Guillain-Barre Syndrome or a shoulder injury (SIRVA).

Where can I get more information?

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