Agriflu is a flu shot for adults against three types of influenza viruses. It is an egg-derived immunization that can trigger allergic reactions, but less than 1% of people experience severe side effects.
How is Agriflu given?
Why was Agriflu recalled in 2012?
Can Agriflu give you the flu?
Who should NOT get Agriflu?
What are minor side effects of Agriflu?
What are the most common side effects of Agriflu?
What is the risk of fever from Agriflu?
What are severe side effects of Agriflu?
What is SIRVA?
What ingredients are in Agriflu?
Does Agriflu have thimerosal?
Where can I get more information?
Agriflu® is an immunization against influenza (“the flu”) for adults 18 years of age and older. It is a trivalent vaccine against three types of influenza viruses: two type A strains and one type B strain. Agriflu is made by Novartis and it was approved by the FDA in November 2009.
A single 0.5-mL injection is given in the deltoid muscle of the upper arm.
Agriflu (known as Agrippal internationally) sparked a short-lived international health scare in 2012 after several doctors in Europe found particles floating in a batch of vaccines that were manufactured in Italy. Canada and six countries in Europe (Germany, Austria, France, Italy, Spain, and Switzerland) temporarily halted distribution.
No injuries were reported, but health officials in Canada told doctors to stop using the vaccine. They said “protein aggregates in vaccine vials do occur and are not linked to any safety or efficacy issues.”
No. Agriflu is an inactivated (dead) influenza virus vaccine. The virus can’t cause the flu, but some people develop mild flu-like symptoms when their body is developing immunity.
Agriflu is contraindicated in people with hypersensitivity to egg proteins, kanamycin, neomycin, or any other ingredients in the vaccine (see below for a list). Agriflu should not be given to anyone who has had a life-threatening allergic reaction to a previous influenza vaccine.
There is latex in the tip cap on 0.5-mL Agriflu pre-filled syringes that could trigger an allergic reaction in people who are sensitive to latex.
- Abdominal pain
- Enlarged lymph nodes
- Eye redness
- Fainting after vaccination
- Hot flush
- Injection-site reactions
- Lump where the shot was given (induration)
- Muscle pain (myalgia)
The following were the most common side effects of the 2007 Agriflu vaccine in three clinical trials:
- Chills (11%)
- Fatigue (11%)
- Headache (23%)
- Injection-site reactions
- Joint pain (7%)
- Lump where the shot was given (6%)
- Malaise (12%)
- Muscle pain (12%)
- Pain (25%)
- Redness (13%)
- Sweating (5%)
- Swelling (5%)
In three clinical trials of the 2007-2008 vaccine, Agriflu was associated with up to a 4% risk of fever higher than 100.4ºF.
- Allergic asthma
- Allergic reaction
- Anaphylactic shock
- Bell’s Palsy
- Brachial plexus neuropathy
- Cranial nerve paralysis
- Extensive swelling of the injected limb for more than 1 week
- Guillain-Barre Syndrome
- Hypersensitivity reactions
- Itching (pruritus)
- Joint pain (arthralgia)
- Kidney problems
- Microscopic polyangitis
- Nerve damage
- Optic neuritis
- Pain limiting limb movement
- Partial facial paralysis
- Shoulder injury
- Throat and mouth swelling
- Thrombocytopenia (some very severe cases)
- Transverse myelitis
- Vasculitis (rare cases associated with transient renal involvement)
- Weakness (asthenia)
SIRVA stands for “Shoulder Injury Related to Vaccine Administration” and it can cause permanent shoulder pain and limited movement. SIRVA is caused by accidentally injecting the vaccine needle too high or too deep into the shoulder bursa, tendons, ligaments, or nerves. It can also be caused by the immune system reacting to the vaccine.
Each 0.5 mL dose from the pre-filled syringe or multi-dose vial may contain residual amounts of egg proteins (<0.4 mcg), formaldehyde (≤10 mcg), polysorbate 80 (≤50 mcg), and CTAB (≤12 mcg). Each dose may also contain residual amounts of neomycin (≤0.02 mcg by calculation), kanamycin (≤0.03 mcg by calculation), and barium (<0.5 mcg by calculation).
The 0.5-mL single-dose pre-filled syringes of Agriflu do not have thimerosal or any other preservative.
The 5.0-mL multi-dose vial containing 10 doses (each dose is 0.5-mL) does contain thimerosal, a mercury-based preservative, with approximately 25 mcg of mercury in each 0.5-mL dose of Agriflu.