Medical Editor: John P. Cunha, DO, FACOEP
- injection site reactions (pain, redness, swelling, and a hard lump in the area of the injection)
- muscle pain, and
- feeling unwell (malaise)
Agriflu should be administered as a single 0.5 mL intramuscular injection, preferably in the region of the deltoid muscle of the upper arm. Agriflu may interact with immunosuppressive therapies including corticosteroids. Tell your doctor all medications and supplements you use and all vaccines you recently received. During pregnancy, Agriflu should be administered only if prescribed. It is unknown if this vaccine passes into breast milk. Consult your doctor before breastfeeding.
Our Agriflu (Influenza Virus Vaccine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.
Keep track of any and all side effects you have. If you receive an influenza virus vaccine in the future, you will need to tell the vaccination provider if the previous shot caused any side effects.
Influenza virus vaccine is made from "killed viruses" and will not cause you to become ill with the flu virus. You may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- severe weakness or unusual feeling in your arms and legs;
- numbness, pain, tingling, burning or prickly feeling;
- vision or hearing problems; or
- a fever higher than 101 degrees F.
Common side effects may include:
- pain, redness, tenderness, swelling, bruising, or a hard lump where the shot was given;
- diarrhea, loss of appetite;
- muscle pain;
- headache, tiredness; or
- fussiness, crying, or drowsiness in a child.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the entire detailed patient monograph for Agriflu (Influenza Virus Vaccine for Intramuscular Injection)
Overall Adverse Reactions
The most common local (injection site) adverse reactions observed in clinical studies with AGRIFLU were pain, induration, swelling, and erythema. The most common systemic adverse reactions observed were headache, myalgia, and malaise. These reactions are typically mild.
Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving AGRIFLU.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect rates observed in clinical practice. The most common local adverse reactions and general adverse reactions observed with AGRIFLU were pain and erythema at the injection site, headache, myalgia, and malaise.
Clinical safety data have been obtained from three randomized, controlled trials one of which was a placebo controlled efficacy study.1,2,3 In these trials, 13480 subjects were randomized to receive either AGRIFLU (5338 subjects included in the safety analysis), a U.S.-licensed comparator influenza vaccine (435 included in the safety analysis), an investigational inactivated influenza vaccine (3813 included in the safety analysis), or placebo (3894 included in the safety analysis). (see Clinical Studies). The overall enrolled population from the 3 studies was 18-64 years of age (mean 33 years), 57 % were female and 75% were Caucasian, 6% were Black, 18% were Hispanic and 1% were of other ethnic origin. The percentage of subjects who had a record of receiving a previous influenza vaccination was 13%. (see Clinical Studies). In all three studies, solicited local (injection site) and systemic reactions were collected from subjects who completed a symptom diary card for seven days following vaccination. Safety data are presented in Table 1.
Table 1: Percentage of Subjects Reporting Solicited
Adverse Reactions in Days 1-7 After Vaccination With AGRIFLU or Comparators
|Percentage of Subjects with Adverse Reactions|
|Study 11 2007 NCT00464672 (18-64 years)||Study 22 2007-2008 NCT00617851 (18-49 years)||Study 33 2007-2008 NCT 00630331 (18-49 years)|
|Local Adverse Reactions|
|Injection site pain|
|Severe painb||< 1||0||< 1||< 1||< 1||< 1|
|Swelling||< 1||1||1||< 1||5||3|
|Erythema||< 1||1||< 1||< 1||13||10|
|Ecchymosis||< 1||0||< 1||< 1||3||4|
|Systemic Adverse Reactions|
|Fever ( ≥ 38°C)||2||3||4||3||< 1||< 1|
|aComparator is U.S.-licensed trivalent,
inactivated influenza virus vaccine (Fluvirin).
bSevere injection site pain= local reaction leading to the inability to perform normal daily activities.
In the two studies with a U.S.-licensed influenza comparator vaccine, unsolicited adverse events were reported by subjects over a 3-week period after vaccination. Unsolicited adverse events that occurred in > 1% of subjects included influenza-like illness (4% of AGRIFLU subjects and 3% of active comparator subjects) and headache (2% of AGRIFLU and comparator subjects). A total of 17% of subjects in both the AGRIFLU and the comparator groups reported unsolicited adverse events: 15% and 16% of subjects in the AGRIFLU and in the comparator groups, respectively, had mild unsolicited adverse events, 2% and 1% of subjects had moderate adverse events, and < 1 % of subjects in both groups had severe adverse events.
In the placebo controlled efficacy study, all unsolicited adverse events were collected for 7 days after vaccination and selected adverse events (serious adverse events, onset of chronic illness, AEs that necessitated a physician consultation and/or led to withdrawal from the study) for up to 3 weeks after vaccination. A total of 13% and 14% of subjects in the AGRIFLU and the comparator groups reported unsolicited adverse events: in both the AGRIFLU and in the comparator groups, 7% of subjects had mild unsolicited adverse events, 5% of subjects had moderate adverse events, and 2% of subjects had severe adverse events. Unsolicited adverse events reported in the 3 week period that occurred in > 1% of subjects included pharyngolaryngeal pain (2% of both AGRIFLU and placebo subjects).
The following additional adverse events have been identified during postapproval use of AGRIFLU in Europe since 2003. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Blood and Lymphatic System Disorders
Thrombocytopenia (some very rare cases were severe with platelet counts less than 5,000 per mm³).
Conjunctivitis, eyelid edema, eye redness
Diarrhea, nausea, vomiting, abdominal pain
General Disorders and Administration Site Conditions
Local injection site reactions, including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration, local lymphadenopathy, Injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than one week), Extensive swelling of injected limb lasting more than one week, and general disorders including, chills, fever, malaise, fatigue, asthenia, facial edema.
Immune System Disorders
Musculoskeletal and Connective Tissue Disorders
Nervous System Disorders
Headache, syncope shortly after vaccination, dizziness, neuralgia, paraesthesia, convulsion, myelitis (including encephalomyelitis and transverse myelitis), neuropathy (including neuritis and brachial plexus neuropathy), paralysis (including Bell's Palsy and other cranial nerve paralyses), Guillain-Barré Syndrome
Skin and Subcutaneous Disorders
Vasculitis (in rare cases associated with transient renal involvement), hot flush
Adverse Events Associated With influenza Vaccines
Anaphylaxis has been reported after administration of AGRIFLU. AGRIFLU contains egg proteins, which can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis [see CONTRAINDICATIONS and DESCRIPTION].
The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated.
Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.
Read the entire FDA prescribing information for Agriflu (Influenza Virus Vaccine for Intramuscular Injection)
© Agriflu Patient Information is supplied by Cerner Multum, Inc. and Agriflu Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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