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Influenza A H1N1 Monovalent Vaccine

"2009 H1N1 influenza (also called Swine Flu) is caused by a new strain of influenza virus. It has spread to many countries. Like other flu viruses, 2009 H1N1 spreads from person to person through coughing, sneezing, and sometimes through touching "...

Influenza A H1N1 Monovalent Vaccine

Influenza A H1N1 Monovalent Vaccine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine used for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. This medication may be available in generic form. Common side effects include pain or inflammation at the injection site, fever, malaise, or muscle pain.

Adults 18 years of age and older should receive a single 0.5 mL intramuscular dose of Influenza A Vaccine. Consult your doctor for pediatric dosing. Influenza A Vaccine may interact with other vaccines or immunosuppressive therapy. Tell your doctor all medications and supplements you use and all vaccines you recently received. During pregnancy, Influenza A Vaccine should be given only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Influenza A (H1N1) 2009 Monovalent 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Influenza A H1N1 Monovalent Vaccine FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Sanofi Pasteur's Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (Fluzone®) are manufactured by the same process. The following sub-sections summarize safety data from clinical experience with seasonal trivalent inactivated influenza vaccines, including Fluzone vaccine.

Clinical Trial Experience

Adverse event information from clinical trials provides the basis for identifying adverse events that appear to be related to vaccine use and for approximating the rates of these events. However, because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial of another vaccine, and may not reflect the rates observed in practice.

Adults and Geriatrics

In placebo-controlled studies among adults, the most frequent side effect of vaccination is soreness at the vaccination site (affecting 10%-64% of patients) that lasts < 2 days, local pain and swelling. These local reactions typically are mild. Fever, malaise, myalgia, and other systemic symptoms can occur following vaccination and most often affect persons who have had no prior exposure to the influenza virus antigens in the vaccine (e.g., young children). These reactions begin 6-12 hours after vaccination and can persist for 1-2 days. Placebo-controlled trials demonstrate that among older persons and healthy young adults, administration of split-virus influenza vaccine is not associated with higher rates of systemic symptoms (e.g., fever, malaise, myalgia, and headache) when compared with placebo injections. (2)

Children

The 2003-2004 formulation of Fluzone vaccine was studied in 19 children 6 to 23 months of age and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and systemic events were solicited for 3 days after each dose. Most local and systemic reactions were mild. The proportions of local and systemic reactions in children were similar to the proportions in adults. No reported local or systemic reaction required a therapeutic intervention other than analgesics. (3)

Post-Marketing Experience

The following additional events have been reported during post-approval use of Fluzone vaccine. 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 vaccine exposure.

Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy

Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)

Nervous System Disorders: GBS, convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia

Vascular Disorders: Vasculitis, vasodilation/flushing

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis

Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome

General Disorders and Administration Site Conditions: Fever, pain, pruritis, asthenia/fatigue, pain in extremities, chest pain

Other Adverse Events Associated with Influenza Vaccines

Anaphylaxis has been reported after administration of influenza vaccines. Although Influenza A (H1N1) 2009 Monovalent Vaccine contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. [See CONTRAINDICATIONS]

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.

Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.

Microscopic polyangitis (vasculitis) has been reported temporally associated with influenza vaccination.

Read the entire FDA prescribing information for Influenza A H1N1 Monovalent Vaccine (Influenza A H1N1 Monovalent Vaccine) »

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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