Influenza virus vaccine, h1n1, inactivated Side Effects

Some side effects of influenza virus vaccine, h1n1, inactivated may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to influenza virus vaccine, h1n1, inactivated: parenteral injectable suspension for im use

Side effects include:

Only limited data available to date regarding adverse effects of parenteral inactivated influenza A (H1N1) 2009 monovalent vaccine. (See Ongoing Safety Review under Cautions.) Adverse effects expected to be similar to those reported with seasonal parenteral trivalent inactivated influenza vaccine. Most common adverse effects reported with seasonal parenteral inactivated influenza vaccine are injection site reactions (i.e., tenderness, pain, redness, swelling), hypersensitivity reactions (e.g., rash), influenza-like symptoms, headache, fatigue, myalgia, fever, malaise.

Data to date indicate the most common solicited adverse effects in healthy adults 18–64 years of age who received a single dose of parenteral inactivated influenza A (H1N1) 2009 vaccine were tenderness at the injection site (36.7%), pain at the injection site (21.7%), headache (31.3%), malaise (17.5%), and myalgia (17.1%).

For Healthcare Professionals

Applies to influenza virus vaccine, h1n1, inactivated: intramuscular suspension

Gastrointestinal

Gastrointestinal side effects have included diarrhea and nausea.

General

General side effects have included malaise and fatigue.

Local

Local side effects have included pain, erythema, ecchymosis, induration, and swelling.

Musculoskeletal

Musculoskeletal side effects have included myalgia.

Nervous system

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

Respiratory

Respiratory side effects have included nasopharyngitis, upper respiratory infection, nasal congestion, and pharyngolaryngeal pain.

Hypersensitivity

Hypersensitivity side effects have included hives, angioedema, allergic asthma, and systemic anaphylaxis.

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