Influenza virus vaccine, h1n1, inactivated Side Effects

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by influenza virus vaccine, h1n1, inactivated. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking influenza virus vaccine, h1n1, inactivated:

• Difficulty with moving
• fever
• general feeling of discomfort or illness
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• swollen joints
• unusual tiredness or weakness

• Back pain, sudden and severe
• black, tarry stools
• bleeding gums
• blindness
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• blue-yellow color blindness
• blurred vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• chest pain
• chills
• congestion
• convulsions
• cough
• decreased vision
• diarrhea
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• dryness or soreness of the throat
• eye pain
• fainting
• fast heartbeat
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• headache
• hives
• hoarseness
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• muscle weakness, sudden and progressing
• pain in the arms or legs
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• redness of the face, neck, arms, and occasionally, upper chest
• redness, soreness, or itching skin
• runny nose
• sensation of pins and needles
• shortness of breath
• skin rash
• sneezing
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sores, welting, or blisters
• stabbing pain
• stuffy nose
• sweating
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tender, swollen glands in the neck
• tightness in the chest
• trouble with swallowing
• unusual bleeding or bruising
• voice changes
• weakness of the muscles in your face
• wheezing

Minor Side Effects

Some of the side effects that can occur with influenza virus vaccine, h1n1, inactivated may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site

• Lack or loss of strength

For Healthcare Professionals

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

Gastrointestinal

Gastrointestinal side effects have included diarrhea and nausea.^[Ref]

General

General side effects have included malaise and fatigue.^[Ref]

Local

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

Musculoskeletal

Musculoskeletal side effects have included myalgia.^[Ref]

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.^[Ref]

Respiratory

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

Hypersensitivity

Hypersensitivity side effects have included hives, angioedema, allergic asthma, and systemic anaphylaxis.^[Ref]

Not all side effects for influenza virus vaccine, h1n1, inactivated may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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