ActHIB

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

• If you have an allergy to any part of ActHIB (b conjugate vaccine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Irritation where the shot is given.
• Feeling irritable.
• Feeling fussy.
• Feeling sleepy.
• Not hungry.
• Mild fever.
• Restlessness.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Sanofi Pasteur, Inc

Applies to haemophilus b conjugate (prp-t) vaccine: intramuscular powder for injection

General

The most common adverse events were pain and redness at the injection site, irritability, drowsiness, fever, loss of appetite, fussiness, and restlessness. Most symptoms occur in the first 48 hours, are mild, and resolve spontaneously.[Ref]

Local

Very common (10% or more): Pain (49.4%), redness (29.4%), tenderness (20%), swelling (18.7%)
Common (1% to 10%): Induration
Very rare (less than 0.01%): Extensive swelling of vaccinated limb, injection site induration[Ref]

Nervous system

Very common (10% or more): Drowsiness (59.9%), decreased activity/lethargy (51.1%), sleepiness (19.9%)
Rare (less than 0.1%): Seizure with apnea, convulsion
Very rare (less than 0.01%): Convulsions (with or without fever), hypotonic-hyporesponsive episode (e.g. sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis), somnolence, syncope, vasovagal responses to injection[Ref]

Psychiatric

Very common (10% or more): Irritability (70.4%), fussiness (25.9%), restlessness (21.8%)
Common (1% to 10%): Nervousness
Uncommon (0.1% to 1%): Emotional lability, insomnia[Ref]

Other

Very common (10% or more): Inconsolable crying (58.5%), fever (34.8%)
Common (1% to 10%): Otitis media
Uncommon (0.1% to 1%): Asthenia, fatigue, injury
Postmarketing reports: Peripheral edema[Ref]

Metabolic

Very common (10% or more): Loss of appetite (28.7%)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (14.6%), vomiting
Common (1% to 10%): Gastroenteritis
Uncommon (0.1% to 1%): Abdominal pain[Ref]

Dermatologic

Common (1% to 10%): Rash erythematous
Uncommon (0.1% to 1%): Sweating increased, purpura
Very rare (less than 0.01%): Angioedema, rash, urticaria
Postmarketing reports: Pruritus[Ref]

Respiratory

Common (1% to 10%): Rhinitis, coughing, respiratory disorder, upper respiratory tract infection, bronchitis
Rare (less than 0.1%): Bilateral pneumonia
Very rare (less than 0.01%): Apnea in very premature infants[Ref]

Hypersensitivity

Rare (less than 0.1%): Allergic reactions (including anaphylactic and anaphylactoid reactions)
Postmarketing reports: Other allergic/hypersensitivity reactions (including urticaria, angioedema)[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Spastic paralysis[Ref]

Ocular

Common (1% to 10%): Conjunctivitis[Ref]

Immunologic

Common (1% to 10%): Viral infection[Ref]

Some side effects of ActHIB may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.