Haemophilus b conjugate (prp-omp) vaccine Side Effects

Some side effects of haemophilus b conjugate (prp-omp) vaccine 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 haemophilus b conjugate (prp-omp) vaccine: intramuscular suspension

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives another haemophilus B vaccine in the future, you will need to tell the child's doctor if the first shot caused any side effects.

Becoming infected with haemophilus B is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if your child has any of these serious side effects:

• pale skin, severe weakness, dizziness, fast heartbeat;

• extreme drowsiness, fainting;

• fussiness, irritability, crying for an hour or longer;

• seizure (black-out or convulsions); or

• high fever (within a few hours or a few days after the vaccine).

Less serious side effects include:

• redness, pain, swelling, or a lump where the shot was given;

• low fever;

• mild fussiness or crying;

• joint pain, body aches;

• drowsiness; or

• diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to haemophilus b conjugate (prp-omp) vaccine: intramuscular suspension

Gastrointestinal

Gastrointestinal side effects have included vomiting and diarrhea.

General

General side effects have included fever greater than 38.3°C (101°F) rectal, crying, unusual high-pitched crying, prolonged crying (more than 4 hours), and otitis media. There have been postmarketing reports of lymphadenopathy.

Local

Local side effects have included local pain, redness, swelling, tenderness at the injection site. There have been postmarketing reports of lymphadenopathy and sterile injection site abscess.

Nervous system

Nervous system side effects have included irritability, drowsiness, and lethargy. There have been postmarketing reports of febrile seizures.

Respiratory

Respiratory side effects have included upper respiratory infection.

Hypersensitivity

Hypersensitivity side effects have included rare reports of angioedema.

Dermatologic

Dermatologic side effects have included rash.

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