Haemophilus b conjugate (prp-omp) vaccine Side Effects

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

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

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Call your doctor at once if your child has:

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

• a seizure; or

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

Common side effects may include:

• irritability, crying;

• drowsiness;

• diarrhea, vomiting;

• rash;

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

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• ear infection--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

General

The most common adverse events were irritability, sleepiness, injections site pain/soreness, injection site swelling, unusual high-pitched crying, prolonged crying (over 4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.^[Ref]

Other

Very common (10% or more): Fever over 38.3C (rectal) (18.1%)

Common (1% to 10%): Unusual high-pitched crying, prolonged crying (over 4 hours), crying, pain^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, vomiting

Frequency not reported: Urticaria^[Ref]

Local

Common (1% to 10%): Erythema over 2.5 cm diameter, swelling over 2.5 cm diameter, injection site pain/soreness

Postmarketing reports: Sterile injection site abscess^[Ref]

Psychiatric

Common (1% to 10%): Irritability, sleepiness^[Ref]

Immunologic

Common (1% to 10%): Otitis media, upper respiratory infection^[Ref]

Dermatologic

Common (1% to 10%): Rash

Postmarketing reports: Angioedema^[Ref]

Nervous system

Postmarketing reports: Febrile seizures^[Ref]

Hematologic

Frequency not reported: Thrombocytopenia^[Ref]

Respiratory

Frequency not reported: Tracheitis^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer