Pneumococcal 13-valent vaccine Side Effects

Some side effects of pneumococcal 13-valent 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 pneumococcal 13-valent vaccine: intramuscular suspension

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

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.

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

Call your doctor at once if you or your child has a serious side effect such as:

• high fever (103 degrees or higher);

• seizure (convulsions);

• wheezing, trouble breathing;

• severe stomach pain, severe vomiting or diarrhea;

• easy bruising or bleeding; or

• severe pain, itching, irritation, or skin changes where the shot was given.

Less serious side effects include

• crying, fussiness;

• headache, tired feeling;

• muscle or joint pain;

• drowsiness, sleeping more or less than usual;

• mild redness, swelling, tenderness, or a hard lump where the shot was given;

• loss of appetite, mild vomiting or diarrhea;

• low fever (102 degrees or less), chills; or

• mild skin rash.

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 pneumococcal 13-valent vaccine: intramuscular suspension

Hypersensitivity

Hypersensitivity side effects have included anaphylactic/anaphylactoid reaction including shock, face edema, dyspnea, and bronchospasm.

Local

Local side effects have included redness, swelling, and tenderness at the injection site, injection-site dermatitis, pruritus, and urticaria.

Dermatologic

Dermatologic side effects have included urticaria or urticaria-like rash, angioneurotic edema, and erythema multiforme.

Respiratory

Respiratory side effects have included apnea.

Nervous system

Nervous system side effects have included seizures (including febrile seizures).

General

General side effects have included fever, decreased appetite, increased sleep, decreased sleep, and irritability.

Gastrointestinal

Gastrointestinal side effects have included diarrhea and vomiting.

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