HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.This vaccine is usually given by injection into a muscle by a health care professional.A series of 3 injections is usually used when the infant is aged 2 months, 4 months, and 12 to 15 months. Your doctor will give you a vaccination schedule, which must be followed closely for best effectiveness. If your infant has an infection with fever at the time a vaccination is scheduled, your doctor may choose to delay the injection until he/she is better.If your infant is exposed to hepatitis B at birth, a different vaccine and other treatments should be used. Consult your doctor for more information.
SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, irritability, increased crying, loss of appetite, and increased sleeping may occur. Less common side effects may include bruising at the injection site, vomiting, runny nose, stuffy nose, cold symptoms, cough, and diarrhea. If any of these effects persist or worsen, tell your infant's doctor or pharmacist promptly.Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if your child has any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.Remember that your child's doctor has prescribed this medication because he or she has judged that the benefit to your infant is greater than the risk of side effects. Many infants using this medication do not have serious side effects. Report all side effects to the doctor before your infant receives the next injection.Tell your infant's doctor immediately if any of these unlikely but serious side effects occur: unusually fast/irregular heartbeat.Tell your infant's doctor immediately if any of these rare but very serious side effects occur: inability to make muscles of the legs/arms/face work (paralysis), seizures, easy bruising/bleeding, mental/mood changes (e.g., unusual behavior, severe drowsiness, stiff neck, closing eyes/turning away from bright light).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice your infant having any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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