Rotavirus Oral Vaccine

• It is used to prevent very bad stomach problems caused by rotavirus infection.

For all patients taking this medicine:

• Tell all of your child's health care providers that your child is taking rotavirus oral vaccine. This includes your child's doctors, nurses, pharmacists, and dentists.
• If your child has a latex allergy, talk with the doctor.
• This medicine may not protect all people who use it. Talk with the doctor.
• Tell the doctor if your child will be in close contact with people who have a weak immune system. This includes people with cancer, immune system problems, or who take drugs that weaken the immune system. There is a chance of spreading the vaccine virus to these people.

If your child is pregnant or breast-feeding a baby:

• Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
• Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.

Applies to rotavirus vaccine: oral powder for suspension, oral suspension

Along with its needed effects, rotavirus vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking rotavirus vaccine:

• Diarrhea
• earache
• fever
• headache
• irritability
• muscle aches
• nausea and vomiting
• pain or cramping in the abdomen or stomach
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

• Cough
• difficulty with breathing
• noisy breathing
• shortness of breath
• tightness in the chest
• wheezing

• Black, tarry stools
• confusion
• decreased urination
• dizziness
• dry mouth
• fainting
• increase in heart rate
• lightheadedness
• loss of appetite
• rapid breathing
• seizures
• sunken eyes
• thirst
• unusual tiredness or weakness
• wrinkled skin

• Blood in the urine
• bloody nose
• heavier menstrual periods
• pinpoint red spots on the skin
• red eyes
• red mouth
• skin rash
• swollen glands
• swollen hands and feet
• unusual bleeding or bruising

Some side effects of rotavirus vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Crying, fussiness, or irritability
• runny nose

• Bloated
• excess air or gas in the stomach or intestines
• full feeling
• passing gas

• Hives or welts
• itching
• redness of the skin
• skin rash

Applies to rotavirus vaccine: oral powder for reconstitution, oral suspension

General

The most common adverse events were irritability, cough, runny nose, fever, loss of appetite, diarrhea, and vomiting.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (24.1%), vomiting (15.2%)
Common (1% to 10%): Flatulence, abdominal pain
Uncommon (0.1% to 1%): Hematochezia, gastroenteritis
Rare (less than 0.1%): Intussusception, frequent bowel movement
Postmarketing reports: Recurrent intussusception (including death), gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID)[Ref]

Other

Very common (10% or more): Fever (28%), otitis media (14.5%)
Uncommon (0.1% to 1%): Death
Postmarketing reports: Maladministration, transmission of vaccine virus strains from vaccine recipient to non-vaccinated contacts[Ref]

Respiratory

Very common (10% or more): Cough/runny nose (31%)
Common (1% to 10%): Nasopharyngitis, bronchospasm
Uncommon (0.1% to 1%): Bronchiolitis, pneumonia
Rare (less than 0.1%): Apnea
Postmarketing reports: Apnea in very premature infants (28 weeks gestation or less)[Ref]

Psychiatric

Very common (10% or more): Fussiness/irritability (52%)[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dermatitis
Rare (less than 0.1%): Urticaria, rash, eczema, dermatitis atopic
Postmarketing reports: Angioedema[Ref]

Metabolic

Very common (10% or more): Loss of appetite (25%)
Uncommon (0.1% to 1%): Gastroenteritis
Rare (less than 0.1%): Dehydration, weight gain poor[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction[Ref]

Nervous system

Rare (less than 0.1%): Seizure, hypotonic-hyporesponsive episode, syncope-vasovagal[Ref]

Cardiovascular

Rare (less than 0.1%): Kawasaki disease[Ref]

Hematologic

Postmarketing reports: Idiopathic thrombocytopenic purpura[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection[Ref]

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

Data not available

Data not available