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Details with Side Effects
Information for Vaccine Recipients and Parents or Guardians
Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of the vaccine, and of the importance of completing the immunization series. The healthcare provider should inform the parents or guardians about the potential for adverse events that have been temporally associated with administration of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) or other vaccines containing similar components.
The parent or guardian accompanying the recipient should be told to report severe or unusual adverse events to the physician or clinic where the vaccine was administered. The parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the CDC website (www.cdc.gov/vaccines).
The United States Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986.5 The VAERS toll-free number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at www.vaers.hhs.gov.
5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.
Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Pediarix Information
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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