Information for Vaccine Recipients and/or Parent or Guardian

Before administration of ADACEL vaccine, health-care providers should inform the vaccine recipient and/or parent or guardian of the benefits and risks.

The health-care provider should inform the vaccine recipient and/or parent or guardian about the potential for adverse reactions that have been temporally associated with ADACEL vaccine or other vaccines containing similar components. The vaccine recipient and/or parent or guardian should be instructed to report any serious adverse reactions to their health-care provider. Females of childbearing potential should be informed that Aventis Pasteur Inc. maintains a pregnancy registry to monitor fetal outcomes of pregnant women exposed to ADACEL vaccine. If they are pregnant or become aware they were pregnant at the time of ADACEL vaccine immunization, they should contact their health-care professional or Aventis Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE).

The health-care provider should provide the Vaccine Information Statements (VISs) that are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization.

The US 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. ⁽¹⁶⁾ The toll-free number for VAERS forms and information is 1-800-822-7967 or visit the VAERS website at http://www.fda.gov/cber/vaers/vaers.htm

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