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Certiva Patient, Information, Instructions - Certiva

Certiva Patient, Information, Instructions - Certiva

PATIENT INFORMATION

INFORMATION FOR VACCINE RECIPIENTS AND PARENTS

Parents or guardians of infants and children to be vaccinated should be fully informed of the benefits and risks of vaccination with CertivaTM and the importance of completing the immunization series, unless contraindicated.

The physician should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with CertivaTM and other pertussis vaccine administrations. The parents or guardians of infants and children with family history of convulsions or other central nervous system disorders should be advised of the potential increased risk of seizures following DTP vaccinations.

Prior to each immunization, the parent or guardian should be provided with the Vaccine Information Materials (VIMs), as required by the National Childhood Vaccine Injury Act of 1986. 26 Parents or guardians should be instructed to report any severe or unusual reactions to their health-care provider.

The U. S. 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. 29, 30 The toll-free number for VAERS forms and information is 1-800-822-7967.

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