"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...
As proof of the childs immunization record, the date, lot number and manufacturer of the vaccine administered must be recorded. 16,17,18
The health-care provider should inform the parent or guardian of the patient about the potential for adverse reactions that have been temporally associated with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) administration. Parents or guardians should be instructed to report any serious adverse reactions to their health-care provider.
IT IS EXTREMELY IMPORTANT WHEN THE CHILD RETURNS FOR THE NEXT DOSE IN THE SERIES, T.A. THE PARENT OR GUARDIAN OF THE PATIENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS DOSE (SEE CONTRAINDICATIONS; ADVERSE REACTIONS SECTIONS).
The health-care provider should inform the parent or guardian of the patient the importance of completing the immunization series.
The health-care provider should provide the Vaccine Information Materials (VIMs) which are required 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.
The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of the vaccine. 17,18
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional DTP 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.
Find out what women really need.