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Appendices

The following text is from an archived Red Book® edition and may not reflect current recommendations or information. To view the current edition, click here.

Section 1. Active and Passive Immunization

ACTIVE IMMUNIZATION

Vaccine Safety and Contraindications

RISKS AND ADVERSE EVENTS
REPORTING OF ADVERSE EVENTS
VACCINE SAFETY DATALINK PROJECT
VACCINE INJURY COMPENSATION
PRECAUTIONS AND CONTRAINDICATIONS
HYPERSENSITIVITY REACTIONS TO VACCINE CONSTITUENTS
MISCONCEPTIONS ABOUT VACCINE CONTRAINDICATIONS

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RISKS AND ADVERSE EVENTS

All licensed vaccines in the United States are safe and effective, but no vaccine is absolutely safe and completely effective. Some vaccine recipients will have an untoward reaction, and some will not always be fully protected. The goal of vaccine development is to achieve the highest degree of protection with the lowest rate of untoward effects.

Risks of immunization may vary from trivial and inconvenient to severe and life-threatening. When developing immunization recommendations, vaccine benefits and safety are weighed against the risks of natural disease to the person and to the community. Recommendations attempt to maximize disease prevention and to minimize risk by providing specific advice on dose, route, and timing of the vaccine and by delineating persons who should be immunized and circumstances that warrant precaution or contraindicate immunization.

Common vaccine side effects usually are mild to moderate in severity and without permanent sequelae. Because such reactions are intrinsic to the immunizing antigen or some other component of the vaccine, they occur frequently and are unavoidable. Examples include local inflammation after administration of DTaP vaccine and fever and rash 1 to 2 weeks after administration of measles vaccine.

Sterile abscesses have occurred at the site of injection of several inactivated vaccines. The abscesses presumably result from the irritating nature of the vaccine or its adjuvant; in some instances, they may be caused by inadvertent subcutaneous inoculation of a vaccine intended for intramuscular use.

Rarely, serious adverse effects of immunization occur that can result in permanent sequelae or be life-threatening. These individual events are not . . . [Go to Full Text]









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