Objectives
a. Describe common adverse reactions by vaccine type.
b. Differentiate between an adverse reaction and an adverse event.
c. Develop a plan to manage an adverse event following vaccination.
d. Describe supplies and staff training needed to manage anaphylaxis.
e. Describe the National Vaccine Injury Compensation Program (NVICP).
f. Describe ongoing processes for vaccine postmarketing safety monitoring (e.g., Vaccine Adverse Event Reporting System [VAERS], Clinical Immunization Safety Assessment [CISA] Project, and Vaccine Safety Datalink [VSD]).
g. Describe who may report to VAERS, what is reported, and how the data are used (i.e., to monitor for signals of vaccine safety problems, which may lead to additional studies in VSD or elsewhere to assess causality).
h. Describe the process of phased clinical trials and FDA approval and licensure of vaccines in the United States.
i. Describe a nurse’s role in monitoring and ensuring vaccine safety.
j. Describe other nursing roles related to safety: records manager, reporter, and lifelong learner.
b. Differentiate between an adverse reaction and an adverse event.
c. Develop a plan to manage an adverse event following vaccination.
d. Describe supplies and staff training needed to manage anaphylaxis.
e. Describe the National Vaccine Injury Compensation Program (NVICP).
f. Describe ongoing processes for vaccine postmarketing safety monitoring (e.g., Vaccine Adverse Event Reporting System [VAERS], Clinical Immunization Safety Assessment [CISA] Project, and Vaccine Safety Datalink [VSD]).
g. Describe who may report to VAERS, what is reported, and how the data are used (i.e., to monitor for signals of vaccine safety problems, which may lead to additional studies in VSD or elsewhere to assess causality).
h. Describe the process of phased clinical trials and FDA approval and licensure of vaccines in the United States.
i. Describe a nurse’s role in monitoring and ensuring vaccine safety.
j. Describe other nursing roles related to safety: records manager, reporter, and lifelong learner.
Web pages
CDC Vaccine Safety
Health Resources and Services Administration (HRSA)–National Vaccine Injury Compensation Program (NVICP)
U.S. Health and Human Services (HHS)–Vaccine Adverse Event Reporting System (VAERS)
- Clinical Immunization Safety Assessment (CISA) Project
www.cdc.gov/vaccinesafety/ensuringsafety/ monitoring/cisa/index.html - Reporting Adverse Events
http://www.cdc.gov/vaccinesafety/hcproviders/reportingadverseevents.html - Vaccine Safety Datalink (VSD)
www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html - Vaccine Safety
www.cdc.gov/vaccinesafety/index.html
Health Resources and Services Administration (HRSA)–National Vaccine Injury Compensation Program (NVICP)
U.S. Health and Human Services (HHS)–Vaccine Adverse Event Reporting System (VAERS)
handouts
Immunization Action Coalition (IAC)
- Medical Management of Vaccine Reactions in Adult Patients
www.immunize.org/catg.d/p3082.pdf - Medical Management of Vaccine Reactions in Children and Teens
www.immunize.org/catg.d/p3082a.pdf
learning module
CDC Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book) webinar series–General Recommendations, Part 2, and Vaccine Safety
books
- American Academy of Pediatrics. Active and Passive Immunization. In: Kimberlin DW, Brady MT, Jackson MA, Long SS, eds. Red Book: 2018 Report of the Committee on Infectious Diseases, 31st ed. Itasca, IL: American Academy of Pediatrics; 2018:1–111.
- CDC. Vaccine Safety. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th ed. Washington, DC: Public Health Foundation; 2015:47–61. Available at www.cdc.gov/vaccines/pubs/pinkbook/safety.html.
- Fraser, D. Health Problems of Infants. In: Hockenberry MJ, Wilson D, Rodgers CC, eds. Wong’s Essentials of Pediatric Nursing, 9th ed. St. Louis, MO: Elsevier Health Sciences; 2012:228–307.
- Marshall G. Standards, Principles, and Regulations. In: Marshall G. The Vaccine Handbook: A Practical Guide for Clinicians, 5th ed. West Islip, NY: Professional Communications, Inc.; 2015:80–100.
- Marshall G. Vaccine Infrastructure in the United States. In: Marshall G. The Vaccine Handbook: A Practical Guide for Clinicians, 5th ed. West Islip, NY: Professional Communications, Inc.; 2015:48–79.