Journal of Pediatrics
Vol 162 | No. 6 | June 2013 | Pages 1087-1298
http://www.jpeds.com/

Comprehensive Assessment of Serious Adverse Events Following Immunization by Health Care Providers
S. Elizabeth Williams, Kathryn M. Edwards, MD, Roger P. Baxter, MD, Philip S. LaRussa, MD,     Neal A. Halsey, MD, Cornelia L. Dekker, MD, Claudia Vellozzi, MD, MPH, Colin D. Marchant, MD,    Peter D. Donofrio, MD, Tyler E. Reimschisel, MD, Melvin Berger, MD, Jane F. Gidudu, MD,     Nicola P. Klein, MD, PhD

Abstract
Many events occurring after vaccination have been attributed to vaccines, when in fact the association was often due to chance.1 However, as with any medical intervention, there are times when adverse events are caused by immunizations.2 Distinguishing which events are causally related to vaccine, rather than coincidental events, is a challenge for the pediatrician and a major focus of vaccine safety science. Consider a child who presents with aseptic meningitis after immunization. Because of the temporal relationship, one may suspect the immunizations as the cause, yet subsequent isolation of enterovirus from cerebrospinal fluid implicates the enteroviral infection instead.3 The term adverse event following immunization (AEFI) is defined as any untoward event that occurs after immunization, regardless of causal association.4 AEFI is the preferred notation to describe such clinical events because the term is free from implications regarding causal relationship and favors an open mind about the role of immunizations. AEFIs are a common part of routine clinical practice. The Clinical Immunization Safety Assessment (CISA) network has reviewed many individual cases of AEFIs and found that when a comprehensive investigation for alternative etiologies of the AEFI is completed, other causes for the event can often be identified. Yet, such comprehensive evaluations are rarely performed.8 We describe a stepwise approach to the comprehensive assessment of serious AEFIs by health care providers. The main objective is to highlight the important role that health care providers play in this effort by actively evaluating for the most likely causes of serious events when they occur after immunization.
http://www.jpeds.com/article/S0022-3476%2813%2900062-0/preview