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Clinical Assessment of Serious Adverse Events in Children Receiving 2009 H1N1 Vaccination.
MedLine Citation:
PMID:  23334340     Owner:  NLM     Status:  Publisher    
BACKGROUND:: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between 2009 and 2013. METHODS:: Vaccine Adverse Event Reporting System received reports of adverse events following immunization (AEFI) after H1N1 vaccination. Selected reports were referred to the Centers for Disease Control and Prevention's Clinical Immunization Safety Assessment network for additional review. We assessed causality using modified World Health Organization criteria. RESULTS:: There were 3,928 reports of AEFI in children younger than age 18 years after 2009 H1N1 vaccination received by January 31, 2010. Of these, 214 (5.4%) were classified as serious nonfatal and 109 were referred to Clinical Immunization Safety Assessment for further evaluation. Ninety-nine (91%) had sufficient initial information to begin investigation and are described here. The mean age was 8 years (range, 6 months-17 years) and 38% were female. Median number of days between vaccination and symptom onset was 2 (range, -11 days to +41 days). Receipt of inactivated, live attenuated, or unknown type of 2009 H1N1 vaccines was reported by 68, 26 and 5 cases, respectively. Serious AEFI were categorized as neurologic events in 47 cases, as hypersensitivity in 15 cases and as respiratory events in 10 cases. At the time of evaluation, recovery was described as complete (61), partial (16), no improvement (1), or unknown (21). Causality assessment yielded the following likelihood of association with 2009 H1N1 vaccination: 8 definitely; 8 probably; 21 possibly; 43 unlikely; 17 unrelated; and 2 unclassifiable. CONCLUSIONS:: Most AEFI in children evaluated were not causally related to vaccine and resolved without sequelae. Detailed clinical assessment of individual serious AEFI can provide reassurance of vaccine safety.
Barbara A Pahud; S Elizabeth Williams; Cornelia L Dekker; Neal Halsey; Philip Larussa; Roger P Baxter; Nicola P Klein; Colin D Marchant; Robert C Sparks; Kathleen Jakob; Laurie Aukes; Susan Swope; Elizabeth Barnett; Paige Lewis; Melvin Berger; Stephen C Dreskin; Peter D Donofrio; James J Sejvar; Barbara A Slade; Jane Gidudu; Claudia Vellozzi; Kathryn M Edwards
Publication Detail:
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  32     ISSN:  1532-0987     ISO Abbreviation:  Pediatr. Infect. Dis. J.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-1-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  163-168     Citation Subset:  -    
From the *Division of Pediatric Infectious Diseases, Stanford University Medical Center, Stanford, CA; †Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, TN; ‡Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; §Division of Pediatric Infectious Diseases, Columbia University, College of Physicians & Surgeons, New York, NY; ¶Vaccine Study Center, Northern California Kaiser Permanente, Oakland, CA; ‖Boston Medical Center, Boston, MA; **Centers for Disease Control and Prevention, Atlanta, GA; ††Immunology Research and Development, CSL Behring, LLC, King of Prussia, PA; and ‡‡University of Colorado Denver, Department of Medicine, Division of Allergy and Clinical Immunology, Denver, CO.
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