PMID- 21042229
OWN - NLM
STAT- MEDLINE
DCOM- 20160309
LR  - 20150620
IS  - 1532-0987 (Electronic)
IS  - 0891-3668 (Linking)
VI  - 30
IP  - 1
DP  - 2011 Jan
TI  - Adverse Events Following Trivalent Inactivated Influenza Vaccination in Children: 
      Analysis of the Vaccine Adverse Event Reporting System.
PG  - e1-8
LID - 10.1097/INF.0b013e3181ff9795 [doi]
AB  - BACKGROUND: The Advisory Committee on Immunization Practices' recommendations for 
      influenza vaccination of children have expanded from the long-standing 
      recommendation to vaccinate high-risk children aged >/=6 months, to vaccinating all 
      6- to 23-month-olds (2004), 2- to 4-year-olds (2006), and 5- to 18-year-olds 
      (2008). OBJECTIVE: To identify new or unexpected adverse events (AEs) after 
      trivalent inactivated vaccine (TIV) in children. METHODS: We analyzed reports 
      after TIV to the Vaccine Adverse Event Reporting System from 1990-2006 in 
      children aged 2 to 17 years, and from the 2008-2009 influenza season in children 
      aged 5 to 17 years. Empiric Bayesian data mining techniques were used to identify 
      new or unexpected AEs during 1990-2006. RESULTS: During 1990-2006, the Vaccine 
      Adverse Event Reporting System received 2054 reports of children aged 2 to 17 
      years with a peak in the 2003-2004 influenza season. In 2008-2009, 506 reports 
      describing 5 to 17 year olds were received. The serious reports of tests 
      performed after TIV were approximately 10% of all reports from 2001-2006, and 6% 
      of the reports in the 2008-2009 season. Data mining showed an increased 
      proportion of medication errors and Guillain Barre Syndrome (GBS). The findings 
      of GBS could not be interpreted as causally related to vaccination. Among 201 
      reports of medication error, 94% had no AE reported other than the medication 
      error itself. CONCLUSION: In this analysis, we found no unexpected AEs. Our 
      review of medication error and GBS reports suggests that ongoing monitoring in 
      these areas is appropriate.
FAU - Muhammad, Riyadh
AU  - Muhammad R
AD  - Food and Drug Administration, Center for Biologics Evaluation and Research, 
      Office of Biostatistics and Epidemiology Rockville, MD, USA.
FAU - Haber, Penina
AU  - Haber P
FAU - Broder, Karen
AU  - Broder K
FAU - Leroy, Zanie
AU  - Leroy Z
FAU - Ball, Robert
AU  - Ball R
FAU - Braun, M Miles
AU  - Braun MM
FAU - Davis, Robert L
AU  - Davis RL
FAU - McMahon, Ann W
AU  - McMahon AW
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - Pediatr Infect Dis J
JT  - The Pediatric infectious disease journal
JID - 8701858
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Child
MH  - Child, Preschool
MH  - Humans
MH  - Infant
MH  - Influenza Vaccines/*adverse effects
MH  - Influenza, Human/prevention & control
MH  - Vaccination/*adverse effects
MH  - Vaccines, Inactivated/*adverse effects
EDAT- 2010/11/03 06:00
MHDA- 2016/03/10 06:00
CRDT- 2010/11/03 06:00
PHST- 2010/11/03 06:00 [entrez]
PHST- 2010/11/03 06:00 [pubmed]
PHST- 2016/03/10 06:00 [medline]
AID - 10.1097/INF.0b013e3181ff9795 [doi]
PST - ppublish
SO  - Pediatr Infect Dis J. 2011 Jan;30(1):e1-8. doi: 10.1097/INF.0b013e3181ff9795.