PMID- 26407428
OWN - NLM
STAT- MEDLINE
DCOM- 20170821
LR  - 20170821
IS  - 2048-7207 (Electronic)
IS  - 2048-7193 (Linking)
VI  - 4
IP  - 3
DP  - 2015 Sep
TI  - Post-Licensure Surveillance of Trivalent Live-Attenuated Influenza Vaccine in 
      Children Aged 2-18 Years, Vaccine Adverse Event Reporting System, United States, 
      July 2005-June 2012.
PG  - 205-13
LID - 10.1093/jpids/piu034 [doi]
AB  - BACKGROUND: The first trivalent live-attenuated influenza vaccine (LAIV3) was 
      licensed in 2003 for use in healthy persons 5-49 years of age. In 2007, the US 
      Food and Drug Administration expanded its indication to healthy children 2-4 
      years of age. METHODS: We searched the Vaccine Adverse Event Reporting System 
      (VAERS) for US reports after LAIV3 from July 1, 2005 to June 30, 2012 in children 
      aged 2-18 years. Medical records were requested for nonmanufacturer reports coded 
      as serious (ie, death, hospitalization, prolonged hospitalization, 
      life-threatening illness, disability). We characterized electronic data and 
      clinically reviewed all serious reports and reports of special interest. 
      Empirical Bayesian data mining was used to identify new or unexpected adverse 
      events (AEs). RESULTS: During the study period, VAERS received 2619 US LAIV3 
      reports for children aged 2-18 years; 197 (7.5%) reports were serious, including 
      5 deaths. The 2 most frequent nonfatal serious reports involved neurological and 
      respiratory systems, with 56 (29.2%) and 43 (22.4%) reports, respectively. The 
      most frequent neurological diagnoses were seizures and Guillain-Barre Syndrome, 
      and the most frequent respiratory conditions were pneumonia and asthma or 
      reactive airway disease. Data mining showed increased proportions for reports of 
      medication errors, most commonly vaccine administration errors not associated 
      with an AE. CONCLUSIONS: In this VAERS analysis of reports following LAIV3, we 
      found no new or unexpected AEs patterns. Reports of LAIV3 administration to 
      persons, for whom it is not recommended, including children with a history of 
      asthma or reactive airway disease or wheezing, indicate that ongoing monitoring 
      and education in vaccine indications are needed.
CI  - Published by Oxford University Press on behalf of the Pediatric Infectious 
      Diseases Society 2014. This work is written by (a) US Government employee(s) and 
      is in the public domain in the US.
FAU - Haber, Penina
AU  - Haber P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia;
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia;
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia;
FAU - Vellozzi, Claudia
AU  - Vellozzi C
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia;
FAU - Lewis, Paige
AU  - Lewis P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia;
FAU - Woo, Emily Jane
AU  - Woo EJ
AD  - Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and 
      Research, US Food and Drug Administration, Rockville, Maryland.
FAU - Broder, Karen
AU  - Broder K
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia;
LA  - eng
PT  - Journal Article
DEP - 20140507
PL  - England
TA  - J Pediatric Infect Dis Soc
JT  - Journal of the Pediatric Infectious Diseases Society
JID - 101586049
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Attenuated)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Bacterial Infections/epidemiology/etiology
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Guillain-Barre Syndrome/chemically induced/epidemiology
MH  - Humans
MH  - Hypersensitivity
MH  - Influenza Vaccines/administration & dosage/*adverse effects
MH  - Influenza, Human/complications/epidemiology/*prevention & control
MH  - Male
MH  - Product Surveillance, Postmarketing
MH  - Seizures/chemically induced/epidemiology
MH  - Vaccines, Attenuated/administration & dosage/*adverse effects
MH  - Vaccines, Inactivated/administration & dosage/*adverse effects
OTO - NOTNLM
OT  - live-attenuated influenza
OT  - postmarketing surveillance
OT  - vaccine
OT  - vaccine safety
EDAT- 2015/09/26 06:00
MHDA- 2017/08/22 06:00
CRDT- 2015/09/26 06:00
PHST- 2013/12/04 00:00 [received]
PHST- 2014/03/19 00:00 [accepted]
PHST- 2015/09/26 06:00 [entrez]
PHST- 2015/09/26 06:00 [pubmed]
PHST- 2017/08/22 06:00 [medline]
AID - piu034 [pii]
AID - 10.1093/jpids/piu034 [doi]
PST - ppublish
SO  - J Pediatric Infect Dis Soc. 2015 Sep;4(3):205-13. doi: 10.1093/jpids/piu034. Epub 
      2014 May 7.