PMID- 25598306
OWN - NLM
STAT- MEDLINE
DCOM- 20150702
LR  - 20220410
IS  - 1097-6833 (Electronic)
IS  - 0022-3476 (Print)
IS  - 0022-3476 (Linking)
VI  - 166
IP  - 4
DP  - 2015 Apr
TI  - Adverse events following Haemophilus influenzae type b vaccines in the Vaccine 
      Adverse Event Reporting System, 1990-2013.
PG  - 992-7
LID - S0022-3476(14)01163-9 [pii]
LID - 10.1016/j.jpeds.2014.12.014 [doi]
AB  - OBJECTIVE: To characterize adverse events (AEs) after Haemophilus influenzae type 
      b (Hib) vaccines reported to the US Vaccine Adverse Event Reporting System 
      (VAERS), a spontaneous reporting surveillance system. STUDY DESIGN: We searched 
      VAERS for US reports after Hib vaccines among reports received from January 1, 
      1990, to December 1, 2013. We reviewed a random sample of reports and 
      accompanying medical records for reports classified as serious. All reports of 
      death were reviewed. Physicians assigned a primary clinical category to each 
      reviewed report. We used empirical Bayesian data mining to identify AEs that were 
      disproportionally reported after Hib vaccines. RESULTS: VAERS received 29,747 
      reports after Hib vaccines; 5179 (17%) were serious, including 896 reports of 
      deaths. Median age was 6 months (range 0-1022 months). Sudden infant death 
      syndrome was the stated cause of death in 384 (51%) of 749 death reports with 
      autopsy/death certificate records. The most common nondeath serious AE categories 
      were neurologic (80; 37%), other noninfectious (46; 22%) (comprising mainly 
      constitutional signs and symptoms); and gastrointestinal (39; 18%) conditions. No 
      new safety concerns were identified after clinical review of reports of AEs that 
      exceeded the data mining statistical threshold. CONCLUSION: Review of VAERS 
      reports did not identify any new or unexpected safety concerns for Hib vaccines.
CI  - Published by Elsevier Inc.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      GA. Electronic address: pmoro@cdc.gov.
FAU - Jankosky, Christopher
AU  - Jankosky C
AD  - Center for Biologics Evaluation and Research, US Food and Drug Administration, 
      Silver Spring, MD.
FAU - Menschik, David
AU  - Menschik D
AD  - Center for Biologics Evaluation and Research, US Food and Drug Administration, 
      Silver Spring, MD.
FAU - Lewis, Paige
AU  - Lewis P
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      GA.
FAU - Duffy, Jonathan
AU  - Duffy J
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      GA.
FAU - Stewart, Brock
AU  - Stewart B
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      GA.
FAU - Shimabukuro, Tom T
AU  - Shimabukuro TT
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, 
      GA.
LA  - eng
GR  - CC999999/Intramural CDC HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20150115
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Haemophilus influenzae type b polysaccharide vaccine)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Bacterial Capsules
MH  - Bayes Theorem
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Follow-Up Studies
MH  - Haemophilus Infections/mortality/*prevention & control
MH  - Haemophilus Vaccines/*adverse effects
MH  - Haemophilus influenzae type b/*immunology
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Retrospective Studies
MH  - Risk Assessment/*methods
MH  - Survival Rate/trends
MH  - United States/epidemiology
PMC - PMC6500451
MID - NIHMS1025290
COIS- Conflict of interest: None of the authors have a conflict of interest.
EDAT- 2015/01/20 06:00
MHDA- 2015/07/03 06:00
PMCR- 2019/05/04
CRDT- 2015/01/20 06:00
PHST- 2014/08/20 00:00 [received]
PHST- 2014/10/20 00:00 [revised]
PHST- 2014/12/05 00:00 [accepted]
PHST- 2015/01/20 06:00 [entrez]
PHST- 2015/01/20 06:00 [pubmed]
PHST- 2015/07/03 06:00 [medline]
PHST- 2019/05/04 00:00 [pmc-release]
AID - S0022-3476(14)01163-9 [pii]
AID - 10.1016/j.jpeds.2014.12.014 [doi]
PST - ppublish
SO  - J Pediatr. 2015 Apr;166(4):992-7. doi: 10.1016/j.jpeds.2014.12.014. Epub 2015 Jan 
      15.