PMID- 27694888
OWN - NLM
STAT- MEDLINE
DCOM- 20180710
LR  - 20231111
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 6
DP  - 2016 Oct 3
TI  - Statistical and Ontological Analysis of Adverse Events Associated with Monovalent 
      and Combination Vaccines against Hepatitis A and B Diseases.
PG  - 34318
LID - 10.1038/srep34318 [doi]
LID - 34318
AB  - Vaccinations often induce various adverse events (AEs), and sometimes serious AEs 
      (SAEs). While many vaccines are used in combination, the effects of 
      vaccine-vaccine interactions (VVIs) on vaccine AEs are rarely studied. In this 
      study, AE profiles induced by hepatitis A vaccine (Havrix), hepatitis B vaccine 
      (Engerix-B), and hepatitis A and B combination vaccine (Twinrix) were studied 
      using the VAERS data. From May 2001 to January 2015, VAERS recorded 941, 3,885, 
      and 1,624 AE case reports where patients aged at least 18 years old were 
      vaccinated with only Havrix, Engerix-B, and Twinrix, respectively. Using these 
      data, our statistical analysis identified 46, 69, and 82 AEs significantly 
      associated with Havrix, Engerix-B, and Twinrix, respectively. Based on the 
      Ontology of Adverse Events (OAE) hierarchical classification, these AEs were 
      enriched in the AEs related to behavioral and neurological conditions, immune 
      system, and investigation results. Twenty-nine AEs were classified as SAEs and 
      mainly related to immune conditions. Using a logistic regression model 
      accompanied with MCMC sampling, 13 AEs (e.g., hepatosplenomegaly) were identified 
      to result from VVI synergistic effects. Classifications of these 13 AEs using OAE 
      and MedDRA hierarchies confirmed the advantages of the OAE-based method over 
      MedDRA in AE term hierarchical analysis.
FAU - Xie, Jiangan
AU  - Xie J
AD  - Key Laboratory of Dependable Service Computing in Cyber Physical Society, 
      Ministry of Education, Chongqing University, Chongqing, 400044, China.
AD  - University of Michigan Medical School, Ann Arbor, Michigan, 48109, USA.
FAU - Zhao, Lili
AU  - Zhao L
AD  - Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, 48109, 
      USA.
FAU - Zhou, Shangbo
AU  - Zhou S
AD  - Key Laboratory of Dependable Service Computing in Cyber Physical Society, 
      Ministry of Education, Chongqing University, Chongqing, 400044, China.
FAU - He, Yongqun
AU  - He Y
AD  - University of Michigan Medical School, Ann Arbor, Michigan, 48109, USA.
LA  - eng
GR  - R01 AI081062/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20161003
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Hepatitis A Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - Adult
MH  - Female
MH  - Hepatitis A Vaccines/*adverse effects
MH  - Hepatitis B/*prevention & control
MH  - Hepatitis B Vaccines/*adverse effects
MH  - Hepatitis C/*prevention & control
MH  - Humans
MH  - Male
MH  - Markov Chains
MH  - Monte Carlo Method
MH  - Vaccines, Combined/administration & dosage/*adverse effects
PMC - PMC5046117
EDAT- 2016/10/04 06:00
MHDA- 2018/07/11 06:00
PMCR- 2016/10/03
CRDT- 2016/10/04 06:00
PHST- 2016/05/17 00:00 [received]
PHST- 2016/09/12 00:00 [accepted]
PHST- 2016/10/04 06:00 [entrez]
PHST- 2016/10/04 06:00 [pubmed]
PHST- 2018/07/11 06:00 [medline]
PHST- 2016/10/03 00:00 [pmc-release]
AID - srep34318 [pii]
AID - 10.1038/srep34318 [doi]
PST - epublish
SO  - Sci Rep. 2016 Oct 3;6:34318. doi: 10.1038/srep34318.