PMID- 28262331
OWN - NLM
STAT- MEDLINE
DCOM- 20171207
LR  - 20181113
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 35
IP  - 14
DP  - 2017 Mar 27
TI  - Adverse events following quadrivalent meningococcal CRM-conjugate vaccine 
      (Menveo(R)) reported to the Vaccine Adverse Event Reporting system (VAERS), 
      2010-2015.
PG  - 1758-1763
LID - S0264-410X(17)30224-4 [pii]
LID - 10.1016/j.vaccine.2017.02.030 [doi]
AB  - BACKGROUND: Limited data are available describing the post-licensure safety of 
      meningococcal vaccines, including Menveo(R). We reviewed reports of adverse events 
      (AEs) to the Vaccine Adverse Event Reporting System (VAERS) to assess safety in 
      all age groups. METHODS: VAERS is a national spontaneous vaccine safety 
      surveillance system co-administered by the Centers for Disease Control and 
      Prevention and the US Food and Drug Administration. We searched the VAERS 
      database for US reports of adverse events in persons who received Menveo from 1 
      January 2010 through 31 December 2015. We clinically reviewed reports and 
      available medical records for serious AEs, selected pre-specified outcomes, and 
      vaccination during pregnancy. We used empirical Bayesian data mining to identify 
      AEs that were disproportionately reported after receipt of Menveo. RESULTS: 
      During the study period, VAERS received 2614 US reports after receipt of Menveo. 
      Of these, 67 were classified as serious, including 1 report of death. Adolescents 
      (aged 11-18years) accounted for 74% of reports. Most of the reported AEs were 
      non-serious and described AEs consistent with data from pre-licensure studies. 
      Anaphylaxis and syncope were the two most common events in the serious reports. 
      We did not identify any new safety concerns after review of AEs that exceeded the 
      data mining threshold, although we did observe disproportionate reporting for 
      terms that were not associated with an adverse event (e.g., "incorrect drug 
      dosage form administered", "wrong technique in drug usage process"). Although 
      reports were limited, we did not find any evidence for concern regarding the use 
      of Menveo during pregnancy. CONCLUSIONS: In our review of VAERS reports, findings 
      of AEs were consistent with the data from pre-licensure studies. Vaccine 
      providers should continue to emphasize and adhere to proper administration of the 
      vaccine.
CI  - Copyright (c) 2017 Elsevier Ltd. All rights reserved.
FAU - Myers, Tanya R
AU  - Myers TR
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA; 
      Rollins School of Public Health, Emory University, 1518 Clifton Road, Atlanta, GA 
      30322, USA. Electronic address: vje9@cdc.gov.
FAU - McNeil, Michael M
AU  - McNeil MM
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.
FAU - Ng, Carmen S
AU  - Ng CS
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.
FAU - Li, Rongxia
AU  - Li R
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.
FAU - Lewis, Paige W
AU  - Lewis PW
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.
FAU - Cano, Maria V
AU  - Cano MV
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, Centers for 
      Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30333, USA.
LA  - eng
GR  - T32 AI074492/AI/NIAID NIH HHS/United States
PT  - Historical Article
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20170303
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Meningococcal Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Anaphylaxis/epidemiology/etiology
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - History, 21st Century
MH  - Humans
MH  - Infant
MH  - Male
MH  - *Mandatory Reporting
MH  - Meningitis, Meningococcal/epidemiology/history/mortality/*prevention & control
MH  - Meningococcal Vaccines/*adverse effects
MH  - Mortality
MH  - Pregnancy
MH  - United States/epidemiology
MH  - Young Adult
PMC - PMC5444082
MID - NIHMS858023
OTO - NOTNLM
OT  - Epidemiology
OT  - Meningitis vaccine
OT  - Meningococcal disease
OT  - Vaccine Adverse Event Reporting System (VAERS)
OT  - Vaccine safety
OT  - Vaccines
COIS- Potential conflicts of interest: All authors: no potential conflicts.
EDAT- 2017/03/07 06:00
MHDA- 2017/12/08 06:00
PMCR- 2018/03/27
CRDT- 2017/03/07 06:00
PHST- 2016/10/11 00:00 [received]
PHST- 2017/02/13 00:00 [revised]
PHST- 2017/02/14 00:00 [accepted]
PHST- 2017/03/07 06:00 [pubmed]
PHST- 2017/12/08 06:00 [medline]
PHST- 2017/03/07 06:00 [entrez]
PHST- 2018/03/27 00:00 [pmc-release]
AID - S0264-410X(17)30224-4 [pii]
AID - 10.1016/j.vaccine.2017.02.030 [doi]
PST - ppublish
SO  - Vaccine. 2017 Mar 27;35(14):1758-1763. doi: 10.1016/j.vaccine.2017.02.030. Epub 
      2017 Mar 3.