PMID- 28174201
OWN - NLM
STAT- MEDLINE
DCOM- 20170628
LR  - 20200225
IS  - 1098-4275 (Electronic)
IS  - 0031-4005 (Print)
IS  - 0031-4005 (Linking)
VI  - 139
IP  - 3
DP  - 2017 Mar
TI  - Safety of Second-Dose Single-Antigen Varicella Vaccine.
LID - 10.1542/peds.2016-2536 [doi]
LID - e20162536
AB  - BACKGROUND AND OBJECTIVE: In 2006, routine 2-dose varicella vaccination for 
      children was recommended to improve control of varicella. We assessed the safety 
      of second-dose varicella vaccination. METHODS: We identified second-dose 
      single-antigen varicella vaccine reports in the Vaccine Adverse Event Reporting 
      System during 2006 to 2014 among children aged 4 to 18 years. We analyzed reports 
      by age group (4-6 and 7-18 years), sex, serious or nonserious status, most common 
      adverse events (AEs), and whether other vaccines were administered concomitantly 
      with varicella vaccine. We reviewed serious reports of selected AEs and conducted 
      empirical Bayesian data mining to detect disproportional reporting of AEs. 
      RESULTS: We identified 14 641 Vaccine Adverse Event Reporting System reports 
      after second-dose varicella vaccination, with 494 (3%) classified as serious. 
      Among nonserious reports, injection site reactions were most common (48% of 
      children aged 4-6 years, 38% of children aged 7-18 years). The most common AEs 
      among serious reports were pyrexia (31%) for children aged 4 to 6 years and 
      headache (28%) and vomiting (27%) for children aged 7 to 18 years. Serious 
      reports of selected AEs included anaphylaxis (83), meningitis (5), encephalitis 
      (16), cellulitis (52), varicella (6), herpes zoster (6), and deaths (7). One 
      immunosuppressed adolescent was reported with vaccine-strain herpes zoster. Only 
      previously known AEs were reported more frequently after second-dose varicella 
      vaccination compared with other vaccines. CONCLUSIONS: We identified no new or 
      unexpected safety concerns for second-dose varicella vaccination. Robust safety 
      monitoring remains an important component of the national varicella vaccination 
      program.
CI  - published in the public domain by the American Academy of Pediatrics.
FAU - Su, John R
AU  - Su JR
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, ezu2@cdc.gov.
FAU - Leroy, Zanie
AU  - Leroy Z
AD  - School Health Branch, Division of Population Health, National Center for Chronic 
      Disease Prevention and Health Promotion, and.
FAU - Lewis, Paige W
AU  - Lewis PW
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases.
FAU - Haber, Penina
AU  - Haber P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases.
FAU - Marin, Mona
AU  - Marin M
AD  - Epidemiology Branch, Division of Viral Diseases, National Center for Immunization 
      and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, 
      Georgia; and.
FAU - Leung, Jessica
AU  - Leung J
AD  - Epidemiology Branch, Division of Viral Diseases, National Center for Immunization 
      and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, 
      Georgia; and.
FAU - Woo, Emily Jane
AU  - Woo EJ
AD  - Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and 
      Research, US Food and Drug Administration, Silver Springs, MD.
FAU - Shimabukuro, Tom T
AU  - Shimabukuro TT
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases.
LA  - eng
GR  - CC999999/Intramural CDC HHS/United States
PT  - Journal Article
DEP - 20170207
PL  - United States
TA  - Pediatrics
JT  - Pediatrics
JID - 0376422
RN  - 0 (Chickenpox Vaccine)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Adolescent
MH  - Adverse Drug Reaction Reporting Systems
MH  - Anaphylaxis/chemically induced
MH  - Cellulitis/chemically induced
MH  - Chickenpox/chemically induced
MH  - Chickenpox Vaccine/administration & dosage/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Encephalitis/chemically induced
MH  - Female
MH  - Fever/chemically induced
MH  - Headache/chemically induced
MH  - Herpes Zoster/chemically induced
MH  - Humans
MH  - Immunization, Secondary/*adverse effects
MH  - Male
MH  - Meningitis, Aseptic/chemically induced
MH  - Meningitis, Viral/chemically induced
MH  - Vaccines, Attenuated/administration & dosage/adverse effects
MH  - Vomiting/chemically induced
PMC - PMC6434520
MID - NIHMS1019100
COIS- POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential 
      conflicts of interest to disclose.
EDAT- 2017/02/09 06:00
MHDA- 2017/06/29 06:00
PMCR- 2019/03/26
CRDT- 2017/02/09 06:00
PHST- 2016/11/22 00:00 [accepted]
PHST- 2017/02/09 06:00 [pubmed]
PHST- 2017/06/29 06:00 [medline]
PHST- 2017/02/09 06:00 [entrez]
PHST- 2019/03/26 00:00 [pmc-release]
AID - peds.2016-2536 [pii]
AID - 10.1542/peds.2016-2536 [doi]
PST - ppublish
SO  - Pediatrics. 2017 Mar;139(3):e20162536. doi: 10.1542/peds.2016-2536. Epub 2017 Feb 
      7.