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Vaccine. 2016 Dec 1;34(49):6015-6026. doi: 10.1016/j.vaccine.2016.03.047. Epub 2016 Jul 18.

Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data.

Author information

1
HealthPartners Institute, United States.
2
Baylor College of Medicine, Houston, TX, United States.
3
School of Paediatrics and Reproductive Health, The University of Adelaide, Australia; Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, South Adelaide, Australia.
4
Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health, United States.
5
Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, South Adelaide, Australia.
6
National Centre for Immunisation Research & Surveillance (NCIRS), Australia; Discipline of Paediatrics and Child Health, University of Sydney, Australia.
7
Immunization Technical Support Unit, Public Health Foundation of India, India.
8
Kenya Medical Research Institute/CDC, Kisumu, Kenya.
9
Reproductive Care Program of Nova Scotia, Canada.
10
WHO Collaborating Centre for the Surveillance of Congenital Anomalies, Ulster University, United Kingdom.
11
Ufficio di Farmacovigilanza, Agenxia Italiana del Farmaco, Italy.
12
Henry M. Jackson Foundation, United States.
13
Novartis influenza vaccines, Cambridge, MA, United States.
14
Sanofi Pasteur, United States.
15
Global Healthcare Consulting, India.
16
HealthPartners Institute, United States. Electronic address: contact@brightoncollaboration.org.

KEYWORDS:

Adverse event; Birth defect; Case definition; Congenital abnormality; Congenital anomaly; Congenital disorders; Congenital malformations; Guidelines; Immunization

PMID:
27435386
PMCID:
PMC5139892
DOI:
10.1016/j.vaccine.2016.03.047
[Indexed for MEDLINE]
Free PMC Article

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