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

Malini DeSilva; Flor M Munoz; Mark Mcmillan; Alison Tse Kawai; Helen Marshall; Kristine K Macartney; Jyoti Joshi; Martina Oneko; Annette Elliott Rose; Helen Dolk; Francesco Trotta; Hans Spiegel; Sylvie Tomczyk; Anju Shrestha; Sonali Kochhar; Elyse O Kharbanda; Brighton Collaboration Congenital Anomalies Working Group

doi:10.1016/j.vaccine.2016.03.047

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

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

Authors

Malini DeSilva¹, Flor M Munoz², Mark Mcmillan³, Alison Tse Kawai⁴, Helen Marshall⁵, Kristine K Macartney⁶, Jyoti Joshi⁷, Martina Oneko⁸, Annette Elliott Rose⁹, Helen Dolk¹⁰, Francesco Trotta¹¹, Hans Spiegel¹², Sylvie Tomczyk¹³, Anju Shrestha¹⁴, Sonali Kochhar¹⁵, Elyse O Kharbanda¹⁶; Brighton Collaboration Congenital Anomalies Working Group

Affiliations

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: [email protected].

No abstract available

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

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Congenital Abnormalities / etiology*
Data Collection*
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine / adverse effects
Female
Guidelines as Topic
Humans
Immunization / adverse effects*
Pregnancy
Pregnancy Complications, Infectious / prevention & control
Vaccines / administration & dosage
Vaccines / adverse effects*

Substances

Diphtheria-Tetanus-Pertussis Vaccine
Vaccines