title: Congenital anomalies: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data.
authors.affiliation: HealthPartners Institute, United States.
authors.forename: Malini
authors.initials: M
authors.lastname: DeSilva
authors.affiliation: Baylor College of Medicine, Houston, TX, United States.
authors.forename: Flor M
authors.initials: FM
authors.lastname: Munoz
authors.affiliation: 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.
authors.forename: Mark
authors.initials: M
authors.lastname: Mcmillan
authors.affiliation: Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health, United States.
authors.forename: Alison Tse
authors.initials: AT
authors.lastname: Kawai
authors.affiliation: Vaccinology and Immunology Research Trials Unit, Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, South Adelaide, Australia.
authors.forename: Helen
authors.initials: H
authors.lastname: Marshall
authors.affiliation: National Centre for Immunisation Research & Surveillance (NCIRS), Australia; Discipline of Paediatrics and Child Health, University of Sydney, Australia.
authors.forename: Kristine K
authors.initials: KK
authors.lastname: Macartney
authors.affiliation: Immunization Technical Support Unit, Public Health Foundation of India, India.
authors.forename: Jyoti
authors.initials: J
authors.lastname: Joshi
authors.affiliation: Kenya Medical Research Institute/CDC, Kisumu, Kenya.
authors.forename: Martina
authors.initials: M
authors.lastname: Oneko
authors.affiliation: Reproductive Care Program of Nova Scotia, Canada.
authors.forename: Annette Elliott
authors.initials: AE
authors.lastname: Rose
authors.affiliation: WHO Collaborating Centre for the Surveillance of Congenital Anomalies, Ulster University, United Kingdom.
authors.forename: Helen
authors.initials: H
authors.lastname: Dolk
authors.affiliation: Ufficio di Farmacovigilanza, Agenxia Italiana del Farmaco, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Trotta
authors.affiliation: Henry M. Jackson Foundation, United States.
authors.forename: Hans
authors.initials: H
authors.lastname: Spiegel
authors.affiliation: Novartis influenza vaccines, Cambridge, MA, United States.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Tomczyk
authors.affiliation: Sanofi Pasteur, United States.
authors.forename: Anju
authors.initials: A
authors.lastname: Shrestha
authors.affiliation: Global Healthcare Consulting, India.
authors.forename: Sonali
authors.initials: S
authors.lastname: Kochhar
authors.affiliation: HealthPartners Institute, United States. Electronic address: contact@brightoncollaboration.org.
authors.forename: Elyse O
authors.initials: EO
authors.lastname: Kharbanda
mesh_terms: D000013:Congenital Abnormalities / Q000209:etiology*; D003625:Data Collection; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control; D014612:Vaccines / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D014612:Vaccines
keywords: Adverse event; Birth defect; Case definition; Congenital abnormality; Congenital anomaly; Congenital disorders; Congenital malformations; Guidelines; Immunization