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

被引:84
作者
DeSilva, Malini [1 ]
Munoz, Flor M. [2 ]
Mcmillan, Mark [3 ,4 ,5 ]
Kawaie, Alison Tse [6 ,7 ]
Marshall, Helen [4 ,5 ]
Macartney, Kristine K. [8 ,9 ]
Joshi, Jyoti [10 ]
Oneko, Martina [11 ]
Rose, Annette Elliott [12 ]
Dolk, Helen [13 ]
Trotta, Francesco [14 ]
Spiegel, Hans [15 ]
Tomczyk, Sylvie [16 ]
Shrestha, Anju [17 ]
Kochhar, Sonali [18 ]
Kharbanda, Elyse O. [1 ]
机构
[1] HealthPartners Inst, Bloomington, MN 55425 USA
[2] Baylor Coll Med, Houston, TX 77030 USA
[3] Univ Adelaide, Sch Paediat & Reprod Hlth, Adelaide, SA 5005, Australia
[4] Univ Adelaide, Womens & Childrens Hosp, Vaccinol & Immunol Res Trials Unit, South Adelaide, Australia
[5] Univ Adelaide, Robinson Res Inst, South Adelaide, Australia
[6] Harvard Med Sch, Dept Populat Med, Boston, MA USA
[7] Harvard Pilgrim Hlth, Boston, MA USA
[8] NCIRS, Westmead, NSW, Australia
[9] Univ Sydney, Discipline Paediat & Child Hlth, Sydney, NSW 2006, Australia
[10] Publ Hlth Fdn India, Immunizat Tech Unit, New Delhi, India
[11] Kenya Med Res Inst CDC, Kisumu, Kenya
[12] Reprod Care Program Nova Scotia, Halifax, NS, Canada
[13] Univ Ulster, WHO Collaborating Ctr Surveillance Congenital Ano, Coleraine BT52 1SA, Londonderry, North Ireland
[14] Agenxia Italiana Farmaco, Ufficio Farmacovigilanza, Rome, Italy
[15] Henry M Jackson Fdn, Bethesda, MD USA
[16] Novartis Influenza Vaccines, Cambridge, MA USA
[17] Sanofi Pasteur, Swiftwater, PA USA
[18] Global Healthcare Consulting, Delhi, India
关键词
Congenital anomaly; Birth defect; Congenital disorders; Congenital malformations; Congenital abnormality; Adverse event; Immunization; Guidelines; Case definition; UNKNOWINGLY PREGNANT-WOMEN; INFLUENZA-VIRUS VACCINE; EVENT REPORTING SYSTEM; HUMAN-PAPILLOMAVIRUS; RUBELLA VACCINATION; ADVERSE EVENTS; H1N1; INFLUENZA; BIRTH-DEFECTS; PNEUMOCOCCAL POLYSACCHARIDE; SPONTANEOUS-ABORTION;
D O I
10.1016/j.vaccine.2016.03.047
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
[No abstract available]
引用
收藏
页码:6015 / 6026
页数:12
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