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

来源：

VACCINE | 2016年 / 34卷 / 49期

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

相关论文

共 68 条

[11] Risks and safety of pandemic h1n1 influenza vaccine in pregnancy: Birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants [J].

Chambers, Christina D. ;

Johnson, Diana ;

Xu, Ronghui ;

Luo, Yunjun ;

Louik, Carol ;

Mitchell, Allen A. ;

Schatz, Michael ;

Jones, Kenneth L. .

VACCINE, 2013, 31 (44) :5026-5032

[12] Serum Proinflammatory Cytokine Responses to Influenza Virus Vaccine among Women during Pregnancy versus Non-Pregnancy [J].

Christian, Lisa M. ;

Porter, Kyle ;

Karlsson, Erik ;

Schultz-Cherry, Stacey ;

Iams, Jay D. .

AMERICAN JOURNAL OF REPRODUCTIVE IMMUNOLOGY, 2013, 70 (01) :45-53

[13] Inflammatory responses to trivalent influenza virus vaccine among pregnant women [J].

Christian, Lisa M. ;

Iams, Jay D. ;

Porter, Kyle ;

Glaser, Ronald .

VACCINE, 2011, 29 (48) :8982-8987

[14] Tetanus toxoid and congenital abnormalities [J].

Czeizel, AE ;

Rockenbauer, M .

INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS, 1999, 64 (03) :253-258

[15] Pregnancy Outcomes Following Rubella Vaccination: A Prospective Study in the State of Rio de Janeiro, Brazil, 2001-2002 [J].

da Silva e Sa, Gloria Regina ;

Bastos Camacho, Luiz Antonio ;

Stavola, Monica Santos ;

Lemos, Xenia Rawena ;

Basilio de Oliveira, Carlos Alberto ;

Siqueira, Marilda Mendonca .

JOURNAL OF INFECTIOUS DISEASES, 2011, 204 :S722-S728

[16] Pregnancy Outcomes From the Pregnancy Registry of a Human Papillomavirus Type 6/11/16/18 Vaccine [J].

Dana, Adrian ;

Buchanan, Karyn M. ;

Goss, Mary Ann ;

Seminack, Margaret M. ;

Shields, Kristine E. ;

Korn, Scott ;

Cunningham, Michael L. ;

Haupt, Richard M. .

OBSTETRICS AND GYNECOLOGY, 2009, 114 (06) :1170-1178

[17] A-NJ-8-76 INFLUENZA VACCINATION PROGRAM - EFFECTS ON MATERNAL HEALTH AND PREGNANCY OUTCOME [J].

DEINARD, AS ;

OGBURN, P .

AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, 1981, 140 (03) :240-245

[18]

Demicheli V, 2014, VACCINES PREVENTING

[19] A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy [J].

Fabiani, Massimo ;

Bella, Antonino ;

Rota, Maria C. ;

Clagnan, Elena ;

Gallo, Tolinda ;

D'Amato, Maurizio ;

Pezzotti, Patrizio ;

Ferrara, Lorenza ;

Demicheli, Vittorio ;

Martinelli, Domenico ;

Prato, Rosa ;

Rizzo, Caterina .

VACCINE, 2015, 33 (19) :2240-2247

[20] Pregnancy and Infant Outcomes in the Clinical Trials of a Human Papillomavirus Type 6/11/16/18 Vaccine A Combined Analysis of Five Randomized Controlled Trials [J].

Garland, Suzanne M. ;

Ault, Kevin A. ;

Gall, Stanley A. ;

Paavonen, Jorma ;

Sings, Heather L. ;

Ciprero, Karen L. ;

Saah, Alfred ;

Marino, Deborah ;

Ryan, Desmond ;

Radley, David ;

Zhou, Haiping ;

Haupt, Richard M. ;

Garner, Elizabeth I. O. .

OBSTETRICS AND GYNECOLOGY, 2009, 114 (06) :1179-1188

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