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Expert Review of Vaccines Volume 13, 2014 - Issue 2
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Active surveillance for adverse events following immunization

Nigel W Crawford;Department of Paediatrics, The University of Melbourne,AustraliaCorrespondence[email protected]
,
Hazel ClothierSAEFVIC, Murdoch Children's Research Institute (MCRI), Parkville, Melbourne, Victoria 3052, Australia;School of Population Health, The University of Melbourne,Australia
,
Kate HodgsonDepartment of General Medicine, Royal Children's Hospital (RCH), Melbourne, Australia
,
Gowri SelvarajSAEFVIC, Murdoch Children's Research Institute (MCRI), Parkville, Melbourne, Victoria 3052, Australia
,
Mee Lee EastonSAEFVIC, Murdoch Children's Research Institute (MCRI), Parkville, Melbourne, Victoria 3052, Australia
&
Jim P ButterySAEFVIC, Murdoch Children's Research Institute (MCRI), Parkville, Melbourne, Victoria 3052, Australia;Paediatric Infectious Diseases Unit, Monash Children's Hospital, Monash Health, Australia;Department of Paediatrics, Monash University, Melbourne, Australia
Pages 265-276 | Published online: 18 Dec 2013

References

  • Waldman EA, Luhm KR, Monteiro SA, Freitas FR. Surveillance of adverse effects following vaccination and safety of immunization programs. Rev. Saude Publica 45(1), 173–184 (2011).
  • Bonhoeffer J, Kohl K, Chen R et al. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI). Vaccine 21(3–4), 298–302 (2002).
  • WHO. Causality Assessment of Adverse Event Following Immunization (AEFI): User Manual for the Revised WHO Classification. WHO Press, Geneva, Switzerland (2013).
  • WHO consultation on global monitoring of adverse events following immunization, 9–10 January 2006. Weekly Epidemiological Record 81(27), 261–265 (2006).
  • Lawrence G, Campbell-Lloyd S, Rixon G. Monitoring adverse events following immunisation. N. S. W. Public Health Bull. 14(1–2), 21–24 (2003).
  • Bonhoeffer J, Bentsi-Enchill A, Chen RT et al. Guidelines for collection, analysis and presentation of vaccine safety data in surveillance systems. Vaccine 27(16), 2289–2297 (2009).
  • Braun MM, Ellenberg SS. Descriptive epidemiology of adverse events after immunization: reports to the Vaccine Adverse Event Reporting System (VAERS), 1991–1994. J. Pediatr. 131(4), 529–535 (1997).
  • Zhou W, Pool V, Iskander JK et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)–United States, 1991-2001. MMWR Surveill. Summ. 52(1), 1–24 (2003).
  • Lankinen KS, Pastila S, Kilpi T, Nohynek H, Makela PH, Olin P. Vaccinovigilance in Europe–need for timeliness, standardization and resources. Bull. World Health Organ. 82(11), 828–835 (2004).
  • Slade BA, Leidel L, Vellozzi C et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 302(7), 750–757 (2009).
  • DuVernoy TS, Braun MM; the VAERS Working Group. Hypotonic-hyporesponsive episodes reported to the vaccine adverse event reporting system (VAERS), 1996–1998. Pediatrics 106(4), e52–e56 (2000).
  • Hua W, Izurieta HS, Slade B et al. Kawasaki disease after vaccination: reports to the vaccine adverse event reporting system 1990–2007. Pediatr. Infect. Dis. J. 28(11), 943–947 (2009).
  • Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am. J. Public Health 85(12), 1706–1709 (1995).
  • Monteiro SA, Takano OA, Waldman EA. [Evaluation of the Brazilian surveillance system for adverse events following vaccination]. Rev. Bras. Epidemiol. 14(3), 361–371 (2011).
  • Isaacs D, Lawrence G, Boyd I, Ronaldson K, McEwen J. Reporting of adverse events following immunization in Australia. J. Paediatr. Child Health 41(4), 163–166 (2005).
  • Rosenthal S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am. J. Public Health 85(12), 1706–1709 (1995).
  • Goodman MJ, Nordin J. Vaccine adverse event reporting system reporting source: a possible source of bias in longitudinal studies. Pediatrics 117(2), 387–390 (2006).
  • Clothier H, Kempe AE, Crawford NW, Buttery JP. Surveillance of adverse events following immunisation: the model of SAEFVIC Victoria. CDI 35(4), 294–298 (2011).
  • Crawford NW, Clothier HJ, Elia S, Lazzaro T, Royle J, Buttery JP. Syncope and seizures following human papillomavirus vaccination: a retrospective case series. Med. J. Aust. 194(1), 16–18 (2011).
  • Liew WK, Crawford N, Tang MLK et al. Hypersensitivity reactions to human papillomavirus vaccine in Australian schoolgirls: retrospective cohort study. BMJ 337, a2642 (2008).
  • Clifford V, Crawford NW, Royle J et al. Recurrent apnoea post immunisation: Informing re-immunisation policy. Vaccine 29(34), 5681–5687 (2011).
  • Richards S, Chalkiadis G, Lakshman R, Buttery JP, Crawford NW. Complex regional pain syndrome following immunisation. Arch. Dis. Child. 97(10), 913–915 (2012).
  • Pahud BA, Williams SE, Dekker CL et al. Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccination. Pediatr. Infect. Dis. J. 32(2), 163–168 (2010).
  • Wood RA, Berger M, Dreskin SC et al. An algorithm for treatment of patients with hypersensitivity reactions after vaccines. Pediatrics 122(3), e771–e777 (2008).
  • Poland GA. Vaccidents and adversomics. Vaccine 28(40), 6549–6550 (2010).
  • McIntosh AM, McMahon J, Dibbens LM et al. Effects of vaccination on onset and outcome of Dravet syndrome: a retrospective study. Lancet Neurol. 9(6), 592–598 (2010).
  • Australian national centre for classification in health. International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM). Canberra, Australia (2010).
  • Siegrist C-A, Lewis EM, Eskola J, Evans SJW, Black SB. Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. Pediatr. Infect. Dis. J. 26(11), 979–984 (2007).
  • Black S, Eskola J, Siegrist CA et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet 374(9707), 2115–2122 (2009).
  • Clothier H, Lee KJ, Sundarajan V, Buttery JP, Crawford NW. Human papillomavirus vaccine in boys: background rates of potential adverse events. MJA 198(10), 554–558 (2013).
  • Yih WK, Kulldorff M, Fireman BH et al. Active surveillance for adverse events: the experience of the vaccine safety datalink project. Pediatrics 127(Suppl. 1), S54–S64 (2011).
  • Gee J, Naleway A, Shui I et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the vaccine safety datalink. Vaccine 29(46), 8279–8284 (2011).
  • McCarthy NL, Gee J, Weintraub E et al. Monitoring vaccine safety using the Vaccine Safety Datalink: utilizing immunization registries for pandemic influenza. Vaccine 29(31), 4891–4896 (2011).
  • France EK, Glanz J, Xu S et al. Risk of immune thrombocytopenic purpura after measles-mumps-rubella immunization in children. Pediatrics 121(3), e687–e692 (2008).
  • Klein NP, Fireman B, Yih WK et al. Measles-mumps-rubella-varicella combination vaccine and the risk of febrile seizures. Pediatrics 126 (2010).
  • Klein NP, Lewis E, Baxter R et al. Measles-containing vaccines and febrile seizures in children age 4 to 6 years. Pediatrics 129(5), 809–814 (2012).
  • Madsen KM, Hviid A, Vestergaard M et al. A population-based study of measles, mumps, and rubella vaccination and autism. N. Engl. J. Med. 347(19), 1477–1482 (2002).
  • Hviid A, Stellfeld M, Wohlfahrt J, Melbye M. Childhood vaccination and type 1 diabetes. N. Engl. J. Med. 350(14), 1398–1404 (2004).
  • Lieu TA, Nguyen MD, Ball R, Martin DB. Health outcomes of interest for evaluation in the post-licensure rapid immunization safety monitoring program. Vaccine 30(18), 2824–2830 (2012).
  • Yih WK, Lee GM, Lieu TA et al. Surveillance for adverse events following receipt of pandemic 2009 h1n1 vaccine in the post-licensure rapid immunization safety monitoring (prism) system, 2009–2010. Am. J. Epidemiol. 175(11), 1120–1128 (2012).
  • Miller E, Waight P, Farrington CP, Andrews N, Stowe J, Taylor B. Short report: idiopathic thrombocytopenic purpura and MMR vaccine. Arch. Dis. Child. 84(3), 227–229 (2001).
  • Andrews N, Miller E, Waight P et al. Does oral polio vaccine cause intussusception in infants? Evidence from a sequence of three self-controlled cases series studies in the united kingdom. Eur. J. Epidemiol. 17(8), 701–706 (2001).
  • Whitaker HJ, Hocine MN, Farrington CP. The methodology of self-controlled case series studies. Stat. Methods Med. Res. 18(1), 7–26 (2009).
  • Le Saux N, Barrowman NJ, Moore DL et al. Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: a report from IMPACT. Pediatrics 112(5), e348 (2003).
  • Sauve LJ, Bettinger J, Scheifele D et al. Postvaccination thrombocytopenia in Canada. Pediatr. Infect. Dis. J. 29(6), 559–561 (2010).
  • Zurynski Y, McIntyre P, Booy R, Elliott EJ, Group PI. Paediatric active enhanced disease surveillance: a new surveillance system for Australia. J. Paediatr. Child Health 49(7), 588–594 (2013).
  • Buttery JP, Danchin MH, Lee KJ et al. Intussusception following rotavirus vaccine administration: post-marketing surveillance in the National Immunization Program in Australia. Vaccine 29, 3061–3066 (2011).
  • Maraskovsky E, Rockman S, Dyson A et al. Scientific investigations into febrile reactions observed in the paediatric population following vaccination with a 2010 Southern Hemisphere Trivalent Influenza Vaccine. Vaccine 30(51), 7400–7406 (2012).
  • Armstrong PK, Dowse GK, Effler PV et al. Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ Open 1(1) (2011).
  • Stokes B. Ministerial review into the public health response into the adverse events to the seasonal influenza vaccine. Government of western australia department of health, Australia (2010).
  • Horvath J. Review of the management of adverse events associated with Panvax and Fluvax. Department of Health and Ageing, Australia (2011).
  • Dennehy PH. Rotavirus vaccines: an overview. Clin. Microbiol. Rev., 21(1), 198–208 (2008).
  • Bines JE, Patel M, Parashar U. Assessment of postlicensure safety of rotavirus vaccines, with emphasis on intussusception. J. Infect. Dis. 200(Suppl. 1), S282–S290 (2009).
  • Murphy TV, Gargiullo PM, Massoudi MS et al. Intussusception among infants given an oral rotavirus vaccine. N. Engl. J. Med. 344(8), 564–572 (2001).
  • Simonsen L, Morens D, Elixhauser A, Gerber M, Van Raden M, Blackwelder W. Effect of rotavirus vaccination programme on trends in admission of infants to hospital for intussusception. Lancet 358(9289), 1224–1229 (2001).
  • Patel MM, Lopez-Collada VR, Bulles MlM et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N. Engl. J. Med. 364(24), 2283–2292 (2011).
  • Haber P, Patel M, Pan Y et al. Intussusception after rotavirus vaccines reported to US VAERS, 2006–2012. Pediatrics 131(6), 1042–1049 (2013).
  • Shui IM, Baggs J, Patel M et al. Risk of intussusception following administration of a pentavalent rotavirus vaccine in US infants. JAMA 307(6), 598–604 (2012).
  • Haber P, Patel M, Izurieta HS et al. Postlicensure monitoring of intussusception after rotateq vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics 121(6), 1206–1212 (2008).
  • Yen C, Tate JE, Steiner CA, Cortese MM, Patel MM, Parashar UD. Trends in Intussusception Hospitalizations Among US infants before and after implementation of the rotavirus vaccination program, 2000–2009. J. Infect. Dis. 206(1), 41–48 (2012).
  • Carlin JB, Macartney K, Lee KJ et al. Intussusception risk and disease prevention associated with rotavirus vaccines in Australia's national immunisation program. Clin. Infect. Dis. 57(10), 1427–1434 (2013).
  • Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ et al. Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976–1977. Am. J. Epidemiol. 110(2), 105–123 (1979).
  • Hughes RAC, Cornblath DR. Guillain-Barré syndrome. Lancet 366(9497), 1653–1666 (2005).
  • Bishop JF, Murnane MP, Owen R. Australia's winter with the 2009 pandemic influenza A (H1N1) virus. N. Engl. J. Med. 361(27), 2591–2594 (2009).
  • Bonhoeffer J, Kohl K, Chen R et al. The Brighton Collaboration-enhancing vaccine safety. Vaccine 22(15–16), 2046 (2004).
  • Sejvar JJ, Kohl KS, Gidudu J et al. Guillain-Barré syndrome and Fisher syndrome: Case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine 29(3), 599–612 (2011).
  • Crawford NWea. Guillain-Barré syndrome following pandemic (H1N1) 2009 influenza A immunisation in Victoria: a self-controlled case series. MJA 197(10), 574–578 (2012).
  • Andrews N, Stowe J, Al-Shahi Salman R, Miller E. Guillain-Barre syndrome and H1N1 (2009) pandemic influenza vaccination using an AS03 adjuvanted vaccine in the United Kingdom: Self-controlled case series. Vaccine 29(45), 7878–7882 (2011).
  • Dieleman J, Romio S, Johansen K, Weibel D, Bonhoeffer J, Sturkenboom M. Guillain-Barrre syndrome and adjuvanted pandemic influenza A (H1N1) 2009 vaccine: multinational case-control study in Europe. BMJ 343 (2011).
  • Wise ME, Viray M, Sejvar JJ et al. Guillain-Barre syndrome during the 2009-2010 H1N1 influenza vaccination campaign: population-based surveillance among 45 million Americans. Am. J. Epidemiol. 175(11), 1110–1119 (2012).
  • De Wals P, Deceuninck G, Toth E et al. Risk of Guillain-Barre Syndrome following H1N1 influenza vaccination in Quebec. JAMA 308(2), 175–181 (2012).
  • Dodd CN, Romio SA, Black S et al. International collaboration to assess the risk of Guillain Barre Syndrome following Influenza A (H1N1) 2009 monovalent vaccines. Vaccine 31(40), 4448–4458 (2013).
  • Baxter R, Bakshi N, Fireman B et al. Lack of association of Guillain-Barre syndrome with vaccinations. Clin. Infect. Dis. 57(2), 197–204 (2013).
  • Salmon DA, Halsey NA. Editorial commentary: Guillain–Barre syndrome and vaccinations. Clin. Infect. Dis. 57(2), 205–207 (2013).
  • Amarasinghe A, Black S, Bonhoeffer J et al. Effective vaccine safety systems in all countries: A challenge for more equitable access to immunization. Vaccine 31(Suppl. 2), B108–B114 (2013).
  • Liang X-F, Li L, Liu D-W et al. Safety of Influenza A (H1N1) Vaccine in postmarketing surveillance in China. N. Engl. J. Med. 364(7), 638–647 (2011).
  • Czarnecki A, Voss S. Safety signals using proportional reporting ratios from company and regulatory authority databases. Drug Inf. J. 29, 205–210 (2008).
  • Evans S, Waller P, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol. Drug Saf. 10, 483–486 (2001).
  • Iskander J, Pool V, Zhou W, English-Bullard R. Data mining in the US using the vaccine adverse event reporting system. Drug Saf. 2006(29), 375–384 (2006).
  • DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am. Stat. 53, 177–202 (1999).
  • Bate A, Lindquist M, Edwards IR, Orre R. A data mining approach for signal detection and analysis. Drug Saf. 25(6), 393–397 (2002).
  • Rasmussen TA, Jorgensen MRS, Bjerrum S et al. Use of population based background rates of disease to assess vaccine safety in childhood and mass immunisation in Denmark: nationwide population based cohort study. BMJ 345, e5823 (2012).
  • (CIOMS) TCfIOoMS. Practical Aspects of Signal Detection in Pharmacovigilance. World Health Organization, Geneva, Switzerland (2010).
  • Goodchild M. Geographic information system (GIS). In. Encyclopedia of Computer Science. John Wiley and Sons Ltd., Chichester, UK 748–750 (2003).
  • Peterson M, Koepsell KS, Pereda G, Trowbridge S. Cloud Mapping: Google Fusion Tables. Cartographic Perspectives, North America (2012).
  • Rushton G. Public health, GIS, and spatial analytic tools. Annu. Rev. Public Health 24, 43–56 (2003).
  • Niccolai LM, Russ C, Julian PJ et al. Individual and geographic disparities in human papillomavirus types 16/18 in high-grade cervical lesions: associations with race, ethnicity, and poverty. Cancer 119(16), 3052–3058 (2013).
  • Ali M, Sur D, Kim DR et al. Impact of Vi vaccination on spatial patterns of typhoid fever in the slums of Kolkata, India. Vaccine 29(48), 9051–9056 (2011).
  • Whitehead SJ, Cui KX, De AK, Ayers T, Effler PV. Identifying risk factors for underimmunization by using geocoding matched to census tracts: a statewide assessment of children in Hawaii. Pediatrics 120(3), e535–e542 (2007).
  • Omer SB, Enger KS, Moulton LH, Halsey NA, Stokley S, Salmon DA. Geographic clustering of nonmedical exemptions to school immunization requirements and associations with geographic clustering of pertussis. Am. J. Epidemiol. 168(12), 1389–1396 (2008).
  • CDC. Centers for Disease Control and Prevention's Immunization Safety Office Scientific Agenda. Immunization Safety Office, USA (2011).
  • WHO. Global Vaccine Safety Advisory Committee. WHO, Geneva, Switzerland (2013).
  • Wright PA, Winford-Thomas D. Koch's postulates revisited. J. Pathol. 165(4), 355–355 (1991).
  • Schlachter K, Gruber-Sedlmayr U, Stogmann E et al. A splice site variant in the sodium channel gene SCN1A confers risk of febrile seizures. Neurology 72(11), 974–978 (2009).
  • Escayg A, Goldin AL. Sodium channel SCN1A and epilepsy: mutations and mechanisms. Epilepsia 51(9), 1650–1658 (2010).
  • Loughlin AM, Marchant CD, Adams W et al. Causality assessment of adverse events reported to the vaccine adverse event reporting system (VAERS). Vaccine 30(50), 7253–7259 (2012).
  • Collet JP, MacDonald N, Cashman N, Pless R. Monitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Advisory committee on causality assessment. Bull. World Health Organ. 78(2), 178–185 (2000).
  • WHO. Definition and application of terms for vaccine pharmacovigilance. Report of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance. Geneva, Switzerland (2012).
  • Tozzi AE, Asturias EJ, Balakrishnan MR, Halsey NA, Law B, Zuber PLF. Assessment of causality of individual adverse events following immunization (AEFI): a WHO tool for global use. Vaccine 31(44), 5041–5046 (2013).

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