Information systems for vaccine safety surveillance

References

• Buttery JP. Developing standard safety outcomes for COVID-19 vaccines. Vaccine. 2021;39(22):1–7. doi:10.1016/j.vaccine.2021.03.004.
   PubMed Web of Science ®Google Scholar
• Danchin M, Buttery J. COVID-19 vaccine hesitancy: a unique set of challenges. Intern Med J. 2021;51(12):1987–1989. doi:10.1111/imj.15599.
   PubMed Web of Science ®Google Scholar
• Kurth R. [Infectious diseases: how big is the real danger? Interview by Strehlow Karen. Dtsch Med Wochenschr. 2005;Suppl 1:64–65.
   PubMedGoogle Scholar
• Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic Thrombocytopenia after ChAdox1 nCov-19 vaccination. N Engl J Med. 2021;384(22):2092–2101. doi:10.1056/NEJMoa2104840.
   PubMed Web of Science ®Google Scholar
• Schultz NH, Sorvoll IH, Michelsen AE, Munthe LA, Lund-Johansen F, Ahlen MT, Wiedmann M, Aamodt A-H, Skattør TH, Tjønnfjord GE, et al. Thrombosis and Thrombocytopenia after ChAdox1 nCov-19 vaccination. N Engl J Med. 2021;384(22):2124–2130. doi:10.1056/NEJMoa2104882.
   PubMed Web of Science ®Google Scholar
• Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, et al. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med 2021 N Engl J Med; 385:2140–49. doi: 10.1056/NEJMoa2109730.
   Google Scholar
• Montgomery J, Ryan M, Engler R, Hoffman D, McClenathan B, Collins L, Loran D, Hrncir D, Herring K, Platzer M, et al. Myocarditis following immunization with mRNA COVID-19 vaccines in members of the US Military. JAMA Cardiol. 2021;6(10):1202–1206. doi:10.1001/jamacardio.2021.2833.
   PubMed Web of Science ®Google Scholar
• Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernán MA, Lipsitch M, Kohane I, Netzer D, et al. Safety of the BNT162b2 mRNA Covid-19 vaccine in a nationwide setting. N Engl J Med. 2021;385(12):1078–1090. doi:10.1056/NEJMoa2110475.
   PubMed Web of Science ®Google Scholar
• Greinacher A, Selleng K, Palankar R, Wesche J, Handtke S, Wolff M, Aurich K, Lalk M, Methling K, Völker U, et al. Insights in ChAdox1 nCov-19 vaccine-induced immune thrombotic thrombocytopenia. Blood. 2021;138(22):2256–2268. doi:10.1182/blood.2021013231.
   PubMed Web of Science ®Google Scholar
• Witberg G, Barda N, Hoss S, Richter I, Wiessman M, Aviv Y, Grinberg T, Auster O, Dagan N, Balicer RD, et al. Myocarditis after Covid-19 vaccination in a large health care organization. N Engl J Med. 2021;385(23):2132–2139. doi:10.1056/NEJMoa2110737.
   PubMed Web of Science ®Google Scholar
• Patone M, Handunnetthi L, Saatci D, Pan J, Katikireddi SV, Razvi S, Hunt D, Mei XW, Dixon S, Zaccardi F, et al. Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection. Nat Med. 2021;27(12):2144–2153. doi:10.1038/s41591-021-01556-7.
   PubMed Web of Science ®Google Scholar
• Lambert PH, Ambrosino DM, Andersen SR, Baric RS, Black SB, Chen RT, Dekker CL, Didierlaurent AM, Graham BS, Martin SD, et al. Consensus summary report for CEPI/BC March 12–13, 2020 meeting: assessment of risk of disease enhancement with COVID-19 vaccines. Vaccine. 2020;38(31):4783–4791. doi:10.1016/j.vaccine.2020.05.064.
   PubMed Web of Science ®Google Scholar
• Black S, Eskola J, Siegrist CA, Halsey N, MacDonald N, Law B, Miller E, Andrews N, Stowe J, Salmon D, et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet. 2009;374(9707):2115–2122. doi:10.1016/S0140-6736(09)61877-8.
   PubMed Web of Science ®Google Scholar
• VIII CIOMS Working Group. Practical aspects of signal detection in pharmacovigilance. Geneva: The Council For International Organizations Of Medical Sciences; 2010.
   Google Scholar
• Berry JG, Gold MS, Ryan P, Duszynski KM, Braunack-Mayer AJ. Vaccine assessment using Linked Data Working G. Public perspectives on consent for the linkage of data to evaluate vaccine safety. Vaccine. 2012;30(28):4167–4174. doi:10.1016/j.vaccine.2012.04.056.
   PubMed Web of Science ®Google Scholar
• World HealthOrganization. Safety of medicines : a guide to detecting and reporting adverse drug reactions : why health professionals need to take action. Report No.: WHO/EDM/QSM/2002.2; Geneva; 2002.
   Google Scholar
• Armstrong PK, Dowse GK, Effler PV, Carcione D, Blyth CC, Richmond PC, Geelhoed GC, Mascaro F, Scully M, Weeramanthri TS, et al. Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine. BMJ Open. 2011;1(1):e000016. doi:10.1136/bmjopen-2010-000016.
   PubMed Web of Science ®Google Scholar
• Gold MS, Effler P, Kelly H, Richmond PC, Buttery JP. Febrile convulsions after 2010 seasonal trivalent influenza vaccine: implications for vaccine safety surveillance in Australia. Med J Aust. 2010;193(9):492–493. doi:10.5694/j.1326-5377.2010.tb04029.x.
   PubMed Web of Science ®Google Scholar
• Wouters OJ, Shadlen KC, Salcher-Konrad M, Pollard AJ, Larson HJ, Teerawattananon Y, Jit M. Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment. Lancet. 2021;397(10278):1023–1034. doi:10.1016/S0140-6736(21)00306-8.
   PubMed Web of Science ®Google Scholar
• ABCFC. As younger children become eligible for the vaccine, anti-vaxxers spread false information about deaths. ABC News: ABC; 2022 [ accessed 2022 Jan 28].
   Google Scholar
• Cassidy C ‘Utter fear’: Gold Coast GP receives death threats from ‘anti-vaxxers’ after false claim of child vaccine deaths. The Guardian. 2022 [accessed 2022 Feb 1].
   Google Scholar
• Sharfstein JM, Callaghan T, Carpiano RM, Sgaier SK, Brewer NT, Galvani AP, Lakshmanan R, McFadden SM, Reiss DR, Salmon DA, et al. Uncoupling vaccination from politics: a call to action. Lancet. 2021;398(10307):1211–1212. doi:10.1016/S0140-6736(21)02099-7.
   PubMed Web of Science ®Google Scholar
• Germani F, Biller-Andorno N, Lavorgna L. The anti-vaccination infodemic on social media: a behavioral analysis. PLoS One. 2021;16(3):e0247642. doi:10.1371/journal.pone.0247642.
   PubMed Web of Science ®Google Scholar
• Sharfstein JM, Goodman JL, Borio L. The US regulatory system and COVID-19 vaccines: the importance of a strong and capable FDA. Jama. 2021;325(12):1153–1154. doi:10.1001/jama.2021.1961.
   PubMed Web of Science ®Google Scholar
• Skirrow H, Barnett S, Bell S, Riaposova L, Mounier-Jack S, Kampmann B, Holder B. Women’s views on accepting COVID-19 vaccination during and after pregnancy, and for their babies: a multi-methods study in the UK. BMC Pregnancy Childbirth. 2022;22(1):33. doi:10.1186/s12884-021-04321-3.
   PubMed Web of Science ®Google Scholar
• Clothier HJ, Crawford NW, Russell M, Kelly H, Buttery JP. Evaluation of ‘SAEFVIC’, a pharmacovigilance surveillance scheme for the spontaneous reporting of adverse events following immunisation in Victoria, Australia. Drug Saf. 2017;40(6):483–495. doi:10.1007/s40264-017-0520-7.
   PubMed Web of Science ®Google Scholar
• Gidudu JF, Shaum A, Dodoo A, Bosomprah S, Bonsu G, Amponsa-Achiano K, Darko DM, Sabblah G, Opare J, Nyaku M, et al. Barriers to healthcare workers reporting adverse events following immunization in four regions of Ghana. Vaccine. 2020;38(5):1009–1014. doi:10.1016/j.vaccine.2019.11.050.
   PubMed Web of Science ®Google Scholar
• Clothier HJ, Selvaraj G, Easton ML, Lewis G, Crawford NW, Buttery JP. Consumer reporting of adverse events following immunization. Hum Vaccin Immunother. 2014;10(12):3726–3730. doi:10.4161/hv.34369.
   PubMed Web of Science ®Google Scholar
• Arana JE, Harrington T, Cano M, Lewis P, Mba-Jonas A, Rongxia L, Stewart B, Markowitz LE, Shimabukuro TT. Post-Licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009–2015. Vaccine. 2018;36(13):1781–1788. doi:10.1016/j.vaccine.2018.02.034.
   PubMed Web of Science ®Google Scholar
• Siegrist CA, Lewis EM, Eskola J, Evans SJ, 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. 2007;26(11):979–984. doi:10.1097/INF.0b013e318149dfea.
   PubMed Web of Science ®Google Scholar
• Mesfin YM, Cheng A, Lawrie J, Buttery J. Use of routinely collected electronic healthcare data for postlicensure vaccine safety signal detection: a systematic review. BMJ Glob Health. 2019;4(4):e001065. doi:10.1136/bmjgh-2018-001065.
   PubMed Web of Science ®Google Scholar
• Crawford NW, Clothier H, Hodgson K, Selvaraj G, Easton ML, Buttery JP. Active surveillance for adverse events following immunization. Expert Rev Vaccines. 2014;13(2):265–276. doi:10.1586/14760584.2014.866895.
   PubMed Web of Science ®Google Scholar
• Costa MA, Huang SS, Moore M, Kulldorff M, Finkelstein JA. New approaches to estimating national rates of invasive pneumococcal disease. Am J Epidemiol. 2011;174(2):234–242. doi:10.1093/aje/kwr058.
   PubMed Web of Science ®Google Scholar
• Van Holle L, Zeinoun Z, Bauchau V, Verstraeten T. Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study. Pharmacoepidemiol Drug Saf. 2012;21(6):603–610. doi:10.1002/pds.3226.
   PubMed Web of Science ®Google Scholar
• Lo Re V 3rd, Klungel OH, Chan KA, Panozzo CA, Zhou W, Winterstein AG. Global covid-19 vaccine rollout and safety surveillance-how to keep pace. Bmj. 2021;373:n1416.
   PubMedGoogle Scholar
• Deeks SL, Clark M, Scheifele DW, Law BJ, Dawar M, Ahmadipour N, Walop W, Ellis CE, King A. Serious adverse events associated with Bacille Calmette-Guérin vaccine in Canada. Pediatr Infect Dis J. 2005;24(6):538–541. doi:10.1097/01.inf.0000164769.22033.2c.
   PubMed Web of Science ®Google Scholar
• Glover C, Crawford N, Leeb A, Wood N, Macartney K. Active SMS-based surveillance of adverse events following immunisation with influenza and pertussis-containing vaccines in Australian pregnant women using AusVaxsafety. Vaccine. 2020;38(31):4892–4900. doi:10.1016/j.vaccine.2020.04.056.
   PubMed Web of Science ®Google Scholar
• Chapin-Bardales J, Myers T, Gee J, Shay DK, Marquez P, Baggs J, Zhang B, Licata C, Shimabukuro TT. Reactogenicity within 2 weeks after mRNA COVID-19 vaccines: findings from the CDC v-safe surveillance system. Vaccine. 2021;39(48):7066–7073. doi:10.1016/j.vaccine.2021.10.019.
   PubMed Web of Science ®Google Scholar
• Cashman P, Macartney K, Khandaker G, King C, Gold M, Durrheim DN. Participant-Centred active surveillance of adverse events following immunisation: a narrative review. Int Health. 2017;9(3):164–176. doi:10.1093/inthealth/ihx019.
   PubMed Web of Science ®Google Scholar
• Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, et al. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. N Engl J Med. 2021;384(24):2273–2282. doi:10.1056/NEJMoa2104983.
   PubMed Web of Science ®Google Scholar
• Pillsbury AJ, Fathima P, Quinn HE, Cashman P, Blyth CC, Leeb A, Macartney KK. Comparative postmarket safety profile of adjuvanted and high-dose influenza vaccines in individuals 65 years or older. JAMA Netw Open. 2020;3(5):e204079. doi:10.1001/jamanetworkopen.2020.4079.
   PubMed Web of Science ®Google Scholar
• Pillsbury A, Quinn H, Cashman P, Leeb A, Macartney K. AusVaxsafety c. Active SMS-based influenza vaccine safety surveillance in Australian children. Vaccine. 2017;35(51):7101–7106. doi:10.1016/j.vaccine.2017.10.091.
   PubMed Web of Science ®Google Scholar
• Carneiro HA, Mylonakis E. Google trends: a web-based tool for real-time surveillance of disease outbreaks. Clin Infect Dis. 2009;49(10):1557–1564. doi:10.1086/630200.
   PubMed Web of Science ®Google Scholar
• Mesfin YM, Cheng AC, Enticott J, Lawrie J, Buttery J. Post-Vaccination healthcare attendance rate as a proxy measure for syndromic surveillance of adverse events following immunisation. Aust N Z J Public Health. 2021;45(2):101–107. doi:10.1111/1753-6405.13052.
   PubMed Web of Science ®Google Scholar
• Mesfin YM, Cheng AC, Enticott J, Lawrie J, Buttery JP. Use of telephone helpline data for syndromic surveillance of adverse events following immunization in Australia: a retrospective study, 2009 to 2017. Vaccine. 2020;38(34):5525–5531. doi:10.1016/j.vaccine.2020.05.078.
   PubMed Web of Science ®Google Scholar
• Wang J, Zhao L, Ye Y, Zhang Y. Adverse event detection by integrating twitter data and VAERS. J Biomed Semantics. 2018;9(1):19. doi:10.1186/s13326-018-0184-y.
   PubMedGoogle Scholar
• Habibabadi SKH, Haghighi PD Topic modelling for identification of vaccine reactions in Twitter. In: ACSW, editor. ACSW 2019: Australasian Computer Science Week Multiconference; 2019 January 29; Sydney: Association for Computing Machinery; 2019. p. 1–10.
   Google Scholar
• Khademi Habibabadi S, Haghighi PD, Burstein F, Buttery J. Vaccine adverse event mining of Twitter conversations: 2-phase classification study. JMIR Medical Informatics. 2022 ;10(6):e34305. doi:10.2196/34305.
   PubMed Web of Science ®Google Scholar
• Suppli CH, Hansen ND, Rasmussen M, Valentiner-Branth P, Krause TG, Molbak K. Decline in HPV-vaccination uptake in Denmark - the association between HPV-related media coverage and HPV-vaccination. BMC Public Health. 2018;18(1):1360. doi:10.1186/s12889-018-6268-x.
   PubMed Web of Science ®Google Scholar
• Nie X, Xu L, Bai Y, Liu Z, Liu Z, Farrington P, Zhan S. Self-Controlled case series design in vaccine safety: a systematic review. Expert Rev Vaccines. 2022;21(3):313–324. doi:10.1080/14760584.2022.2020108.
   PubMed Web of Science ®Google Scholar
• Martin TJ, Fahey M, Easton M, Clothier HJ, Samuel R, Crawford NW, Buttery JP. Acute disseminated encephalomyelitis and routine childhood vaccinations – a self-controlled case series. Hum Vaccin Immunother. 2021;17(8):2578–2585. doi:10.1080/21645515.2021.1901544.
   PubMed Web of Science ®Google Scholar
• Donahue JG, Kieke BA, King JP, Mascola MA, Shimabukuro TT, DeStefano F, Hanson KE, McClure DL, Olaiya O, Glanz JM, et al. Inactivated influenza vaccine and spontaneous abortion in the Vaccine Safety Datalink in 2012–13, 2013–14, and 2014–15. Vaccine. 2019;37(44):6673–6681. doi:10.1016/j.vaccine.2019.09.035.
   PubMed Web of Science ®Google Scholar
• Dodd CN, Romio SA, Black S, Vellozzi C, Andrews N, Sturkenboom M, Zuber P, Hua W, Bonhoeffer J, Buttery J, et al. International collaboration to assess the risk of Guillain Barré Syndrome following influenza a (H1N1) 2009 monovalent vaccines. Vaccine. 2013;31(40):4448–4458. doi:10.1016/j.vaccine.2013.06.032.
   PubMed Web of Science ®Google Scholar
• Burns EM, Rigby E, Mamidanna R, Bottle A, Aylin P, Ziprin P, Faiz OD. Systematic review of discharge coding accuracy. J Public Health (Oxf). 2012;34(1):138–148. doi:10.1093/pubmed/fdr054.
   PubMed Web of Science ®Google Scholar
• Yu W, Zheng C, Xie F, Chen W, Mercado C, Sy LS, Qian L, Glenn S, Tseng HF, Lee G, et al. The use of natural language processing to identify vaccine-related anaphylaxis at five health care systems in the Vaccine Safety Datalink. Pharmacoepidemiol Drug Saf. 2020;29(2):182–188. doi:10.1002/pds.4919.
   PubMed Web of Science ®Google Scholar
• Hviid A, Hansen JV, Frisch M, Measles MM. Vaccination and autism: a nationwide cohort study. Ann Intern Med. 2019;170(8):513–520. doi:10.7326/M18-2101.
   PubMed Web of Science ®Google Scholar
• Ali M, Canh GD, Clemens JD, Park JK, von Seidlein L, Minh TT, Thiem DV, Tho HL, Trach DD. The use of a computerized database to monitor vaccine safety in Vietnam. Bull World Health Organ. 2005;83:604–610.
   PubMed Web of Science ®Google Scholar
• Asturias EJ, Contreras-Roldan IL, Ram M, Garcia-Melgar AJ, Morales-Oquendo V, Hartman K, et al. Post-Authorization safety surveillance of a liquid pentavalent vaccine in Guatemalan children. Vaccine. 2013;31(49):5909–5914. doi:10.1016/j.vaccine.2013.09.015.
   PubMed Web of Science ®Google Scholar
• Amarasinghe A, Black S, Bonhoeffer J, Carvalho SM, Dodoo A, Eskola J, Larson H, Shin S, Olsson S, Balakrishnan MR, et al. Effective vaccine safety systems in all countries: a challenge for more equitable access to immunization. Vaccine. 2013;31(Suppl 2):B108–14. doi:10.1016/j.vaccine.2012.10.119.
   PubMedGoogle Scholar
• Organization WH. Global vaccine safety blueprint 2.0 (GVSB2.0) 2021-2023. Geneva; 2021.
   Google Scholar
• Gouglas D, Christodoulou M, Plotkin SA, Hatchett R. CEPI: driving progress toward epidemic preparedness and response. Epidemiol Rev. 2019;41(1):28–33. doi:10.1093/epirev/mxz012.
   PubMed Web of Science ®Google Scholar
• Sow SO, Okoko BJ, Diallo A, Viviani S, Borrow R, Carlone G, Tapia M, Akinsola AK, Arduin P, Findlow H, et al. Immunogenicity and safety of a meningococcal a conjugate vaccine in Africans. N Engl J Med. 2011;364(24):2293–2304. doi:10.1056/NEJMoa1003812.
   PubMed Web of Science ®Google Scholar
• Djingarey MH, Diomande FV, Barry R, Kandolo D, Shirehwa F, Lingani C, Novak RT, Tevi-Benissan C, Perea W, Preziosi M-P, et al. Introduction and rollout of a new group a meningococcal conjugate vaccine (PsA-TT) in African Meningitis Belt countries, 2010–2014. Clin Infect Dis. 2015;61(Suppl 5):S434–41. doi:10.1093/cid/civ551.
   PubMedGoogle Scholar