{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T16:43:48Z","timestamp":1764175428814,"version":"3.37.3"},"reference-count":54,"publisher":"Springer Science and Business Media LLC","issue":"7","license":[{"start":{"date-parts":[[2023,5,30]],"date-time":"2023-05-30T00:00:00Z","timestamp":1685404800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2023,5,30]],"date-time":"2023-05-30T00:00:00Z","timestamp":1685404800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Clin Pharmacol"],"published-print":{"date-parts":[[2023,7]]},"DOI":"10.1007\/s00228-023-03505-4","type":"journal-article","created":{"date-parts":[[2023,5,30]],"date-time":"2023-05-30T12:02:08Z","timestamp":1685448128000},"page":"989-1002","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Imprecision in vaccine adverse event reporting and a methodological analysis of reporting systems to improve pharmacovigilance and public health"],"prefix":"10.1007","volume":"79","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1991-7893","authenticated-orcid":false,"given":"Yasuko","family":"Inokuma","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Kneller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,5,30]]},"reference":[{"key":"3505_CR1","doi-asserted-by":"publisher","unstructured":"Noguchi Y, Tachi T, Teramachi H (2021) Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source. Brief Bioinform. 22:bbab347. https:\/\/doi.org\/10.1093\/bib\/bbab347","DOI":"10.1093\/bib\/bbab347"},{"key":"3505_CR2","doi-asserted-by":"publisher","first-page":"261","DOI":"10.1016\/j.therap.2022.03.001","volume":"77","author":"JL Montastruc","year":"2022","unstructured":"Montastruc JL (2022) Pharmacovigilance and drug safety: fair prescribing and clinical research. Therapie 77:261\u2013263. https:\/\/doi.org\/10.1016\/j.therap.2022.03.001","journal-title":"Therapie"},{"key":"3505_CR3","unstructured":"National Institute of Infectious Diseases, Vaccination schedule in Japan, April 1, 2018.\u00a0https:\/\/www.niid.go.jp\/niid\/images\/vaccine\/schedule\/2018\/JP20180401_02.gif. Accessed Mar 2022."},{"key":"3505_CR4","unstructured":"Centers for Disease Control and Prevention, Immunization schedule, February 3 2020.\u00a0https:\/\/www.cdc.gov\/vaccines\/schedules\/index.html. Accessed Mar 2022."},{"key":"3505_CR5","unstructured":"Centers for Disease Control and Prevention, Estimates of influenza vaccination coverage among adults\u2014United States, 2017\u201318 Flu Season.\u00a0https:\/\/www.cdc.gov\/flu\/fluvaxview\/coverage-1718estimates.htm. Accessed Mar 2022"},{"key":"3505_CR6","unstructured":"Kaiser Family Foundation, Population distribution by age, https:\/\/www.kff.org\/other\/state-indicator\/distribution-by-age\/.Accessed Mar 2022."},{"issue":"7","key":"3505_CR7","first-page":"354","volume":"61","author":"H Nobuhara","year":"2014","unstructured":"Nobuhara H et al (2014) Estimation of influenza vaccination coverage ratio in Japan. Japanese J Public Health 61(7):354\u2013359","journal-title":"Japanese Journal of Public Health"},{"key":"3505_CR8","unstructured":"Ministry of Health, Labour and Welfare, Outline of the amendment of the Immunization Act, March 30, 2013.\u00a0http:\/\/www.mhlw.go.jp\/topics\/bcg\/tp250330-2.html."},{"key":"3505_CR9","unstructured":"The Law on Securing Quality, Efficacy and safety of products including pharmaceuticals and medical devices, Act No. 145 of 1960.\u00a0http:\/\/www.japaneselawtranslation.go.jp\/law\/detail\/?ft=1&re=01&dn=1&x=35&y=11&co=01&ia=03&ky=%E5%8C%BB%E8%96%AC%E5%93%81%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8&page=2"},{"key":"3505_CR10","unstructured":"Code of Federal Regulations Title 21--Food and drugs chapter I--Food and Drug Administration, Department of Health and Human Services subchapter F--Biologics part 600 --biological products: general subpart D--reporting of adverse experiences Sec. 600.80 Postmarketing reporting of adverse experiences.\u00a0https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=600.80"},{"key":"3505_CR11","unstructured":"Tobenkin, An introduction to drug safety surveillance and the FDA adverse event reporting system, April 2018.\u00a0https:\/\/www.fda.gov\/files\/about%20fda\/published\/Drug-Safety-Surveillance-and-the-FDA-Adverse-Event-Reporting-System-%28PDF---1.31MB%29.pdf. Accessed Aug 2020"},{"issue":"2","key":"3505_CR12","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1007\/s40290-018-0230-1","volume":"32","author":"Y Inokuma","year":"2018","unstructured":"Inokuma Y, Sato Y, Matsuda S (2018) Adverse event reporting patterns of marketing authorization holders, healthcare professionals and patients in Japan: lessons learnt from the human papilloma virus vaccine. Pharmaceutical Medicine 32(2):123\u2013129","journal-title":"Pharmaceutical Medicine"},{"key":"3505_CR13","unstructured":"Japan Pharmaceutical Manufacturers Association, Protecting patients and its medicines \u2013accumulation and utilization of safety information-, March 2008"},{"key":"3505_CR14","unstructured":"Vaccine Adverse Event Reporting System, Table of reportable events following vaccination, March 2017.\u00a0https:\/\/vaers.hhs.gov\/docs\/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf. Accessed Aug 2020"},{"key":"3505_CR15","unstructured":"National Childhood Vaccine Injury Act of 1986 (42 U.S.C. \u00a7\u00a7 300aa-1 to 300aa-34).\u00a0https:\/\/uscode.house.gov\/view.xhtml?path=\/prelim@title42\/chapter6A\/subchapter19&edition=prelim"},{"key":"3505_CR16","unstructured":"Food and Drug Administration, Guidance for industry postmarketing safety reporting for human drug and biological products including vaccines. March 2001.\u00a0https:\/\/www.fda.gov\/files\/vaccines%2C%20blood%20%26%20biologics\/published\/Draft-Guidance-for-Industry--Postmarketing-Safety-Reporting-for-Human-Drug-and-Biological-Products-Including-Vaccines.pdf. Accessed Aug 2020"},{"key":"3505_CR17","unstructured":"Vaccine Adverse Event Reporting System, VAERS form, February 2020.\u00a0https:\/\/wonder.cdc.gov\/wonder\/help\/vaers\/vaers_form_2.0.pdf. Accessed Aug 2020"},{"key":"3505_CR18","unstructured":"Vaccine Adverse Event Reporting System, Front page of Vaccine Adverse Event Reporting System (VAERS).\u00a0https:\/\/vaers.hhs.gov\/. Accessed Aug 2020"},{"key":"3505_CR19","unstructured":"Ministry of Health, Labour and Welfare, Form to report AEFI, 2018.\u00a0http:\/\/www.mhlw.go.jp\/file\/06-Seisakujouhou-10900000-Kenkoukyoku\/saishin.pdf#search=%27%E5%89%AF%E5%8F%8D%E5%BF%9C+%E6%A7%98%E5%BC%8F%27. Accessed Aug 2020."},{"key":"3505_CR20","unstructured":"Pharmaceuticals and Medical Devices Agency, Pilot and official implementation of patient AE reporting system.\u00a0https:\/\/www.pmda.go.jp\/files\/000228628.pdf. Accessed Mar 2020"},{"key":"3505_CR21","unstructured":"Final report of the committee for investigation of drug-induced hepatitis cases and appropriate regulatory administration to prevent recurrence of drug-induced suffering, April 28, 2010.\u00a0http:\/\/www.mhlw.go.jp\/shingi\/2010\/04\/dl\/s0428-8a.pdf. Accessed Aug 2020"},{"key":"3505_CR22","unstructured":"Ministry of Health, Labour and Welfare, Starting patient adverse reporting system today.\u00a0https:\/\/www.mhlw.go.jp\/stf\/newpage_04169.html. Accessed Aug 2020"},{"key":"3505_CR23","unstructured":"Pharmaceuticals and Medical Devices Agenc, Front page of patient reporting system (PMDA).\u00a0https:\/\/www.pmda.go.jp\/safety\/reports\/patients\/0024.html. Accessed Aug 2020"},{"key":"3505_CR24","unstructured":"Vaccine Adverse Reactions Review Committee meeting material convened on March 23, 2018.\u00a0http:\/\/www.mhlw.go.jp\/file\/05-Shingikai-10601000-Daijinkanboukouseikagakuka-Kouseikagakuka\/0000199232.pdf. Accessed Aug 2020"},{"key":"3505_CR25","unstructured":"Vaccine Adverse Event Reporting System, VAERS fact sheet.\u00a0https:\/\/www.cdc.gov\/vaccinesafety\/00_pdf\/09_207294_VAERS_FactSheet.pdf. Accessed Aug 2020"},{"key":"3505_CR26","unstructured":"Vaccine Adverse Reactions Review Committee.\u00a0https:\/\/www.mhlw.go.jp\/stf\/shingi\/shingi-yakuji_127869.html, Accessed November 2020"},{"key":"3505_CR27","unstructured":"Pharmaceuticals and Medical Devices Agency, Information about adverse events reported to PMDA.\u00a0https:\/\/www.pmda.go.jp\/safety\/reports\/patients\/0002.html. Accessed Nov 2020"},{"key":"3505_CR28","unstructured":"Vaccine Adverse Event Reporting System.\u00a0https:\/\/vaers.hhs.gov\/. Accessed Nov 2020"},{"key":"3505_CR29","doi-asserted-by":"crossref","unstructured":"Gold MS, Gidudu J, Erlewyn-Lajeunesse M, Law B, (2010) Brighton Collaboration Working Group on Anaphylaxis, Can the Brighton Collaboration case definitions be used to improve the quality of adverse event following immunization (AEFI) reporting?: Anaphylaxis as a case study. Vaccine\u00a028(28):4487\u20134498","DOI":"10.1016\/j.vaccine.2010.04.041"},{"key":"3505_CR30","unstructured":"Centers for Disease Control and Prevention, ACIP Committee Members, October 2019.\u00a0https:\/\/www.cdc.gov\/vaccines\/acip\/members\/index.html. Accessed Aug 2020"},{"key":"3505_CR31","unstructured":"Food and Drug Administration, Roster of the Vaccines and Related Biological Products Advisory Committee, April 2020.\u00a0https:\/\/www.fda.gov\/advisory-committees\/vaccines-and-related-biological-products-advisory-committee\/roster-vaccines-and-related-biological-products-advisory-committee. Accessed Aug 2020"},{"key":"3505_CR32","unstructured":"Food and Drug Administration, FDA and CDC update on fluzone influenza vaccine and VAERS reports of febrile seizures in children, January 20, 2011.\u00a0https:\/\/www.fda.gov\/BiologicsBloodVaccines\/SafetyAvailability\/VaccineSafety\/ucm240037.htm. Accessed Aug 2020"},{"key":"3505_CR33","unstructured":"Centers for Disease Control and Prevention, ACIP February 2011 summary meeting minutes.\u00a0https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/downloads\/min-archive\/min-feb11.pdf. Accessed Aug 2020"},{"key":"3505_CR34","unstructured":"Food and Drug Administration, February 25, 2011: Vaccines and Related Biological Products Advisory Committee meeting transcript.\u00a0https:\/\/wayback.archive-it.org\/7993\/20161024004521\/http:\/\/www.fda.gov\/AdvisoryCommittees\/CommitteesMeetingMaterials\/BloodVaccinesandOtherBiologics\/VaccinesandRelatedBiologicalProductsAdvisoryCommittee\/ucm249303.htm. Accessed Aug 2020"},{"key":"3505_CR35","unstructured":"Ministry of Health, Labour and Welfare, Meeting material number 1, Joint meeting of the Vaccine Adverse Reactions Review Committee, 2020. https:\/\/www.mhlw.go.jp\/content\/10601000\/000590703.pdf. Accessed Aug 2020."},{"key":"3505_CR36","unstructured":"Inokuma, Y and Kneller, K. Imprecision in adverse event reports following immunization against HPV in Japan and Covid-19 in the US, UK and Japan \u2013 and the effects of vaccine hesitancy and government policy. In preparation"},{"key":"3505_CR37","unstructured":"Centers for Disease Control and Prevention, Health, United States, 2017.\u00a0https:\/\/www.cdc.gov\/nchs\/data\/hus\/hus17.pdf. Accessed Aug 2020"},{"key":"3505_CR38","unstructured":"United States Census Bureau, 2014 national population projections datasets.\u00a0https:\/\/www.census.gov\/programs-surveys\/popproj\/data\/datasets.html. Accessed Aug 2020"},{"key":"3505_CR39","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Clinical safety data management: definitions and standards for expedited reporting E2A. (1994)"},{"key":"3505_CR40","doi-asserted-by":"crossref","unstructured":"Shimabukuro TT et al (2015) Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine\u00a033(36):4398\u20134405","DOI":"10.1016\/j.vaccine.2015.07.035"},{"key":"3505_CR41","doi-asserted-by":"publisher","first-page":"295","DOI":"10.1016\/j.ebiom.2016.08.042.AccessedMarch2022","volume":"12","author":"HJ Larson","year":"2016","unstructured":"Larson HJ, de Figueiredo A, Zhao XH et al (2016) The state of vaccine confidence 2016: global insights through a 67-country survey. EBioMedicine 12:295\u2013301.\u00a0https:\/\/doi.org\/10.1016\/j.ebiom.2016.08.042. Accessed Mar 2022","journal-title":"EBioMedicine"},{"issue":"7076","key":"3505_CR42","doi-asserted-by":"publisher","first-page":"524","DOI":"10.1038\/439524a","volume":"439","author":"A Abbott","year":"2006","unstructured":"Abbott A (2006) Lyme disease: uphill struggle. Nature 439(7076):524\u2013525","journal-title":"Nature"},{"issue":"6","key":"3505_CR43","first-page":"360","volume":"40","author":"H Nakajima","year":"2014","unstructured":"Nakajima H et al (2014) Healthcare professionals\u2019 awareness of adverse effects on eyes caused by anticancer drugs. Iryoyakugaku 40(6):360\u2013368","journal-title":"Iryoyakugaku"},{"key":"3505_CR44","unstructured":"Japanese Society of Allergology, definition of anaphylaxis.\u00a0https:\/\/www.jsaweb.jp\/modules\/stwn\/index.php?content_id=7. Accessed Mar 2021"},{"key":"3505_CR45","doi-asserted-by":"crossref","unstructured":"Turner PJ, Worm M, Ansotegui IJ et al (2019) Time to revisit the definition and clinical criteria for anaphylaxis? World Allergy Organ J 12(10)","DOI":"10.1016\/j.waojou.2019.100066"},{"key":"3505_CR46","unstructured":"Center for Disease Control, Guillain-Barr\u00e9 syndrome and vaccine, August 14 2020.\u00a0https:\/\/www.cdc.gov\/vaccinesafety\/concerns\/guillain-barre-syndrome.html#. Accessed Nov 2020"},{"key":"3505_CR47","unstructured":"Center for Disease Control, Estimates of flu vaccination coverage among children \u2014 United States, 2017\u201318 Flu Season, September 2018.\u00a0https:\/\/www.cdc.gov\/flu\/fluvaxview\/coverage-1718estimates-children.htm. Accessed Mar 2021"},{"issue":"5","key":"3505_CR48","doi-asserted-by":"publisher","first-page":"624","DOI":"10.1016\/j.vaccine.2017.12.058","volume":"36","author":"S Tsuzuki","year":"2018","unstructured":"Tsuzuki S, Schwehm M, Eichner M (2018) Simulation studies to assess the long-term effects of Japan\u2019s change from trivalent to quadrivalent influenza vaccination. Vaccine 36(5):624\u2013630","journal-title":"Vaccine"},{"issue":"3","key":"3505_CR49","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1111\/j.1440-1819.1995.tb02223.x","volume":"49","author":"M Kusumi","year":"1995","unstructured":"Kusumi M et al (1995) Epidemiology of inflammatory neurological and inflammatory neuromuscular diseases in Tottori Prefecture. Japan Psychiatry and clinical neurosciences 49(3):169\u2013174","journal-title":"Japan Psychiatry and clinical neurosciences"},{"key":"3505_CR50","unstructured":"Health Action International, Direct patient reporting in the European Union: a snapshot of reporting systems in seven member states (2015).\u00a0https:\/\/haiweb.org\/wp-content\/uploads\/2015\/09\/Direct-Patient-Reporting-in-the-EU.pdf. Accessed Aug 2020"},{"issue":"2","key":"3505_CR51","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1007\/s002280050611","volume":"55","author":"PMLA Van den Bemt","year":"1999","unstructured":"Van den Bemt PMLA et al (1999) Adverse drug events in hospitalized patients: a comparison of doctors, nurses and patients as sources of reports. Eur J Clin Pharmacol 55(2):155\u2013158","journal-title":"Eur J Clin Pharmacol"},{"key":"3505_CR52","first-page":"152","volume":"50","author":"L G\u00e4wert","year":"2010","unstructured":"G\u00e4wert L, Hierse F, Zink A, Strangfeld A (2010) How well do patient reports reflect adverse drug reactions reported by rheumatologists? Agreement of physician-and patient-reported adverse events in patients with rheumatoid arthritis observed in the German biologics register. Rheumatology 50:152\u2013160","journal-title":"Agreement of physician-and patient-reported adverse events in patients with rheumatoid arthritis observed in the German biologics register, Rheumatology"},{"key":"3505_CR53","doi-asserted-by":"crossref","unstructured":"Egberts TCG et al (1996) Can adverse drug reactions be detected earlier? A comparison of reports by patients and professionals. BMJ, 1996 313(7056):530\u2013531","DOI":"10.1136\/bmj.313.7056.530"},{"key":"3505_CR54","doi-asserted-by":"crossref","unstructured":"Sekine M et al (2020) Japan\u2019s ongoing crisis on HPV vaccination. Vaccines\u00a08(3):362","DOI":"10.3390\/vaccines8030362"}],"container-title":["European Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00228-023-03505-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00228-023-03505-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00228-023-03505-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,6,17]],"date-time":"2023-06-17T07:02:45Z","timestamp":1686985365000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00228-023-03505-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,5,30]]},"references-count":54,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2023,7]]}},"alternative-id":["3505"],"URL":"https:\/\/doi.org\/10.1007\/s00228-023-03505-4","relation":{},"ISSN":["0031-6970","1432-1041"],"issn-type":[{"type":"print","value":"0031-6970"},{"type":"electronic","value":"1432-1041"}],"subject":[],"published":{"date-parts":[[2023,5,30]]},"assertion":[{"value":"17 June 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 April 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 May 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate and for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}