{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T00:59:55Z","timestamp":1793408395135,"version":"4.5.0"},"reference-count":29,"publisher":"Elsevier BV","issue":"11","license":[{"start":{"date-parts":[[2019,3,1]],"date-time":"2019-03-01T00:00:00Z","timestamp":1551398400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2019,3,1]],"date-time":"2019-03-01T00:00:00Z","timestamp":1551398400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Vaccine"],"published-print":{"date-parts":[[2019,3]]},"DOI":"10.1016\/j.vaccine.2019.01.052","type":"journal-article","created":{"date-parts":[[2019,2,9]],"date-time":"2019-02-09T22:45:34Z","timestamp":1549752334000},"page":"1516-1520","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":19,"title":["Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016\u2013June 2018"],"prefix":"10.1016","volume":"37","author":[{"given":"Penina","family":"Haber","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro L.","family":"Moro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmen","family":"Ng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3985-2935","authenticated-orcid":false,"given":"Gra\u00e7a M.","family":"Dores","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paige","family":"Lewis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Cano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.vaccine.2019.01.052_b0005","unstructured":"FLUAD\u00ae - Seqirus Inc. US package insert; March 2017. <https:\/\/www.fda.gov\/downloads\/BiologicsBloodVaccines\/SafetyAvailability\/VaccineSafety\/UCM474387.pdf>."},{"key":"10.1016\/j.vaccine.2019.01.052_b0010","unstructured":"Advisory Committee on Immunization Practices (ACIP) Summary Report. October 15; 2015. <https:\/\/www.cdc.gov\/vaccines\/acip\/meetings\/downloads\/min-archive\/min-2015-10.pdf>."},{"key":"10.1016\/j.vaccine.2019.01.052_b0015","doi-asserted-by":"crossref","first-page":"2673","DOI":"10.1016\/S0264-410X(00)00499-0","article-title":"The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine","volume":"19","author":"Podda","year":"2001","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2019.01.052_b0020","doi-asserted-by":"crossref","first-page":"5027","DOI":"10.1016\/j.vaccine.2014.07.013","article-title":"Comparison of the safety and immunogenicity of an MF59\u00ae-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects","volume":"32","author":"Frey","year":"2014","journal-title":"Vaccine"},{"issue":"Suppl. 2","key":"10.1016\/j.vaccine.2019.01.052_b0025","doi-asserted-by":"crossref","first-page":"B3","DOI":"10.1016\/j.vaccine.2014.11.062","article-title":"Safety and effectiveness of MF-59 adjuvanted influenza vaccines in children and adults","volume":"33","author":"Black","year":"2015","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2019.01.052_b0030","doi-asserted-by":"crossref","first-page":"1139","DOI":"10.1093\/aje\/kwt078","article-title":"Safety of MF59-adjuvanted influenza vaccination in the elderly: results of a comparative study of MF59-adjuvanted vaccine versus nonadjuvanted influenza vaccine in northern Italy","volume":"178","author":"Villa","year":"2013","journal-title":"Am J Epidemiol"},{"issue":"15","key":"10.1016\/j.vaccine.2019.01.052_b0035","doi-asserted-by":"crossref","first-page":"1406","DOI":"10.1056\/NEJMoa1010331","article-title":"Oil-in-water emulsion adjuvant with influenza vaccine in young children","volume":"365","author":"Timo","year":"2011","journal-title":"N Engl J med"},{"key":"10.1016\/j.vaccine.2019.01.052_b0040","doi-asserted-by":"crossref","first-page":"6959","DOI":"10.1016\/j.vaccine.2009.08.101","article-title":"MF59-adjuvanted versus non-adjuvanted influenza vaccines: integrated analysis from large safety database","volume":"27","author":"Pellegrini","year":"2009","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2019.01.052_b0045","unstructured":"Prevention and control of seasonal influenza with vaccines: recommendations of the advisory committee on immunization practices (ACIP)\u2014United States; 2017\u201318. <https:\/\/www.cdc.gov\/flu\/professionals\/acip\/2017-18summary.htm>."},{"key":"10.1016\/j.vaccine.2019.01.052_b0050","doi-asserted-by":"crossref","first-page":"4398","DOI":"10.1016\/j.vaccine.2015.07.035","article-title":"Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)","volume":"33","author":"Shimabukuro","year":"2015","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2019.01.052_b0055","first-page":"1","article-title":"Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS) \u2013 United States, 1991\u20132001","volume":"52","author":"Zhou","year":"2003","journal-title":"MMWR Surveill Summ"},{"key":"10.1016\/j.vaccine.2019.01.052_b0060","unstructured":"Food and Drug Administration. 21CFR Part 600.80. Postmarketing reporting of adverse experiences. Federal Register 1997;62:52252\u201353."},{"key":"10.1016\/j.vaccine.2019.01.052_b0065","unstructured":"Medical Dictionary for Regulatory Activities. International conference on harmonization of technical requirements for pharmaceuticals for human. <http:\/\/www.meddramsso.com> [accessed September 11, 2013]."},{"key":"10.1016\/j.vaccine.2019.01.052_b0070","doi-asserted-by":"crossref","first-page":"980","DOI":"10.1093\/cid\/civ423","article-title":"Death reported to the Vaccine Adverse event reporting System, United States, 1997\u20132013","volume":"61","author":"Moro","year":"2015","journal-title":"Clin Infect Dis"},{"key":"10.1016\/j.vaccine.2019.01.052_b0075","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1080\/00031305.1999.10474456","article-title":"Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system","volume":"53","author":"DuMouchel","year":"1999","journal-title":"Am Stat"},{"key":"10.1016\/j.vaccine.2019.01.052_b0080","doi-asserted-by":"crossref","first-page":"381","DOI":"10.2165\/00002018-200225060-00001","article-title":"Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA\u2019s Spontaneous Reports Database","volume":"25","author":"Szarfman","year":"2002","journal-title":"Drug Saf"},{"issue":"1","key":"10.1016\/j.vaccine.2019.01.052_b0085","doi-asserted-by":"crossref","first-page":"e20174171","DOI":"10.1542\/peds.2017-4171","article-title":"Safety surveillance of diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccines","volume":"142","author":"Moro","year":"2018","journal-title":"Pediatrics"},{"key":"10.1016\/j.vaccine.2019.01.052_b0090","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1016\/j.vaccine.2010.06.003","article-title":"Guillain-Barr\u00e9 syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data","volume":"29","author":"Sejvar","year":"2011","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2019.01.052_b0095","doi-asserted-by":"crossref","first-page":"5675","DOI":"10.1016\/j.vaccine.2007.02.064","article-title":"Anaphylaxis: case definition and guidelines for data collection, analysis, and presentation of immunization safety data","volume":"25","author":"Ruggeberg","year":"2007","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2019.01.052_b0100","series-title":"Immunization safety review: influenza vaccines and neurological complications","year":"2004"},{"key":"10.1016\/j.vaccine.2019.01.052_b0105","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1093\/oxfordjournals.aje.a112795","article-title":"Guillain-Barre syndrome following vaccination in the National Influenza Immunization Program, United States, 1976\u20131977","volume":"110","author":"Schonberger","year":"1979","journal-title":"Am J Epidemiol"},{"issue":"26","key":"10.1016\/j.vaccine.2019.01.052_b0110","doi-asserted-by":"crossref","first-page":"1557","DOI":"10.1056\/NEJM198106253042601","article-title":"Guillain-Barre syndrome and the 1978\u20131979 influenza vaccine","volume":"304","author":"Hurwitz","year":"1981","journal-title":"N Engl J Med"},{"issue":"6","key":"10.1016\/j.vaccine.2019.01.052_b0115","doi-asserted-by":"crossref","first-page":"962","DOI":"10.1093\/aje\/kwt051","article-title":"Chart-confirmed Guillain-Barre syndrome after 2009 H1N1 influenza vaccination among the Medicare population, 2009\u20132010","volume":"178","author":"Polakowski","year":"2013","journal-title":"Am J Epidemiol"},{"key":"10.1016\/j.vaccine.2019.01.052_b0120","series-title":"1. Adverse effects of vaccines: evidence and causality","author":"IOM (Institute of Medicine)","year":"2012"},{"issue":"31","key":"10.1016\/j.vaccine.2019.01.052_b0125","doi-asserted-by":"crossref","first-page":"3773","DOI":"10.1016\/j.vaccine.2015.05.013","article-title":"Guillain-Barre syndrome and influenza vaccines: a meta-analysis","volume":"33","author":"Martin Arias","year":"2015","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2019.01.052_b0130","doi-asserted-by":"crossref","first-page":"7248","DOI":"10.1016\/j.vaccine.2010.09.021","article-title":"Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009\u2013January 31, 2010","volume":"28","author":"Vellozzi","year":"2010","journal-title":"Vaccine"},{"key":"10.1016\/j.vaccine.2019.01.052_b0135","first-page":"1","article-title":"Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs","volume":"vol. 6","author":"Weber","year":"1984"},{"key":"10.1016\/j.vaccine.2019.01.052_b0140","series-title":"Preventing medication errors: quality chasm series. Committee on identifying and preventing medication errors","author":"IOM (Institute of Medicine)","year":"2007"},{"key":"10.1016\/j.vaccine.2019.01.052_b0145","doi-asserted-by":"crossref","first-page":"3171","DOI":"10.1016\/j.vaccine.2015.05.006","article-title":"Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000\u20132013","volume":"33","author":"Hibbs","year":"2015","journal-title":"Vaccine"}],"container-title":["Vaccine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0264410X19301288?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0264410X19301288?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T10:31:54Z","timestamp":1759401114000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0264410X19301288"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,3]]},"references-count":29,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2019,3]]}},"alternative-id":["S0264410X19301288"],"URL":"https:\/\/doi.org\/10.1016\/j.vaccine.2019.01.052","relation":{},"ISSN":["0264-410X"],"issn-type":[{"value":"0264-410X","type":"print"}],"subject":[],"published":{"date-parts":[[2019,3]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Post-licensure surveillance of trivalent adjuvanted influenza vaccine (aIIV3; Fluad), Vaccine Adverse Event Reporting System (VAERS), United States, July 2016\u2013June 2018","name":"articletitle","label":"Article Title"},{"value":"Vaccine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.vaccine.2019.01.052","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2019 Elsevier Ltd. All rights reserved.","name":"copyright","label":"Copyright"}]}}