{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:12:49Z","timestamp":1787008369838,"version":"build-2736575974"},"reference-count":44,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2022,2,13]],"date-time":"2022-02-13T00:00:00Z","timestamp":1644710400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,3,24]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The recombinant herpes zoster vaccine (RZV), approved as a 2-dose series in the United States in October 2017, has proven highly effective and generally safe. However, a small risk of Guillain-Barr\u00e9 syndrome after vaccination was identified after approval, and questions remain about other possible adverse events. This data-mining study assessed RZV safety in the United States using the self-controlled tree-temporal scan statistic, scanning data on thousands of diagnoses recorded during follow-up to detect any statistically unusual temporal clustering of cases within a large hierarchy of diagnoses. IBM MarketScan data on commercially insured persons at least 50 years of age receiving RZV between January 1, 2018, and May 5, 2020, were used, including 56 days of follow-up; 1,014,329 doses were included. Statistically significant clustering was found within a few days of vaccination for unspecified adverse effects, complications, or reactions to immunization or other medical substances\/care; fever; unspecified allergy; syncope\/collapse; cellulitis; myalgia; and dizziness\/giddiness. These findings are consistent with the known safety profile of this and other injected vaccines. No cluster of Guillain-Barr\u00e9 syndrome was detected, possibly due to insufficient sample size. This signal-detection method has now been applied to 5 vaccines, with consistently plausible results, and seems a promising addition to vaccine-safety evaluation methods.<\/jats:p>","DOI":"10.1093\/aje\/kwac030","type":"journal-article","created":{"date-parts":[[2022,2,9]],"date-time":"2022-02-09T15:12:31Z","timestamp":1644419551000},"page":"957-964","source":"Crossref","is-referenced-by-count":21,"title":["A Broad Safety Assessment of the Recombinant Herpes Zoster Vaccine"],"prefix":"10.1093","volume":"191","author":[{"given":"W Katherine","family":"Yih","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Kulldorff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inna","family":"Dashevsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith C","family":"Maro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,3,12]]},"reference":[{"issue":"3","key":"2022050522343565100_ref1","doi-asserted-by":"crossref","first-page":"539","DOI":"10.1016\/j.cger.2016.02.011","article-title":"Herpes zoster","volume":"32","author":"Schmader","year":"2016","journal-title":"Clin Geriatr Med."},{"issue":"10","key":"2022050522343565100_ref2","doi-asserted-by":"crossref","first-page":"928","DOI":"10.1212\/WNL.0b013e3182a3516e","article-title":"The global epidemiology of herpes zoster","volume":"81","author":"Yawn","year":"2013","journal-title":"Neurology."},{"key":"2022050522343565100_ref3","author":"Centers for Disease Control and Prevention"},{"key":"2022050522343565100_ref4","author":"Shingrix"},{"issue":"22","key":"2022050522343565100_ref5","doi-asserted-by":"crossref","first-page":"2087","DOI":"10.1056\/NEJMoa1501184","article-title":"Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults","volume":"372","author":"Lal","year":"2015","journal-title":"N Engl J Med."},{"issue":"6","key":"2022050522343565100_ref6","doi-asserted-by":"crossref","first-page":"941","DOI":"10.1093\/cid\/ciab125","article-title":"Recombinant zoster vaccine (Shingrix): real-world effectiveness in the first 2 years post-licensure","volume":"73","author":"Izurieta","year":"2021","journal-title":"Clin Infect Dis."},{"key":"2022050522343565100_ref7","author":"Zostavax"},{"issue":"3","key":"2022050522343565100_ref8","doi-asserted-by":"crossref","first-page":"1","DOI":"10.15585\/mmwr.ss7003a1","article-title":"Surveillance of vaccination coverage among adult populations\u2014United States, 2018","volume":"70","author":"Lu","year":"2021","journal-title":"MMWR Surveill Summ."},{"key":"2022050522343565100_ref9","volume-title":"Presented at the Advisory Committee on Immunization Practices Meeting (online)","author":"Lee","year":"2021"},{"issue":"4","key":"2022050522343565100_ref10","doi-asserted-by":"crossref","first-page":"91","DOI":"10.15585\/mmwr.mm6804a4","article-title":"Postlicensure safety surveillance of recombinant zoster vaccine (Shingrix)\u2014United States, October 2017\u2013June 2018","volume":"68","author":"Hesse","year":"2019","journal-title":"MMWR Morb Mortal Wkly Rep."},{"issue":"18","key":"2022050522343565100_ref11","doi-asserted-by":"crossref","first-page":"3489","DOI":"10.1016\/j.vaccine.2019.11.058","article-title":"Review of the initial post-marketing safety surveillance for the recombinant zoster vaccine","volume":"38","author":"Tavares-da-Silva","year":"2020","journal-title":"Vaccine."},{"issue":"12","key":"2022050522343565100_ref12","doi-asserted-by":"crossref","first-page":"1623","DOI":"10.1001\/jamainternmed.2021.6227","article-title":"Risk of Guillain-Barr\u00e9 syndrome following recombinant zoster vaccine in Medicare beneficiaries","volume":"181","author":"Goud","year":"2021","journal-title":"JAMA Intern Med."},{"key":"2022050522343565100_ref13","volume-title":"Presented at the Advisory Committee on Immunization Practices Meeting (virtual)","author":"Anderson","year":"2021"},{"issue":"18","key":"2022050522343565100_ref14","doi-asserted-by":"crossref","first-page":"2482","DOI":"10.1016\/j.vaccine.2019.03.043","article-title":"Safety profile of the adjuvanted recombinant zoster vaccine: pooled analysis of two large randomised phase 3 trials","volume":"37","author":"L\u00f3pez-Fauqued","year":"2019","journal-title":"Vaccine."},{"issue":"1","key":"2022050522343565100_ref15","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1016\/j.vaccine.2020.10.029","article-title":"Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. 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