Article Document Academic Article Information Content Entity Journal Article Continuant Continuant Entity Entity Generically Dependent Continuant 2025-05-08T02:41:51 RDF description of Active postlicensure safety surveillance for recombinant zoster vaccine using electronic health record data - http://repository.healthpartners.com/individual/document-rn31421 document-rn31421 Adverse Effects 20867 American Journal of Epidemiology public Infectious Diseases 192 Safety 2 Vaccination Active postlicensure safety surveillance for recombinant zoster vaccine using electronic health record data Medical Records Systems, Computerized Prevention 2023-02-28T13:45:22.642-06:00 Prospective Studies 35794 10.1093/aje/kwac170 <p>Recombinant zoster vaccine (RZV) (Shingrix; GlaxoSmithKline, Brentford, United Kingdom) is an adjuvanted glycoprotein vaccine that was licensed in 2017 to prevent herpes zoster (shingles) and its complications in older adults. In this prospective, postlicensure Vaccine Safety Datalink study using electronic health records, we sequentially monitored a real-world population of adults aged � 50 years who received care in multiple US Vaccine Safety Datalink health systems to identify potentially increased risks of 10 prespecified health outcomes, including stroke, anaphylaxis, and Guillain-Barré syndrome (GBS). Among 647,833 RZV doses administered from January 2018 through December 2019, we did not detect a sustained increased risk of any monitored outcome for RZV recipients relative to either historical (2013-2017) recipients of zoster vaccine live, a live attenuated virus vaccine (Zostavax; Merck & Co., Inc., Kenilworth, New Jersey), or contemporary non-RZV vaccine recipients who had an annual well-person visit during the 2018-2019 study period. We confirmed prelicensure trial findings of increased risks of systemic and local reactions following RZV. Our study provides additional reassurance about the overall safety of RZV. Despite a large sample, uncertainty remains regarding potential associations with GBS due to the limited number of confirmed GBS cases that were observed.<p>