PMID- 29580194 OWN - NLM STAT- MEDLINE DCOM- 20190429 LR - 20190518 IS - 2164-554X (Electronic) IS - 2164-5515 (Print) IS - 2164-5515 (Linking) VI - 14 IP - 8 DP - 2018 TI - Post-licensure safety surveillance of zoster vaccine live (Zostavax(R)) in the United States, Vaccine Adverse Event Reporting System (VAERS), 2006-2015. PG - 1963-1969 LID - 10.1080/21645515.2018.1456598 [doi] AB - BACKGROUND: Herpes zoster (HZ), or shingles, is caused by reactivation of varicella-zoster virus in latently infected individuals. Live-attenuated HZ vaccine (zoster vaccine live, ZVL) is approved in the United States for persons aged >/=50 years and recommended by the CDC for persons >/=60 years. METHODS: We analyzed U.S. reports of adverse events (AEs) following ZVL submitted to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system to monitor vaccine safety, for persons vaccinated May 1, 2006, through January 31, 2015. We conducted descriptive analysis, clinical reviews of reports with selected pre-specified conditions, and empirical Bayesian data mining. RESULTS: VAERS received 23,092 reports following ZVL, of which 22,120 (96%) were classified as non-serious. Of reports where age was documented (n = 18,817), 83% were in persons aged >/=60 years. Reporting rates of AEs were 106 and 4.4 per 100,000 ZVL doses distributed for all reports and serious reports, respectively. When ZVL was administered alone among persons aged >/=50 years, injection site erythema (27%), HZ (17%), injection site swelling (17%), and rash (14%) were the most commonly reported symptoms among non-serious reports; HZ (29%), pain (18%), and rash (16%) were the most commonly reported symptoms among serious reports. Six reports included laboratory evidence of vaccine-strain varicella-zoster virus (Oka/Merck strain) infection; AEs included HZ, HZ- or varicella-like illness, and local reaction with vesicles. In our review of reports of death with sufficient information to determine cause (n = 46, median age 75 years), the most common causes were heart disease (n = 28), sepsis (n = 4), and stroke (n = 3). Empirical Bayesian data mining did not detect new or unexpected safety signals. CONCLUSIONS: Findings from our safety review of ZVL are consistent with those from pre-licensure clinical trials and other post-licensure assessments. Transient injection-site reactions, HZ, and rashes were most frequently reported to VAERS following ZVL. Overall, our results are reassuring regarding the safety of ZVL. FAU - Miller, Elaine R AU - Miller ER AD - a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA. FAU - Lewis, Paige AU - Lewis P AD - a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA. FAU - Shimabukuro, Tom T AU - Shimabukuro TT AD - a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA. FAU - Su, John AU - Su J AD - a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA. FAU - Moro, Pedro AU - Moro P AD - a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA. FAU - Woo, Emily Jane AU - Woo EJ AD - b Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , Maryland , USA. FAU - Jankosky, Christopher AU - Jankosky C AD - b Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , Maryland , USA. FAU - Cano, Maria AU - Cano M AD - a Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention , Atlanta , Georgia , USA. LA - eng PT - Journal Article DEP - 20180518 PL - United States TA - Hum Vaccin Immunother JT - Human vaccines & immunotherapeutics JID - 101572652 RN - 0 (Herpes Zoster Vaccine) RN - 0 (Vaccines, Attenuated) SB - IM MH - Adult MH - Adverse Drug Reaction Reporting Systems/*statistics & numerical data MH - Age Factors MH - Aged MH - Aged, 80 and over MH - Anaphylaxis/epidemiology/etiology MH - Cause of Death MH - Drug Approval MH - Drug Eruptions/epidemiology/etiology MH - Female MH - Herpes Zoster/epidemiology/*prevention & control/virology MH - Herpes Zoster Vaccine/*adverse effects MH - Herpesvirus 3, Human/immunology/*pathogenicity MH - Humans MH - Injection Site Reaction/epidemiology/etiology MH - Male MH - Middle Aged MH - Pregnancy MH - Product Surveillance, Postmarketing/*statistics & numerical data MH - United States/epidemiology MH - Vaccination/adverse effects/legislation & jurisprudence MH - Vaccines, Attenuated/adverse effects PMC - PMC6150039 OTO - NOTNLM OT - Adverse event OT - Vaccine Adverse Event Reporting System (VAERS) OT - herpes zoster OT - immunization OT - shingles OT - vaccine OT - vaccine safety OT - varicella EDAT- 2018/03/28 06:00 MHDA- 2019/04/30 06:00 PMCR- 2019/05/18 CRDT- 2018/03/28 06:00 PHST- 2018/03/28 06:00 [pubmed] PHST- 2019/04/30 06:00 [medline] PHST- 2018/03/28 06:00 [entrez] PHST- 2019/05/18 00:00 [pmc-release] AID - 1456598 [pii] AID - 10.1080/21645515.2018.1456598 [doi] PST - ppublish SO - Hum Vaccin Immunother. 2018;14(8):1963-1969. doi: 10.1080/21645515.2018.1456598. Epub 2018 May 18.