Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19 years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012–December 31, 2015. Issue 50 (7th December 2016)

• Record Type: Journal Article
• Authors: Haber, Penina; Arana, Jorge; Pilishvili, Tamara; Lewis, Paige; Moro, Pedro L.; Cano, Maria
• Is Part Of: Vaccine. Volume 34:Issue 50(2016)
• Page Start: 6330
• Page End: 6334
• Publication Date: 2016-12-07
• Subjects: Vaccine safety -- Post-licensure surveillance -- 13-Valent pneumococcal conjugate vaccine (PCV13); Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2016.10.052
• Languages: English
• ISSNs: 0264-410X

Abstract

Abstract: Background: The 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged ⩾19 years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged ⩾65 years. Methods: We assessed adverse events (AEs) reports following PCV13 in adults aged ⩾19 years reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to December 2015. VAERS is a national spontaneous reporting system for monitoring AEs following vaccination. Our assessment included automated data analysis, clinical review of all serious reports and reports of special interest. We conducted empirical Bayesian data mining to assess for disproportionate reporting. Results: VAERS received 2976 US PCV13 adult reports; 2103 (71%) of these reports were from PCV13 administered alone. Fourteen percent were in persons aged 19–64 years and 86% were in persons aged ⩾65 years. Injection site erythema (28%), injection site pain (24%) and fever (22%) were the most frequent AEs among persons aged 19–64 years; injection site erythema (30%), erythema (20%) and injection site swelling (18%) were the most frequent among persons aged ⩾65 years who were given the vaccine alone. The most frequently reported AEs among non-death serious reports were injection site reactions and general malaise among persons 19–64 years old; injection site reactions, general malaise and Guillain-Barré syndrome among those ⩾65 years (Table 2). Data mining did not detect disproportional reporting for any unexpected AE. Conclusions: The results of this study were consistent with safety data from pre-licensure studies of PCV13. We did not detect any new or unexpected AEs.