Post-licensure Surveillance of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Children 6 weeks–59 months old, Vaccine Adverse Event Reporting System (VAERS), United States, 2010–2017

Abstract

BackgroundIn February 2010, the Food and Drug Administration (FDA) licensed the 13-valent pneumococcal conjugate vaccine (PCV13) for use in children aged 6 weeks through 59 months. The Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 for all children ages 2, 4, and 6 months with a booster at 12–15 months. For incomplete or unvaccinated children, catch-up vaccination should occur through age 59 months.MethodsWe searched the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive surveillance system, for reports of adverse events (AEs) following PCV13 from February 24, 2010 through February 24, 2017, in children aged 6 weeks through 59 months. Signs and symptoms of AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA). Physicians reviewed the VAERS forms and available medical records of serious reports (death, life-threatening illness, hospitalization, prolongation of hospitalization and permanent disability) and reports of Kawasaki disease and anaphylaxis. Cause of death was ascertained by review of death certificate and/or autopsy report.ResultsVAERS received 10,007 reports after PCV13; 1,706 (17.0%) were serious. In 927 (9.3%), PCV13 was administered alone. The most frequently reported symptoms were pyrexia (26.4%), injection site erythema (15.3%) and irritability (14.6%). Injection site erythema (25.4%), injection site swelling (20.6%) and pyrexia (20.1%) were most frequent among children who were given PCV13 alone. Median time from vaccination to start of symptoms was 1 day (range: day of vaccination – 2,033 days). There were 222 (2.2%) death reports with sudden infant death syndrome as the most common cause (37.8%). Pyrexia (45.1%), irritability (40.4%), and vomiting (39.7%) were most commonly reported among non-death serious reports. There were 20 (0.2%) reports of Kawasaki disease and 20 (0.2%) reports of anaphylaxis.ConclusionAES reported to VAERS following PCV13 were consistent with AEs previously observed in pre-licensure clinical trials and other post-licensure studies of PCV13. No new or unexpected patterns of AEs were identified.Disclosures All authors: No reported disclosures.