| アブストラクト | INTRODUCTION: The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons >/=65years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group. METHODS: We searched for and analyzed U.S. VAERS reports of Tdap among individuals >/=65years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting. RESULTS: VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were injection site erythema (26%; n=468), injection site pain (19%; n=335), injection site swelling (18%; n=329), and erythema (18%; n=321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n=34) and infections and infestations (n=18.6%; n=18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected. CONCLUSIONS: We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults >/=65years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies. |
|---|
| ジャーナル名 | Vaccine |
|---|
| 投稿日 | 2019/12/31 |
|---|
| 投稿者 | Haber, Penina; Moro, Pedro L; Ng, Carmen; Dores, Graca M; Perez-Vilar, Silvia; Marquez, Paige L; Cano, Maria |
|---|
| 組織名 | Immunization Safety Office, Division of Healthcare Quality Promotion, National;Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control;and Prevention, United States. Electronic address: phaber@cdc.gov.;and Prevention, United States.;Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for;Biologics Evaluation and Research, U.S. Food and Drug Administration, United;States. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/31883809/ |
|---|
