PMID- 31883809
OWN - NLM
STAT- MEDLINE
DCOM- 20210308
LR  - 20210308
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 38
IP  - 6
DP  - 2020 Feb 5
TI  - Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis 
      vaccines (Tdap) in adults aged >/=65 years, Vaccine Adverse Event reporting System 
      (VAERS), United States, September 2010-December 2018.
PG  - 1476-1480
LID - S0264-410X(19)31628-7 [pii]
LID - 10.1016/j.vaccine.2019.11.074 [doi]
AB  - INTRODUCTION: The Advisory Committee on Immunization Practices (ACIP) recommends 
      vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular 
      pertussis vaccine (Tdap) in persons >/=65 years 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 >/=65 years 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 >/=65 years of age. Findings from this post-marketing review are 
      consistent with prior post-marketing observations and pre-licensure studies.
CI  - Published by Elsevier Ltd.
FAU - Haber, Penina
AU  - Haber P
AD  - 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.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Ng, Carmen
AU  - Ng C
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Dores, Graca M
AU  - Dores GM
AD  - Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for 
      Biologics Evaluation and Research, U.S. Food and Drug Administration, United 
      States.
FAU - Perez-Vilar, Silvia
AU  - Perez-Vilar S
AD  - Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for 
      Biologics Evaluation and Research, U.S. Food and Drug Administration, United 
      States.
FAU - Marquez, Paige L
AU  - Marquez PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Cano, Maria
AU  - Cano M
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
LA  - eng
PT  - Journal Article
DEP - 20191226
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Diphtheria Toxoid)
RN  - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines)
RN  - 0 (Tetanus Toxoid)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Diphtheria Toxoid/*adverse effects
MH  - Diphtheria-Tetanus-acellular Pertussis Vaccines/*adverse effects
MH  - Humans
MH  - Injection Site Reaction/*epidemiology
MH  - Tetanus Toxoid/*adverse effects
MH  - United States/epidemiology
MH  - Vaccination/*adverse effects
OTO - NOTNLM
OT  - Post-licensure surveillance
OT  - Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap)
OT  - Vaccine Adverse Event Reporting System
OT  - Vaccine safety
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2019/12/31 06:00
MHDA- 2021/03/09 06:00
CRDT- 2019/12/30 06:00
PHST- 2019/08/13 00:00 [received]
PHST- 2019/11/26 00:00 [revised]
PHST- 2019/11/27 00:00 [accepted]
PHST- 2019/12/31 06:00 [pubmed]
PHST- 2021/03/09 06:00 [medline]
PHST- 2019/12/30 06:00 [entrez]
AID - S0264-410X(19)31628-7 [pii]
AID - 10.1016/j.vaccine.2019.11.074 [doi]
PST - ppublish
SO  - Vaccine. 2020 Feb 5;38(6):1476-1480. doi: 10.1016/j.vaccine.2019.11.074. Epub 
      2019 Dec 26.