PMID- 23142308
OWN - NLM
STAT- MEDLINE
DCOM- 20130812
LR  - 20131121
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 31
IP  - 10
DP  - 2013 Feb 27
TI  - U.S. Postlicensure safety surveillance for adolescent and adult tetanus, 
      diphtheria and acellular pertussis vaccines: 2005-2007.
PG  - 1447-52
LID - S0264-410X(12)01570-8 [pii]
LID - 10.1016/j.vaccine.2012.10.097 [doi]
AB  - BACKGROUND: Pre-licensure clinical trials for two U.S. licensed tetanus toxoid, 
      reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal 
      any major safety concerns. However, routine use in large adolescent and adult 
      populations could reveal rare and potentially serious adverse events (AEs). 
      METHODS: To characterize reported AEs following Tdap vaccination and identify 
      potential safety concerns warranting further evaluation, we analyzed data from 
      the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and 
      proportions of AEs and reporting rates (reports per 100,000 vaccine doses 
      distributed). RESULTS: A total of 2090 reports (7% were serious; 55% listed Tdap 
      alone) involving Tdap vaccines were submitted to VAERS May 2005-June 2007. The 
      crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median 
      age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The 
      majority of reports described common local and systemic signs and symptoms, such 
      as injection site reactions, fever, and headache. Rarely reported AEs included 
      myopericarditis, demyelinating diseases of the central nervous system, 
      Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's 
      palsy, anaphylaxis, and thrombocytopenia. CONCLUSIONS: Because adolescents and 
      adults were not routinely vaccinated against pertussis in the past, this 
      surveillance summary provides important - and reassuring - information about the 
      use of Tdap in these age groups. Although subject to the limitations of passive 
      surveillance, the findings of this VAERS review support the pre-licensure 
      clinical trial data with regard to the safety of the U.S. licensed Tdap vaccines. 
      Continued monitoring of clinically significant AEs that are temporally associated 
      with Tdap vaccination and further assessment of such events using controlled 
      observational studies may provide additional information about the safety of 
      these vaccines.
CI  - Published by Elsevier Ltd.
FAU - Chang, Soju
AU  - Chang S
AD  - Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and 
      Research, US Food and Drug Administration, Rockville, MD 20852, United States. 
      soju.chang@nih.hhs.gov
FAU - O'Connor, Patrick M
AU  - O'Connor PM
FAU - Slade, Barbara A
AU  - Slade BA
FAU - Woo, Emily Jane
AU  - Woo EJ
LA  - eng
PT  - Journal Article
DEP - 20121108
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Diphtheria-Tetanus-acellular Pertussis Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Child
MH  - Child, Preschool
MH  - Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage/*adverse 
      effects
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/*pathology
MH  - Female
MH  - Humans
MH  - Infant
MH  - Male
MH  - Middle Aged
MH  - *Product Surveillance, Postmarketing
MH  - United States/epidemiology
MH  - Vaccination/*adverse effects/methods
MH  - Young Adult
EDAT- 2012/11/13 06:00
MHDA- 2013/08/13 06:00
CRDT- 2012/11/13 06:00
PHST- 2012/09/09 00:00 [received]
PHST- 2012/10/25 00:00 [revised]
PHST- 2012/10/27 00:00 [accepted]
PHST- 2012/11/13 06:00 [entrez]
PHST- 2012/11/13 06:00 [pubmed]
PHST- 2013/08/13 06:00 [medline]
AID - S0264-410X(12)01570-8 [pii]
AID - 10.1016/j.vaccine.2012.10.097 [doi]
PST - ppublish
SO  - Vaccine. 2013 Feb 27;31(10):1447-52. doi: 10.1016/j.vaccine.2012.10.097. Epub 
      2012 Nov 8.