PMID- 21920404
OWN - NLM
STAT- MEDLINE
DCOM- 20120410
LR  - 20111114
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 29
IP  - 50
DP  - 2011 Nov 21
TI  - Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular 
      pertussis (Tdap) vaccine administered to adults 65 years of age and older 
      reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010.
PG  - 9404-8
LID - 10.1016/j.vaccine.2011.05.100 [doi]
AB  - BACKGROUND: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis 
      (Tdap) vaccine was not licensed for use in adults aged >/=65 years due to lack of 
      sufficient efficacy and safety data. OBJECTIVE: To characterize reports to the 
      Vaccine Adverse Event Reporting System (VAERS) among adults aged >/=65 years who 
      received Tdap vaccine 'off-label' to assess for potential vaccine safety 
      concerns. METHODS: We searched VAERS for US reports of adverse events (AEs) in 
      subjects aged >/=65 years who received Tdap vaccine from 9/1/2005 to 9/08/2010. 
      Medical records were requested for all reports coded as serious (death, 
      hospitalization, prolonged hospitalization, permanent disability, 
      life-threatening-illness). Proportional reporting ratio (PRR) was used to assess 
      for higher proportionate reporting for AEs after Tdap compared with Td reports in 
      subjects aged >/=65 years. RESULTS: VAERS received 243 reports following Tdap 
      administered to persons aged >/=65 years. Eleven (4.5%) reports were serious, 
      including two deaths. Most common AEs were local reactions in 100 (41.2%) 
      reports. Seventy-eight (32.1%) reports contained coding terms that denoted 
      inappropriate administration of vaccine. 'Cough' was the only term associated 
      with disproportionately higher reporting after Tdap compared with Td. Six of 
      seven Tdap reports containing the term 'Cough' were non-serious. Clinical review 
      of serious reports identified no unusual patterns of AEs. CONCLUSION: Our VAERS 
      review of the 'off-label' use of Tdap vaccine in adults >/=65 years did not find 
      any safety concerns that warrant further study. These data will provide useful 
      baseline information to assist CDC and FDA with monitoring efforts as permissive 
      recommendations for Tdap in older persons are adopted.
CI  - Published by Elsevier Ltd.
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, Atlanta, GA 30333, USA. psm9@cdc.gov
FAU - Yue, Xin
AU  - Yue X
FAU - Lewis, Paige
AU  - Lewis P
FAU - Haber, Penina
AU  - Haber P
FAU - Broder, Karen
AU  - Broder K
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20110913
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/*statistics & numerical data
MH  - Aged
MH  - Aged, 80 and over
MH  - Clinical Coding
MH  - Diphtheria Toxoid/*adverse effects
MH  - Diphtheria-Tetanus-acellular Pertussis Vaccines/*adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Tetanus Toxoid/*adverse effects
EDAT- 2011/09/17 06:00
MHDA- 2012/04/11 06:00
CRDT- 2011/09/17 06:00
PHST- 2011/05/13 00:00 [received]
PHST- 2011/05/27 00:00 [revised]
PHST- 2011/05/31 00:00 [accepted]
PHST- 2011/09/17 06:00 [entrez]
PHST- 2011/09/17 06:00 [pubmed]
PHST- 2012/04/11 06:00 [medline]
AID - S0264-410X(11)01405-8 [pii]
AID - 10.1016/j.vaccine.2011.05.100 [doi]
PST - ppublish
SO  - Vaccine. 2011 Nov 21;29(50):9404-8. doi: 10.1016/j.vaccine.2011.05.100. Epub 2011 
      Sep 13.