PMID- 17382435
OWN - NLM
STAT- MEDLINE
DCOM- 20070820
LR  - 20070430
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 25
IP  - 21
DP  - 2007 May 22
TI  - Safety review of the purified chick embryo cell rabies vaccine: Data from the 
      Vaccine Adverse Event Reporting System (VAERS), 1997-2005.
PG  - 4244-51
AB  - On October 20, 1997, the U.S. Food and Drug Administration (FDA) licensed 
      Purified Chick Embryo Cell (PCEC, RabAvert) vaccine against rabies in humans 
      following clinical trials demonstrating safety and efficacy. From October 1997 
      through December 2005, the Vaccine Adverse Event Reporting System (VAERS) 
      received 336 reports of adverse events (AEs) following vaccination with PCEC 
      vaccine in the U.S.; there were no death reports. Serious events, including 20 
      hospitalizations and 13 neurological events, were described in 24 (7%) reports. 
      There was no pattern among the 13 neurological AEs suggesting a plausible 
      relationship to vaccination. A total of 20 AEs, 3 serious, were classified as 
      possible anaphylaxis. There were 312 non-serious AEs (93%). Nineteen reports (6%) 
      described that the vaccination series was discontinued because of non-serious 
      AEs. Most reported AEs are non-serious and consistent with pre-licensure safety 
      data. The rabies risk must be carefully considered before vaccine 
      discontinuation.
FAU - Dobardzic, Azra
AU  - Dobardzic A
AD  - Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 
      Rockville Pike, Rockville, MD 20852, USA. azra.dobardzic@fda.hhs.gov
FAU - Izurieta, Hector
AU  - Izurieta H
FAU - Woo, Emily Jane
AU  - Woo EJ
FAU - Iskander, John
AU  - Iskander J
FAU - Shadomy, Sean
AU  - Shadomy S
FAU - Rupprecht, Charles
AU  - Rupprecht C
FAU - Ball, Robert
AU  - Ball R
FAU - Braun, M Miles
AU  - Braun MM
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20070315
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Rabies Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Anaphylaxis
MH  - Arthus Reaction/etiology
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Hospitalization
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Medication Errors
MH  - Middle Aged
MH  - Nervous System Diseases/etiology
MH  - Rabies Vaccines/administration & dosage/*adverse effects
MH  - Syncope/etiology
EDAT- 2007/03/27 09:00
MHDA- 2007/08/21 09:00
CRDT- 2007/03/27 09:00
PHST- 2006/12/27 00:00 [received]
PHST- 2007/02/22 00:00 [revised]
PHST- 2007/02/23 00:00 [accepted]
PHST- 2007/03/27 09:00 [pubmed]
PHST- 2007/08/21 09:00 [medline]
PHST- 2007/03/27 09:00 [entrez]
AID - S0264-410X(07)00276-9 [pii]
AID - 10.1016/j.vaccine.2007.02.075 [doi]
PST - ppublish
SO  - Vaccine. 2007 May 22;25(21):4244-51. doi: 10.1016/j.vaccine.2007.02.075. Epub 
      2007 Mar 15.