PMID- 24066727
OWN - NLM
STAT- MEDLINE
DCOM- 20140602
LR  - 20131025
IS  - 1744-8395 (Electronic)
IS  - 1476-0584 (Linking)
VI  - 12
IP  - 11
DP  - 2013 Nov
TI  - Safety profile of the yellow fever vaccine Stamaril(R): a 17-year review.
PG  - 1351-68
LID - 10.1586/14760584.2013.836320 [doi]
AB  - Since the creation by the manufacturer in 1993, of an electronic 
      pharmacovigilance database for all spontaneous, voluntary reports of adverse 
      events (AEs) after vaccination, 276 million doses of Stamaril(R) have been 
      distributed worldwide. We review this database for the safety of Stamaril with 
      emphasis on yellow fever (YF) vaccine associated acute viscerotropic and 
      neurotropic diseases, anaphylaxis and on specific at risk groups: elderly adults, 
      pregnant and lactating women and the immunosuppressed. Findings confirm that the 
      vaccine's safety profile in routine practice is favorable and consistent with the 
      summary of product characteristics. Estimated reporting rates of serious adverse 
      events associated after Stamaril vaccination are lower than the previously 
      published and widely cited estimates of the worldwide reporting rate for YF 
      vaccines in general. These data provide important additional information for the 
      prescribers in assessing the risks and benefits associated with the use of 
      Stamaril in individuals exposed to YF virus.
FAU - Cottin, Pascale
AU  - Cottin P
AD  - Global Pharmacovigilance Department Sanofi Pasteur, 2 avenue du Pont Pasteur, 
      69367 Lyon cedex 07, France.
FAU - Niedrig, Matthias
AU  - Niedrig M
FAU - Domingo, Cristina
AU  - Domingo C
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20130925
PL  - England
TA  - Expert Rev Vaccines
JT  - Expert review of vaccines
JID - 101155475
RN  - 0 (Yellow Fever Vaccine)
SB  - IM
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/*pathology
MH  - Humans
MH  - Risk Assessment
MH  - Yellow Fever Vaccine/*administration & dosage/*adverse effects
EDAT- 2013/09/27 06:00
MHDA- 2014/06/03 06:00
CRDT- 2013/09/27 06:00
PHST- 2013/09/27 06:00 [entrez]
PHST- 2013/09/27 06:00 [pubmed]
PHST- 2014/06/03 06:00 [medline]
AID - 10.1586/14760584.2013.836320 [doi]
PST - ppublish
SO  - Expert Rev Vaccines. 2013 Nov;12(11):1351-68. doi: 10.1586/14760584.2013.836320. 
      Epub 2013 Sep 25.