PMID- 21957494
OWN - NLM
STAT- MEDLINE
DCOM- 20120321
LR  - 20151119
IS  - 1554-8619 (Electronic)
IS  - 1554-8600 (Linking)
VI  - 7
IP  - 10
DP  - 2011 Oct
TI  - Two doses of pandemic influenza A(H1N1) vaccine: tolerability in healthy young 
      children in the Netherlands.
PG  - 1048-54
LID - 10.4161/hv.7.10.16692 [doi]
AB  - During the 2009 influenza pandemic, children aged 6 months up to and including 4 
      years, without chronic illness, were vaccinated with two doses of Pandemrix((R)) 
      through mass vaccination in the Netherlands. During the vaccination campaign a 
      warning was issued about fever after the second dose of Pandemrix((R)). Therefore, 
      we investigated the tolerability of both doses Pandemrix((R)) in these children. 
      Among parents of children eligible for vaccination, 1500 questionnaires were 
      distributed during both, the first and second mass vaccination session. We asked 
      for the occurrence, time interval, and duration of local reactions and systemic 
      adverse events (AEs). The responses were 36.7% and 29.5% after each dose, 
      respectively. Local reactions were reported in 40.4% and 39.3%, most frequently, 
      pain at the injection site. After the first and second dose, 29.6% and 30.7% of 
      all children experienced fever (mean temperature 38.8degree signC). Other 
      systemic AEs were reported in 41.6% and 42.9% of the children. No differences 
      were seen between the first and second dose for all reported AEs except for 
      pallor. One child was hospitalized after the first dose, but a causal relation to 
      the vaccination was considered improbable. In conclusion, fever was frequently 
      reported in children 6 months up to and including 4 years of age after the first 
      and second dose of Pandemrix((R)). However, for almost all AEs, including fever, no 
      dose effect was observed. Reported AEs were mostly mild and all were transient.
FAU - van't Klooster, Tessa M
AU  - van't Klooster TM
AD  - Department of Epidemiology and Surveillance, Centre for Infectious Disease 
      Control, National Institute for Public Health and the Environment, Bilthoven, The 
      Netherlands.
FAU - Kemmeren, Jeanet M
AU  - Kemmeren JM
FAU - de Melker, Hester E
AU  - de Melker HE
FAU - Vermeer-de Bondt, Patricia E
AU  - Vermeer-de Bondt PE
FAU - van der Maas, Nicoline A T
AU  - van der Maas NA
LA  - eng
PT  - Journal Article
DEP - 20111001
PL  - United States
TA  - Hum Vaccin
JT  - Human vaccines
JID - 101265291
RN  - 0 (Influenza Vaccines)
RN  - 0 (pandemrix)
SB  - IM
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Humans
MH  - Immunization, Secondary/*adverse effects/*methods
MH  - Infant
MH  - Influenza A Virus, H1N1 Subtype/immunology
MH  - Influenza Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Influenza, Human/immunology/*prevention & control
MH  - Male
MH  - Netherlands
MH  - Surveys and Questionnaires
MH  - Vaccination/*adverse effects/*methods
EDAT- 2011/10/01 06:00
MHDA- 2012/03/22 06:00
CRDT- 2011/09/30 06:00
PHST- 2011/09/30 06:00 [entrez]
PHST- 2011/10/01 06:00 [pubmed]
PHST- 2012/03/22 06:00 [medline]
AID - 16692 [pii]
AID - 10.4161/hv.7.10.16692 [doi]
PST - ppublish
SO  - Hum Vaccin. 2011 Oct;7(10):1048-54. doi: 10.4161/hv.7.10.16692. Epub 2011 Oct 1.