PMID- 22293889
OWN - NLM
STAT- MEDLINE
DCOM- 20120529
LR  - 20211021
IS  - 1643-3750 (Electronic)
IS  - 1234-1010 (Print)
IS  - 1234-1010 (Linking)
VI  - 18
IP  - 2
DP  - 2012 Feb
TI  - The temporal relationship between RotaTeq immunization and intussusception 
      adverse events in the Vaccine Adverse Event Reporting System (VAERS).
PG  - PH12-17
AB  - BACKGROUND: In August of 2006, the Advisory Committee on Immunization Practices 
      (ACIP) recommended RotaTeq for routine vaccination of US infants. The hypothesis 
      tested in the present study is that rotavirus vaccines are associated with an 
      increased risk of intussusception adverse events (AEs) characterized by an onset 
      in a biologically plausible a priori identified temporal period post-vaccination 
      (days 3 to 7). MATERIAL/METHODS: The Vaccine Adverse Event Reporting System 
      (VAERS) updated as of December 28, 2010 was analyzed. RESULTS: Following RotaTeq 
      vaccination, a significantly (p<0.001) higher percentage of AEs were classified 
      as serious, permanently disabling, resulted in hospitalizations, or were 
      life-threatening among intussusception AEs in comparison to the total AE reports 
      (removing intussusception AE reports) submitted to VAERS. A significantly greater 
      portion of intussusception AEs in comparison to the portion of total AE reports 
      (removing intussusception AE reports) were reported to VAERS in the onset 
      interval from 3 to 7 days post-RotaTeq vaccination than within the onset interval 
      from 1 to 2 days post-RotaTeq vaccination (78.7% vs. 29.1%, risk ratio=2.7, 95% 
      CI=2.4-3.0, p<0.0001). It was assumed in our onset time-trend analyses of the 
      distribution of AEs following Rota-Teq vaccination that the AE's should be 
      equally likely to be reported with an onset time for each day, from 1 to 9 days 
      post-vaccination or, alternatively, should follow similar daily proportions as 
      observed for total AEs reports (removing intussusception AE reports). Results of 
      this onset time-trend analyses of the distribution of intussusception AEs 
      reported to VAERS following Rota-Teq vaccination revealed significant differences 
      (p<0.001) from our expectations. Consistent and similarly remarkable trends were 
      observed for intussusception AE reports associated with RotaShield vaccine. 
      CONCLUSIONS: The present study significantly associates RotaTeq vaccination with 
      intussusception AEs.
FAU - Geier, David A
AU  - Geier DA
AD  - Institute of Chronic Illnesses, Inc., Silver Spring, MD, USA.
FAU - King, Paul G
AU  - King PG
FAU - Sykes, Lisa K
AU  - Sykes LK
FAU - Geier, Mark R
AU  - Geier MR
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Med Sci Monit
JT  - Medical science monitor : international medical journal of experimental and 
      clinical research
JID - 9609063
RN  - 0 (RotaTeq)
RN  - 0 (Rotavirus Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Humans
MH  - Infant
MH  - Intussusception/*etiology
MH  - Rotavirus Vaccines/*adverse effects
MH  - United States
MH  - Vaccines, Attenuated/adverse effects
PMC - PMC3560585
EDAT- 2012/02/02 06:00
MHDA- 2012/05/30 06:00
PMCR- 2012/02/01
CRDT- 2012/02/02 06:00
PHST- 2012/02/02 06:00 [entrez]
PHST- 2012/02/02 06:00 [pubmed]
PHST- 2012/05/30 06:00 [medline]
PHST- 2012/02/01 00:00 [pmc-release]
AID - 882470 [pii]
AID - 10.12659/msm.882470 [doi]
PST - ppublish
SO  - Med Sci Monit. 2012 Feb;18(2):PH12-17. doi: 10.12659/msm.882470.