Eric K. France
1,
Jason Glanz1, Stanley Xu
1, Robert L Davis
2, Steven Black
3, Henry R Shinefield
4, Kenneth M Zangwill
5, Michael Marcy
6, John P Mullooly
7, Lisa Jackson
8, and Vaccine Safety Datalink Team. (1) Clinical Research Unit, Kaiser Permanente of Colorado, 2550 S. Parker Road, Suite 300, Aurora, CO, USA, (2) Department of Pediatrics, University of Washington School of Medicine, BOX 358853, 146 North Canal Street, Suite 300, Seattle, WA, USA, (3) Kaiser Permanente, Oakland, CA, USA, (4) Kaiser Vaccine Study Center, Kaiser Permanente of Northern California, 4131 Geary Blvd, Room 23, San Francisco, CA, USA, (5) Center for Vaccine Research Harbor-UCLA Medical Center, Harbor-UCLA Medical Center, 1124 W. Carson St, Bldg E-6, Torrance, CA, USA, (6) Kaiser Foundation Hospital, Kaiser Permanente of Southern California, 13652 Cantara St, Panorama City, CA, USA, (7) Kaiser Foundation Hospital Center for Health Research, Northwest Kaiser Permanente, 3800 N. Interstate Ave, Portland, OR, USA, (8) Center for Health Studies, Group Health Cooperative, 1730 Minor Ave, Suite 1600, Seattle, WA, USA
KEYWORD1:
trivalent influenza vaccine, vaccine safety datalink, medically attended event, vaccine-associated adverse effect, risk, significant
BACKGROUND:
There are no population-based studies on the safety of the trivalent influenza vaccine (TIV) among children. We used the Vaccine Safety Datalink (VSD) dataset to assess the safety of this vaccine among children under 18 years of age.
OBJECTIVE:
METHOD:
We examined the risk of medically attended events (MAEs) following TIV vaccination among children in the VSD. Analyses used outpatient, emergency department (ED) and inpatient data. Outpatient and ED analyses assessed vaccinations over 5 years (1995 - 1999), and inpatient analyses spanned 7 years (1993 - 1999). The cohort was randomly divided into two equal groups. In group A, the risks of MAEs during the 14 days following vaccination were compared to the risks of events in 2 control periods (15 - 28 days before and 15 -28 days after vaccination). Medically plausible MAEs significantly associated with receipt of TIV in group A were subsequently analyzed in group B, using the same 2 control periods. MAEs significant in both groups were considered potential vaccine-associated adverse events and were assessed by chart review. Secondary analyses included using shorter risk interval periods (0-2 and 1-3 days) and restricted age categories (6 - 23 months).
RESULT:
A total of 251,600 children received TIV in our study. These children incurred 1,165; 230; and 489 different diagnoses during the 14 days following vaccination in the outpatient, ED and inpatient data, respectively. Four MAEs were positively associated with the vaccine, but none of these MAEs were confirmed by medical record review.
CONCLUSION:
This large screening safety study did not reveal any evidence of important MAEs associated with pediatric TIV vaccination.
LEARNINGOBJECTIVES:
To assess the safety of the pediatric TIV
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