Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age

Children and adults will be immunized with Q/LAIV as part of routine clinical practice at
Kaiser Permanente Northern California (NCKP) sites. Using existing data on healthcare
utilization, rates of medically attended events (MAEs) of interest will be evaluated in all
eligible Q/LAIV recipients who are vaccinated in the Kaiser Permanente (KP) Northern
California Health Care Plan during the 2013-2014 influenza season. Enrollment must include a
minimum of 10,000 children 2 through 8 years of age; based on previous utilization of
FluMist at NCKP, enrollment is expected to include approximately 80,000 children and adults
2 to 49 years of age.

Inclusion Criteria:

1. . Age 2 through 49 years at the time of vaccination (or index date for unvaccinated
controls)

2. . Membership in the KP Health Care Plan for at least 12 months prior to
vaccination/index date

3. . Continuous enrollment in KP Health Care Plan through 6 months following
vaccination/index date.

Exclusion Criteria:

NONE