The only rare diagnosis event selleckchem present in more than 1 subject was viral meningitis (n = 5). One death due to viral myocarditis occurred 1586 days postvaccination. No event was considered by investigators to be causally

related to LAIV. In the analysis, no rare diagnosis potentially related to wild-type influenza was significantly increased or decreased in LAIV recipients relative to control groups in any comparison. To analyze the many rate comparisons for individual MAEs that occurred at a significantly higher or lower rate among LAIV recipients within the varied aged groups, settings, time intervals and dose number, graphic representations were constructed. The statistically significant differences are represented in 2-dimensional “heat map” graphics, ABT737 similar to those commonly used to display up- and downregulation of various associated gene segments [10] (Fig. 1 and Fig. 2). Of the 9496 incidence

rate comparisons performed, a total of 372 (4%) yielded statistically significant differences: 204 incidence rates were higher and 168 incidence rates were lower in LAIV recipients in comparison with any of the 3 control groups in various settings and within various time frames postvaccination. Of the 372 rate comparisons, 307 were from individual MAE terms and 65 were from PSDIs. Of the 65 significant comparisons from the PSDI collected across all settings 45 came from individual diagnoses; these differences were also identified as elevated MAEs in the clinic setting (Fig. 1 and Fig. 2). The remaining 20 PSDI comparisons resulted from analyses of any acute respiratory tract, acute gastrointestinal

tract, or asthma and wheezing events (Table 3). By control group, 155 (76%) of the rate comparisons that were increased after LAIV were in relationship to unvaccinated controls, and 126 (75%) of the rate comparisons that were decreased after LAIV were in relationship to TIV-vaccinated controls. The majority of significant individual MAEs occurred in the clinic setting (96%), only 3% and 1% occurred in the ED and hospital Edoxaban settings, respectively. Only 1 MAE rate comparison was associated with a significant increase among LAIV recipients relative to all 3 control groups. There were 7 events of breast lump/cyst in LAIV recipients 9–17 years of age in the clinic setting through 21 days postvaccination and no events in the TIV-vaccinated, unvaccinated and within-cohort controls. Five of these events were preexisting, and 1 event appeared to be gynecomastia in an adolescent male. Respiratory events were found to occur at a lower rate among LAIV recipients in comparison with TIV-vaccinated controls.