Events present in

>1 subject included viral meningitis (n = 5) and Guillain–Barre syndrome (n = 4). The latency period for viral AZD5363 meningitis was 178–969 days and for Guillain–Barre syndrome was 74–1314 days. No event was considered by investigators to be causally related to LAIV. No rare diagnosis potentially related to wild-type influenza occurred at a significantly higher or lower rate in LAIV recipients relative to control groups in any comparison. In total, 5580 incidence rate comparisons were performed of which 257 (5%) yielded statistically significant differences: 72 rates were higher and 185 rates were lower in LAIV recipients compared with control groups. Of the 257 significant comparisons, 232 came from individual I-BET-762 order MAEs, while 19 came from PSDI and 6 were related to SAEs and hospitalizations (discussed

above). Of all significant rate comparisons from individual MAEs, 54%, 38%, and 9% were in comparison with the TIV-vaccinated, unvaccinated, and within-cohort groups, respectively (Fig. 1). Of those compared with TIV recipients 10% were increased and 90% were decreased after LAIV, while those compared with unvaccinated subjects 58% were increased and 43% were decreased after LAIV. In the self-controlled analysis 35% of events were increased after LAIV while 65% of events were decreased after LAIV. The majority of individual MAEs occurred in the clinic setting (89%) followed by the hospital (6%) and ED (5%) setting. Of the 19 significant comparisons from the PSDI collected across all settings, 12 came from individual diagnoses whose significant comparisons were also captured as individual MAEs in the clinic setting (Fig. 1), as most events occurred in the clinic. The remaining 7 PSDI comparisons came from any event in the categories of acute respiratory tract events, acute gastrointestinal tract events, and asthma and wheezing events (Table 3). One MAE comparison, mastitis (n = 30), occurred at a significantly higher rate among LAIV recipients relative to all

3 control groups. Of these cases, 20 were associated with the post-partum state or breastfeeding. not Breast lump/cyst events (n = 37) occurred at a higher rate after LAIV in comparison with unvaccinated and TIV-vaccinated controls, but not within the self-controlled cohort. Of these 37 events in LAIV recipients, 16 (43%) were preexisting at the time of vaccination. Other events occurring at a higher rate after LAIV in comparison with no vaccine and TIV included genital pain, lentigo, obesity, and sleep disorder ( Fig. 1). Of the 49 sleep disorder events after LAIV, the most common causes were insomnia (n = 17), sleep apnea (n = 15) and unspecified sleep disturbance (n = 9); none were classified as narcolepsy.