Deaths included cardiac-related events (acute myocardial infarction, cardiomyopathy and acute infective myocarditis), trauma, poisoning, and pancreatitis CP-673451 order (n = 1 each). During the same time period 3 deaths occurred in the unvaccinated comparison group and 4 deaths occurred in the TIV-vaccinated comparison group. Deaths in the unvaccinated group included suicide (n = 2) and

unknown cause (n = 1), while deaths in TIV-vaccinated group included staphylococcal infection (n = 1), aortic aneurysm (n = 2) and unknown cause (n = 1). The rate of death was not significantly higher among those vaccinated with LAIV compared with those unvaccinated or vaccinated with TIV. Within 42 days of vaccination with LAIV, 47 SAEs occurred in 39 subjects resulting in an incidence rate of 1.29 per 1000 person months. The most common primary diagnoses were pancreatitis (n = 5), trauma (n = 5), cholelithiasis/cholecystitis (n = 4) and urinary tract infection (n = 4). No individual SAE occurred at a significantly higher or lower rate in LAIV recipients relative to control

groups Selumetinib in any comparison. The incidence rate for any SAE within 21 days (1.47 vs 7.98; p < 0.01) and 42 days (1.29 vs 8.06; p < 0.01) of vaccination with LAIV was lower than with TIV. The incidence rate for any SAE within 21 days (1.33 vs 3.85; p < 0.01) and 42 days (1.28 vs 3.87; p < 0.01) of vaccination with LAIV was lower compared with no vaccination. The incidence rate for any SAE within 21 days of vaccination with LAIV (risk period) was similar to the incidence rate for any PD184352 (CI-1040) SAE 22–42 days following vaccination with LAIV (reference period) in the self-controlled analysis (1.33 vs 1.36; p = 0.94). Of the 47 SAEs occurring within 42 days postvaccination, 3 events were categorized by investigators as possibly or probably related to LAIV and included migraine/sinusitis 3 days postvaccination, and 2 diagnoses of Bell’s palsy 8 days postvaccination (one subject had a prior history of Bell’s palsy). All subjects recovered completely. There were 447 hospitalizations observed within 180

days of LAIV vaccination. The most common first diagnoses were trauma (n = 55), elective procedure (n = 37), psychiatric (n = 28), cholelithiasis (n = 25) and benign lesion (n = 23). The only diagnosis in the hospital setting within 42 days of vaccination that occurred at a significantly higher rate in LAIV recipients compared with unvaccinated controls was elective procedure. Events in the hospital setting that occurred at a lower rate in LAIV recipients in comparison to control groups were elective procedure (self-controlled group), menstrual disorder (unvaccinated control), pregnancy-delivery (unvaccinated control) and pregnancy-threatened premature labor (TIV-vaccinated control). The rate of hospitalization or death due to any condition within 180 days of vaccination with LAIV was lower than with TIV (1.46 vs 9.10; p < 0.01) or no vaccine (1.46 vs 3.36; p < 0.01).