TABLE 3

Summary of Common Adverse Events Using ESA in Subgroups Evaluated With the Concurrent Comparison Group

Adverse EventSubgroup, Sex, Age Group in y, 9vHPV DoseWeek When First SignaledNo. 9vHPV Vaccinations in SubgroupNo. Total CasesaNo. Exposed CasesaRRP
Allergic reactionbFemale, 9–17, ED or inpatient, any82242 72633262.7.04
Female, 9–17, outpatient, anyNo signalc242 72686600.8.75
Female, 9–17, ED or inpatient, dose 194109 89626172.8.04
Female, 9–17, outpatient, dose 1No signald109 89682501.2.28
Female, 18–26, outpatient, dose 28633 11838151.9.04
Female, 18–26, ED or inpatient, dose 2No signale33 118810.4.92
AppendicitisfMale, 9–17, dose 38473 12250302.1.03
Male, 9–17, anyNo signalg271 679103811.5.09
Male, 9–17, dose 1No signalg106 74147251.4.23
Male, 9–17, dose 2No signalg91 15647261.5.23
Injection site reactionMale, 9–17, dose 32623 40929182.5.03
Nonspecific reactionMale, 18–26, dose 32540543295.0.04
Male, 18–26, dose 13413 22814911.1.04
Female, 18–26, dose 15026 71171341.7.03
Female, 18–26, any105128 8062151261.3.04
SyncopeFemale, 18–26, any2528 23498671.8.007
Female, 18–26, dose 12512 24565352.0.004
Female, 18–26, dose 23110 92460251.7.04
  • Results were extracted from the report for the week when the adverse event first signaled. NS, no signal.

  • a Cases in a specific subgroup are only counted for analytic strata with ≥1 case (either exposed or not), ≥1 9vHPV vaccine, and ≥1 comparator vaccine, in which analytic strata are defined by age (in 1-y increments), site, sex, and week of the vaccination visit.

  • b Diagnoses were made in the ED or inpatient setting or in the outpatient setting.

  • c No signal was detected for this subgroup. Data were extracted from the report for the week when allergic reaction signaled for girls 9 to 17 y old with any dose in the ED or inpatient setting.

  • d No signal was detected for this subgroup. Data were extracted from the report for the week when allergic reaction signaled for girls 9 to 17 y old with dose 1 in the ED or inpatient setting.

  • e No signal was detected for this subgroup. Data were extracted from the report for the week when allergic reaction signaled for women 18 to 26 y old with dose 2 in the outpatient setting.

  • f Appendicitis was classified as an uncommon adverse event in this study, but a statistical signal was detected with ESA, and it is therefore included here.

  • g No signal was detected for this subgroup. Data were extracted from the report for the week when appendicitis signaled for boys 9 to 17 y old with dose 3.