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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 reactionb Female, 9–17, ED or inpatient, any 82 242 726 33 26 2.7 .04 
 Female, 9–17, outpatient, any No signalc 242 726 86 60 0.8 .75 
 Female, 9–17, ED or inpatient, dose 1 94 109 896 26 17 2.8 .04 
 Female, 9–17, outpatient, dose 1 No signald 109 896 82 50 1.2 .28 
 Female, 18–26, outpatient, dose 2 86 33 118 38 15 1.9 .04 
 Female, 18–26, ED or inpatient, dose 2 No signale 33 118 0.4 .92 
Appendicitisf Male, 9–17, dose 3 84 73 122 50 30 2.1 .03 
 Male, 9–17, any No signalg 271 679 103 81 1.5 .09 
 Male, 9–17, dose 1 No signalg 106 741 47 25 1.4 .23 
 Male, 9–17, dose 2 No signalg 91 156 47 26 1.5 .23 
Injection site reaction Male, 9–17, dose 3 26 23 409 29 18 2.5 .03 
Nonspecific reaction Male, 18–26, dose 3 25 4054 95.0 .04 
 Male, 18–26, dose 1 34 13 228 14 11.1 .04 
 Female, 18–26, dose 1 50 26 711 71 34 1.7 .03 
 Female, 18–26, any 105 128 806 215 126 1.3 .04 
Syncope Female, 18–26, any 25 28 234 98 67 1.8 .007 
 Female, 18–26, dose 1 25 12 245 65 35 2.0 .004 
 Female, 18–26, dose 2 31 10 924 60 25 1.7 .04 
Adverse EventSubgroup, Sex, Age Group in y, 9vHPV DoseWeek When First SignaledNo. 9vHPV Vaccinations in SubgroupNo. Total CasesaNo. Exposed CasesaRRP
Allergic reactionb Female, 9–17, ED or inpatient, any 82 242 726 33 26 2.7 .04 
 Female, 9–17, outpatient, any No signalc 242 726 86 60 0.8 .75 
 Female, 9–17, ED or inpatient, dose 1 94 109 896 26 17 2.8 .04 
 Female, 9–17, outpatient, dose 1 No signald 109 896 82 50 1.2 .28 
 Female, 18–26, outpatient, dose 2 86 33 118 38 15 1.9 .04 
 Female, 18–26, ED or inpatient, dose 2 No signale 33 118 0.4 .92 
Appendicitisf Male, 9–17, dose 3 84 73 122 50 30 2.1 .03 
 Male, 9–17, any No signalg 271 679 103 81 1.5 .09 
 Male, 9–17, dose 1 No signalg 106 741 47 25 1.4 .23 
 Male, 9–17, dose 2 No signalg 91 156 47 26 1.5 .23 
Injection site reaction Male, 9–17, dose 3 26 23 409 29 18 2.5 .03 
Nonspecific reaction Male, 18–26, dose 3 25 4054 95.0 .04 
 Male, 18–26, dose 1 34 13 228 14 11.1 .04 
 Female, 18–26, dose 1 50 26 711 71 34 1.7 .03 
 Female, 18–26, any 105 128 806 215 126 1.3 .04 
Syncope Female, 18–26, any 25 28 234 98 67 1.8 .007 
 Female, 18–26, dose 1 25 12 245 65 35 2.0 .004 
 Female, 18–26, dose 2 31 10 924 60 25 1.7 .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.

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