American Academy of Pediatrics

TABLE 3

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

Adverse Event	Subgroup, Sex, Age Group in y, 9vHPV Dose	Week When First Signaled	No. 9vHPV Vaccinations in Subgroup	No. Total Cases^a	No. Exposed Cases^a	RR	P
Allergic reaction^b	Female, 9–17, ED or inpatient, any	82	242 726	33	26	2.7	.04
	Female, 9–17, outpatient, any	No signal^c	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 signal^d	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 signal^e	33 118	8	1	0.4	.92
Appendicitis^f	Male, 9–17, dose 3	84	73 122	50	30	2.1	.03
	Male, 9–17, any	No signal^g	271 679	103	81	1.5	.09
	Male, 9–17, dose 1	No signal^g	106 741	47	25	1.4	.23
	Male, 9–17, dose 2	No signal^g	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	3	2	95.0	.04
	Male, 18–26, dose 1	34	13 228	14	9	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 Event	Subgroup, Sex, Age Group in y, 9vHPV Dose	Week When First Signaled	No. 9vHPV Vaccinations in Subgroup	No. Total Cases^a	No. Exposed Cases^a	RR	P
Allergic reaction^b	Female, 9–17, ED or inpatient, any	82	242 726	33	26	2.7	.04
	Female, 9–17, outpatient, any	No signal^c	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 signal^d	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 signal^e	33 118	8	1	0.4	.92
Appendicitis^f	Male, 9–17, dose 3	84	73 122	50	30	2.1	.03
	Male, 9–17, any	No signal^g	271 679	103	81	1.5	.09
	Male, 9–17, dose 1	No signal^g	106 741	47	25	1.4	.23
	Male, 9–17, dose 2	No signal^g	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	3	2	95.0	.04
	Male, 18–26, dose 1	34	13 228	14	9	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.

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.

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

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.

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.

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.

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.

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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