Real-world safety profile of the 9-valent human papillomavirus vaccine: A study in Zhejiang, China from 2019 to 2021

Figures & data

Table 1. Characteristics of adverse events following immunization (AEFI) with 9-valent HPV vaccine.

Report characteristics	No.	%
Category
Vaccine product-related reaction (minor)	290	87.61
Vaccine product-related reaction (severe)	19	5.74
Coincidental event	6	1.81
Psychogenic reaction	16	4.83
Severity
Serious	2	0.60
Non-serious	329	99.40
Age group
16–18	35	10.57
19–21	64	19.33
22–24	149	45.02
25–26	83	25.08
Onset from vaccination
<1 d	204	61.63
1–2	82	24.77
3–4	15	4.53
5–9	18	5.44
≥10 d	12	3.63

Figure 1. Reporting rate of adverse event following immunization of 9vhpv from 2019 to 2021, Zhejiang province (/10,000 doses).

Table 2. Distribution of 9vHPV AEFI reports by city.

		AEFI		Vaccine product-related reaction (severe)
City	9vHPV doses administered	No.	Reporting rate	No.	Reporting rate
Hangzhou	291,327	70	2.40	6	0.21
Ningbo	163,268	51	3.12	2	0.12
Wenzhou	187,244	65	3.47	4	0.21
Jiaxing	76,928	32	4.16	3	0.39
Huzhou	43,238	19	4.39	1	0.23
Shaoxing	61,475	17	2.77	2	0.33
Jinhua	88,134	35	3.97	1	0.11
Quzhou	34,723	6	1.73	–	–
Zhoushan	8,862	–	–	–	–
Taizhou	66,610	23	3.45	1	0.15
Lishui	43,042	13	3.02	–	–
Total	1,064,851	331	3.12	20	0.19

Reporting rate: /10,000 doses.

Table 3. Reporting rate of the 9vHPV AEFI by doses.

		Vaccine product-related reaction (minor)		Vaccine product-related reaction (severe)		Coincidental event		Psychogenic reaction
Dose	Administered doses	No	Reporting rate	No	Reporting rate	No	Reporting rate	No	Reporting rate
1	450,108	134	2.98	12	0.27	4	0.09	14	0.31
2	353,212	76	2.15	5	0.14	2	0.06	1	0.03
3	261,531	80	3.06	2	0.08	0	0.00	1	0.04
Total	1,064,851	290	2.72	19	0.18	6	0.06	16	0.15

Reporting rate: /10,000 doses.

Table 4. Clinical diagnosis of AEFI reports following human papillomavirus 9-valent vaccine (9vHPV) from 2019–2021.

	No. of AEFI records
Clinical diagnosis	Vaccine product-related reaction (minor)	Vaccine product-related reaction (severe)	Coincidental event	Psychogenic reaction	Reporting rate	ROR-1.96SE
Maculopapular rash	1	0	0	0	0.01	0.22
Angioedema	0	1	0	0	0.01	0.32
Encephalitis	0	0	1	0	0.01	5.45
Sterile Abscess	0	1	0	0	0.01	2.43
Hysteria	0	0	0	1	0.01	0.82
Urticaria	3	6	0	0	0.08	1.16
Allergic rash	0	10	0	0	0.09	0.26
Syncope	1	0	0	9	0.09	43.96
Fever/redness/induration	281	0	0	0	2.64	0.51
Other reactions	4	1	5	6	0.15	1.03

Reporting rate: /10,000 doses.

Table 5. Interval between AEFI onset and immunization.

	Vaccine product-related reaction (minor)		Vaccine product-related reaction (severe)		Coincidental event		Psychogenic reaction
Onset from vaccination	No	%	No	%	No	%	No	%
<1 d	181	62.41	5	26.32	2	33.33	16	100
1 ≤ d < 2	57	19.66	8	42.11	0	–	0	–
2 ≤ d < 4	24	8.28	1	5.26	1	16.67	0	–
4 ≤ d < 10	21	7.24	3	15.79	0	–	0	–
≥ 10 d	7	2.41	12	10.53	3	50	0	–