Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine using the national adverse event following immunization surveillance system from Zhejiang province, 2018-2020

Figures & data

Table 1. Characteristics of AEFI reports following human papillomavirus quadrivalent vaccine (4vHPV) from 2018–2020 (N = 238)

Report characteristics	No.	%
Category
Vaccine product-related reaction (minor)	183	76.89
Vaccine product-related reaction (severe)	38	15.97
Vaccination error	1	0.42
Coincidental event	12	5.04
Anxiety reaction	4	1.68
Severity
Serious	50	21.01
non-serious	188	78.99
Type of reporter
Health care provider	188	78.99
Patients or caregivers	39	16.39
Manufacturer	11	4.62
Age group
<20	1	0.42
20-	65	27.31
30-	140	58.82
40–45	32	13.45
Onset from vaccination
0–1d	196	82.35
2–3d	24	10.08
4–7d	10	4.20
8–14d	3	1.26
≥15d	5	2.10
4vHPV administered alone	207	86.97

Table 2. Serious AEFI and non-serious AEFI reports following human papillomavirus quadrivalent vaccine (4vHPV) from 2018–2020, by city

City	4vHPV doses administered	AEFI		Serious AEFI
		No.	Reporting rate	No.	Reporting rate
Hangzhou	281072	78	2.78	17	0.60
Ningbo	100848	43	4.26	11	1.09
Wenzhou	170532	37	2.17	8	0.47
Jiaxing	80165	18	2.25	5	0.62
Huzhou	27765	8	2.88	1	0.36
Shaoxing	60810	9	1.48	1	0.16
Jinhua	57076	19	3.33	2	0.35
Quzhou	19409	3	1.55	1	0.52
Zhoushan	8610	2	2.32	0	0.00
Taizhou	44345	13	2.93	2	0.45
Lishui	38650	8	2.07	2	0.52
Total	889282	238	2.68	50	0.56

Reporting rate:/10000 doses.

Figure 1. Reporting rate of adverse event following immunization of 4vHPV from 2018 to 2020, Zhejiang province (/10000 doses).

Table 3. Clinical diagnosis of AEFI reports following human papillomavirus quadrivalent vaccine (4vHPV) from 2018–2020

Clinical diagnosis	No. of AEFI reports					Reporting rate	ROR‑1.96SE
	Vaccine product-related reaction (minor)	Vaccine product-related reaction (severe)	Coincidental event	Anxiety reaction	Vaccination error
Aseptic abscess	0	0	2	0	0	0.02	0.78
Urticaria	2	5	0	0	0	0.08	0.71
Allergic purpura	0	2	0	0	0	0.02	0.58
Thrombocytopenic purpura	0	1	0	0	0	0.01	0.42
Angioedema	0	3	0	0	0	0.03	0.91
Seizure	0	6	0	0	0	0.07	2.09
Anaphylactic shock	0	2	0	0	0	0.02	0.38
Laryngeal edema	0	2	0	0	0	0.02	0.43
Polyneuritis	0	3	0	0	0	0.03	0.61
Guillain Barre Syndrome	0	3	0	0	0	0.03	0.48
Epilepsy	0	0	2	0	0	0.02	0.57
Cellulitis	0	0	3	0	0	0.03	0.52
Syncope	0	0	0	4	0	0.04	1.33
Acute disseminated encephalomyelitis	0	2	0	0	0	0.02	0.92
Allergic rash	33	9	5	0	0	0.53	1.58
Headache	48	0	0	0	0	0.54	2.08
Fever/redness/induration	100	0	0	0	1	1.14	0.79

Reporting rate:/10000 doses.