Surveillance on the adverse events following immunization with the pentavalent vaccine in Zhejiang, China

Figures & data

Figure 1. The reporting rate of AEFI following DPT-IPV/Hib from 2015 to 2020, by month of onset.

Table 1. Characteristics and reporting rate of AEFI reports following DPT-IPV/Hib from 2015 to 2020

Variable	Level	Administered doses	AEFI reports	Reporting rate*	χ^2	p
		2860884	5726
Gender	Male	1430420	2858	19.98	6.22	>.05
	Female	1430464	2868	20.05
Dose number	1	730223	1066	14.60	201.62	<.01
	2	721654	1304	18.07
	3	711423	1548	21.76
	4	697584	1808	25.92
Category	Vaccine product-related reaction (minor)	2860884	5460	19.09	338.29	<.01
	Vaccine product-related reaction (severe)	2860884	202	0.71
	Vaccination error	2860884	17	0.06
	Coincidental event	2860884	42	0.15
	Anxiety reaction	2860884	5	0.02
Severity	Serious	2860884	227	0.79	280.45	<.01
	Non-serious	2860884	5499	19.22
Type of reporter	Health care provider	2860884	778	2.72	163.82	<.01
	Caregivers	2860884	4941	17.27
	Manufacturer	2860884	7	0.02
Onset from vaccination	0–1d	2860884	3597	12.57	118.5	<.01
	2–3d	2860884	1507	5.27
	4–7d	2860884	367	1.28
	8–14d	2860884	177	0.62
	≥15d	2860884	78	0.27
Administrated alone		2577129	5211	20.22

*: /10000 doses.

Table 2. Serious AEFI and non-serious AEFI reports following DPT-IPV/Hib from 2015–2020, by city

City	Administered doses	AEFI reports		Serious AEFI reports		Non-serious AEFI reports
		No.	Reporting rate*	No.	Reporting rate*	No.	Reporting rate*
Hangzhou	789244	1609	20.39	125	1.58	1484	18.80
Ningbo	710320	1335	18.79	111	1.56	1224	17.23
Wenzhou	288818	698	24.17	44	1.52	654	22.64
Jiaxing	271362	547	20.16	41	1.51	506	18.65
Huzhou	101275	200	19.75	17	1.68	183	18.07
Shaoxing	208334	380	18.24	32	1.54	348	16.70
Jinhua	182077	399	21.91	28	1.54	371	20.38
Quzhou	45776	87	19.01	8	1.75	79	17.26
Zhoushan	29456	45	15.28	4	1.36	41	13.92
Taizhou	172477	309	17.92	28	1.62	281	16.29
Lishui	61744	117	18.95	6	0.97	111	17.98
Total	2860884	5726	20.01	444	1.55	5282	18.46

*: /10000 doses.

Table 3. Clinical diagnosis of AEFI reports following DPT-IPV/Hib from 2015–2020

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	25	0	0	0	0.09	0.83
Urticaria	2	107	0	0	0	0.38	0.92
Allergic purpura	0	15	3	0	0	0.06	0.78
Thrombocytopenic purpura	0	12	3	0	0	0.05	0.92
Angioedema	0	21	0	0	0	0.07	0.53
Febrile convulsion	1	12	2	0	0	0.05	1.32
Anaphylactic shock	0	2	0	0	0	0.01	0.70
Guillain Barre Syndrome	0	5	6	0	0	0.04	1.16
Epilepsy	0	1	6	0	0	0.02	0.59
Cellulitis	0	0	4	0	10	0.05	0.62
Acute disseminated encephalomyelitis	0	2	3	0	0	0.02	0.73
Allergic rash	1202	0	0	0	0	4.20	1.36
Fever/redness/induration	4255	0	15	5	7	14.97	0.59

*: /10000 doses.