Analysis of adverse events following immunization in Zhejiang, China, 2019: a retrospective cross-sectional study based on the passive surveillance system

Pan, Xuejiao; Lv, Huakun; Chen, Fuxing; Wang, Ying; Liang, Hui; Shen, Linzhi; Chen, Yaping; Hu, Yu

doi:10.1080/21645515.2021.1939621

Cited by 7 publications

(13 citation statements)

References 23 publications

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“…Similar to the previous reports, 13 , 16 most of the AEFI cases were reported by caregivers in this study, which would provide more sufficient identifying information and help the following medical review for inducing a confirmed category. On the other hand, it would also induce the report bias that caregivers would not be sensitive enough or even ignored to some mild AEFI.…”

Section: Discussionsupporting

confidence: 86%

“…Another finding in this analysis was that the reporting rates for general and serious AEFI associated with DTP-IPV/Hib were higher than those for all the vaccines used in Zhejiang province in 2019 (5.66/10000 doses for the general AEFI and 0.57/10000 doses for the serious AEFI). 13 These serious AEFI reports included urticarial, aseptic abscess, angioedema, allergic purpura, thrombocytopenic purpura, febrile convulsion, GBS, anaphylactic shock, acute disseminated encephalomyelitis, epilepsy.We also found that allergic rash, febrile convulsion and GBS as a positive signal for the higher reporting rate of AEFI associated with DTP-IPV/Hib. Although the reporting rates of these serious AEFI were still at low level, some of them were considered as the positive signals and were not found in the the pre- or post-safety studies or pharmacovigilance data (discussed below).…”

Section: Discussionmentioning

confidence: 99%

“…Our previous reports also revealed that the majority of the AEFI were non-serious events. 13 Of them, fever and injection site reaction were the most common forms of reactogenicity experienced after immunization.…”

Section: Discussionmentioning

confidence: 99%

“…In this study, majority of AEFI reports were onset on the day of vaccination, which was consistent with the previous reports on the surveillance of AEFI for all vaccines used in Zhejiang province. 13 The interval between vaccination and onset of AEFI was generally very short for the most frequent AEFI, such as fever or rash. Most of the AEFI associated with DTP-IPV/Hib was in the case of being administered alone in our analysis.…”

Section: Discussionmentioning

confidence: 99%

“…Continuous assessment of the safety analysis of the post-licensure vaccines can evaluate the benefit-risk profiles of a specific vaccine that cannot be evaluated in pre-licensure clinical trials due to sample size limitations. 13 Public trust in vaccines can also be strengthened by monitoring the vaccine safety. Surveillance of adverse events following immunization (AEFI) enables us to monitor the safety of vaccination programs and thereby contribute to validating the vaccination program.…”

Section: Introductionmentioning

confidence: 99%

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

Pan

Liang

et al. 2022

Human Vaccines & Immunotherapeutics

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Objectives The aim of this study is to describe the reporting rate of adverse events following immunization (AEFI) with pentavalent vaccine: diphtheria-pertussis-tetanus-poliomyelitis-Haemophilus influenzae type b (DPT-IPV/Hib), and to determine whether the reporting rate of AEFI following DPT-IPV/Hib was higher than the average level of the other vaccines. Methods Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2015 to 2020. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories. The data mining algorithm used in this study was reporting odds ratio (ROR). A value of ROR‑1.96SE >1 (standard error [SE]) was considered as positive signal. Results NAEFISS received 5726 AEFI reports following DTP-IPV/Hib, with a reporting rate of 20.01/10000 doses. Of the reported AEFI, 202 were serious vaccine product-related reactions, including two cases of anaphylactic shock, five cases of Guillain Barre Syndrome (GBS) and two cases of acute disseminated encephalomyelitis. The reporting rate of fever/redness/induration was the highest among all the clinical diagnosis (14.97/10000 doses). The positive signals were obtained for allergic rash (ROR-1.96SE: 1.36), febrile convulsion (ROR-1.96SE: 1.32) and GBS (ROR-1.96SE: 1.16). Conclusion The present findings bolstered that the DTP-IPV/Hib administered as the four-dose schedule was generally well tolerated in Chinese infants as we did not identify any new/unexpected safety concern from the NAEFISS during a six-year timespan.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

Pan

Liang

et al. 2022

Human Vaccines & Immunotherapeutics

Self Cite

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Adverse events following Measles-Mumps-Rubella and varicella immunization: A safety profile analysis and comparison of different vaccination schedules based on the Italian Pharmacovigilance Network in the Veneto Region

Soriolo,

Benoni,

Dalla Valle

et al. 2024

Preventive Medicine Reports

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Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants, in Zhejiang province, China

Pan

Chen

et al. 2022

Human Vaccines & Immunotherapeutics

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Objectives To evaluate the safety of 13-valent pneumococcal conjugate vaccine (PCV13) after its licensure. Methods Review and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2017 to 2020. Reporting rates of AEFI were calculated by age, city, severity of AEFI, categories of AEFI, and reaction categories. The data mining algorithm used in this study was reporting odds ratio (ROR). A value of ROR-1.96SE >1 (standard error [SE]) was considered as the positive signal. Results NAEFISS received 3332 AEFI cases following PCV13, with a reporting rate of 17.58/10000 doses. Of the reported AEFI, 652 were serious AEFI cases and the reporting rate was 3.44 for serious AEFI. The reporting rate of fever was the highest among all the clinical diagnosis (7.39/10000 doses). The positive signals were obtained for injection site reaction (ROR-1.96SE: 1.55), hypotonic hyporesponsive episode (HHE) (ROR-1.96SE: 1.62) and febrile seizure (ROR-1.96SE: 1.52). Conclusion The present results supported previous observations that the PCV13 administered as the four-dose schedule was generally well tolerated in Chinese infants as we did not identify any new/unexpected safety concern from the NAEFISS during a four-year time period.

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Analysis of adverse events following immunization in Zhejiang, China, 2019: a retrospective cross-sectional study based on the passive surveillance system

Cited by 7 publications

References 23 publications

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

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

Adverse events following Measles-Mumps-Rubella and varicella immunization: A safety profile analysis and comparison of different vaccination schedules based on the Italian Pharmacovigilance Network in the Veneto Region

Surveillance of adverse events following immunization of 13-valent pneumococcal conjugate vaccine among infants, in Zhejiang province, China

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