Evidence map›Paper›PMID 40865054›Full record

ArticleHuman vaccines & immunotherapeutics2025

A post-marketing safety surveillance study on vaccines in Chongqing, China from 2006 to 2021: Using a nationwide spontaneous reporting database with multiple data mining methods.

Binyue Xu, Qing Wang, Jiawei Xu, Jianqiao Li, Ningpei Bai

Abstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Binyue XuEPI Department, Chongqing Municipal Center for Disease Control and Prevention, Chongqing, China.
Qing WangEPI Department, Chongqing Municipal Center for Disease Control and Prevention, Chongqing, China.ORCID 0000-0003-1492-7571
Jiawei XuEPI Department, Chongqing Municipal Center for Disease Control and Prevention, Chongqing, China.
Jianqiao LiEPI Department, Chongqing Municipal Center for Disease Control and Prevention, Chongqing, China.
Ningpei BaiEPI Department, Chongqing Municipal Center for Disease Control and Prevention, Chongqing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Chinese National Adverse Events Following Immunization Information System (CNAEFIS) is the national-level passive vaccine safety surveillance system. This study aims to identify post-marketing vaccine adverse reaction signals in Chongqing through systematic analysis of 15-year AEFI data, verify the safety profile of locally recommended vaccines, and provide localized evidence for clinical practice and immunization policy formulation. The study included all 36 marketed vaccines in mainland China and collected all rare adverse reactions (RAR) reported in Chongqing through CNAEFIS from 2006 to 2021. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Gamma-Poisson Shrinker (GPS) were employed to mine potential safety signals within the database. From 2006 to 2021, approximately 90.1 million vaccine doses were recorded in Chongqing, China, and 20,195 individual cases of Adverse Events Following Immunization (AEFIs) were reported. Of these, 3,110 cases (15.4%) were linked to RAR, at an incidence rate of 32.2 per 100,000 doses. Allergic reactions were the most prevalent, with 2,743 cases (88.2% of the RAR), and the Measles-Rubella Vaccine (MR) had the highest IR of allergic reactions, reaching 267.1 cases per 100,000 doses administered. A total of 23 suspicious signals were identified through the combined use of PRR, ROR, GPS, and BCPNN methods. The corresponding clinical diagnoses were mainly non-serious diseases such as angioedema, Henoch-Schönlein purpura, and local abscess. The warning signals of severe diseases such as anaphylactic shock and laryngeal edema, which could be life-threatening due to improper clinical treatment, were weak. The overall safety of vaccines in Chongqing is satisfactory. Vaccine manufacturers should optimize the production process to enhance vaccine tolerability.

Indexed as

Adverse Drug Reaction Reporting SystemsData MiningDrug-Related Side Effects and Adverse ReactionsProduct Surveillance, PostmarketingVaccinesAdolescentAdultAgedBayes TheoremChildChild, PreschoolChinaDatabases, FactualFemaleHumansIncidenceVaccinesdisproportionality analysesEpidemiologypost marketingsignal detectionsurveillancevaccinevaccine safety

Identifiers

PMID40865054
PMCPMC12392794

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.