Evidence map›Paper›PMID 34613883›Full record

ArticleHuman vaccines & immunotherapeutics2021

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

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

Open access · bronzeAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 47% of its field
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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Observational
  2. Review
  3. Article
  4. 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

8 authors at 1 institution in 1 country.

Yu HuInstitute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Xuejiao PanInstitute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Linzhi ShenInstitute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Fuxing ChenInstitute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Ying WangInstitute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Hui LiangInstitute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Yaping ChenInstitute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Huakun LvInstitute of Immunization and Prevention, Zhejiang Center for Disease Control and Prevention, Hangzhou, China.
Zhejiang Center for Disease Control and Prevention · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the reporting rate of adverse events following immunization (AEFI) of the quadrivalent human papillomavirus vaccine (4vHPV) and to compare the reporting rate of AEFI following 4vHPV with those following other vaccines.

methodsReview and describe the AEFI reported to national adverse event following immunization surveillance system (NAEFISS) in Zhejiang province from 2018 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.

resultsNAEFISS received 238 reports after receipt of 4vHPV and 899,282 doses of 4vHPV were administered during the study period, with a crude reporting rate of 2.7/10000 doses. Fever/redness/induration (101 reports) was the most common event reported (1.12/10000 doses). Two cases of anaphylactic shock, three cases of Guillain Barre Syndrome and two cases of acute disseminated encephalomyelitis were reported. ROR showed positive signals for seizure (ROR‑1.96SE: 2.1), syncope (ROR‑1.96SE: 1.3), allergic rash (ROR‑1.96SE: 1.6) and headache (ROR‑1.96SE: 2.1).

conclusionThe present analysis did not identify new/unexpected safety concerns. Further epidemiological studies are required to systematically validate the data provided by NAEFISS.

Indexed as

Guillain-Barre SyndromePapillomavirus VaccinesAdverse Drug Reaction Reporting SystemsHumansImmunizationVaccinationPapillomavirus VaccinesAEFI (adverse events following immunization)quadrivalent human papillomavirus vaccinesafetysurveillancevaccination

Identifiers

PMID34613883
PMCPMC8903994
OpenAlexW3203094496

What OpenQuestion holds

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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.