Evidence map›Paper›PMID 28744844›Full record

ArticleDrug safety2017

Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan.

Kazuki Ozawa, Akiyo Hineno, Tomomi Kinoshita, Sakiko Ishihara, Shu-Ichi Ikeda

Abstract read
In one paragraph

Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing 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

24 citing papers in PubMed.

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  15. Human papillomavirus vaccine - lower risk, higher benefit.Journal of family medicine and primary care · 2020
    Article
  16. Review
  17. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Kazuki OzawaDepartment of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine, Matsumoto, Japan.
Akiyo HinenoDepartment of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine, Matsumoto, Japan.
Tomomi KinoshitaDepartment of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine, Matsumoto, Japan.
Sakiko IshiharaDepartment of Rehabilitation, Shinshu University Hospital, Matsumoto, Japan.
Shu-Ichi IkedaIntractable Disease Care Center, Shinshu University Hospital, Matsumoto, 390-0802, Japan. ikedasi@shinshu-u.ac.jp.

Funding

Health and Labour Science Research Grant on Emerging and Re-emerging Infectious Disease Establishment of Treatments and Providing Information on Symptoms after HPV vaccination, H28-001
6 · The paper itself

Abstract

introductionIn Japan, after receiving human papillomavirus vaccination, a significant number of adolescent girls experienced various symptoms, the vast majority of which have been ascribed to chronic regional pain syndrome, orthostatic intolerance, and/or cognitive dysfunction. However, a causal link has not been established between human papillomavirus vaccination and the development of these symptoms.

objectiveThe aim of this study was to clarify the temporal relationship between human papillomavirus vaccination and the appearance of post-vaccination symptoms.

methodsBetween June 2013 and December 2016, we examined symptoms and objective findings in 163 female patients who had received human papillomavirus vaccination. We used newly defined diagnostic criteria for accurate inclusion of patients who experienced adverse symptoms after human papillomavirus vaccination; these diagnostic criteria were created for this study, and thus their validity and reliability have not been established.

resultsOverall, 43 female patients were excluded. Among the remaining 120 patients, 30 were diagnosed as having definite vaccine-related symptoms, and 42 were diagnosed as probable. Among these 72 patients, the age at initial vaccination ranged from 11 to 19 years (average 13.6 ± 1.6 years), and the age at appearance of symptoms ranged from 12 to 20 years (average 14.4 ± 1.7 years). The patients received the initial human papillomavirus vaccine injection between May 2010 and April 2013. The first affected girl developed symptoms in October 2010, and the last two affected girls developed symptoms in October 2015. The time to onset after the first vaccine dose ranged from 1 to 1532 days (average 319.7 ± 349.3 days).

conclusionsThe period of human papillomavirus vaccination considerably overlapped with that of unique post-vaccination symptom development. Based on these sequential events, it is suggested that human papillomavirus vaccination is related to the transiently high prevalence of the previously mentioned symptoms including chronic regional pain syndrome and autonomic and cognitive dysfunctions in the vaccinated patients.

Indexed as

AdolescentAdverse Drug Reaction Reporting SystemsChildDrug-Related Side Effects and Adverse ReactionsFemaleHumansJapanPapillomavirus InfectionsPapillomavirus VaccinesPrevalenceSpatio-Temporal AnalysisUterine Cervical NeoplasmsVaccinationYoung AdultPapillomavirus Vaccines

Identifiers

PMID28744844
PMCPMC5688202

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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.