Evidence map›Paper›PMID 30660400›Full record

ArticleVaccine2019

Safety of 9-valent human papillomavirus vaccine administration among pregnant women: Adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), 2014-2017.

Claudia S Landazabal, Pedro L Moro, Paige Lewis, Saad B Omer

Abstract read
In one paragraph

Article in Vaccine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

4 authors.

Claudia S LandazabalEmory University Rollins School of Public Health, Department of Epidemiology, 1518 Clifton Road, Atlanta, GA 30322, United States. Electronic address: claudialandazabal@alumni.emory.edu.
Pedro L MoroCenters for Disease Control and Prevention, National Center for Zoonotic and Emerging Infectious Diseases, Division of Healthcare Quality Promotion, Immunization Safety Office, 1600 Clifton Road, Atlanta, GA 30333, United States. Electronic address: psm9@cdc.gov.
Paige LewisCenters for Disease Control and Prevention, National Center for Zoonotic and Emerging Infectious Diseases, Division of Healthcare Quality Promotion, Immunization Safety Office, 1600 Clifton Road, Atlanta, GA 30333, United States. Electronic address: fqv9@cdc.gov.
Saad B OmerEmory University Rollins School of Public Health, Department of Epidemiology, 1518 Clifton Road, Atlanta, GA 30322, United States; Emory University Rollins School of Public Health, Hubert Department of Global Health, 1518 Clifton Road, Atlanta, GA 30322, United States; Emory Vaccine Center, 954 Gatewood Road, Atlanta, GA 30329, United States. Electronic address: somer@emory.edu.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

introduction9-valent human papillomavirus vaccine (9vHPV) was approved by the Food and Drug Administration (FDA) in December 2014. 9vHPV is not recommended during pregnancy, but some women of childbearing age may be inadvertently exposed. This study aims to evaluate reports submitted to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women exposed to 9vHPV.

methodsWe searched the VAERS database, a national post-licensure vaccine safety surveillance system, for reports of pregnant women vaccinated with 9vHPV in the United States between December 10, 2014 and December 31, 2017. Disproportionate reporting of adverse events (AEs) was assessed using proportional reporting ratios (PRRs).

resultsA total of 82 pregnancy reports were identified. Sixty reports (73.2%) did not describe an AE and were submitted only to report the vaccine exposure during pregnancy. The most frequently reported pregnancy-specific AE was spontaneous abortion (n = 3; 3.7%), followed by vaginal bleeding (n = 2; 2.4%). Among non-pregnancy-specific AEs, injection site reaction (n = 3; 3.7%) was most common. No disproportionate reporting of any AE was found. DISCUSSION: No unexpected AEs were observed among these pregnancy reports.

Indexed as

Pregnant PeopleAdolescentAdultAdverse Drug Reaction Reporting SystemsChildDatabases, FactualEpidemiological MonitoringFemaleHumansInjection Site ReactionPapillomavirus VaccinesPregnancyProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationVaccinationPapillomavirus VaccinesAdverse eventEpidemiologyHuman papillomavirus vaccineSurveillanceVaccine safety

Identifiers

PMID30660400
PMCPMC6505695

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.