Evidence map›Paper›PMID 24378675›Full record

ArticleAmerican journal of obstetrics and gynecology2014

Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women.

Pedro L Moro, Oidda I Museru, Manette Niu, Paige Lewis, Karen Broder

Open access · greenAbstract read
In one paragraph

Article in American journal of obstetrics and gynecology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
6.2field-weighted citation impact, top 3% 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

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Article
  8. Maternal vaccination: a review of current evidence and recommendations.American journal of obstetrics and gynecology · 2022
    Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Viral hepatitis and pregnancy.Nature reviews. Gastroenterology & hepatology · 2021
    Review
  14. Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
    Article
  15. Hepatitis A vaccination.Human vaccines & immunotherapeutics · 2020
    Article
  16. Article
  17. Review
  18. Article
  19. Hepatitis A Virus Prevention and Vaccination Within and Outside the Veterans Health Administration in Light of Recent Outbreaks.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2018
    Article
  20. 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 at 2 institutions in 1 country.

Pedro L MoroImmunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
Oidda I MuseruImmunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
Manette NiuCenter for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD.
Paige LewisImmunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
Karen BroderImmunization Safety Office, Division Of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.
Centers for Disease Control and Prevention · USUnited States Food and Drug Administration · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

objectiveTo characterize adverse events (AEs) after hepatitis A vaccines (Hep A) and hepatitis A and hepatitis B combination vaccine (Hep AB) in pregnant women reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. STUDY

designWe searched VAERS for AEs reports in pregnant women who received Hep A or Hep AB from Jan. 1, 1996-April 5, 2013. Clinicians reviewed all reports and available medical records.

resultsVAERS received 139 reports of AEs in pregnant women; 7 (5.0%) were serious; no maternal or infant deaths were identified. Sixty-five (46.8%) did not describe any AEs. For those women whose gestational age was available, most were vaccinated during the first trimester, 50/60 (83.3%) for Hep A and 18/21 (85.7%) for Hep AB. The most common pregnancy-specific outcomes following Hep A or Hep AB vaccinations were spontaneous abortion in 15 (10.8%) reports, elective termination in 10 (7.2%), and preterm delivery in 7 (5.0%) reports. The most common nonpregnancy specific outcome was urinary tract infection and nausea/vomiting with 3 (2.2%) reports each. One case of amelia of the lower extremities was reported in an infant following maternal Hep A immunization.

conclusionThis review of VAERS reports did not identify any concerning pattern of AEs in pregnant women or their infants following maternal Hep A or Hep AB immunizations during pregnancy.

Indexed as

Adverse Drug Reaction Reporting SystemsAbortion, SpontaneousAdultFemaleHepatitis AHepatitis BHumansInfant, NewbornPregnancyPremature BirthUnited StatesUrinary Tract InfectionsViral Hepatitis VaccinesViral Hepatitis Vaccineshepatitis A hepatitis B combined vaccinehepatitis A vaccinepregnancysurveillancevaccine safety

Identifiers

PMID24378675
PMCPMC6500450
OpenAlexW2070524346

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.