Evidence map›Paper›PMID 31591347›Full record

ArticleVaccines2019

Adverse Events Following Measles-Mumps-Rubella-Varicella Vaccination and the Case of Seizures: A Post Marketing Active Surveillance in Puglia Italian Region, 2017-2018.

Pasquale Stefanizzi, Paolo Stella, Domenica Ancona, Katia Nicoletta Malcangi, Francesco Paolo Bianchi, Sara De Nitto, Davide Ferorelli, Cinzia Annatea Germinario, Silvio Tafuri

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
4.6field-weighted citation impact, top 5% 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

20 citing papers in PubMed, 34 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Observational
  8. Article
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Immediate side effects of Comirnaty COVID-19 vaccine: A nationwide survey of vaccinated people in Israel, December 2020 to March 2021.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2022
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. 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

9 authors at 2 institutions in 1 country.

Pasquale StefanizziDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari 70124, Italy. pasquale.stefanizzi@uniba.it.
Paolo StellaApulian Regional Health Department, Bari 70126, Italy.
Domenica AnconaApulian Regional Health Department, Bari 70126, Italy.
Katia Nicoletta MalcangiDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari 70124, Italy.
Francesco Paolo BianchiDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari 70124, Italy.
Sara De NittoDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari 70124, Italy.
Davide FerorelliInterdisciplinary Department of Medicine, Aldo Moro University of Bari, Bari 70124, Italy.
Cinzia Annatea GerminarioDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari 70124, Italy.
Silvio TafuriDepartment of Biomedical Science and Human Oncology, Aldo Moro University of Bari, Bari 70124, Italy. silvio.tafuri@uniba.it.
University of Bari Aldo Moro · ITAgenzia Regionale Sanitaria della Puglia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Since 2012, the Italian Ministry of Health has recommended to improve the surveillance of adverse events following the measles-mumps-rubella-varicella (MMRV) tetravalent vaccine that was provided in the official immunization schedule of some Italian regions for children during the second year of life. This recommendation was based on data from some surveys that showed an additional risk of seizure following the administration of this vaccine. Responding to the Ministry commitment, the Puglia Region launched, from May 2017 to November 2018, a post-marketing active surveillance program of adverse events following MMRV immunization (AEFIs). Immunized children (second year of life) were enrolled on a voluntary basis, AEFIs diaries were used, and their parents were interviewed 25 days after the immunization. There were 2540 children enrolled; 2149/2540 (84.6%) completed the post-vaccination follow-up. Of these, 992 AEFIs were registered with a reporting rate of 46.2 × 100 doses: 883/992 (89.0%) AEFIs were not serious, while 109/992 (11.0%) were serious. For serious AEFIs, the evaluation of causality assessment was performed using the algorithm proposed by the World Health Organisation (WHO): 82/109 consistent causal associations to MMRV immunization were detected (reporting rate of consistent AEFIs: 3.8 × 100 follow-up). All serious AEFIs consistently associated with immunization resulted completely resolved at the follow-up. The reporting rate of seizure consistently associated with immunization was 0.05 × 100, lower than data previous published in the literature that did not report the causality assessment. Because no emerging signals were detected, our data from the active surveillance program confirmed the safety profile of the MMRV vaccine.

Indexed as

causality assessmentfebrile seizurespharmacovigilancereporting ratesafety vaccinevaccine confidence

Identifiers

PMID31591347
PMCPMC6963278
OpenAlexW2978545607

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.