Evidence map›Paper›PMID 39370676›Full record

ArticleOral diseases2025

Oropharyngeal Adverse Events to Drugs and Vaccines: Pharmacovigilance Data From Italy (2019-2021).

Liberata Sportiello, Gaetano La Mantia, Vera Panzarella, Giuseppe Colella, Simona Potenza, Giacomo Oteri, Laura Sottosanti, Giuseppe Bellavia, Mario Gaio, Alessia Zinzi and 7 more

Abstract read
In one paragraph

Article in Oral diseases, 2025. 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
–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

4 citing papers in PubMed.

  1. Article
  2. Article
  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

17 authors.

Liberata SportielloCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.ORCID https://orcid.org/0000-0002-5884-9889
Gaetano La MantiaUnit of Oral Medicine and Dentistry for Fragile Patients, Department of Rehabilitation, Fragility, and Continuity of Care, University Hospital Palermo, Palermo, Italy.
Vera PanzarellaDepartment Me.Pre.CC, University of Palermo, Palermo, Italy.ORCID https://orcid.org/0000-0001-6339-6020
Giuseppe ColellaOral and Maxillofacial Surgery Unit, Multidisciplinary Department of Medical-Surgical and Dental Specialties, University of Campania "Luigi Vanvitelli", Naples, Italy.
Simona PotenzaItalian Medicines Agency, Rome, Italy.
Giacomo OteriDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.ORCID https://orcid.org/0000-0002-0941-1645
Laura SottosantiItalian Medicines Agency, Rome, Italy.
Giuseppe BellaviaDepartment of Drug, ASP Agrigento, Agrigento, Italy.
Mario GaioCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.ORCID https://orcid.org/0000-0003-4287-5510
Alessia ZinziCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.
Ilaria MorrealeInternal Medicine, Pharmacovigilance and Clinical Pharmacology Unit, Department of Promoting Health, Maternal-Infant, Excellence and Internal and Specialized Medicine (PROMISE) G. D'Alessandro, Sicilian Regional Pharmacovigilance Centre, University of Palermo, Palermo, Italy.
Gaspare ParrinelloDepartment of Promoting Health, Maternal-Infant, Excellence and Internal and Specialized Medicine (PROMISE) G. D'Alessandro, University of Palermo, Palermo, Italy.
Elisabetta GeninattiPiedmont Regional Centre for Pharmacovigilance, Turin, Italy.
Eleonora MarrazzoPiedmont Regional Centre for Pharmacovigilance, Turin, Italy.
Vittorio FuscoOncology Unit, Azienda Ospedaliera Di Alessandria SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.
Annalisa CapuanoCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.
Giuseppina CampisiUnit of Oral Medicine and Dentistry for Fragile Patients, Department of Rehabilitation, Fragility, and Continuity of Care, University Hospital Palermo, Palermo, Italy.ORCID https://orcid.org/0000-0002-9443-0495

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this study was to perform a descriptive analysis of oropharyngeal adverse events (AEs) related to drugs and/or vaccines in order to provide useful information for clinicians.

methodsData related to three regions of Italy were analyzed from 2019 to 2021 by using the National Pharmacovigilance database.

resultsAmong overall 67,384 cases, 2773 (4.1%) reported at least one oropharyngeal AE. Most cases referred to females (71.0%) and adults (70.8%). The majority of cases were reported as not serious (68.4%) and the outcome was mainly positive (73.5%). The cases related to drugs (52.2%) were slightly more than those related to vaccines (47.8%), the latter nearly completely represented by COVID-19 vaccines. Among 3324 oropharyngeal AEs, the most commonly reported were oropharyngeal conditions (65.9%). The most reported AEs related to vaccines were paresthesia oral and oropharyngeal pain, whereas the most reported AEs related to drugs were throat tightness and angioedema. A marked under-reporting of osteonecrosis of the jaw (2.9%) was observed, despite this risk was well documented in the same country.

conclusionsThis analysis suggested an under-reporting of oropharyngeal AEs and the need to better train dentists, dental hygienists, and also general practitioners.

Indexed as

COVID-19 VaccinesDrug-Related Side Effects and Adverse ReactionsPharmacovigilancePharyngeal DiseasesVaccinesAdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overChildFemaleHumansItalyMaleMiddle AgedCOVID-19 VaccinesVaccinesdatabasedentistsoropharyngeal adverse eventspharmacovigilancespontaneous reporting

Identifiers

PMID39370676
PMCPMC12021317

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.