Evidence map›Paper›PMID 36274082›Full record

Observational studyClinical drug investigation2022

COVID-19 mRNA Vaccines: A Retrospective Observational Pharmacovigilance Study.

Francesco Ferrara, Carolina Mancaniello, Alessia Varriale, Sarah Sorrentino, Andrea Zovi, Eduardo Nava, Ugo Trama, Mariarosaria Boccellino, Antonio Vitiello

Open access · bronzeAbstract readObservational Study
In one paragraph

Observational study in Clinical drug investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.1field-weighted citation impact, top 11% 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

11 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Trend analysis of proton pump inhibitor consumption and expenditure: The real-world evidence.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Article
  5. Article
  6. COVID-19 Pandemic: Therapeutic Strategies and Vaccines.International journal of molecular sciences · 2023
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
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 4 institutions in 1 country.

Francesco FerraraPharmaceutical Department, Asl Napoli 3 Sud, Dell'amicizia street 22, Nola, 80035, Naples, Italy. ferrarafr@libero.it.ORCID http://orcid.org/0000-0001-9298-6783
Carolina MancanielloPharmaceutical Department, Asl Napoli 3 Sud, Dell'amicizia street 22, Nola, 80035, Naples, Italy.
Alessia VarrialePharmaceutical Department, Asl Napoli 3 Sud, Dell'amicizia street 22, Nola, 80035, Naples, Italy.
Sarah SorrentinoPharmaceutical Department, Asl Napoli 3 Sud, Dell'amicizia street 22, Nola, 80035, Naples, Italy.
Andrea ZoviDepartment of Pharmaceutical Sciences, University of Milan, G. Colombo street 71, 20133, Milan, Italy.
Eduardo NavaPharmaceutical Department, Asl Napoli 3 Sud, Dell'amicizia street 22, Nola, 80035, Naples, Italy.
Ugo TramaGeneral Direction for Health Protection and Coordination of the Campania Regional Health System, Naples, Italy.
Mariarosaria BoccellinoDepartment of Biochemistry, Biophysics and General Pathology, University of Campania "Luigi Vanvitelli", Naples, Italy.
Antonio VitielloPharmaceutical Department Usl Umbria 1, XIV Settembre street, 06121, Perugia, Italy.ORCID http://orcid.org/0000-0003-2623-166X
Analysis and Monitoring of Environmental Risk · ITRegione Campania · ITUniversity of Campania "Luigi Vanvitelli" · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveCoronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus has caused millions of deaths worldwide. The mRNA vaccines prevented the figure from being more severe. The objective of this retrospective study is to evaluate the safety of COVID-19 vaccines by analyzing the adverse events following immunization (AEFIs).

methodsA retrospective observational pharmacovigilance study was conducted, based on the collection of reports of suspected AEFIs reported between 1 January 2021 and 31 December 2021 at the Naples 3 local health authority. AEFIs were stratified and described according to mRNA vaccine, demographics, clinical status, description of AEFI, and degree of severity. In 2021, local health authority Asl Naples 3 South received 1164 reports of suspected adverse events that occurred following the administration of mRNA vaccines.

resultsDuring the reporting period, 746 reports were related to the Comirnaty vaccine (64.1%), 281 to the Vaxzevria vaccine (24.1%), 107 to the Spikevax vaccine (9.2%), and 30 to the Jcovden vaccine (2.6%); 89.3% of the reports were classified as not serious (N = 1039 reports), the remaining 10.7% as serious (N = 125 reports).

conclusionsThis retrospective pharmacovigilance study demonstrates that COVID-19 mRNA vaccines are safe in all population groups.

Indexed as

COVID-19COVID-19 VaccinesVaccinesAdverse Drug Reaction Reporting SystemsHumansmRNA VaccinesPharmacovigilanceRetrospective StudiesRNA, MessengerSARS-CoV-2VaccinationCOVID-19 VaccinesmRNA VaccinesRNA, MessengerVaccines

Identifiers

PMID36274082
PMCPMC9589581
OpenAlexW4307106851

What OpenQuestion holds

Textmetadata
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.