Evidence map›Paper›PMID 36679876›Full record

ArticleVaccines2022

COVID-19 Vaccination Did Not Increase the Risk of Potentially Related Serious Adverse Events: 18-Month Cohort Study in an Italian Province.

Maria Elena Flacco, Cecilia Acuti Martellucci, Graziella Soldato, Giuseppe Di Martino, Roberto Carota, Marco De Benedictis, Graziano Di Marco, Giustino Parruti, Rossano Di Luzio, Antonio Caponetti and 1 more

Open access · goldAbstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.0field-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

17 citing papers in PubMed, 20 citations in OpenAlex.

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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

11 authors at 3 institutions in 1 country.

Maria Elena FlaccoDepartment of Environmental and Prevention Sciences, University of Ferrara, 44121 Ferrara, Italy.
Cecilia Acuti MartellucciDepartment of Environmental and Prevention Sciences, University of Ferrara, 44121 Ferrara, Italy.ORCID 0000-0002-4308-2144
Graziella SoldatoLocal Health Unit of Pescara, 65124 Pescara, Italy.
Giuseppe Di MartinoLocal Health Unit of Pescara, 65124 Pescara, Italy.ORCID 0000-0001-7047-7611
Roberto CarotaLocal Health Unit of Pescara, 65124 Pescara, Italy.
Marco De BenedictisLocal Health Unit of Pescara, 65124 Pescara, Italy.
Graziano Di MarcoLocal Health Unit of Pescara, 65124 Pescara, Italy.
Giustino ParrutiLocal Health Unit of Pescara, 65124 Pescara, Italy.
Rossano Di LuzioLocal Health Unit of Pescara, 65124 Pescara, Italy.
Antonio CaponettiLocal Health Unit of Pescara, 65124 Pescara, Italy.
Lamberto ManzoliDepartment of Medical and Surgical Sciences, University of Bologna, 40100 Bologna, Italy.ORCID 0000-0002-8129-9344
Azienda USL di Pescara · ITUniversity of Ferrara · ITUniversity of Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This cohort study on the entire population of an Italian Province assessed the incidence of potentially vaccine-related serious adverse events (PVR-SAEs) by COVID-19 vaccination status. From January 2021 to July 2022, we extracted all deaths and hospitalizations due to several cardiovascular diseases, pulmonary embolism, and deep vein thrombosis from National Healthcare System official data. During the follow-up, 5743 individuals died, and 2097 were hospitalized for PVR-SAEs. Vaccinated subjects (n = 259,821) did not show an increased risk of all-cause death, non-COVID death, or any PVR-SAEs, as compared to the unvaccinated (n = 56,494). These results were consistent across genders, age-classes, vaccine types, and SARS-CoV-2 infection status and did not vary in Cox models adjusting for age, gender, SARS-CoV-2 infection, and selected comorbidities. In the infected population, any dose of vaccine was associated with a lower likelihood of death and PVR-SAE. In the uninfected population, subjects who received one or two doses showed a significantly higher incidence of most outcomes, likely due to a large selection bias introduced by the Italian restriction policies targeting uninfected subjects who received less than three doses. In conclusion, COVID-19 vaccination was not associated with an increase of mortality or selected PVR-SAEs incidence. Further research is warranted to evaluate the long-term safety of COVID-19 vaccines.

Indexed as

adverse eventscohort studyCOVID-19ItalySARS-CoV-2

Identifiers

PMID36679876
PMCPMC9861956
OpenAlexW4312100677

What OpenQuestion holds

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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.