Evidence map›Paper›PMID 38021647›Full record

ArticleCureus2023

Adverse Events Following mRNA COVID-19 Vaccine in 2021 and 2022: A Retrospective Analysis in Costa Rica and Italy.

Bruno Serrano-Arias, Francesco Ferrara, Esteban Zavaleta, Andrea Zovi, Adolfo Ortiz-Barboza, Roberta Pasquinucci, Sebastián Arguedas-Chacón, Eduardo Nava, Roberto Langella, Giuseppe Russo

Open access · diamondAbstract read
In one paragraph

Article in Cureus, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 80% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

10 authors at 1 institution in 2 countries.

Bruno Serrano-AriasResearch Department, Hospital Clinica Biblica, San Jose, CRI.
Francesco FerraraPharmacy Department, ASL (Azienda Sanitaria Locale) Napoli 3 Sud, Napoli, ITA.
Esteban ZavaletaResearch Department, Hospital Clinica Biblica, San Jose, CRI.
Andrea ZoviHygiene Department, Ministry of Health, Rome, ITA.
Adolfo Ortiz-BarbozaSchool of Public Health, Universidad de Costa Rica, San Pedro, CRI.
Roberta PasquinucciPharmacy Department, ASL (Azienda Sanitaria Locale) Napoli 3 Sud, Nola, ITA.
Sebastián Arguedas-ChacónResearch Department, Hospital Clinica Biblica, San Jose, CRI.
Eduardo NavaPharmacy Department, ASL (Azienda Sanitaria Locale) Napoli 3 Sud, Nola, ITA.
Roberto LangellaItalian Society of Hospital Pharmacy, Secretariat of the Lombardy Region, Milan, ITA.
Giuseppe RussoStrategic Management Department, ASL (Azienda Sanitaria Locale) Napoli 3 Sud, Naples, ITA.
Ministero della Salute · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction Pharmacovigilance plays a crucial role in evaluating and monitoring the safety of medicines, which is essential for preventing harm to patients and improving public health. This study aims to compare the pharmacovigilance systems of Costa Rica and Italy and assess the safety profile of coronavirus disease 2019 (COVID-19) vaccines in both countries. Methods Data were collected from the official pharmacovigilance platforms in Costa Rica and Italy. Adverse events following immunization (AEFIs) were categorized by system organ class. Reports of suspected AEFIs associated with COVID-19 vaccines were analyzed for the period from January 1, 2021, to December 31, 2022. Results Both countries achieved high vaccination rates, with 84.9% in Italy and 92.9% in Costa Rica. A higher proportion of AEFIs occurred in females in both countries, with 53% and 65% in Naples and Costa Rica, respectively. Most AEFIs were observed in individuals aged 18-64 years. The rate of serious adverse reactions was lower in both countries than the international average. However, Naples reported a higher incidence of serious events per 100,000 inhabitants. Discussion The study sheds light on the importance of vaccine safety profiling and the significance of a comprehensive understanding of vaccine safety and effectiveness, specific population data, and collaborative strategies to mitigate and improve safety. Additionally, the study highlighted the significance of considering sex and gender when evaluating vaccine safety and efficacy, as sex-specific differences may impact vaccine outcomes. Conclusion Continuous pharmacovigilance efforts, collaborative approaches, and comprehensive data analysis are critical in ensuring vaccine safety and efficacy and safeguarding global public health. Lessons learned from the COVID-19 pandemic highlight the importance of proactive measures in addressing emerging challenges in vaccine safety and rollout programs worldwide.

Indexed as

adverse eventscovid-19 vaccinespharmacoepidemiologypharmacovigilancepublic healthpublic health and safety

Identifiers

PMID38021647
PMCPMC10676764
OpenAlexW4387969157

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.