Evidence map›Paper›PMID 34739452›Full record

ArticleActa bio-medica : Atenei Parmensis2021

Immediate adverse events following COVID-19 immunization. A cross-sectional study of 314,664 Italian subjects.

Vincenza Gianfredi, Massimo Minerva, Giulia Casu, Michele Capraro, Greta Chiecca, Giovanni Gaetti, Rosaria Mantecca Mazzocchi, Patrizia Musarò, Pasquale Berardinelli, Paola Basteri and 6 more

Open access · greenAbstract read
In one paragraph

Article in Acta bio-medica : Atenei Parmensis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.2field-weighted citation impact, top 18% 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

15 citing papers in PubMed, 19 citations in OpenAlex.

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  13. COVID-19 vaccination surveillance: a public health commitment.Acta bio-medica : Atenei Parmensis · 2022
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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

16 authors at 4 institutions in 2 countries.

Vincenza GianfrediSchool of Public Health, Vita-Salute San Raffaele University, Milan, Italy; CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands. gianfredi.vincenza@hsr.it.
Massimo MinervaSchool of Medicine, Vita-Salute San Raffaele University, Milan, Italy. minerva.massimo@hsr.it.
Giulia CasuSchool of Medicine, Vita-Salute San Raffaele University, Milan, Italy. casu.giulia@hsr.it.
Michele CapraroSchool of Medicine, Vita-Salute San Raffaele University, Milan, Italy. capraro.michele@hsr.it.
Greta ChieccaSchool of Medicine, Vita-Salute San Raffaele University, Milan, Italy. chiecca.greta@hsr.it.
Giovanni GaettiSchool of Medicine, Vita-Salute San Raffaele University, Milan, Italy. gaetti.giovanni@hsr.it.
Rosaria Mantecca MazzocchiIRCCS Ospedale San Raffaele, Milano, Italy . manteccamazzocchi.rosanna@hsr.it.
Patrizia MusaròIRCCS Ospedale San Raffaele, Milano, Italy . musaro.patrizia@hsr.it.
Pasquale BerardinelliSovrintendenza Sanitaria del Gruppo San Donato, Milano, Italy. berardinelli.pasqualino@hsr.it.
Paola BasteriSovrintendenza Sanitaria del Gruppo San Donato, Milano, Italy. paola.basteri@grupposandonato.it.
Beatrice BertiniSovrintendenza Sanitaria del Gruppo San Donato, Milano, Italy. Beatrice.Bertini@grupposandonato.it.
Camilla FerriSovrintendenza Sanitaria del Gruppo San Donato, Milano, Italy. camilla.ferri@grupposandonato.it.
Anna OdoneIRCCS Ospedale San Raffaele, Milano, Italy . anna.odone@unipv.it.
Carlo SignorelliSchool of Medicine, Vita-Salute San Raffaele University, Milan, Italy. signorelli.carlo@hsr.it.
Valerio Fabio AlbertiSovrintendenza Sanitaria del Gruppo San Donato, Milano, Italy. valeriofabio.alberti@grupposandonato.it.
Gilda GastaldiSovrintendenza Sanitaria del Gruppo San Donato, Milano, Italy. gilda.gastaldi@grupposandonato.it.
Gruppo CLAS (Italy) · ITVita-Salute San Raffaele University · ITIRCCS Ospedale San Raffaele · ITDepartment of Health · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimThe urgency of having rapidly safe and efficient COVID-19 vaccines called for the need to shorten trial phases, reduce sample sizes, and speed-up the approval process by the regulatory Agencies. In light of this, monitoring adverse effects (AEFI) (both immediate and at medium-long term) become of great importance. Aim of this cross-sectional study was to explore the associations between several factors and risk of immediate AEFI.

methodsData come from the electronic dataset developed ad hoc to record demographic data, anamnesis and data related to immunization, set-up in the mass vaccination site in Novegro (Milan). Novegro mass vaccination site was one of the mass vaccinations sites with the highest flow in Lombardy Region, with a maximum capacity of 5,000 vaccinations/day. The center opened in April 2021 and closed the 1st of August 2021. A multivariable logistic regression model was used. Odds ratios adjusted (aOR) for age and sex are presented. Statistical significance was set at p<0.05. Analyses were conducting using STATA.

resultsAmong the total of 314,671 subjects vaccinated, 0.5% developed an immediate AEFI, on average 17.0 ± 0.43 minutes after the administration. The three most frequent AEFI recorded were vagal response (30%), anxiety reaction (24%) and dizziness (21%). AEFI were more frequently observed among women [aOR= 2.24 (95%CI= 2.00 - 2.50)], and those with at least one previous disease [aOR= 1.47 (95%CI= 1.22-1.76)].

conclusionsIn conclusion, AEFI were less likely to occur for increasing age and after the second dose. Results from this large, complete and representative sample population regarding enrich the interesting scientific debate on potential adverse events following COVID-19 immunization.

Indexed as

COVID-19VaccinationAdverse Drug Reaction Reporting SystemsCOVID-19 VaccinesCross-Sectional StudiesFemaleHumansImmunizationItalyMaleCOVID-19 Vaccines

Identifiers

PMID34739452
PMCPMC8851022
OpenAlexW3210403132

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.