Evidence map›Paper›PMID 34739472›Full record

ArticleActa bio-medica : Atenei Parmensis2021

Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital.

Giacomo Pietro Vigezzi, Alessandra Lume, Massimo Minerva, Paola Nizzero, Anna Biancardi, Vincenza Gianfredi, Anna Odone, Carlo Signorelli, Matteo Moro

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 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.5field-weighted citation impact, top 15% 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

18 citing papers in PubMed, 24 citations in OpenAlex.

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  13. COVID-19 immunisation in older people.The lancet. Healthy longevity · 2022
    Article
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  15. Safety and BNT162b2 mRNA COVID-19 vaccination.Acta bio-medica : Atenei Parmensis · 2022
    Article
  16. COVID-19 vaccination surveillance: a public health commitment.Acta bio-medica : Atenei Parmensis · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Giacomo Pietro VigezziSchool of Medicine, Vita-Salute San Raffaele University. gvigezzi@hotmail.com.
Alessandra LumeSchool of Medicine, Vita-Salute San Raffaele University. lume.alessandra@hsr.it.
Massimo MinervaSchool of Medicine, Vita-Salute San Raffaele University. minerva.massimo@hsr.it.
Paola NizzeroInfection Control Committee, IRCCS San Raffaele Hospital. nizzero.paola@hsr.it.
Anna BiancardiInfection Control Committee, IRCCS San Raffaele Hospital. biancari.anna@hsr.it.
Vincenza GianfrediSchool of Medicine, Vita-Salute San Raffaele University. gianfredi.vincenza@hsr.it.
Anna OdoneDepartment of Public Health, Experimental and Forensic Medicine, University of Pavia. anna.odone@unipv.it.
Carlo SignorelliSchool of Medicine, Vita-Salute San Raffaele University. signorelli.carlo@hsr.it.
Matteo MoroInfection Control Committee, IRCCS San Raffaele Hospital. moro.matteo@hsr.it.
Vita-Salute San Raffaele University · ITUniversity of Pavia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimComirnaty® was the first COVID-19 vaccine available for the vaccination campaign of healthcare workers in Italy. With the aim of assessing vaccine safety, we conducted a cross-sectional survey administrating a voluntary-based questionnaire on adverse events following immunisation (AEFIs) in San Raffaele Hospital, Milano, Italy.

methodsFrom 4th January 2021 to 27th April 2021, we collected 2,659 questionnaires (response rate: 24,5%). We analyzed data, reporting AEFIs by gender, age, self-reported severity, type, time of insurgence and duration, and estimating relative-risk ratios (RRR) and corresponding 95% confidence intervals (CI).

resultsThe most reported symptoms were injection site pain, fatigue, headache, myalgia, chills, fever, and arthralgia. Severe systemic reactions were more frequent after receiving the second dose (RRR 6.25, 95% CI 4.57-8.55), in women (RRR 3.33, 95% CI 2.30-4.82), and less frequent in individuals aged 60 or more (RRR 0.26, 95% CI 0.14-0.49). In addition, we noted a wide range of adverse events of special interest (AESIs).

conclusionsConsistently with clinical trials and pharmacovigilance surveillance, AEFIs were frequent, but severe ones were uncommon, supporting the massive implementation of the COVID-19 vaccination campaign and providing valuable data for a risk profiling of vaccinees. (www.actabiomedica.it).

Indexed as

COVID-19COVID-19 VaccinesVaccinationBNT162 VaccineCross-Sectional StudiesFemaleHospitals, TeachingHumansItalyMaleRNA, MessengerBNT162 VaccineCOVID-19 VaccinesRNA, Messenger

Identifiers

PMID34739472
PMCPMC8851005
OpenAlexW3210196302

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.