Dataset Information

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

ABSTRACT:

Background and aim

Comirnaty® 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.

Methods

From 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).

Results

The 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).

Conclusions

Consistently 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).

SUBMITTER: Vigezzi GP

PROVIDER: S-EPMC8851005 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Vigezzi Giacomo Pietro GP Lume Alessandra A Minerva Massimo M Nizzero Paola P Biancardi Anna A Gianfredi Vincenza V Odone Anna A Signorelli Carlo C Moro Matteo M

Acta bio-medica : Atenei Parmensis 20211001 S6

<h4>Background and aim</h4>Comirnaty® 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.<h4>Methods</h4>From 4th January 2021 to 27th April 2021, we collected 2,659 questionnaires (response rate: 24,5%). We analyzed data, reporting ...[more]

PMID: 34739472

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Dataset Information

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

Background and aim

Methods

Results

Conclusions

Publications

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

Similar Datasets

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