• Dolores Rodríguez, Pilar Ordoñez, Roser Llop, Sebastián Videla, Aurema Otero, Thiago Carnaval, Violeta Poltorak, Miguel Moya-Guerola, Cristina Masuet-Aumatell, Soledad Rodriguez, and Pilar Hereu.
• Clinical Pharmacology Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.
• Medicine (Baltimore). 2022 Oct 14; 101 (41): e30976.

AimVaccination against SARS-CoV2 has been proposed as a fundamental element for the control of the pandemic. This study aimed to describe the suspected adverse reactions (ADR) reported by vaccinated hospital workers.MethodsA descriptive study of suspected ADR was conducted between January and March 2021. The suspected ADR were identified using a specifically designed electronic form and spontaneous reporting. Data were also collected regarding the characteristics of the professionals, vaccine administered, severity, and outcome of ADR.Results8169 professionals received 2 doses of SARS-CoV2 vaccine (6672 Comirnaty® and 1497 Spikevax®) and 894 reports of suspected ADR were reported (762 for Comirnaty® and 132 for Spikevax®), resulting in a cumulative ADR incidence of 10.94% (95%CI: 10.27-11.62). The majority of ADR were reported only after the second dose, 497 (56.2%), while 211 (23.6%) were reported only after the first dose and 186 (21%) after both doses. The symptoms were mostly mild, did not require medical assistance, and disappeared within approximately 3 days. One hundred and seventeen professionals had a history of COVID-19 infection. These studies reported, statistically significant, more suspected ADR after the first dose (42.7%) than those with no history of COVID-19 (20.7%). Among professionals, more ADR occurred after the first dose with the Spikevax® vaccine (41.6%) than with the Comirnaty® vaccine (20.5%).ConclusionThe majority of suspected ADR reported were described in the summary of product characteristics (SmPC). Professionals with a history of COVID-19 reported more suspected ADR after the first dose than did those without a history.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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