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https://hdl.handle.net/2445/190158
Title: | Suspected adverse events following immunization against SARS-CoV2 in a university hospital in 2021: Observational study |
Author: | Rodríguez, Dolores Ordoñez, Pilar Llop, Roser Videla, Sebastián Otero, Aurema Carnaval, Thiago Poltorak, Violeta Moya-guerola, Miguel Masuet Aumatell, Cristina Rodriguez, Soledad Hereu, Pilar |
Keywords: | COVID-19 Vacunació COVID-19 Vaccination |
Issue Date: | 14-Oct-2022 |
Publisher: | Ovid Technologies (Wolters Kluwer Health) |
Abstract: | Aim: Vaccination 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. Methods: A 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. Results: 8169 professionals received 2 doses of SARS-CoV2 vaccine (6672 Comirnaty (R) and 1497 Spikevax (R)) and 894 reports of suspected ADR were reported (762 for Comirnaty (R) and 132 for Spikevax (R)), 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 (R) vaccine (41.6%) than with the Comirnaty (R) vaccine (20.5%). Conclusion: The 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1097/MD.0000000000030976 |
It is part of: | Medicine, 2022, vol. 101, issue. 41, p. e30976 |
URI: | https://hdl.handle.net/2445/190158 |
Related resource: | https://doi.org/10.1097/MD.0000000000030976 |
ISSN: | 1536-5964 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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Suspected_adverse_events_following_immunization.115.pdf | 740.65 kB | Adobe PDF | View/Open |
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