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Suspected adverse events following immunization against SARS-CoV2 in a university hospital in 2021
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  • Dolores Rodriguez,
  • Pilar Ordoñez,
  • Roser Llop,
  • Sebastian Videla,
  • Aurema Otero,
  • Thiago Carnaval,
  • Violeta Poltorak,
  • Miguel Moya-Guerola,
  • Cristina Masuet,
  • Soledad Rodriguez,
  • Pilar Hereu
Dolores Rodriguez
Hospital Universitari de Bellvitge

Corresponding Author:[email protected]

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Pilar Ordoñez
Hospital Universitari de Bellvitge
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Roser Llop
Hospital Universitari de Bellvitge
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Sebastian Videla
Hospital Universitari de Bellvitge
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Aurema Otero
IDIBELL
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Thiago Carnaval
Hospital Universitari de Bellvitge
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Violeta Poltorak
Hospital Universitari de Bellvitge
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Miguel Moya-Guerola
Hospital Universitari de Bellvitge
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Cristina Masuet
Hospital Universitari de Bellvitge
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Soledad Rodriguez
Hospital Universitari de Bellvitge
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Pilar Hereu
Hospital Universitari de Bellvitge
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Abstract

Aim: Vaccination against SARS-CoV2 has been proposed as a fundamental element for the control of the pandemic. The aim of this study is to describe the suspected adverse reactions (ADRs) reported among vaccinated hospital workers. Methods: Descriptive study of suspected ADRs identified between January and March 2021. The suspected ADRs were identified by specifically designed electronic form and by spontaneous reporting. Data was also collected regarding the characteristics of the professionals, vaccine administered, severity, and outcome of the ADR. Results: 8,169 professionals received the two doses of SARS-CoV2 vaccine (6,672 Comirnaty® and 1,497 Spikevax®) and 894 reports of suspected ADR were reported (762 for Comirnaty® and 132 for Spikevax®), so a cumulative AEFIs incidence of 10.94% (95%CI: 10.27-11.62). The majority of ADRs were reported only after the second dose, 497(56.2%) while 211 (23.6%) was reported only after the first dose and a 186 (21%) after both doses. Symptoms were mostly mild, did not require medical assistance and disappeared in about 3 days. One hundred and seventeen professionals had a history of COVID-19. These reported, statistically significant, more suspected ADRs after the first dose (42.7%) than professionals with no history of COVID-19 (20.7%). Among the professionals, more ADRs occurred after the first dose with the Spikevax® vaccine (41.6%) than with the Comirnaty® vaccine (20.5%). Conclusion: The majority of the suspected ADRs reported were those described in the summary of product characteristics (SmPC). Professionals with history of COVID-19 reported more suspected ADRs after the first dose than professionals without history.