Suspected adverse events following immunization against SARS-CoV2 in a
university hospital in 2021
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.