Spontaneous adverse event reporting by COVID-19 vaccinated healthcare
professionals through an electronic form implemented by the hospital
pharmacy
Abstract
Aim Implementation of a web-form based pharmacovigilance plan for the
spontaneous notification of adverse events to the Comirnaty® COVID-19
vaccine during its administration to hospital healthcare professionals.
Methods An electronic pharmacovigilance form was developed containing 8
pre-defined event options, an open answer option for the description of
other events and/or symptoms, and a question about the overall intensity
of symptoms. The adverse events reports were standardised according to
physiological and pathological condition. Results A total of 4119
adverse events notifications were obtained with a 45% rate of
electronic notification. The most clinically relevant events reported
were: tachycardia (n=19), dyspnoea (n=7), chest pain (n=6),
facial/labial oedema (n=6), lipothymia (n=5), bronchospasm (n=2),
herpetic infection (n=2), vasculitis (n=2), arrhythmia (n=1), difficult
to control arterial hypertension (n=1), gastritis (n=1) and spontaneous
abortion (n=1). Regarding the intensity of symptoms (n=2928), 70.0%
were reported as mild, 25.8% as moderate and 4.27% as severe, with
higher intensity in the 2nd dose compared to 1st dose. The highest
frequency of severe events were reported in the groups from 40 to 59
years in both vaccination periods. During the vaccination process, no
hospitalisations and no deaths were notified and/or recorded. Conclusion
In this real world study, comparing with Comirnaty clinical trials
program, it was observed a higher frequency of adenomegaly and
gastrointestinal disorders. Noteworthy, the notification of a case of
miscarriage. The use of hospital pharmacy pharmacovigilance electronic
forms, seemed to be relevant to notification adherence and to obtain a
greater and faster knowledge of COVID-19 vaccine safety profile.