A prospective observational study to evaluate the safety of COVID-19 mRNA vaccines administered to Qatar Rehabilitation Institute patients.

Abstract

The safety of the COVID-19 mRNA vaccine in the outpatient setting has been extensively studied; however, there need to be more reports that specifically assess their safety in the inpatient population. It is hence imperative to explore the adverse drug reaction (ADR) profile in this population and monitor the progression of these ADRs in a hospital setting. This provides a unique opportunity to closely observe patients to ensure no side effects go undiagnosed. This study aims to explore and quantify the incidence and severity of ADRs in patients who have received the COVID-19 vaccine during their stay in the rehabilitation facility. This is a prospective observational study, which included adult patients admitted to the rehabilitation facility who were deemed eligible to receive the COVID-19 vaccine during their hospital stay. Data were collected by the investigators from June 2021 to May 2022 at 24 hours, 48 hours, and 7 days post-vaccination. A piloted data collection tool was utilized. Thirty-five patients met the inclusion criteria. Pain at the injection site was the most commonly reported local ADR, while headache was the most frequent systemic ADR. The majority of the reported ADRs were mild to moderate in nature, with only one severe reaction detected. Although no statistical significance was noted among the variables, common patterns were identified, such as a higher occurrence of fever at 24 hours after the second dose as opposed to the first dose. Close monitoring of the included study subjects did not reveal any unanticipated ADRs or an increase in ADRs susceptibility and severity compared to the general population. This study supports the initiation of vaccination campaigns in inpatient rehabilitation settings. This approach would offer the advantage of gaining full immunity and reducing the risk of contracting COVID-19 infection and complications once discharged.