JMIR Hum Factors. 2022 Aug 2. doi: 10.2196/38701. Online ahead of print.
BACKGROUND: Over the last few years, increasingly studies focused on the development of mobile apps as complementary tools to existing pharmacovigilance traditional surveillance systems for improving and facilitating adverse drug reactions reporting.
OBJECTIVE: In this study, we evaluated the potentiality of a new mobile app (vaxEffect@UniMiB) to perform longitudinal studies while preserving the anonymity of the respondents. We applied it to monitor the adverse drug reactions during COVID-19 vaccination campaign in a sample of Italian population.
METHODS: We administered vaxEffect@UniMiB to a convenience sample of academic subjects vaccinated at Milano-Bicocca University hub for COVID-19 during the Italian national vaccination campaign. vaxEffect@UniMiB was developed for both Android and iOS devices. The mobile app asks users to send their medical history and, upon every vaccine administration, their vaccination data and the adverse reactions that occurred within seven days after the vaccination, allowing the follow of reactions dynamic for each respondent. The app sends data over the web to an application server. The web server, along with receiving all user data, saves them in a SQL database server, and reminds patients to submit vaccine and adverse reactions’ data by push notifications sent to the mobile app through Firebase Cloud Messaging. On initial startup of the app, a unique user identifier was generated for each respondent, so that its anonymity is completely ensured, while enabling longitudinal studies.
RESULTS: A total of 3712 people have been vaccinated during the first vaccination wave. A total of 2733 respondents between the ages of 19 and 80, coming from the University of Milano-Bicocca and the Politecnico of Milan, participated in the survey. Overall, we collected the information about vaccination and adverse reactions to the first vaccine dose for 2226 subjects (60.0% of vaccinated), to the second dose for 1610 subjects (43.3%), and, in a non-sponsored fashion, to the third dose for 169 individuals.
CONCLUSIONS: vaxEffect@UniMiB revealed to be the first attempt in performing longitudinal studies to monitor the same subject over time in terms of the reported ADRs after each vaccine administration, while guaranteeing at the same time complete anonymity of the subjects. A series of aspects contributed to a positive involvement from people in using this application to report their ADRs to vaccination: ease of use, availability from multiple platforms, anonymity of all the survey participants and protection of the submitted data and the healthcare workers’ support.