Postmarketing Safety Monitoring After Influenza Vaccination Using a Mobile Health App: Prospective Longitudinal Feasibility Study

Abstract

Background: For the safety monitoring of vaccinations postlicensure, reports of adverse events after immunization (AEFIs) are crucial. New technologies such as digital mobile apps can be used as an active approach to capture these events. We therefore conducted a feasibility study among recipients of the influenza vaccination using an app for assessment of the reporting of AEFIs.

Objective: The goal of the research was to determine factors influencing adherence to and correct use of a newly developed app for individuals to report AEFI for 3 months using regular reminder functions, to identify determinants of AEFI occurrence and define reported AEFI types.

Methods: We developed the app (SafeVac) and offered it to recipients of the influenza vaccination in 3 occupational settings in fall 2018. In this prospective longitudinal feasibility study, data on AEFIs were generated through SafeVac for 3 months. Using logistic and Cox regression, we assessed associations between app adherence, correct app entry, AEFIs, and sociodemographic parameters.

Results: Of the individuals who logged into SafeVac, 61.4% (207/337) used the app throughout a 3-month period. App use adherence was negatively associated with female sex (odds ratio [OR] 0.47; CI 0.25-0.91) and correct app entry was negatively associated with older age (OR 0.96; CI 0.93-0.99) and lower education (OR 0.31; CI 0.13-0.76). AEFI occurrence was associated with female sex (hazard ratio 1.41; CI 1.01-1.96) and negatively with older age (hazard ratio 0.98; CI 0.97-0.99). The most common AEFIs reported were injection site pain (106/337), pain in extremity (103/337), and fatigue/asthenia (73/337).

Conclusions: Digital AEFI reporting was feasible with SafeVac and generated plausible results for this observation period and setting. Studies directly comparing SafeVac with conventional passive reporting schemes could determine whether such digital approaches improve completeness, timeliness, and sensitivity of vaccine vigilance. Further studies should evaluate if these results are transferable to other vaccinations and populations and if introduction of such a tool has an influence on vaccination readiness and therefore vaccine safety.

Keywords: active reporting; adverse effect; adverse event; adverse event following immunization; digital health; mHealth; mobile health; pharmacovigilance; therapeutic use.

Figure 1

Screenshot of SafeVac app.

Figure 2

Study participant recruitment. ¹Obtained through personal communication and estimates based on institutional website; for PEI and IBB only ≥18 years old included; ²included participants who were vaccinated before study days.

Figure 3

Reported adverse event following immunization occurrences per time point after influenza vaccination.

Figure 4

Factors associated with fully adherent app use versus partially adherent app use over 3 months, pseudoR2 (McFadden) = 0.065. F: female; M; male; Y: yes; N: no; IBB: Investitionsbank Berlin; FFM: University Hospital Frankfurt; PEI: Paul Ehrlich Institute.

Figure 5

Factors associated with correct versus incorrect entry of vaccination information, pseudoR2 (McFadden) = 0.124. F: female; M; male; Y: yes; N: no; IBB: Investitionsbank Berlin; FFM: University Hospital Frankfurt; PEI: Paul Ehrlich Institute.

Figure 6

Factors associated with adverse event following immunization occurrence versus nonoccurrence. F: female; M; male; Y: yes; N: no; IBB: Investitionsbank Berlin; FFM: University Hospital Frankfurt; PEI: Paul Ehrlich Institute.