Adverse effect investigation using application software after vaccination against SARS-CoV-2 for healthcare workers

Abstract

Introduction: The usefulness of smartphone-based application software as a way to manage adverse events (AEs) after vaccination is well known. The purpose of this study is to clarify the usefulness and precautions of employing a smartphone application for collecting AEs after the administration of Comirnaty®️.

Methods: Healthcare workers (HCWs) who were vaccinated with Comirnaty®️ were asked to register for the application software and to report AEs for 14 days after vaccination. AEs were self-reported according to severity. The software was set to output an alert in case of fever.

Results: The number of HCWs who received the first dose was 2,551, and 2,406 (94.3%) reported their vaccinations. 2,547 received the second dose, and 2,347 (92.1%) reported their vaccinations. With the first dose, the reporting rate stayed above 83.3% until the final day. On the other hand, that of the second dose decreased rapidly after 6 days. The most frequent symptom was "pain at injection site" (more than 70%). Severe AEs were 6.6% after the second dose, with 0.6% visiting a clinic. Many AEs peaked on the day after administration and disappeared within 1 week. There were few reports of fever.

Conclusion: Smartphone applications can be used to collect information on AEs after vaccination. Application settings and dissemination are necessary to maintain the reporting rate of HCWs.

Keywords: Adverse event; Application software; SARS-CoV2; Vaccine.

Fig. 1

Changes in health status reporting rate The black and gray lines indicate the reporting rates after the first and second doses, respectively.

Fig. 2

Classification of adverse events by age The severity of adverse events during the study period after vaccination is shown by age. HCWs, health care workers.

Fig. 3

Ratio of HCWs reporting adverse events and the day after vaccination HCWs, health care workers.