Patient-Reported Outcomes for Fully Vaccinated COVID-19 Patients Over 6 Weeks: The Experiences of Clinical Breakthrough Cases

BACKGROUND: While coronavirus disease 2019 (COVID-19) vaccines have high rates of efficacy, fully vaccinated individuals can become infected with COVID-19. Among this population, symptoms tend to be less severe and shorter lasting. Less is known about how vaccinated individuals who contract COVID-19 experience the disease through patient-reported outcomes (PROs) and how this changes over time. OBJECTIVE: The aim of this study was to describe the physical, mental, and social health PROs for fully vaccinated individuals who contracted COVID-19 over a 6-week period. DESIGN: Prospective design using the Patient-Reported Outcomes Measurement Information System short-form (PROMIS-10) collected through a mobile application-based platform. PARTICIPANT: 1114 fully vaccinated patients who tested positive for COVID-19 at a large US health system and engaged with the study on or after 1 March 2021 and reported onset of illness prior to 1 November 2021. MAIN MEASURES: Global physical and mental health PROMIS-10 T-scores for the 6-week period, component PROMIS-10 questions for the 6-week period, and component PROMIS-10 questions restricted to a subset of participants for the first month to measure individual recovery were analyzed. KEY RESULTS: Mean global physical and mental health T-scores increased over time and remained within one standard deviation of the population mean. At baseline, at least 40% of participants reported good health for all component questions except Fatigue (25%), and the proportion reporting good health increased over time for all questions, with the largest improvements in Fatigue (25.5 to 67.5%), Pain (59.1 to 82.8%), and Emotional Problems (42.3 to 62.5%). Over the first month, the greatest positive changes in individual recovery were observed for Fatigue (65.0%), Pain (53.0%), and Emotional Problems (41.1%); at least 30% of respondents reported no change in at least one category, and the greatest decreases were for Usual Social Activities (23.9%), Social Satisfaction (23.2%), and Mental Health (21.8%). CONCLUSIONS: This study provides an important step towards better understanding the impact of ‘breakthrough’ COVID-19 infections on clinically engaged, fully vaccinated patients’ physical and mental health to improve support for their treatment and recovery. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40271-022-00605-8.