Background Clinical trial guidelines for assessing the safety of vaccines, are primarily based on self-reported questionnaires. Despite the tremendous technological advances in recent years, objective, continuous assessment of physiological measures post-vaccination is rarely performed. Methods We conducted a prospective observational study during the mass vaccination campaign in Israel. 160 participants >18 years who were not previously found to be COVID-19 positive and who received the BNT162b2 COVID-19 (Pfizer BioNTech) vaccine were equipped with an FDA-approved chest-patch sensor and a dedicated mobile application. The chest-patch sensor continuously monitored 13 different cardiovascular, and hemodynamic vitals: heart rate, blood oxygen saturation, respiratory rate, systolic and diastolic blood pressure, pulse pressure, mean arterial pressure, heart rate variability, stroke volume, cardiac output, cardiac index, systemic vascular resistance and skin temperature. The mobile application collected daily self-reported questionnaires on local and systemic reactions. Results We identify continuous and significant changes following vaccine administration in nearly all vitals. Markedly, these changes are observed even in presumably asymptomatic participants who did not report any local or systemic reaction. Changes in vitals are more apparent at night, in younger participants, and in participants following the second vaccine dose. Conclusion the considerably higher sensitivity of wearable sensors can revolutionize clinical trials by enabling earlier identification of abnormal reactions with fewer subjects.

The unprecedented restrictions imposed due to the COVID-19 pandemic altered our daily habits and severely affected our well-being and physiology. The effect of these changes is yet to be fully understood. Here, we analysed highly detailed data on 169 participants for two to six months, before and during the second COVID-19 lockdown in Israel. We extracted 12 well-being indicators from sensory data of smartwatches and from self-reported questionnaires, filled daily using a designated mobile application. We found that, in general, lockdowns resulted in significant changes in mood, sleep duration, sport duration, social encounters, resting heart rate and number of steps. Examining subpopulations, we found that younger participants (aged 20–40 years) suffered from a greater decline in mood and number of steps than older participants (aged 60–80 years). Likewise, women suffered from a higher increase in stress and reduction in social encounters than men. Younger early chronotypes did not increase their sleep duration and exhibited the highest drop in mood. Our findings underscore that while lockdowns severely impacted our well-being and physiology in general, greater damage has been identified in certain subpopulations. Accordingly, special attention should be given to younger people, who are usually not in the focus of social support, and to women.

The unprecedented restrictions imposed due to the COVID-19 pandemic, including movement control orders and lockdowns, altered our daily habits, and severely affected our well-being and physiology. The effect of these changes is yet to be fully understood. Here, we analyzed highly detailed data on 169 participants for 2-6 months, before and during the second COVID-19 lockdown in Israel. Our entire study was conducted during the COVID-19 pandemic, and therefore is the first to decipher the specific effects of the lockdown from the general effects of the pandemic. We extracted 12 well-being indicators from sensory data of smartwatches and from self-reported questionnaires, filled on a daily basis using a designated mobile application. We used a mixed ANOVA model to study the interplay between age, gender, and chorotype on well-being before and after lockdowns. We found that at the population level, lockdowns resulted in significant changes in mood, sleep duration, sport duration, social encounters, resting heart rate, and the number of steps. The lockdown's adverse effects were greater for young early chronotypes who did not increase their sleep duration, reduced activity level and suffered from significantly reduced mood, and for women, who further suffered an increase in stress levels and a greater decline in social encounters. Our findings underscore that while lockdowns severely impacted our well-being and physiology in general, greater damage has been identified in certain subpopulations. Based on the observed effects, special attention should be given to younger people, who are usually not in the focus of social support, and to women.

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Background: Clinical trial guidelines for assessing the safety of vaccines, including the FDA criteria, are primarily based on subjective, self-reported questionnaires. Despite the tremendous technological advances in recent years, objective, continuous assessment of physiological measures post-vaccination is rarely performed. Methods: To evaluate the short-term effects of the BNT162b2 COVID-19 vaccine on physiological measures, we conducted a prospective observational study during the mass vaccination campaign in Israel. 160 individuals >18 years who were not previously found to be COVID-19 positive and who received the second dose of the COVID-19 vaccine between 1 January 2021, and 13 March 2021 were equipped with a chest-patch sensor and a dedicated mobile application. The chest-patch sensor continuously measured 13 physiological vitals one day before the inoculation (baseline), for four days: heart rate, blood oxygen saturation, respiratory rate, systolic and diastolic blood pressure, pulse pressure, mean arterial pressure, heart rate variability, stroke volume, cardiac output, cardiac index, systemic vascular resistance, and body temperature. The mobile application collected daily self-reported questionnaires starting one day before the inoculation, for 15 days on local and systemic reactions, sleep quality, stress levels, physical activity, and mood levels. Findings: Within the first 48 hours post-vaccination, we identified significant changes (p-value <0.05) in nearly all 13 chest-patch indicators compared to their baseline levels. 48.5% (n=78) reported no local or systemic reaction. Nevertheless, we identified considerable changes in chest-patch indicators during the first 48 hours post-vaccination also in this group of presumably asymptomatic participants. Within three days from vaccination, these measures returned to baseline levels in both groups, further supporting the safety of the vaccine. Interpretation: Our work underscores the importance of obtaining objective physiological data in addition to self-reported questionnaires when performing clinical trials, particularly in ones conducted in very short time frames. Funding: The European Research Council (ERC) project #949850.