Adverse Events in COVID-19 Vaccination
Conditions
Brief summary
The study investigates the side effects of different COVID-19 vaccines.
Detailed description
In this observational study side effects of COVID-19 vaccines will be documented using an open-source mobile application. Participants are invited to answer a questionnaire on a daily basis. Common and unknown events are queried and collected. The primary result of this study will be a descriptive analysis of the collected data.
Interventions
BIOLOGICALCOVID-19 vaccines
Participants will be vaccinated with one of the approved COVID-19 vaccines
Sponsors
University of Ulm
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
* received COVID-19 vaccination * age ≥ 18 years * mobile device (iOS or Android)
Exclusion criteria
* No knowledge of German or English language * No written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related side effects | 4 weeks | Number of participants with treatment-related side effects as assessed by the toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (status September 2007) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution and deviation of documented side effects | 4 weeks | Descriptive statistics for different side effects |
Countries
Germany
Contacts
Primary ContactThomas Seufferlein, Prof. Dr.
Outcome results
None listed