Survey of Symptoms After a COVID Vaccination in Employees

Survey of Symptoms After a COVID Vaccination in Employees: a Retrospective Study.

Background:

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) has had us firmly in its grip for more than two years. In January 2021, the quality and risk management unit of the LKH (Landeskrankenhaus) -Univ. Klinikum Graz commissioned to carry out vaccinations for employees and subsequently for high-risk patients.

In the vaccination line, which was open for 85 days in 2021/22, the vaccines from Astra Zeneca, Biontech-Pfizer and Moderna were vaccinated. There were hardly any complications. The primary immunization, booster vaccination and booster vaccination were carried out.

Despite the small number of incidents in the sense of an immediate reaction, there were numerous sick leave.

Methods:

For this reason, in the course of the booster vaccination, starting from October 2021 to January 2022, every vaccinated person was asked to fill out a questionnaire. Participation was voluntary and was supported by the works councils of the Medical University and the LKH-University clinic Graz approved. The survey served to retrospectively record how many employees developed symptoms in response to the respective vaccination.

With this approach it will be possible to subject the responses to an in-depth statistical analysis in order to obtain a data-based contribution to the side effects of vaccines categorized with different vaccination schemes.

Study Overview

• Status: Completed
• Conditions: Symptoms Recoding SARS-CoV-2 After Vaccination
• Intervention / Treatment: Other: questionnaire

• Study Type: Observational
• Enrollment (Actual): 1093

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Employees of the University Clinic Graz who get a booster vaccination.

Description

Inclusion Criteria:

• Employees with appropriate indication (>4 months after the second vaccination) according to the recommendations of the national vaccination committee.
• Signed vaccination information sheet.

Exclusion Criteria:

• no booster vaccination.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of symptoms after the respective vaccination	Occurence of symptoms, assessed by a questionnaire	10 Minutes

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Symptoms
• Other Study ID Numbers: EC number: 34-326 ex 21/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No