Post Vaccination Adverse Events in Covid-19 Vaccine Recipients
- Conditions
- Vaccine Adverse ReactionCOVID-19 Vaccination
- Interventions
- Drug: Standard Preparation
- Registration Number
- NCT05254977
- Lead Sponsor
- Islamia University of Bahawalpur
- Brief Summary
Covid-19 pandemic is caused by Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-Cov-2) since its outbreak 2019. Protection against Covid-19 can be achieved through global immunization. Various vaccines for SARS-Cov-2 has been registered and approved for administration in humans. It is important to understand the safety and efficacy of vaccines during robust research to develop global immunity against SARS-Cov-2. This study aimed to collect data on post vaccination adverse events in regional population of District Bahawalpur.
- Detailed Description
Bahawalpur District of Punjab province has population of 3.998 million and among these 2.6 million above 12 years of age are eligible for vaccination against SARS-Cov-2. 28 centers were established for vaccination within the districts at designated sites for Covid-19 vaccination. 87% targeted population has been vaccinated till 15th February 2022. Investigators designed this study to collect and evaluate data on adverse effects after vaccination of Covid-19. Investigators aimed to collect information through interviewing participants in general places of designated sites of vaccination centers established in District Bahawalpur. History will be recorded from participants and in case of adverse events detailed available history will be recorded including following adverse effects from available records on following.
* Cardiovascular adverse effects
* Cerebrospinal adverse events
* Respiratory disturbances
* Hepatobiliary disorders
* Urogenital adverse effects
* Musculoskeletal adverse effect
* Psychological diseases
* Blood biomarkers changes
* Autoimmune adverse events
* Allergic reactions and hypersensitivity Collected data will be summarized to get percentage of adverse effects in general population. Recorded adverse events will be assessed for their frequency in participants and association with vaccination will be assessed through employing statistical methods. Subsequent information on handling of adverse events will be recorded including
* Nature of adverse event
* Hospitalization and severity of adverse events
* Mortality / morbidity caused by vaccination
* Days of hospitalization
* Changes in Blood biomarkers
* Interventions adopted for adverse events
* Diseased period
* Covid-19 infection positivity through RT-PCR / imaging for round glass opacities / Covid-19 changes Overall efficacy and safety of vaccination will be assessed through collected data.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3515
Age >12 year Vaccinated (Single Dose, Double Dose, Booster Dose) Clinical diagnosis of Allergic reactions and hypersentivity, Cardiovascular diseases Musculoskeletal diseases Respiratory disease Immunological disease Kidney diseases
Age <12 years of age Not vaccinated History of disease before vaccination
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description B.V. HOSPITAL Standard Preparation Local population in surrounding premises of site Baldia Hall Yazman Standard Preparation Local population in surrounding premises of site THQ HOSPITAL, AHMADPUR Standard Preparation Local population in surrounding premises of site THQ HOSPITAL, HASILPUR. Standard Preparation Local population in surrounding premises of site THQ KHAIR PUR TAMEWALI Standard Preparation Local population in surrounding premises of site THQ YAZMAN Standard Preparation Local population in surrounding premises of site TMA Office Hasilpur (NEW) Standard Preparation Local population in surrounding premises of site Papulation Welfare office APE Standard Preparation Local population in surrounding premises of site RHC Ballah Jhulan Standard Preparation Local population in surrounding premises of site RHC Channi Goth Standard Preparation Local population in surrounding premises of site RHC Choona wala Standard Preparation Local population in surrounding premises of site CIVIL HOSPITAL Bahahwalpur Standard Preparation Local population in surrounding premises of site DDHO KPT Standard Preparation Local population in surrounding premises of site Govt Girls Elementry School Standard Preparation Local population in surrounding premises of site Govt Higher Secondary School Standard Preparation Local population in surrounding premises of site Govt Sadiq Higher Secondary School Standard Preparation Local population in surrounding premises of site Govt TibIA College Bahawalpur Standard Preparation Local population in surrounding premises of site CEO Office DHA BWP Standard Preparation Local population in surrounding premises of site RHC Dera Bakha Standard Preparation Local population in surrounding premises of site RHC Headrajkan Standard Preparation Local population in surrounding premises of site RHC Khanqah sharif Standard Preparation Local population in surrounding premises of site RHC Khutri Banglow Standard Preparation Local population in surrounding premises of site RHC Kud Wala Standard Preparation Local population in surrounding premises of site RHC Lal Sohanra Standard Preparation Local population in surrounding premises of site RHC Qaimpur Standard Preparation Local population in surrounding premises of site RHC Uch Sharif Standard Preparation Local population in surrounding premises of site Special Education Degree Colage Standard Preparation Local population in surrounding premises of site RHC Mubarkpur Standard Preparation Local population in surrounding premises of site
- Primary Outcome Measures
Name Time Method Allergic reactions and hypersensitivity 1st January 2021 to 31st December 2021 Questionnaire for Allergic reaction at injection site or generalized allergic responses excluding previously known disease
Cardiovascular Diseases 1st January 2021 to 31st December 2021 Questionnaire for Post Vaccination adverse development of Hypertension, heart diseases, vascular diseases excluding previously known disease
Respiratory disorders and Respiratory hypersensitivity 1st January 2021 to 31st December 2021 Questionnaire for Cough, dyspnea, Tachypnea, Asthma, Rhinitis, excluding previously known disease
Urologic Diseases 1st January 2021 to 31st December 2021 Questionnaire for Kidney diseases, Urinary tract infection, Urolithiasis excluding previously known disease
Immune system disorders 1st January 2021 to 31st December 2021 Questionnaire for Autoimmune diseases, Erythroblastosis, Glomerulonephritis, thrombocytopenia, Autoimmune Lymphoproliferative Syndrome excluding previously known disease
Musculoskeletal diseases 1st January 2021 to 31st December 2021 Questionnaire for fatigue syndrome, muscle weakness, muscle spasticity, muscle rigidity, Musculoskeletal pain, myalgia, osteoarthritis, Myositis excluding previously known disease
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University College of Conventional Medicine
🇵🇰Bahawalpur, Punajb, Pakistan