Post Vaccination Adverse Events in Covid-19 Vaccine Recipients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Data Collection for Post Vaccination Adverse Events in Covid-19 Vaccine Recipients in District Bahawalpur A Multi-center Observational Study

Conditions
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COVID-19 Vaccination, Vaccine Adverse Reaction

Intervention / Treatment
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* Drug: Standard Preparation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Age <12 years of age Not vaccinated History of disease before vaccination -

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B.V. HOSPITAL<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| Baldia Hall Yazman<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| CIVIL HOSPITAL Bahahwalpur<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| DDHO KPT<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| Govt Girls Elementry School<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| Govt Higher Secondary School<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| Govt Sadiq Higher Secondary School<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| Govt TibIA College Bahawalpur<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| CEO Office DHA BWP<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| Papulation Welfare office APE<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Ballah Jhulan<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Channi Goth<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Choona wala<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Dera Bakha<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Headrajkan<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Khanqah sharif<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Khutri Banglow<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Kud Wala<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Lal Sohanra<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Mubarkpur<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Qaimpur<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| RHC Uch Sharif<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| Special Education Degree Colage<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| THQ HOSPITAL, AHMADPUR<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| THQ HOSPITAL, HASILPUR.<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| THQ KHAIR PUR TAMEWALI<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| THQ YAZMAN<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|
| TMA Office Hasilpur (NEW)<br>Local population in surrounding premises of site | Drug: Standard Preparation<br>* Any kind of intervention received to reduce adverse effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergic reactions and hypersensitivity | Questionnaire for Allergic reaction at injection site or generalized allergic responses excluding previously known disease | 1st January 2021 to 31st December 2021 | 
| Cardiovascular Diseases | Questionnaire for Post Vaccination adverse development of Hypertension, heart diseases, vascular diseases excluding previously known disease | 1st January 2021 to 31st December 2021 | 
| Respiratory disorders and Respiratory hypersensitivity | Questionnaire for Cough, dyspnea, Tachypnea, Asthma, Rhinitis, excluding previously known disease | 1st January 2021 to 31st December 2021 | 
| Urologic Diseases | Questionnaire for Kidney diseases, Urinary tract infection, Urolithiasis excluding previously known disease | 1st January 2021 to 31st December 2021 | 
| Immune system disorders | Questionnaire for Autoimmune diseases, Erythroblastosis, Glomerulonephritis, thrombocytopenia, Autoimmune Lymphoproliferative Syndrome excluding previously known disease | 1st January 2021 to 31st December 2021 | 
| Musculoskeletal diseases | Questionnaire for fatigue syndrome, muscle weakness, muscle spasticity, muscle rigidity, Musculoskeletal pain, myalgia, osteoarthritis, Myositis excluding previously known disease | 1st January 2021 to 31st December 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19 Vaccination, Inactivated Vaccine, RNA vaccine