Post Vaccination Adverse Events in Covid-19 Vaccine Recipients

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

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.

Study Overview

• Status: Completed
• Conditions: Vaccine Adverse Reaction; COVID-19 Vaccination
• Intervention / Treatment: Drug: Standard Preparation

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.

• Study Type: Observational
• Enrollment (Actual): 3515

Contacts and Locations

Study Locations

• Pakistan
  • Punajb
    • Bahawalpur, Punajb, Pakistan, 63100
      • University College of Conventional Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

General population above age of 12 years will be eligible to collection information on adverse effects of SARS-Cov-2 vaccination

Description

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

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Retrospective

Number of groups / cohorts

28

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Islamia University of Bahawalpur
• Collaborators: District Health Authority (DHA) Bahawalpur District Bahawalpur, Government of Punjab.
• Investigators: Principal Investigator: Hafiz Abdul Sattar, M.Phil, lecturer

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2022
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: February 19, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Covid-19 Vaccination, Inactivated Vaccine, RNA vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: UCCM/2022/Covid-19/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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