Post Vaccination Adverse Events in Covid-19 Vaccine Recipients

Islamia University of Bahawalpur

Status

Completed

Conditions

Vaccine Adverse Reaction

COVID-19 Vaccination

Treatments

Drug: Standard Preparation

Study type

Observational

Funder types

Other

Identifiers

NCT05254977

UCCM/2022/Covid-19/01

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,515 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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