Clinical trial NCT05254977: Post Vaccination Adverse Events in Covid-19 Vaccine Recipients
Official title: Data Collection for Post Vaccination Adverse Events in Covid-19 Vaccine Recipients in District Bahawalpur A Multi-center Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccination
Vaccine Adverse Reaction
Keywords: Covid-19 Vaccination, Inactivated Vaccine, RNA vaccine
Lead sponsor: Islamia University of Bahawalpur
Sponsor class: OTHER
Collaborators: name: District Health Authority (DHA) Bahawalpur District Bahawalpur, Government of Punjab.
First posted: 2022-02-24
Enrollment: 3515
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

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Primary outcomes:
measure: Allergic reactions and hypersensitivity
timeFrame: 1st January 2021 to 31st December 2021
measure: Cardiovascular Diseases
timeFrame: 1st January 2021 to 31st December 2021
measure: Respiratory disorders and Respiratory hypersensitivity
timeFrame: 1st January 2021 to 31st December 2021
measure: Urologic Diseases
timeFrame: 1st January 2021 to 31st December 2021
measure: Immune system disorders
timeFrame: 1st January 2021 to 31st December 2021
measure: Musculoskeletal diseases
timeFrame: 1st January 2021 to 31st December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: University College of Conventional Medicine
state: Punajb
Study officials:
affiliation: Lecturer
name: Hafiz Abdul Sattar, M.Phil
role: PRINCIPAL_INVESTIGATOR
References: