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Completed

NCT Number: NCT05254977

Post Vaccination Adverse Events in Covid-19 Vaccine Recipients

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.

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Key information

Conditions

COVID-19 Vaccination Vaccine Adverse Reaction

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University College of Conventional Medicine

Bahawalpur, Punajb, 63100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Standard Preparation

Drug

Any kind of intervention received to reduce adverse effects

Primary outcomes

  1. Allergic reactions and hypersensitivity

    Time frame: 1st January 2021 to 31st December 2021

    Questionnaire for Allergic reaction at injection site or generalized allergic responses excluding previously known disease

  2. Cardiovascular Diseases

    Time frame: 1st January 2021 to 31st December 2021

    Questionnaire for Post Vaccination adverse development of Hypertension, heart diseases, vascular diseases excluding previously known disease

  3. Respiratory disorders and Respiratory hypersensitivity

    Time frame: 1st January 2021 to 31st December 2021

    Questionnaire for Cough, dyspnea, Tachypnea, Asthma, Rhinitis, excluding previously known disease

  4. Urologic Diseases

    Time frame: 1st January 2021 to 31st December 2021

    Questionnaire for Kidney diseases, Urinary tract infection, Urolithiasis excluding previously known disease

  5. Immune system disorders

    Time frame: 1st January 2021 to 31st December 2021

    Questionnaire for Autoimmune diseases, Erythroblastosis, Glomerulonephritis, thrombocytopenia, Autoimmune Lymphoproliferative Syndrome excluding previously known disease

  6. Musculoskeletal diseases

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Islamia University of Bahawalpur

Other

Collaborators

  • District Health Authority (DHA) Bahawalpur District Bahawalpur, Government of Punjab.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2022
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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