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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05254977
Enrollment
3515
Registered
2022-02-24
Start date
2022-02-26
Completion date
2022-03-30
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Vaccination, Vaccine Adverse Reaction

Keywords

Covid-19 Vaccination, Inactivated Vaccine, RNA vaccine

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.

Interventions

Any kind of intervention received to reduce adverse effects

Sponsors

District Health Authority (DHA) Bahawalpur District Bahawalpur, Government of Punjab.
CollaboratorUNKNOWN
Islamia University of Bahawalpur
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Allergic reactions and hypersensitivity1st January 2021 to 31st December 2021Questionnaire for Allergic reaction at injection site or generalized allergic responses excluding previously known disease
Cardiovascular Diseases1st January 2021 to 31st December 2021Questionnaire for Post Vaccination adverse development of Hypertension, heart diseases, vascular diseases excluding previously known disease
Respiratory disorders and Respiratory hypersensitivity1st January 2021 to 31st December 2021Questionnaire for Cough, dyspnea, Tachypnea, Asthma, Rhinitis, excluding previously known disease
Urologic Diseases1st January 2021 to 31st December 2021Questionnaire for Kidney diseases, Urinary tract infection, Urolithiasis excluding previously known disease
Immune system disorders1st January 2021 to 31st December 2021Questionnaire for Autoimmune diseases, Erythroblastosis, Glomerulonephritis, thrombocytopenia, Autoimmune Lymphoproliferative Syndrome excluding previously known disease
Musculoskeletal diseases1st January 2021 to 31st December 2021Questionnaire for fatigue syndrome, muscle weakness, muscle spasticity, muscle rigidity, Musculoskeletal pain, myalgia, osteoarthritis, Myositis excluding previously known disease

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026