Replication Data for: Active vaccine safety surveillance in sub-Saharan Africa: Experience from a prospective cohort event monitoring study of COVID-19 vaccines in Kenya. (doi:10.7910/DVN/15QZIF)

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Part 1: Document Description
Part 2: Study Description
Part 3: Data Files Description
Part 5: Other Study-Related Materials
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Document Description

Citation

Title:

Replication Data for: Active vaccine safety surveillance in sub-Saharan Africa: Experience from a prospective cohort event monitoring study of COVID-19 vaccines in Kenya.

Identification Number:

doi:10.7910/DVN/15QZIF

Distributor:

Harvard Dataverse

Date of Distribution:

2025-02-24

Version:

1

Bibliographic Citation:

Odhiambo, Don B.; Akech, Donald; Karia, Boniface; Kimani, Makobu; Sang, Samuel; Sigilai, Antipa; Voller, Shirine; Mataza, Christine; Mang’ong’o, David; Jalang’o, Rose; Mandale, Martha; Etyang, Anthony O.; Scott, Anthony G.; Agweyu, Ambrose; Kagucia, E. Wangeci, 2025, "Replication Data for: Active vaccine safety surveillance in sub-Saharan Africa: Experience from a prospective cohort event monitoring study of COVID-19 vaccines in Kenya.", https://doi.org/10.7910/DVN/15QZIF, Harvard Dataverse, V1, UNF:6:empS9SZrZiS2xzgKvUuD7w== [fileUNF]

Study Description

Citation

Title:

Replication Data for: Active vaccine safety surveillance in sub-Saharan Africa: Experience from a prospective cohort event monitoring study of COVID-19 vaccines in Kenya.

Identification Number:

doi:10.7910/DVN/15QZIF

Authoring Entity:

Odhiambo, Don B. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Akech, Donald (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Karia, Boniface (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Kimani, Makobu (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Sang, Samuel (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Sigilai, Antipa (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Voller, Shirine (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya; London School of Hygiene and Tropical Medicine, London, UK)

Mataza, Christine (Department of Health, Kilifi County, Kenya)

Mang’ong’o, David (Department of Health, Kilifi County, Kenya)

Jalang’o, Rose (National Vaccination and Immunization Programme, Ministry of Health, Government of Kenya)

Mandale, Martha (Pharmacy and Poisons Board, Ministry of Health, Government of Kenya)

Etyang, Anthony O. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Scott, Anthony G. (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya; London School of Hygiene and Tropical Medicine, London, UK)

Agweyu, Ambrose (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya; London School of Hygiene and Tropical Medicine, London, UK)

Kagucia, E. Wangeci (KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya)

Distributor:

Harvard Dataverse

Access Authority:

Odhiambo, Don B.

Access Authority:

The Data Governance Committee

Depositor:

Odhiambo, Don B.

Date of Deposit:

2025-02-20

Holdings Information:

https://doi.org/10.7910/DVN/15QZIF

Study Scope

Keywords:

Medicine, Health and Life Sciences, Cohort event monitoring, COVID-19 vaccine, systemic reactogenicity events, adverse events following immunization, active vaccine safety surveillance, SMS, Kenya

Abstract:

<p>This is a replication dataset for the manuscript titled: "<i><strong>Active vaccine safety surveillance in sub-Saharan Africa: Experience from a prospective cohort event monitoring study of COVID-19 vaccines in Kenya</strong></i>."</p> <p>This study conducted in Kilifi county, Kenya involved active safety surveillance of COVID-19 vaccines administered routinely at the participating health facilities. The dataset contains suspected adverse events associated with the COVID-19 vaccines as well as sociodemographic and clinical information of the participants. </p>

Kind of Data:

Restricted Access

Notes:

<p><strong>Data Access: </strong>Restricted</p> <strong>Data Availability</strong> <p>Access to these data requires submission of a formal request for consideration by our Data Governance Committee. </p> <strong>How to request</strong> <ol> <li>Download and complete the <a href="https://kemri-wellcome.org/zp-content/uploads/2021/02/KWTRP_Dataverse_Data_Request_Form_2019.docx"><strong>data request form</strong></a></li> <li> Email completed data request form to the Data Governance Committee at <a href="mailto:dgc@kemri-wellcome.org?cc=lmwango@kemri-wellcome.org?Subject=Data%20Access%20Request"><strong>dgc@kemri-wellcome.org</strong></a> </li> </ol>

Methodology and Processing

Sources Statement

Data Access

Notes:

he dataset contains sensitive information on participants and therefore its access is restricted. Its documentation is available under open access. For more detailed information beyond the metadata and documentation provided, there is a process of managed access requiring submission of a request form for consideration by our Data Governance Committee. Contact the author(s) OR the data governance office via this email address: dgc@kemri-wellcome.org

Other Study Description Materials

File Description--f10901498

File: cem_baseline_characteristics_anon.tab

  • Number of cases: 2440

  • No. of variables per record: 72

  • Type of File: text/tab-separated-values

Notes:

UNF:6:IFNlBqQ7WjtXhbvGOG0kzA==

Baseline data such socio-demographic characteristics, medical history, and vaccination history collected on the enrolment date

File Description--f10901501

File: cem_postvaccine_anon.tab

  • Number of cases: 34345

  • No. of variables per record: 20

  • Type of File: text/tab-separated-values

Notes:

UNF:6:r+pBe5XTo7jl1ikMxPXkMQ==

Weekly post-vaccination data for 13 weeks.

File Description--f10901499

File: reactogenicity_events_anon-1.tab

  • Number of cases: 6720

  • No. of variables per record: 21

  • Type of File: text/tab-separated-values

Notes:

UNF:6:RNLXwlqtMBEOZXVKygKmyQ==

Reactogenicity subset data collected daily within 7 days post-vaccination for solicited systemic reactogenicity events, i.e., fever, nausea, malaise, chills, headache, joint pain, muscle aches, and fatigue

File Description--f10901502

File: reactogenicity_events_anon.tab

  • Number of cases: 6720

  • No. of variables per record: 21

  • Type of File: text/tab-separated-values

Notes:

UNF:6:4Jz/jsOT4Gbeja/nVfw2PQ==

-Reactogenicity subset data collected daily within 7 days post-vaccination for solicited systemic reactogenicity events, i.e., fever, nausea, malaise, chills, headache, joint pain, muscle aches, and fatigue

Other Study-Related Materials

Label:

CEM Analysis.do

Text:

Generates descriptive statistics as well as well as inferential statistics summary tables and graphs

Notes:

application/x-stata-syntax

Other Study-Related Materials

Label:

cem_baseline_characteristics_anon.csv

Text:

Baseline data such socio-demographic characteristics, medical history, and vaccination history collected on the enrolment date

Notes:

text/csv

Other Study-Related Materials

Label:

cem_postvaccine_anon.csv

Text:

Weekly post-vaccination data for 13 weeks.

Notes:

text/csv

Other Study-Related Materials

Label:

DON_COVEK_CEM_Data Dictionary.pdf

Notes:

application/pdf

Other Study-Related Materials

Label:

DON_COVEK_CEM_Readme.txt

Notes:

text/plain