Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute

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Objective. To describe the ESAVIs reported in the immunization carried out on health personnel with the Sinopharm vaccine (Vero cell) and to verify the causality of suspected adverse reactions. Material and methods. The study has a quantitative approach and cross-sectional design. It was developed a...

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Detalles Bibliográficos
Autores: Chipa Avila, Mishel Rocio, Montoya Juro, Carlos Jesús
Formato: artículo
Fecha de Publicación:2022
Institución:Instituto Nacional Materno Perinatal
Repositorio:Revista Peruana de Investigación Materno Perinatal
Lenguaje:español
OAI Identifier:oai:investigacionmaternoperinatal.inmp.gob.pe:article/288
Enlace del recurso:https://investigacionmaternoperinatal.inmp.gob.pe/index.php/rpinmp/article/view/288
Nivel de acceso:acceso abierto
Materia:Farmacovigilancia;
reportes;
vacunación;
Pharmacovigilance;
reports;
vaccination
id REVINMP_2341b0094ce007eae3585c92e7c0117d
oai_identifier_str oai:investigacionmaternoperinatal.inmp.gob.pe:article/288
network_acronym_str REVINMP
network_name_str Revista Peruana de Investigación Materno Perinatal
repository_id_str
dc.title.none.fl_str_mv Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute
Eventos adversos supuestamente atribuidos a la vacunación o inmunización (ESAVI) reportados a la vacuna contra la COVID-19 en el Instituto Nacional Materno Perinatal
title Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute
spellingShingle Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute
Chipa Avila, Mishel Rocio
Farmacovigilancia;
reportes;
vacunación;
Pharmacovigilance;
reports;
vaccination
title_short Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute
title_full Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute
title_fullStr Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute
title_full_unstemmed Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute
title_sort Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal Institute
dc.creator.none.fl_str_mv Chipa Avila, Mishel Rocio
Montoya Juro, Carlos Jesús
Chipa Avila, Mishel Rocio
Montoya Juro, Carlos Jesús
author Chipa Avila, Mishel Rocio
author_facet Chipa Avila, Mishel Rocio
Montoya Juro, Carlos Jesús
author_role author
author2 Montoya Juro, Carlos Jesús
author2_role author
dc.subject.none.fl_str_mv Farmacovigilancia;
reportes;
vacunación;
Pharmacovigilance;
reports;
vaccination
topic Farmacovigilancia;
reportes;
vacunación;
Pharmacovigilance;
reports;
vaccination
description Objective. To describe the ESAVIs reported in the immunization carried out on health personnel with the Sinopharm vaccine (Vero cell) and to verify the causality of suspected adverse reactions. Material and methods. The study has a quantitative approach and cross-sectional design. It was developed at the National Maternal Perinatal Institute in 2021, where 60 workers who manifested some type of reaction after immunization (first and second dose) were evaluated. The instruments used were the ESAVI report sheet and the instructions for the decision algorithm for the evaluation of causality of an ADR, Karch and Lasagna, proposed by the Peruvian Pharmacovigilance System of the DIGEMID. Results. It was verified that the highest percentage of ESAVI reports occurred in the female sex, between the ages of 30 to 59 years. The most reported clinical manifestations were headache, diarrhea, dizziness and weakness. It was shown that the categories assigned as "probable", with 84.8%, and "definite", with 15.2%, were the total reported. In addition, in the mild ESAVI, 75.8% were in the "probable" category and only in the first dose was a severe case of ESAVI reported. Conclusions. The most frequent reports occurred in the female sex and the ESAVI, defined with the category of "probable" causality, were the most reported.
publishDate 2022
dc.date.none.fl_str_mv 2022-12-22
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://investigacionmaternoperinatal.inmp.gob.pe/index.php/rpinmp/article/view/288
10.33421/inmp.2022288
url https://investigacionmaternoperinatal.inmp.gob.pe/index.php/rpinmp/article/view/288
identifier_str_mv 10.33421/inmp.2022288
dc.language.none.fl_str_mv spa
language spa
dc.relation.none.fl_str_mv https://investigacionmaternoperinatal.inmp.gob.pe/index.php/rpinmp/article/view/288/325
dc.rights.none.fl_str_mv Derechos de autor 2022 Revista Peruana de Investigación Materno Perinatal
https://creativecommons.org/licenses/by-nc-sa/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Derechos de autor 2022 Revista Peruana de Investigación Materno Perinatal
https://creativecommons.org/licenses/by-nc-sa/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional Materno Perinatal (INMP), Lima - Perú.
publisher.none.fl_str_mv Instituto Nacional Materno Perinatal (INMP), Lima - Perú.
dc.source.none.fl_str_mv Revista Peruana de Investigación Materno Perinatal; Vol. 11 No. 3 (2022): Peruvian Journal of Maternal Perinatal Research; 16-20
Revista Peruana de Investigación Materno Perinatal; Vol. 11 Núm. 3 (2022): Revista Peruana de Investigación Materno Perinatal; 16-20
2663-113X
2305-3887
10.33421/113
reponame:Revista Peruana de Investigación Materno Perinatal
instname:Instituto Nacional Materno Perinatal
instacron:INMP
instname_str Instituto Nacional Materno Perinatal
instacron_str INMP
institution INMP
reponame_str Revista Peruana de Investigación Materno Perinatal
collection Revista Peruana de Investigación Materno Perinatal
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling Unexpected events attributed to vaccination or immunization (ESAVI) reported to the COVID-19 vaccine at the National Maternal Perinatal InstituteEventos adversos supuestamente atribuidos a la vacunación o inmunización (ESAVI) reportados a la vacuna contra la COVID-19 en el Instituto Nacional Materno PerinatalChipa Avila, Mishel RocioMontoya Juro, Carlos JesúsChipa Avila, Mishel RocioMontoya Juro, Carlos JesúsFarmacovigilancia;reportes;vacunación;Pharmacovigilance;reports;vaccinationObjective. To describe the ESAVIs reported in the immunization carried out on health personnel with the Sinopharm vaccine (Vero cell) and to verify the causality of suspected adverse reactions. Material and methods. The study has a quantitative approach and cross-sectional design. It was developed at the National Maternal Perinatal Institute in 2021, where 60 workers who manifested some type of reaction after immunization (first and second dose) were evaluated. The instruments used were the ESAVI report sheet and the instructions for the decision algorithm for the evaluation of causality of an ADR, Karch and Lasagna, proposed by the Peruvian Pharmacovigilance System of the DIGEMID. Results. It was verified that the highest percentage of ESAVI reports occurred in the female sex, between the ages of 30 to 59 years. The most reported clinical manifestations were headache, diarrhea, dizziness and weakness. It was shown that the categories assigned as "probable", with 84.8%, and "definite", with 15.2%, were the total reported. In addition, in the mild ESAVI, 75.8% were in the "probable" category and only in the first dose was a severe case of ESAVI reported. Conclusions. The most frequent reports occurred in the female sex and the ESAVI, defined with the category of "probable" causality, were the most reported.Objetivo. Describir los ESAVI reportados en la inmunización realizada al personal de salud, con la vacuna Sinopharm (Vero cell) y verificar la causalidad de las sospechas de sus reacciones adversas. Material y métodos. El estudio tiene un enfoque cuantitativo y diseño transversal. Fue desarrollado en el Instituto Nacional Materno Perinatal en el año 2021, donde se evaluó a 60 trabajadores que manifestaron algún tipo de reacción posterior a la inmunización (primera y segunda dosis). Los instrumentos utilizados fueron la ficha de reporte de ESAVI y el instructivo del algoritmo de decisiones para la evaluación de causalidad de una RAM, Karch y Lasagna, propuesta por el Sistema Peruano de Farmacovigilancia de la DIGEMID. Resultados. Se verificó que el mayor porcentaje de reportes ESAVI se dio en el sexo femenino, entre las edades de 30 a 59 años. Las manifestaciones clínicas más reportadas fueron la cefalea, diarrea, mareos y debilidad. Se evidenció que las categorías asignadas como ¨probable¨, con un 84.8 %, y “definida”, con un 15.2 %, fueron el total de reportados. Además, en los ESAVI leve, el 75.8 % se ubicó en la categoría de “probable” y solo en la primera dosis se reportó un caso severo de ESAVI. Conclusiones. Los reportes más frecuentes se dieron en el sexo femenino y los ESAVI, definidos con la categoría de causalidad “probable”, fueron las más reportadas.Instituto Nacional Materno Perinatal (INMP), Lima - Perú.2022-12-22info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://investigacionmaternoperinatal.inmp.gob.pe/index.php/rpinmp/article/view/28810.33421/inmp.2022288Revista Peruana de Investigación Materno Perinatal; Vol. 11 No. 3 (2022): Peruvian Journal of Maternal Perinatal Research; 16-20Revista Peruana de Investigación Materno Perinatal; Vol. 11 Núm. 3 (2022): Revista Peruana de Investigación Materno Perinatal; 16-202663-113X2305-388710.33421/113reponame:Revista Peruana de Investigación Materno Perinatalinstname:Instituto Nacional Materno Perinatalinstacron:INMPspahttps://investigacionmaternoperinatal.inmp.gob.pe/index.php/rpinmp/article/view/288/325Derechos de autor 2022 Revista Peruana de Investigación Materno Perinatalhttps://creativecommons.org/licenses/by-nc-sa/4.0/info:eu-repo/semantics/openAccessoai:investigacionmaternoperinatal.inmp.gob.pe:article/2882024-10-31T05:57:59Z
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