Title

Occurrence of adverse effects to the new dengue vaccine in school-aged children (9 years old and above) after the first dose in the Province of Cavite : a case report

Date of Completion

2017

Document Type

Thesis

Degree Name

Clinical Pharmacology

Keywords

Dengue, Children

Abstract

The study is a case report that was done to determine the number of school-aged children (9 years old and above) who acquired their first dose of the new dengue vaccine, Dengvaxia, and those that experienced any adverse event following immunization (AEFI) and identify these adverse effects related to the dengue vaccine administration in the province of Cavite from April to June 2016. The method of data collection used came from the records of the Cavite Provincial Health Office. Participants included all children who were enrolled in the mass dengue vaccination program who received the first dose of the new dengue vaccine, had their consent approved and did not meet the deference criteria. Only 45, 416 out of 68, 396 who were registered had their consent approved and were able to get their first dose of the new dengue vaccine. There were 211 children who reported adverse effects related to the dengue vaccine administration although the data provided did not indicate whether the adverse events occurred less than 30 days following the administration of the vaccine. Hence, the adverse events reported cannot be attributed as a direct effect of the administration of Dengvaxia due to the limitations of the data provided. The top three most commonly reported adverse effects were dizziness, dizziness with headache and headache. There were 8 children who reported unique adverse effects. These recipients presented with fainting, difficulty of breathing, and swelling of the eyes. Unfortunately, no factors can identified at this point. Baseline characteristics of the recipients were not collected. There were no prior consults, interviews, or examinations done with the recipients of the vaccine. There were no follow-up done with the children who presented with adverse effects. This study covered only the first dose of the vaccination, which was from April to June 2016. There were no adequate studies on post-marketing surveillance assessing the long term efficacy and adverse effects of the vaccine during the time when the study was conducted. Further studies regarding the long term effects of the new dengue vaccine with meticulous monitoring to determine the adverse events attributed to the direct effects of the new dengue vaccine was recommended.

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