Tesis

Kejadian dan Luaran Reaksi Hipersensitivitas Vaksin COVID-19 dan Keberhasilan Tes Provokasi Vaksin COVID-19 pasca Hipersensitivitas Vaksin COVID-19 Sebelumnya = Incidence and Outcomes of COVID-19 Vaccine Hypersensitivity Reactions and Success of the COVID-19 Vaccine Provocation Test after previous COVID-19 Vaccine Hypersensitivity.

Latar Belakang : Era pandemi COVID-19 menyebabkan tingginya angka mortalitas, vaksinasi merupakan strategi yang efektif untuk mengatasi pandemi. Keamanan vaksin COVID-19 telah teruji dalam fase uji klinis, namun terdapat laporan reaksi hipersensitivitas pada beberapa penelitian, dengan gejala ringan sampai berat. Faktor jenis vaksin, usia, jenis kelamin dikaitkan dengan terjadinya reaksi hipersensitivitas. Tes Provokasi atau pemberian dosis vaksin secara bertahap vaksin COVID-19 menjadi pilihan protokol vaksinasi pada individu yang memiliki riwayat hipersensitivitas. Tujuan : Mengetahui gambaran kejadian, derajat keparahan, luaran reaksi hipersensitivitas dan keberhasilan tes provokasi vaksin COVID-19 pada peserta vaksinasi di RSCM. Metode : Penelitian kohort retrospektif, subjek diambil dari data rekam medis di Rumah Sakit Umum Pusat Cipto Mangunkusumo (RSCM) yang telah menerima vaksinasi COVID-19 dengan riwayat hipersensitivitas. Sampel penelitian adalah peserta vaksinasi dengan riwayat reaksi hipersensitivitas vaksin COVID-19. Data diambil melalui catatan vaksinasi COVID-19 yang diselengggarakan di RSCM. Data penerima vaksin di RSCM diperoleh melalui aplikasi Primary Care Badan Penyelenggara Jaminan Sosial (BPJS) Kesehatan. Hasil : Total 29.036 dosis vaksin COVID-19, 44 mengalami reaksi hipersensitivitas, 20 vaksin Coronavac dan 24 vaksin Moderna. Derajat keparahan reaksi hipersensitivitas ringan sebesar 75%. Sebanyak 44 peserta vaksinasi yang mengalami reaksi hipersensitivitas sebanyak 38.64% tidak melanjutkan vaksinasi dosis berikutnya, 2.27% mengalami hipersensitivitas ringan dan 59.44% berhasil vaksinasi dosis berikutnya tanpa terjadi hipersensitivitas. Simpulan : Kejadian reaksi hipersensitivitas vaksin COVID-19 pada peserta vaksinasi di RSCM sebesar 0.15%. Derajat keparahan reaksi hipersensitivitas vaksin COVID-19 pada peserta vaksinasi dominan pada kelompok derajat ringan. Peserta vaksinasi vaksin COVID-19 yang memiliki riwayat reaksi hipersensitivitas vaksin COVID sebelumnya, dapat melakukan vaksinasi vaksin COVID-19 selanjutnya pada fasilitas kesehatan yang dilengkapi kit anafilaksis dan ahli alergi imunologi
Kata Kunci : Hipersensitivitas, Vaksin COVID-19, vaksinasi


Background : The COVID-19 pandemic era causes high mortality rates, vaccination is an effective strategy to overcome the pandemic. The safety of the COVID-19 vaccine has been tested in the clinical trial phase, however there have been reports of hypersensitivity reactions in several studies, with mild to severe symptoms. The factors such as vaccine type, age and gender are associated with the occurrence of hypersensitivity reactions. Provocation testing or gradual administration of vaccine doses for the COVID-19 vaccine is the vaccination protocol of choice for individuals who have a history of hypersensitivity. Objective : To understand the description of the incidence, degree of severity, outcome of hypersensitivity reactions and success of to the COVID-19 vaccine in vaccination participants at RSCM. Methods : Retrospective cohort study, subjects were taken from medical record data at the Cipto Mangunkusumo Central General Hospital (RSCM) who had received COVID-19 vaccination with a history of hypersensitivity. The research sample was vaccination participants with a history of hypersensitivity reactions to the COVID-19 vaccine. Data was taken through COVID-19 vaccination records held at RSCM. Data on vaccine recipients at RSCM was obtained through the Primary Care application of the Health Social Security Administering Agency (BPJS). Results : A total of 29,036 doses of the COVID-19 vaccine, 44 experienced hypersensitivity reactions, 20 the Coronavac vaccine and 24 the Moderna vaccine. The severity of mild hypersensitivity reactions is 75%. Of the 44 vaccination participants who experienced hypersensitivity reactions, 38.64% did not continue with the next dose of vaccination, 2.27% experienced mild hypersensitivity and 59.44% successfully vaccinated the next dose without hypersensitivity occurring. Conclusions : The incidence of hypersensitivity reactions to the COVID vaccine in vaccination participants at RSCM was 0.15%. The severity of hypersensitivity reactions to the COVID-19 vaccine in vaccination participants is predominantly in the mild degree group. COVID-19 vaccine vaccination participants who have a history of previous COVID vaccine hypersensitivity reactions, can carry out further COVID-19 vaccine vaccination at health facilities equipped with anaphylaxis kits and immunology allergists.
Key wods : Hypersensitivity, COVID-19 Vaccine, Vaccination participant