Monitoring Of Adverse Events In Rotavirus Vaccine Administration: A Single Center Experience

Öz

OBJECTIVE: This study aims to assess the adverse events following rotavirus vaccination, which is a major cause of preventable hospitalizations in early childhood. MATERIAL AND METHODS: At Gazi University Faculty of Medicine Hospital, rotavirus vaccination is recommended for all immunocompetent children in the social pediatrics clinic. This study included healthy infants who received a rotavirus vaccine between June 1, 2020, and December 31, 2022. Unforunately rotavirus vaccines are still not included in the national immunization program in Türkiye. The decision on vaccination and vaccine type was made together with families, based on information regarding doses, cost, and efficacy. Patients were monitored daily for one week after each dose of vaccination and contacted six months after the completion of the vaccination series. RESULTS: During the study period, 107 healthy infants (mean age: 4.1 months) received the rotavirus vaccine. Of these, 11 received RotaTeq® and 96 received Rotarix®. Adverse events occurred in 4 infants (3.7%). Among those vaccinated with Rotarix®, one experienced transient vomiting and diarrhea (increased frequency of defecation), another had intermittent bloody stools for one week, and a third had a single episode of bloody stool. One infant vaccinated with RotaTeq® experienced 2 episodes of non-bloody, watery diarrhea. All symptoms occurred after the first dose, resolving without additional treatment or hospitalization. No adverse events previously reported in the literature, such as fever, intussusception, irritability, seizures, apnea, bloating, bronchospasm, nasopharyngitis, bronchiolitis, Kawasaki disease, allergic reactions, or immune thrombocytopenic purpura, were observed following vaccination. CONCLUSION: In conclusion, consisted with existing literature, this study confirms that rotavirus vaccines are well tolerated and safe during infancy. Vaccination has the potential to reduce hospitalization rates, prevent complications associated with rotavirus infection, enhance protection against rotavirus disease. The rotavirus vaccine should be recommended for all infants without contraindications, and parents should be thoroughly informed of its benefits and safety.

Anahtar Kelimeler

• Rotavirus vaccine
• adverse events
• Post-Vaccination Monitoring

Etik Beyan

This study has been approved by the Gazi University Clinical Research Ethics Committee (approval date 10.12.2024, number 2024 - 1882).

Rotavirüs Aşısı Uygulamasında Advers Olayların İzlenmesi: Tek Merkez Deneyimi

Öz

AMAÇ: Bu çalışmada erken çocukluk döneminde önlenebilir hastane yatışlarının önemli bir nedeni olan rotavirüs aşılaması sonrası oluşan advers olayların değerlendirilmesi amaçlanmıştır. GEREÇ VE YÖNTEMLER: Gazi Üniversitesi Tıp Fakültesi Hastanesi'nde, sosyal pediatri kliniğinde tüm immünokompetan çocuklara rotavirüs aşısı önerilmektedir. Bu çalışmaya 1 Haziran 2020 ile 31 Aralık 2022 tarihleri arasında rotavirüs aşısı olan sağlıklı bebekler dahil edildi. Ne yazık ki rotavirüs aşıları Türkiye'de hala ulusal bağışıklama programına dahil değildir. Aşılama ve aşı türü kararı doz, maliyet ve etkinlik hakkındaki bilgilere dayanarak ailelerle birlikte verildi. Hastalar her aşı dozundan sonra 1 hafta boyunca günlük izlendi ve aşılama serisinin tamamlanmasından altı ay sonra iletişime geçildi. BULGULAR: Çalışma süresince 107 sağlıklı bebeğe (ortalama yaş: 4,1 ay) rotavirüs aşısı uygulanmıştır. Bunlardan 11'ine RotaTeq® ve 96'sı Rotarix® uygulandı. Dört bebekte (%3,7) olumsuz olaylar meydana geldi. Rotarix® ile aşılananlar arasında, birinde geçici kusma ve ishal (dışkılama sıklığının artması) görüldü, bir diğerinde bir hafta boyunca aralıklı kanlı dışkılama oldu ve üçüncüsünde tek bir kanlı dışkılama görüldü. RotaTeq® ile aşılanan bir bebekte 2 kez kanlı olmayan, sulu ishal görüldü. Tüm semptomlar ilk dozdan sonra ortaya çıktı ve ek tedavi veya hastaneye yatış olmadan düzeldi. Aşılamadan sonra ateş, intususepsiyon, iritabilite, nöbetler, apne, şişkinlik, bronkospazm, nazofarenjit, bronşiolit, Kawasaki hastalığı, alerjik reaksiyonlar, veya immün trombositopenik purpura gibi literatürde daha önce bildirilen hiçbir olumsuz reaksiyon görülmedi. SONUÇ: Sonuç olarak, mevcut literatürle tutarlı olarak, bu çalışma rotavirüs aşılarının bebeklik döneminde iyi tolere edildiğini ve güvenli olduğunu doğrulamaktadır. Aşılamanın hastaneye yatış oranlarını azaltma, rotavirüs enfeksiyonuyla ilişkili komplikasyonları önleme, rotavirüs hastalığına karşı korumayı artırma potansiyeli vardır. Rotavirüs aşısı kontrendikasyonları olmayan tüm bebeklere önerilmeli ve ebeveynler faydaları ve güvenliği konusunda kapsamlı bir şekilde bilgilendirilmelidir.

Anahtar Kelimeler

• Rotavirüs aşısı
• advers olay
• aşılama sonrası izlem

Kaynakça

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