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İzmir'de Bir Aile Sağlığı Merkezinde Covid-19 Aşısı Uygulanan Kişilerde Yan Etki Profilinin İncelenmesi

Year 2023, Volume: 17 Issue: 1, 109 - 116, 31.03.2023
https://doi.org/10.21763/tjfmpc.1181110

Abstract

Giriş ve Amaç: Günümüzde dünya genelinde hızla yayılan COVID-19 bir “pandemi” olarak kabul edilmiştir. COVID-19 için etkili bir tedavi bulunmamaktadır. Bu nedenle hasta olmadan kişilerin korunması önemlidir. Bu çalışmada bir Aile Sağlığı Merkezi (ASM)’nde inaktive COVID-19 aşısı uygulanan kişilerde oluşan yan etkilerin sıklığının belirlenmesi ve yan etki oluşumunda etkili olan parametrelerin değerlendirilmesi amaçlanmıştır. Yöntem: Kesitsel tipte olan bu araştırma, İzmir Buca 12 No’lu ASM’de 14 Nisan-14 Haziran 2021 tarihleri arasında gerçekleştirilmiştir. İlgili ASM’de inaktive COVID-19 aşısı olan 560 kişi çalışmaya dâhil edilmiş, kişilerde oluşan yan etkiler ve etkili olabilecek parametreler kaydedilmiştir. Bulgular: Kişilerin %52,7’si kadın ve yaş ortalaması 64,17 ± 10,28 yıldır. İlk aşı sonrası ilk haftada en sık gelişen yan etkiler; %8,6 enjeksiyon yerinde ağrı, %4,1 baş ağrısı ve %4,1 yorgunluk-halsizlik olarak tespit edilmiştir. İkinci aşı sonrasında ise, ilk haftada en sık gelişen yan etkiler; %8,7 enjeksiyon yerinde ağrı, %5,4 yorgunluk-halsizlik, %2,9 baş ağrısı ve %2,7 eklem ağrısı olarak belirlenmiştir. Her iki doz aşıdan sonra görülen enjeksiyon yerinde ağrı, 65 yaşından küçüklerde ve kadınlarda daha sık olduğu bulunmuştur (p<0,05). Pandemi döneminde vitamin/bitki takviyesi alanlarda ilk doz sonrası enjeksiyon yerinde ağrı, baş ağrısı ve eklem ağrısı; ikinci doz aşı sonrasında ise enjeksiyon yerinde ağrı istatistiksel olarak anlamlı düzeyde daha fazla sıklıkta bulunmuştur (p<0,05). Alerji tanısı olan hastalarda birinci doz sonrası enjeksiyon yerinde ağrı ve baş ağrısı; ikinci doz sonrası ise sadece baş ağrısı istatistiksel olarak anlamlı düzeyde daha fazla sıklıkta olduğu görülmüştür (p<0,05). İkinci doz sonrasında yorgunluk-halsizlik sıklığı kanser öyküsü olan kişilerde daha fazla tespit edilmiştir (p=0,001). Sonuç: Çalışma sonucunda inaktive COVID-19 aşısı uygulaması sonrası sık görülen yan etkilerin her iki dozdan sonra da enjeksiyon yerinde ağrı, baş ağrısı ve yorgunluk-halsizlik olduğu saptanmıştır. Ayrıca 65 yaşından küçüklerde, kadınlarda ve alerji öyküsü olanlarda enjeksiyon yerinde ağrı şikayeti daha fazla görülmüştür.

Thanks

Sayın hocalarım Prof. Dr. Selma TOSUN ve Uzm. Dr. Özge TUNCER'e katkıları için teşekkür ediyorum.

References

  • 1.Yuen K-S, Ye Z-W, Fung S-Y, Chan C-P, Jin D-Y. SARS-CoV-2 and COVID-19: The most important research questions. Cell & bioscience. 2020;10(1):1-5.
  • 2.Schett G, Sticherling M, Neurath MF. COVID-19: risk for cytokine targeting in chronic inflammatory diseases? Nature Reviews Immunology. 2020;20(5):271-2.
  • 3.WHO Coronavirus (COVID-19) Dashboard. [Internet] https://COVID-19.who.int/ Erişim:05.09.2022.
  • 4.Zaim S, Chong JH, Sankaranarayanan V, Harky A. COVID-19 and multiorgan response. Current problems in cardiology. 2020;45(8):100618.
  • 5.Riou J, Althaus CL. Pattern of early human-to-human transmission of Wuhan 2019 novel coronavirus (2019-nCoV), December 2019 to January 2020.
  • 6.World Health Organization. COVID-19 vaccine tracker and landscape. [Internet] https://www.who.int/publications/m/item/draft-landscape-of-COVID-19-candidate-vaccines. Erişim:1.2.22.
  • 7.Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, et al. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020;369(6499):77-81.
  • 8.Bayram A, Demirbakan H, Günel Karadeniz P, Erdoğan M, Koçer I. Quantitation of antibodies against SARS-CoV-2 spike protein after two doses of Coronavac in healthcare workers. Journal of medical virology. 2021;93(9):5560-7.
  • 9.Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (Coronavac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. The Lancet Infectious Diseases. 2021;21(6):803-12.
  • 10.Soysal A, Gönüllü E, Karabayır N, Alan S, Atıcı S, Yıldız İ, et al. Comparison of immunogenicity and reactogenicity of inactivated SARS-CoV-2 vaccine (Coronavac) in previously SARS-CoV-2 infected and uninfected health care workers. Human vaccines & immunotherapeutics. 2021:1-5.
  • 11.Sharma O, Sultan AA, Ding H, Triggle CR. A Review of the Progress and Challenges of Developing a Vaccine for COVID-19. Frontiers in immunology. 2020;11:2413.
  • 12.Food and Health Bureau (FHB) Report on Evaluation of Safety, Efficacy and Quality of Coronavac COVID-19 Vaccine (VeroCell) Inactivated.2021[Internet]:https://www.fhb.gov.hk/download/our_work/health/201200/e_evaluation_report_ Coronavac.pdf. Erişim:12.9.2021
  • 13.Ling Y, Zhong J, Luo J. Safety and effectiveness of SARS-CoV-2 vaccines: a systematic review and meta-analysis. Journal of Medical Virology. 2021;93(12):6486-95.
  • 14.Tosun S, Ozkan Ozdemir H, Erdogan E, Akcay S, Aysin M, Eskut N, et al. Adverse events report of inactivated COVID-19 vaccine from 4040 healthcare workers. Postgraduate medicine. 2021:1-7.
  • 15.Riad A, Sağıroğlu D, Üstün B, Pokorná A, Klugarová J, Attia S, et al. Prevalence and risk factors of Coronavac Side effects: an independent cross-sectional study among healthcare workers in Turkey. Journal of clinical medicine. 2021;10(12):2629.
  • 16.Klein SL, Jedlicka A, Pekosz A. The Xs and Y of immune responses to viral vaccines. The Lancet infectious diseases. 2010;10(5):338-49.
  • 17.Hernández JL, Nan D, Fernandez-Ayala M, García-Unzueta M, Hernández-Hernández MA, López-Hoyos M, et al. Vitamin D status in hospitalized patients with SARS-CoV-2 infection. The Journal of Clinical Endocrinology & Metabolism. 2021;106(3):1343-53.
  • 18.Tavakol S, Seifalian AM. Vitamin E at a high dose as an anti-ferroptosis drug and not just a supplement for COVID-19 treatment. Biotechnology and applied biochemistry. 2022;69(3):1058-1060.
  • 19.Boretti A, Banik BK. Zinc role in COVID-19 disease and prevention. 2022;23(2):147-150.
  • 20.WHO. Evidence Assessment: Sinovac/ Coronavac COVID-19 vaccine. [Internet] https://cdn.who.int/media/docs/default-source/immunization/sage/2021/april/5_sage29apr2021_critical-evidence_sinovac.pdf. Erişim:12.9.21.

Investigation of The Side Effect Profile In People Who Get The Covid-19 Vaccine In A Family Health Center In Izmir

Year 2023, Volume: 17 Issue: 1, 109 - 116, 31.03.2023
https://doi.org/10.21763/tjfmpc.1181110

Abstract

Objective: Today, COVID-19, which is spreading rapidly around the world, has been accepted as a "pandemic".There is no effective treatment available for COVID-19. Therefore, it is important to protect people without getting sick. In this study, it was aimed to determine the frequency of side effects in people who received inactivated COVID-19 vaccine in a Family Health Center (FHC) and to evaluate the parameters that are effective in the occurrence of side effects. Methods: This cross-sectional study was conducted in İzmir Buca ASM No. 12 between 14 April and 14 June 2021. A total of 560 people who had the inactivated COVID-19 vaccine in the relevant FHC was included in the study, and the adverse events and parameters that could be effective were recorded. Results: 52.7% of the subjects were female and the mean age was 64.17 ± 10.28 years. The most common adverse effects in the first week after the first vaccination were pain at the injection site 8.6%, headache 4.1%, and fatigue 4.1%. After the second vaccination, the most common adverse effects in the first week were 8.7% injection site pain, 5.4% fatigue-weakness, 2.9% headache and 2.7% joint pain.Injection site pain that developed after both doses of vaccine was more common in women and those younger than 65 years of age (p<0.05).Pain at the injection site, headache, and joint pain after the first dose, and pain at the injection site after the second dose of vaccine were statistically significantly more frequent in those taking any vitamin/herbal supplement during the pandemic period(p<0.05) In patients with a diagnosis of allergy, pain at the injection site and headache after the first dose and only headache after the second dose were found to be statistically significantly more frequent (p<0.05).After the second dose, the frequency of fatigue was higher in patients with a history of malignancy (p=0.001). Conclusion: As a result of the study, it was determined that the common side effects after administration of inactivated COVID-19 vaccine were pain at the injection site, headache, and fatigue-weakness after both doses. In addition, pain at the injection site was more common in people younger than 65 years of age, women, and those with a history of allergy.

References

  • 1.Yuen K-S, Ye Z-W, Fung S-Y, Chan C-P, Jin D-Y. SARS-CoV-2 and COVID-19: The most important research questions. Cell & bioscience. 2020;10(1):1-5.
  • 2.Schett G, Sticherling M, Neurath MF. COVID-19: risk for cytokine targeting in chronic inflammatory diseases? Nature Reviews Immunology. 2020;20(5):271-2.
  • 3.WHO Coronavirus (COVID-19) Dashboard. [Internet] https://COVID-19.who.int/ Erişim:05.09.2022.
  • 4.Zaim S, Chong JH, Sankaranarayanan V, Harky A. COVID-19 and multiorgan response. Current problems in cardiology. 2020;45(8):100618.
  • 5.Riou J, Althaus CL. Pattern of early human-to-human transmission of Wuhan 2019 novel coronavirus (2019-nCoV), December 2019 to January 2020.
  • 6.World Health Organization. COVID-19 vaccine tracker and landscape. [Internet] https://www.who.int/publications/m/item/draft-landscape-of-COVID-19-candidate-vaccines. Erişim:1.2.22.
  • 7.Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, et al. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020;369(6499):77-81.
  • 8.Bayram A, Demirbakan H, Günel Karadeniz P, Erdoğan M, Koçer I. Quantitation of antibodies against SARS-CoV-2 spike protein after two doses of Coronavac in healthcare workers. Journal of medical virology. 2021;93(9):5560-7.
  • 9.Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (Coronavac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. The Lancet Infectious Diseases. 2021;21(6):803-12.
  • 10.Soysal A, Gönüllü E, Karabayır N, Alan S, Atıcı S, Yıldız İ, et al. Comparison of immunogenicity and reactogenicity of inactivated SARS-CoV-2 vaccine (Coronavac) in previously SARS-CoV-2 infected and uninfected health care workers. Human vaccines & immunotherapeutics. 2021:1-5.
  • 11.Sharma O, Sultan AA, Ding H, Triggle CR. A Review of the Progress and Challenges of Developing a Vaccine for COVID-19. Frontiers in immunology. 2020;11:2413.
  • 12.Food and Health Bureau (FHB) Report on Evaluation of Safety, Efficacy and Quality of Coronavac COVID-19 Vaccine (VeroCell) Inactivated.2021[Internet]:https://www.fhb.gov.hk/download/our_work/health/201200/e_evaluation_report_ Coronavac.pdf. Erişim:12.9.2021
  • 13.Ling Y, Zhong J, Luo J. Safety and effectiveness of SARS-CoV-2 vaccines: a systematic review and meta-analysis. Journal of Medical Virology. 2021;93(12):6486-95.
  • 14.Tosun S, Ozkan Ozdemir H, Erdogan E, Akcay S, Aysin M, Eskut N, et al. Adverse events report of inactivated COVID-19 vaccine from 4040 healthcare workers. Postgraduate medicine. 2021:1-7.
  • 15.Riad A, Sağıroğlu D, Üstün B, Pokorná A, Klugarová J, Attia S, et al. Prevalence and risk factors of Coronavac Side effects: an independent cross-sectional study among healthcare workers in Turkey. Journal of clinical medicine. 2021;10(12):2629.
  • 16.Klein SL, Jedlicka A, Pekosz A. The Xs and Y of immune responses to viral vaccines. The Lancet infectious diseases. 2010;10(5):338-49.
  • 17.Hernández JL, Nan D, Fernandez-Ayala M, García-Unzueta M, Hernández-Hernández MA, López-Hoyos M, et al. Vitamin D status in hospitalized patients with SARS-CoV-2 infection. The Journal of Clinical Endocrinology & Metabolism. 2021;106(3):1343-53.
  • 18.Tavakol S, Seifalian AM. Vitamin E at a high dose as an anti-ferroptosis drug and not just a supplement for COVID-19 treatment. Biotechnology and applied biochemistry. 2022;69(3):1058-1060.
  • 19.Boretti A, Banik BK. Zinc role in COVID-19 disease and prevention. 2022;23(2):147-150.
  • 20.WHO. Evidence Assessment: Sinovac/ Coronavac COVID-19 vaccine. [Internet] https://cdn.who.int/media/docs/default-source/immunization/sage/2021/april/5_sage29apr2021_critical-evidence_sinovac.pdf. Erişim:12.9.21.
There are 20 citations in total.

Details

Primary Language Turkish
Subjects ​Internal Diseases
Journal Section Orijinal Articles
Authors

Esra Okumuş 0000-0003-2252-3446

Özge Tuncer 0000-0002-0683-1695

Selma Tosun 0000-0001-9844-9399

Publication Date March 31, 2023
Submission Date September 28, 2022
Published in Issue Year 2023 Volume: 17 Issue: 1

Cite

Vancouver Okumuş E, Tuncer Ö, Tosun S. İzmir’de Bir Aile Sağlığı Merkezinde Covid-19 Aşısı Uygulanan Kişilerde Yan Etki Profilinin İncelenmesi. TJFMPC. 2023;17(1):109-16.

English or Turkish manuscripts from authors with new knowledge to contribute to understanding and improving health and primary care are welcome.