CHARACTERISTICS OF ADVERSE EVENTS OF CORONAVIRUS DISEASE 2019 VACCINES FIRST, SECOND AND BOOSTER

Authors

  • Wiwiek Probowati Department of Internal Medicine Bethesda Hospital Yogyakarta. Faculty of Medicine, Universitas Kristen Duta Wacana, Indonesia
  • Tejo Jayadi Department of Pathology Anatomy Bethesda Hospital Yogyakarta. Faculty of Medicine, Universitas Kristen Duta Wacana, Indonesia
  • Brenda Miriane Rustam Faculty of Medicine, Universitas Kristen Duta Wacana, Indonesia

DOI:

https://doi.org/10.21460/bikdw.v8i2.721

Keywords:

adverse events, COVID-19, SARS-CoV-2, vaccination, vaccines

Abstract

Background Coronavirus Disease 2019 (COVID-19)  was a new type of highly contagious disease that had a high risk of developing Acute Respiratory Distress Syndrome (ARDS). According to the World Health Organization (WHO), COVID-19 can be transmitted mainly through aerosol particles contiguous to another human in one meter. To cope with this pandemic, the government programmed vaccinations around the world, including in Indonesia. Objective This study provided new information about the description of the characteristics of adverse events following vaccination participation in vaccination COVID-19 first, second and booster doses. Method This descriptive research was conducted using a cross-sectional method. Subjects were populations with various characteristics at Bethesda Hospital, Bethesda Lempuyangwangi Hospital, and the Jawa Dayu Christian Church who had received the COVID-19 vaccine. The data were univariately presented as a distribution table using the IBM  SPSS - Statistical Program for Social Science Statistics 23. Result From 400 respondents, the most common types of vaccine received during the first dose were Sinovac, the second dose of Sinovac,  and the Moderna for booster dose. Conclusion The first dose was the same as the second dose. Most felt drowsiness 87.9%, swelling and pain at the injection site 77.9%, and weakness at 60.4%.   In phase 1 clinical research of the mRNA vaccine from Moderna, side effects occurred in more than 50% of vaccination participants in the form of fatigue, chills, headache, myalgia, and pain at the injection site, especially at higher doses.

References

(WHO) WHO. No Title [Internet]. Sinovac/CoronaVac COVID-19 vaccine [Internet]. STRATEGIC ADVISORY GROUP OF EXPERTS (SAGE) ON IMMUNIZATION. 2021. Available from: https://cdn.who.int/media/docs/default-source/immunization/sage/2021/april/5_sage29apr2021_critical-evidence_sinovac.pdf

Kementerian Kesehatan RI. Strategi Komunikasi Vaksinasi Covid-19. 2020. 1–74 p.

Pérez-Campos Mayoral L, Hernández-Huerta MT, Mayoral-Andrade G, Pérez-Campos Mayoral E, Pérez-Campos E. A letter to the editor on “World Health Organization declares global emergency: A review of the 2019 novel Coronavirus (COVID-19).” Int J Surg. 2020;79(January):163–4. https://doi.org/10.1016/j.ijsu.2020.05.066

Dhamanti I, Suwantika AA, Adlia A, Yamani LN, Yakub F. Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies. Int J Gen Med. 2023;16(February):609–18. https://doi.org/10.2147/IJGM.S400458

Mushtaq HA, Khedr A, Koritala T, Bartlett BN, Jain NK, Khan SA. A review of adverse effects of COVID-19 vaccines. Infez Med. 2022;30(1):1–10. https://doi.org/10.53854/liim-3001-1

Supangat, Sakinah EN, Nugraha MY, Qodar TS, Mulyono BW, Tohari AI. COVID-19 Vaccines Programs: adverse events following immunization (AEFI) among medical Clerkship Student in Jember, Indonesia. BMC Pharmacol Toxicol. 2021;22(1):1–7. https://doi.org/10.1186/s40360-021-00528-4.

Bhandari B, Rayamajhi G, Lamichhane P, Shenoy AK. Adverse Events following Immunization with COVID-19 Vaccines: A Narrative Review. Biomed Res Int. 2022;2022(5). https://doi.org/10.1155/2022/2911333

Basuki AR, Mayasari G, Handayani E. Gambaran Kipi (Kejadian Ikutan Pasca Imunisasi) Pada Karyawan Rumah Sakit yang Mendapatkan Imunisasi Dengan Vaksin Sinovac di RSUD Kota Yogyakarta. Maj Farm. 2022;18(1):30. https://doi.org/10.22146/farmaseutik.v18i1.71908

Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis [Internet]. 2021;21(2):181–92. Available from: http://dx.doi.org/10.1016/S1473-3099(20)30843-4 doi: 10.1016/S1473-3099(20)30843-4

Kadali RAK, Janagama R, Peruru S, Gajula V, Madathala RR, Chennaiahgari N, et al. Non-life-threatening adverse effects with COVID-19 mRNA-1273 vaccine: A randomized, cross-sectional study on healthcare workers with detailed self-reported symptoms. J Med Virol. 2021;93(7):4420–9. https://doi.org/10.1002/jmv.26996

Riad A, Pokorná A, Attia S, Klugarová J, Koš?ík M, Klugar M. Prevalence of covid-19 vaccine side effects among healthcare workers in the Czech Republic. J Clin Med. 2021;10(7):1–18. https://doi.org/10.3390/jcm10071428

Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis [Internet]. 2021;21(7):939–49. Available from: http://dx.doi.org/10.1016/S1473-3099(21)00224-3 doi: 10.1016/S1473-3099(21)00224-3

Al-Kaffas M, Aboelnour A, Aboelela M. Adverse effects of Oxford–AstraZeneca COVID-19 vaccine among Egyptian healthcare workers. Microbes Infect Dis. 2022;3(4):860–8. https://doi.org/10.21608/MID.2022.148304.1337

Zhang MX, Zhang TT, Shi GF, Cheng FM, Zheng YM, Tung TH, et al. Safety of an inactivated SARS-CoV-2 vaccine among healthcare workers in China. Expert Rev Vaccines [Internet]. 2021;20(7):891–8. Available from: https://doi.org/10.1080/14760584.2021.1925112 doi: 10.1080/14760584.2021.1925112

Jeon M, Kim J, Oh CE, Lee JY. Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System. J Korean Med Sci. 2021;36(17):1–8. https://doi.org/10.3346/jkms.2021.36.e114

Puspitarani F, Sitaresmi MN, Ahmad RA. Adverse events following immunization of COVID-19 vaccine among children aged 6–11 years. Front Public Heal. 2022;10. https://doi.org/10.3389/fpubh.2022.999354

Wood N, Lopez LK, Glover C, Leeb A, Cashman P, Deng L, et al. Short term adverse event profile of COVID-19 mRNA vaccines in children aged 5–15 years in Australia. Lancet Reg Heal - West Pacific [Internet]. 2023;31:100684. Available from: https://doi.org/10.1016/j.lanwpc.2023.100684 doi: 10.1016/j.lanwpc.2023.100684

Wibowo J, Heriyanto RS, Wijovi F, Halim DA, Claudia C, Marcella E, et al. Factors associated with side effects of COVID-19 vaccine in Indonesia. Clin Exp Vaccine Res. 2022;11(1):89–95. https://doi.org/10.7774/cevr.2022.11.1.89

(WHO) WHO. No Title [Internet]. Sinovac/CoronaVac COVID-19 vaccine [Internet]. STRATEGIC ADVISORY GROUP OF EXPERTS (SAGE) ON IMMUNIZATION. 2021. Available from: https://cdn.who.int/media/docs/default-source/immunization/sage/2021/april/5_sage29apr2021_critical-evidence_sinovac.pdf

Kementerian Kesehatan RI. Strategi Komunikasi Vaksinasi Covid-19. 2020. 1–74 p.

Pérez-Campos Mayoral L, Hernández-Huerta MT, Mayoral-Andrade G, Pérez-Campos Mayoral E, Pérez-Campos E. A letter to the editor on “World Health Organization declares global emergency: A review of the 2019 novel Coronavirus (COVID-19).” Int J Surg. 2020;79(January):163–4. https://doi.org/10.1016/j.ijsu.2020.05.066

Dhamanti I, Suwantika AA, Adlia A, Yamani LN, Yakub F. Adverse Reactions of COVID-19 Vaccines: A Scoping Review of Observational Studies. Int J Gen Med. 2023;16(February):609–18. https://doi.org/10.2147/IJGM.S400458

Mushtaq HA, Khedr A, Koritala T, Bartlett BN, Jain NK, Khan SA. A review of adverse effects of COVID-19 vaccines. Infez Med. 2022;30(1):1–10. https://doi.org/10.53854/liim-3001-1

Supangat, Sakinah EN, Nugraha MY, Qodar TS, Mulyono BW, Tohari AI. COVID-19 Vaccines Programs: adverse events following immunization (AEFI) among medical Clerkship Student in Jember, Indonesia. BMC Pharmacol Toxicol. 2021;22(1):1–7. https://doi.org/10.1186/s40360-021-00528-4

Bhandari B, Rayamajhi G, Lamichhane P, Shenoy AK. Adverse Events following Immunization with COVID-19 Vaccines: A Narrative Review. Biomed Res Int. 2022;2022(5). https://doi.org/10.1155/2022/2911333

Basuki AR, Mayasari G, Handayani E. Gambaran Kipi (Kejadian Ikutan Pasca Imunisasi) Pada Karyawan Rumah Sakit yang Mendapatkan Imunisasi Dengan Vaksin Sinovac di RSUD Kota Yogyakarta. Maj Farm. 2022;18(1):30. https://doi.org/10.22146/farmaseutik.v18i1.71908

Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis [Internet]. 2021;21(2):181–92. Available from: http://dx.doi.org/10.1016/S1473-3099(20)30843-4 doi: 10.1016/S1473-3099(20)30843-4

Kadali RAK, Janagama R, Peruru S, Gajula V, Madathala RR, Chennaiahgari N, et al. Non-life-threatening adverse effects with COVID-19 mRNA-1273 vaccine: A randomized, cross-sectional study on healthcare workers with detailed self-reported symptoms. J Med Virol. 2021;93(7):4420–9. https://doi.org/10.1002/jmv.26996

Riad A, Pokorná A, Attia S, Klugarová J, Koš?ík M, Klugar M. Prevalence of covid-19 vaccine side effects among healthcare workers in the Czech Republic. J Clin Med. 2021;10(7):1–18. https://doi.org/10.3390/jcm10071428

Menni C, Klaser K, May A, Polidori L, Capdevila J, Louca P, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis [Internet]. 2021;21(7):939–49. Available from: http://dx.doi.org/10.1016/S1473-3099(21)00224-3 doi: 10.1016/S1473-3099(21)00224-3

Al-Kaffas M, Aboelnour A, Aboelela M. Adverse effects of Oxford–AstraZeneca COVID-19 vaccine among Egyptian healthcare workers. Microbes Infect Dis. 2022;3(4):860–8. https://doi.org/10.21608/MID.2022.148304.1337

Zhang MX, Zhang TT, Shi GF, Cheng FM, Zheng YM, Tung TH, et al. Safety of an inactivated SARS-CoV-2 vaccine among healthcare workers in China. Expert Rev Vaccines [Internet]. 2021;20(7):891–8. Available from: https://doi.org/10.1080/14760584.2021.1925112 doi: 10.1080/14760584.2021.1925112

Jeon M, Kim J, Oh CE, Lee JY. Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System. J Korean Med Sci. 2021;36(17):1–8. https://doi.org/10.3346/jkms.2021.36.e114

Puspitarani F, Sitaresmi MN, Ahmad RA. Adverse events following immunization of COVID-19 vaccine among children aged 6–11 years. Front Public Heal. 2022;10. https://doi.org/10.3389/fpubh.2022.999354

Wood N, Lopez LK, Glover C, Leeb A, Cashman P, Deng L, et al. Short term adverse event profile of COVID-19 mRNA vaccines in children aged 5–15 years in Australia. Lancet Reg Heal - West Pacific [Internet]. 2023;31:100684. Available from: https://doi.org/10.1016/j.lanwpc.2023.100684 doi: 10.1016/j.lanwpc.2023.100684

Wibowo J, Heriyanto RS, Wijovi F, Halim DA, Claudia C, Marcella E, et al. Factors associated with side effects of COVID-19 vaccine in Indonesia. Clin Exp Vaccine Res. 2022;11(1):89–95. https://doi.org/10.7774/cevr.2022.11.1.89

Desalegn M, Garoma G, Tamrat H, Desta A, Prakash A. The prevalence of AstraZeneca COVID-19 vaccine side effects among Nigist Eleni Mohammed memorial comprehensive specialized hospital health workers. Cross sectional survey. PLoS One [Internet]. 2022;17(6 June):1–10. Available from: http://dx.doi.org/10.1371/journal.pone.0265140 doi: 10.1371/journal.pone.0265140

Jhaj R, Chaudhary D, Shukla AK, Yadav J. Stimulated Reporting of Adverse Events Following Immunization with COVID-19 Vaccines. Vaccines. 2022;10(12):1–10. https://doi.org/10.3390/vaccines10122133

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403–16. https://doi.org/10.1056/nejmoa2035389

Hidayat R, Mustika AP, Avisha F, Djuliannisaa Z, Winari DD, Putri RA, et al. Surveillance of Adverse Events Following Immunization (AEFI) after Third Dose Booster Vaccination with mRNA-Based Vaccine in Universitas Indonesia Hospital Health Personnel. Vaccines. 2022;10(6):1–10. https://doi.org/10.3390/vaccines10060877

Einstein EH, Shahzadi A, Desir L, Katz J, Boockvar J, D’Amico R. New-Onset Neurologic Symptoms and Related Neuro-Oncologic Lesions Discovered After COVID-19 Vaccination: Two Neurosurgical Cases and Review of Post-Vaccine Inflammatory Responses. Cureus. 2021;13(6):4–7. https://doi.org/10.7759/cureus.15664

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Published

2023-12-30

Issue

Vol. 8 No. 2 (2023): BERKALA ILMIAH KEDOKTERAN DUTA WACANA

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Research

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