1887
Volume 2023, Issue 1
  • ISSN: 0253-8253
  • EISSN: 2227-0426

Abstract

Background: The safety of the COVID-19 mRNA vaccine in the outpatient setting has been extensively studied; however, there need to be more reports that specifically assess their safety in the inpatient population. It is hence imperative to explore the adverse drug reaction (ADR) profile in this population and monitor the progression of these ADRs in a hospital setting. This provides a unique opportunity to closely observe patients to ensure no side effects go undiagnosed. This study aims to explore and quantify the incidence and severity of ADRs in patients who have received the COVID-19 vaccine during their stay in the rehabilitation facility.

Methods: This is a prospective observational study, which included adult patients admitted to the rehabilitation facility who were deemed eligible to receive the COVID-19 vaccine during their hospital stay. Data were collected by the investigators from June 2021 to May 2022 at 24 hours, 48 hours, and 7 days post-vaccination. A piloted data collection tool was utilized.

Results: Thirty-five patients met the inclusion criteria. Pain at the injection site was the most commonly reported local ADR, while headache was the most frequent systemic ADR. The majority of the reported ADRs were mild to moderate in nature, with only one severe reaction detected. Although no statistical significance was noted among the variables, common patterns were identified, such as a higher occurrence of fever at 24 hours after the second dose as opposed to the first dose. Close monitoring of the included study subjects did not reveal any unanticipated ADRs or an increase in ADRs susceptibility and severity compared to the general population.

Conclusion: This study supports the initiation of vaccination campaigns in inpatient rehabilitation settings. This approach would offer the advantage of gaining full immunity and reducing the risk of contracting COVID-19 infection and complications once discharged.

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2023-03-01
2024-04-20
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References

  1. COVID-19 dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University: Johns Hopkins University Coronavirus Resource Center 2022 [Internet]. [cited 2022 June 12]. Available from: https://coronavirus.jhu.edu/map.html.
  2. Coronavirus disease (COVID-19): World Health Organization 2022 [Internet]. [cited 2022 June 14]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019.
  3. Nitulescu GM, Paunescu H, Moschos SA, Petrakis D, Nitulescu G, Daniel Ion GN, et al. Comprehensive analysis of drugs to treat SARS-CoV-2 infection: Mechanistic insights into current COVID-19 therapies (Review). Int J Mol Med. 2020; 46:(2):467–88.
    [Google Scholar]
  4. Kornowski R. Shifting paradigms in cardiovascular therapeutic strategies during the COVID-19 era. JACC Cardiovasc Interv. 2020; 13:(16):1949–50.
    [Google Scholar]
  5. Sharif N, Alzahrani KJ, Ahmed SN, Dey SK. Efficacy, immunogenicity and safety of COVID-19 vaccines: A systematic review and meta-analysis. Front Immunol. 2021;12:714170.
    [Google Scholar]
  6. COVID-19 Vaccines U.S. Food and Drug Administration; 2022 [Internet]. [cited 2022 June 14]. Available from: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines#authorized-vaccines.
  7. Pardi N, Hogan MJ, Porter FW, Weissman D. mRNA vaccines – a new era in vaccinology. Nat Rev Drug Discov. 2018; 17:(4):261–79.
    [Google Scholar]
  8. Hendaus MA, Jomha FA. mRNA vaccines for COVID-19: A simple explanation. Qatar Med J. 2021; 2021:(1):7.
    [Google Scholar]
  9. Chen M, Yuan Y, Zhou Y, Deng Z, Zhoa J, Feng F, et al. Safety of SARS-CoV-2 vaccines: a systematic review and meta-analysis of randomized controlled trials. Infect Dis Poverty. 2021; 10:(1):.
    [Google Scholar]
  10. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020; 383:(27):2603–15.
    [Google Scholar]
  11. Sáez-Llorens X, Bandyopadhyay AS, Gast C, De Leon T, DeAntonio R, Jimeno J, et al. Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in children and infants: two clinical trials. Lancet. 2021; 397:(10268):27–38.
    [Google Scholar]
  12. Chappell KJ, Mordant FL, Li Z, Wijesundara DK, Ellenberg P, Lackenby JA, et al. Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2021; 21:(10):1383–94.
    [Google Scholar]
  13. Emary KRW, Golubchik T, Aley PK, Ariani CV, Angus B, Bibi S, et al. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 variant of concern 202012/01 (B.1.1.7): an exploratory analysis of a randomised controlled trial. Lancet. 2021; 397:(10282):1351–62.
    [Google Scholar]
  14. Huang B, Dai L, Wang H, Hu Z, Yang X, Tan W, et al. Serum sample neutralisation of BBIBP-CorV and ZF2001 vaccines to SARS-CoV-2 501Y.V2. Lancet Microbe. 2021; 2:(7):e285.
    [Google Scholar]
  15. Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021; 397:(10275):671–81.
    [Google Scholar]
  16. 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. 2021; 21:(7):939–49.
    [Google Scholar]
  17. 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, doubleblind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021; 21:(6):803–12.
    [Google Scholar]
  18. Fatima M, Ahmad Cheema H, Ahmed Khan MH, Shahid H, Saad Ali M, Hassan U, et al. Development of myocarditis and pericarditis after COVID-19 vaccination in adult population: A systematic review. Ann Med Surg (Lond). 2022;76:103486.
    [Google Scholar]
  19. Lane S, Yeomans A, Shakir S. Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature. BMJ Open. 2022; 12:(5):e059223.
    [Google Scholar]
  20. Centers for Disease Control and Prevention (CDC). Operational considerations for routine immunization services during the COVID-19 pandemic in non-US settings focusing on low- and middle-income countries; 2022 [Internet]. [cited 2022 June 14]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/global-covid-19/maintaining-immunization-services.html.
  21. Tan JTC, Tan C, Teoh J, Wahab MT, Tan GZ, Chin RYZ, et al. Adverse reactions and safety profile of the mRNA COVID-19 vaccines among Asian military personnel. Ann Acad Med Singap. 2021; 50:(11):827–37.
    [Google Scholar]
  22. Kadali RAK, Janagama R, Peruru S, Malayala SV. Side effects of BNT162b2 mRNA COVID-19 vaccine: A randomized, cross-sectional study with detailed self-reported symptoms from healthcare workers. Int J Infect Dis. 2021;106:376–81.
    [Google Scholar]
  23. El-Shitany NA, Harakeh S, Badr-Eldin SM, Bagher AM, Eid B, Almukadi H, et al. Minor to moderate side effects of Pfizer-BioNTech COVID-19 vaccine among Saudi residents: A retrospective cross-sectional study. Int J Gen Med. 2021;14:1389–401.
    [Google Scholar]
  24. Amanzio M, Mitsikostas DD, Giovannelli F, Bartoli M, Cipriani GE, Brown WA. Adverse events of active and placebo groups in SARS-CoV-2 vaccine randomized trials: A systematic review. Lancet Reg Health Eur. 2022;12:100253.
    [Google Scholar]
  25. Shafie'ei M, Jamali M, Akbari Z, Sarvipour N, Ahmadzade M, Ahramiyanpour N. Cutaneous adverse reactions following COVID-19 vaccinations: A systematic review and meta-analysis. J Cosmet Dermatol. 2022; 21:(9):3636–50.
    [Google Scholar]
  26. Centers for Disease Control and Prevention (CDC). Pfizer-BioNTech COVID-19 vaccine reactions & adverse events; 2022 [Internet]. [cited 2022 December 4]. Available from: https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html.
  27. Naghavi M. Global, regional, and national burden of suicide mortality 1990 to 2016: systematic analysis for the Global Burden of Disease Study 2016. BMJ. 2019;364:l94.
    [Google Scholar]
  28. Garcia-Azorin D, Baykan B, Beghi E, Doheim MF, Fernandez-de-Las-Penas C, Gezegen H, et al. Timing of headache after COVID-19 vaccines and its association with cerebrovascular events: An analysis of 41,700 VAERS reports. Cephalalgia. 2022; 42:(11–12):1207-17.
    [Google Scholar]
  29. Sakai A, Morishita T, Matsunami H. Antibody response after a second dose of the BNT162b2 mRNA COVID-19 vaccine in liver transplant recipients. Transpl Int. 2022;35:10321.
    [Google Scholar]
  30. Xing K, Tu X-Y, Liu M, Liang Z-W, Chen J-N, Li J-J, et al. Efficacy and safety of COVID-19 vaccines: a systematic review. Zhongguo Dang Dai Er Ke Za Zhi. 2021; 23:(3):221–8.
    [Google Scholar]
  31. Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, et al. Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020; 323:(16):1574–81.
    [Google Scholar]
  32. Centers for Disease Control and Prevention (CDC). Selected adverse events reported after COVID-19 vaccination; 2022 [Internet]. [cited 2022 December 4]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html .
  33. Heidecker B, Dagan N, Balicer R, Eriksson U, Rosano G, Coats A, et al. Myocarditis following COVID-19 vaccine: incidence, presentation, diagnosis, pathophysiology, therapy, and outcomes put into perspective. A clinical consensus document supported by the Heart Failure Association of the European Society of Cardiology (ESC) and the ESC Working Group on Myocardial and Pericardial Diseases. Eur J Heart Fail. 2022; 24:(11):2000–18.
    [Google Scholar]
  34. Fazlollahi A, Zahmatyar M, Noori M, Nejadghaderi SA, Sullman MJM, Shekarriz-Foumani R, et al. Cardiac complications following mRNA COVID-19 vaccines: A systematic review of case reports and case series. Rev Med Virol. 2022; 32:(4):e2318.
    [Google Scholar]
  35. Montano D. Frequency and associations of adverse reactions of COVID-19 vaccines reported to pharmacovigilance systems in the European Union and the United States. Front Public Health. 2021;9:756633.
    [Google Scholar]
  36. Bawa T, Smith D, Andreeva D, Vaidya S, Kruja B, Farrell T, et al. Inpatient COVID-19 vaccination rollout: Improving access to vaccination. Clin Med. 2022; 22:(5):.
    [Google Scholar]
  37. Freiser D, Roca M, Chung T, Bhakta T, Winston LG, Ortiz GM. The evolution of a hospital-based Covid-19 vaccination program for inpatients. NEJM Catalyst. 2022; 3:(2):CAT.21.0340.
    [Google Scholar]
  38. Berger RE, Diaz DC, Chacko S, Louh I, Wheaton C, Ipolitti C, et al. Implementation of an inpatient Covid-19 vaccination program. NEJM Catalyst. 2021; 2:(10).
    [Google Scholar]
  39. Guzman E, Boland J, Van De Rijn J, Suresh M, Fraulein L, Makhoul J, et al. Improving inpatient COVID-19 vaccination rates among adult patients at a Tertiary Academic Medical Center. J Clin Outcomes Manag. 2022; 29:(5):178–82.
    [Google Scholar]
  40. Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, et al. Characteristics and outcomes of 21 critically Ill patients with COVID-19 in Washington State. JAMA. 2020; 323:(16):1612–4.
    [Google Scholar]
  41. Guan W-J, Ni Z-Y, Hu Y, Liang W-H, Ou C-Q, He J-X, et al. Clinical characteristics of Coronavirus disease 2019 in China. N Engl J Med. 2020; 382:(18):1708–20.
    [Google Scholar]
  42. Meo SA, Bukhari IA, Akram J, Meo AS, Klonoff DC. COVID-19 vaccines: comparison of biological, pharmacological characteristics and adverse effects of Pfizer/BioNTech and Moderna vaccines. Eur Rev Med Pharmacol Sci. 2021; 25:(3):1663–9.
    [Google Scholar]
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  • Article Type: Research Article
Keyword(s): adverse drug reactionsCOVID-19mRNArehabilitation and vaccine
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