Covid-19 Research

Observational Studies

Safety Profile of COVID-19 Vaccines: Retrospective Analysis of Short, Medium, and Long-Term Side Effects: The Military Hospital Experience

Journal of Biomedical Research & Environmental Sciences article abstract with citation details, DOI, publication dates, subject areas, full text links, and references.

View DOI Submit Manuscript

Article Details

Publication record, authors, dates, abstract, and full text access.

Open Access
Article Type Observational Studies
Subject Medicine Group
OCLC JBRES Record
Antonio Sabba*, Giancarlo Pontoni, Maria Santangelo, Nadir Rachedi, Maurizio D Ercole, Davide Lardo, Angelo Raffaele Chiarelli and Vincenzo Campagna
Issue: Volume6-Issue10
Pages: 1432-1439
Received: 2025-09-11
Accepted: 2025-10-12
Published: 2025-10-13

Abstract

Background: Vaccination is a key strategy to reduce infectious disease incidence and COVID-19 severity. Monitoring vaccine safety is essential to identify Adverse Reactions (ARs) and ensure public confidence.
Objective: To evaluate adverse reactions following COVID-19 vaccination at the Military Polyclinic of Rome “Celio” between 2020 and 2023, analyzing variables such as sex, age, vaccine type, and dose number, and comparing results with national (AIFA) and European (EMA) data.
Methods: A retrospective observational study was conducted on 41,276 doses administered across five vaccine types (Pfizer, Moderna, AstraZeneca, Johnson & Johnson, Novavax). ARs were classified by severity and system involved. Statistical analyses, including Chi-square and Fisher’s Exact Test, assessed correlations by age, sex, dose, and vaccine type.
Results: Total ARs: 41 (0.1% of doses); 92.7% non-severe, 7.3% severe.
Most ARs involved musculoskeletal (29.2%) and immune (26.8%) systems.
Female subjects experienced more ARs (66%) than males (34%).
ARs were most frequent after the first dose, decreasing with subsequent doses.
By vaccine type, AstraZeneca showed the highest relative rate of ARs (0.41%), followed by Moderna (0.09%) and Pfizer (0.05%).
Severe ARs were rare, predominantly in the 30–49 age group.
Local reporting rates (0.1%) aligned closely with national data (0.097%).
Conclusions: COVID-19 vaccines administered at the Military Polyclinic demonstrated a high safety profile. Severe adverse events were rare, nonsevere reactions predominated, and findings were consistent with national and European surveillance data. The benefits of vaccination in preventing severe disease, hospitalization, and death significantly outweigh the risks.

FullText HTML FullText PDF DOI: 10.37871/jbres2199 Crossmark

Certificate of Publication

Certificate of Publication

Copyright

© 2025 Sabba A, et al. Distributed under Creative Commons CC-BY 4.0 Creative CommonsAttribution

How to cite this article

Sabba A, Pontoni G, Santangelo M, Rachedi N, Ercole MD, Lardo D, Chiarelli AR, Campagna V. Safety Profi le of COVID-19 Vaccines: Retrospective Analysis of Short, Medium, and Long-Term Side Effects: The Military Hospital Experience. J Biomed Res Environ Sci. 2025 Oct 13; 6(10): 1432-1439. doi: 10.37871/jbres2199, Article ID: JBRES2199, Available at: https://www.jelsciences.com/articles/jbres2199.pdf

Subject area(s)

Pharmaceutica Analytica ActaPublic Health

References

  1. Hosseini R, Askari N. A review of neurological side effects of COVID-19 vaccination. Eur J Med Res. 2023 Feb 25;28(1):102. doi: 10.1186/s40001-023-00992-0. PMID: 36841774; PMCID: PMC9959958.
  2. Ogar CK, Quick J, Gilbert HN, Vreman RA, Mantel-Teeuwisse AK, Mugunga JC. Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study. Drug Saf. 2023 Apr;46(4):357-370. doi: 10.1007/s40264-023-01279-3. Epub 2023 Feb 22. PMID: 36811813; PMCID: PMC9945828.
  3. Salmon DA, Lambert PH, Nohynek HM, Gee J, Parashar UD, Tate JE, Wilder-Smith A, Hartigan-Go KY, Smith PG, Zuber PLF. Novel vaccine safety issues and areas that would benefit from further research. BMJ Glob Health. 2021 May;6(Suppl 2):e003814. doi: 10.1136/bmjgh-2020-003814. PMID: 34011502; PMCID: PMC8137224.
  4. Barda N, Dagan N, Ben-Shlomo Y, Kepten E, Waxman J, Ohana R, Hernán MA, Lipsitch M, Kohane I, Netzer D, Reis BY, Balicer RD. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2021 Sep 16;385(12):1078-1090. doi: 10.1056/NEJMoa2110475. Epub 2021 Aug 25. PMID: 34432976; PMCID: PMC8427535.
  5. Patone M, Handunnetthi L, Saatci D, Pan J, Katikireddi SV, Razvi S, Hunt D, Mei XW, Dixon S, Zaccardi F, Khunti K, Watkinson P, Coupland CAC, Doidge J, Harrison DA, Ravanan R, Sheikh A, Robertson C, Hippisley-Cox J. Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection. Nat Med. 2021 Dec;27(12):2144-2153. doi: 10.1038/s41591-021-01556-7. Epub 2021 Oct 25. Erratum in: Nat Med. 2021 Dec;27(12):2249. doi: 10.1038/s41591-021-01644-8. PMID: 34697502; PMCID: PMC8629105.
  6. Klein NP, Lewis N, Goddard K, Fireman B, Zerbo O, Hanson KE, Donahue JG, Kharbanda EO, Naleway A, Nelson JC, Xu S, Yih WK, Glanz JM, Williams JTB, Hambidge SJ, Lewin BJ, Shimabukuro TT, DeStefano F, Weintraub ES. Surveillance for Adverse Events After COVID-19 mRNA Vaccination. JAMA. 2021 Oct 12;326(14):1390-1399. doi: 10.1001/jama.2021.15072. PMID: 34477808; PMCID: PMC8511971.
  7. Beatty AL. Analysis of myocarditis among 2.5 million vaccinated individuals. Annals of Internal Medicine. 2021;174:1686-1688.
  8. Mevorach D, Anis E, Cedar N, Bromberg M, Haas EJ, Nadir E, Olsha-Castell S, Arad D, Hasin T, Levi N, Asleh R, Amir O, Meir K, Cohen D, Dichtiar R, Novick D, Hershkovitz Y, Dagan R, Leitersdorf I, Ben-Ami R, Miskin I, Saliba W, Muhsen K, Levi Y, Green MS, Keinan-Boker L, Alroy-Preis S. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. N Engl J Med. 2021 Dec 2;385(23):2140-2149. doi: 10.1056/NEJMoa2109730. Epub 2021 Oct 6. PMID: 34614328; PMCID: PMC8531987.
  9. Hause AM, Baggs J, Gee J, Marquez P, Myers TR, Shimabukuro TT, Shay DK. Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021. MMWR Morb Mortal Wkly Rep. 2021 Oct 1;70(39):1379-1384. doi: 10.15585/mmwr.mm7039e4. PMID: 34591835; PMCID: PMC8486391.
  10. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR, Burkel VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM; CDC v-safe COVID-19 Pregnancy Registry Team. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med. 2021 Jun 17;384(24):2273-2282. doi: 10.1056/NEJMoa2104983. Epub 2021 Apr 21. Erratum in: N Engl J Med. 2021 Oct 14;385(16):1536. doi: 10.1056/NEJMx210016. PMID: 33882218; PMCID: PMC8117969.
  11. Ledford H. Why COVID vaccines are so difficult to compare. Nature. 2021 Mar;591(7848):16-17. doi: 10.1038/d41586-021-00409-0. PMID: 33623151.
  12. Kaur RJ, Dutta S, Bhardwaj P, Charan J, Dhingra S, Mitra P, Singh K, Yadav D, Sharma P, Misra S. Adverse Events Reported From COVID-19 Vaccine Trials: A Systematic Review. Indian J Clin Biochem. 2021 Oct;36(4):427-439. doi: 10.1007/s12291-021-00968-z. Epub 2021 Mar 27. PMID: 33814753; PMCID: PMC7997788.
  13. Gee J, Marquez P, Su J, Calvert GM, Liu R, Myers T, Nair N, Martin S, Clark T, Markowitz L, Lindsey N, Zhang B, Licata C, Jazwa A, Sotir M, Shimabukuro T. First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021. MMWR Morb Mortal Wkly Rep. 2021 Feb 26;70(8):283-288. doi: 10.15585/mmwr.mm7008e3. PMID: 33630816; PMCID: PMC8344985.
  14. Lee EJ, Cines DB, Gernsheimer T, Kessler C, Michel M, Tarantino MD, Semple JW, Arnold DM, Godeau B, Lambert MP, Bussel JB. Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. Am J Hematol. 2021 May 1;96(5):534-537. doi: 10.1002/ajh.26132. Epub 2021 Mar 9. PMID: 33606296; PMCID: PMC8014568.
  15. Klein NP, Lewis N, Goddard K, Fireman B, Zerbo O, Hanson KE, Donahue JG, Kharbanda EO, Naleway A, Nelson JC, Xu S, Yih WK, Glanz JM, Williams JTB, Hambidge SJ, Lewin BJ, Shimabukuro TT, DeStefano F, Weintraub ES. Surveillance for Adverse Events After COVID-19 mRNA Vaccination. JAMA. 2021 Oct 12;326(14):1390-1399. doi: 10.1001/jama.2021.15072. PMID: 34477808; PMCID: PMC8511971.
  16. Oster ME, Shay DK, Su JR, Gee J, Creech CB, Broder KR, Edwards K, Soslow JH, Dendy JM, Schlaudecker E, Lang SM, Barnett ED, Ruberg FL, Smith MJ, Campbell MJ, Lopes RD, Sperling LS, Baumblatt JA, Thompson DL, Marquez PL, Strid P, Woo J, Pugsley R, Reagan-Steiner S, DeStefano F, Shimabukuro TT. Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From December 2020 to August 2021. JAMA. 2022 Jan 25;327(4):331-340. doi: 10.1001/jama.2021.24110. PMID: 35076665; PMCID: PMC8790664.
  17. Krug A. Incidence of severe adverse events after vaccination with mRNA-based COVID-19 vaccines. Vaccine. 2022;40:4487-4494.
  18. Chouchana L. Incidence of myocarditis and pericarditis after COVID-19 mRNA vaccines. Clinical Pharmacology & Therapeutics. 2022;112:1003-1012.
  19. Høeg TB, Kruget A, Mandrola J. SARS-CoV-2 mRNA vaccinationassociated myocarditis in children aged. 2021:12-17. doi: 10.1101/2021.08.30.21262866.
  20. Kaur U. Systematic review of adverse events associated with COVID-19 vaccines. Frontiers in Public Health. 2022;10:912671.
  21. Wise J. Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots. BMJ. 2021 Mar 11;372:n699. doi: 10.1136/bmj.n699. PMID: 33707182.
  22. Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination. N Engl J Med. 2021 Jun 3;384(22):2092-2101. doi: 10.1056/NEJMoa2104840. Epub 2021 Apr 9. PMID: 33835769; PMCID: PMC8095372.
  23. Schulz JB. COVID-19 vaccine-associated neurological autoimmune diseases. Brain. 2021;144:3576-3588.
  24. Wang W. Adverse events of COVID-19 vaccines in patients with autoimmune diseases. Autoimmunity Reviews 2022;21:103160. doi: 10.1016/S2665-9913(21)00181-8.
  25. Al Khames Aga Q. Safety of COVID-19 vaccines in pregnancy: A systematic review.Pharmaceuticals. 2021;14:849. doi: 10.1016/j.vaccine.2023.03.038.
  26. Kaminski M. Immunological responses to COVID-19 vaccines: A review. Cells. 2022;11:439.
  27. Hatmal MM. Comprehensive analysis of reported adverse events of COVID-19 vaccines. Vaccines. 2021;9:926.
  28. Widge AT, Rouphael NG, Jackson LA, Anderson EJ, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Buchanan W, Luke CJ, Ledgerwood JE, Mascola JR, Graham BS, Beigel JH; mRNA-1273 Study Group. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. N Engl J Med. 2021 Jan 7;384(1):80-82. doi: 10.1056/NEJMc2032195. Epub 2020 Dec 3. PMID: 33270381; PMCID: PMC7727324.
  29. Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. 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 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2. Erratum in: Lancet. 2021 Feb 20;397(10275):670. doi: 10.1016/S0140-6736(21)00386-X. PMID: 33545094; PMCID: PMC7852454.
  30. McDonald I. Comparative systematic review and meta-analysis of reactogenicity, immunogenicity and efficacy of COVID-19 vaccines. NPJ Vaccines. 2021;6:1-14.
  31. De Vuyst H. Vaccine safety surveillance in the context of COVID- 19: WHO approaches. Vaccine. 2021;39:6670-6675.
  32. Singh A. Myocarditis and pericarditis after mRNA COVID-19 vaccination. Heart, Lung and Circulation 31 (2022): 532-541.
  33. Barda N. Effectiveness and safety of third dose of BNT162b2 mRNA COVID-19 vaccine. The Lancet. 2021;398:2093-2100.
Publish with JBRES — Peer-reviewed, multidisciplinary Open Access with rapid review, DOI, and global visibility.
Double-Blind CrossRef DOI Discoverable
Submit Manuscript Membership