A review on vaccine pharmacovigilance during covid-19

  • Jyothi K Navya Clinical research intern, Clinosol research private limited, Hyderabad, India
  • Jaka Archana Clinical research intern, Clinosol research private limited, Hyderabad, India
  • Velpula Padma sujaya Clinical research intern, Clinosol research private limited, Hyderabad, India.
  • Rupavath Pallavi Nayak Clinical research intern, Clinosol research private limited, Hyderabad, India
  • Randeep Raj C Vaddadi Clinical SAS trainer , Clinosol research private limited , Hyderabad, India.


Pharmacovigilance is important for collecting, detecting, monitoring adverse events which is the main objective. The adverse events reported should be assessed in order to know the casual relationship and avoid unnecessary effects on the recipient. Many people are vaccinating in a short period, so it is becoming much burden to the pharmacovigilance centers. The international society of pharmacovigilance (ISOP), the French national agency for medicines and health products safety (ANSM), and many others were in continuous collaboration and taking many initiatives to identify the safety and efficacy of vaccines and to provide answers to the raised questions respectively. Through pharmacovigilance, signals were detected, and many adverse events were identified. Pharmacovigilance of BioNTech/Pfizer-m-RNA, Moderna-mRNA vaccine, Covishield, Johnson and Johnson, Vaxzevria, Sputnik V, Convidecia are addressed. With BioNTech/Pfizer-m-RNA 12,249 ADRs, with Moderna-mRNA vaccine 577 ADRs, with Covishield 447 ADRs, with Johnson and Johnson 653 ADRs, with Vaxzevria 743 ADRs were reported. These vaccines resulted in immune thrombocytopenic purpura, cerebrovascular events, thrombosis, thrombocytopenia, facial paralysis, deaths, and many other reactions which may be fatal. But the events reported were less compared to the safety of the patients. All these events were maintained by the Uppsala monitoring center.

Keywords: Vaccine, COVID-19, Virus, Immunization, Pharmacovigilance, Clinical trails, ISOP


1. Chandler R, McCarthy D, Delumeau J, Harrison-Woolrych M. The Role of Pharmacovigilance and ISoP During the Global COVID-19 Pandemic. Drug Safety. 2020;43(6):511-512.
2. Le T, Cramer J, Chen R, Mayhew S. Evolution of the COVID-19 vaccine development landscape. Nature Reviews Drug Discovery. 2020;19(10):667-668.
3. Meher B. Need of vibrant vaccine pharmacovigilance during current global COVID-19 pandemic: More than ever. Journal of Pharmacy And Bioallied Sciences. 2021;13(1):1.
4. Dhanda S, Osborne V, Lynn E, Shakir S. Postmarketing studies: can they provide a safety net for COVID-19 vaccines in the UK?. BMJ Evidence-Based Medicine. 2020;:bmjebm-2020-111507.
5. Olivier P, Montastruc J. The nature of the scientific evidence leading to drug withdrawals for pharmacovigilance reasons in France. Pharmacoepidemiology and Drug Safety. 2006;15(11):808-812.
6. Abou Taam M, Jacquot B, Ferard C, Thery A, Mounier C, Grandvuillemin A et al. The French pharmacovigilance surveys: A French distinctiveness, a real input. Therapies. 2020;.
7. Soeiro T, Lacroix C, Micallef J. Adverse drug reaction monitoring: Doing it the French way – Act II. Therapies. 2020;.
8. Lacroix C, Salvo F, Gras-Champel V, Gautier S, Massy N, Valnet-Rabier M et al. French organization for the pharmacovigilance of COVID-19 vaccines: A major challenge. Therapies. 2021;.
9. Agence nationale de sécurité du médicament et des produits de santé. Journal de Pédiatrie et de Puériculture. 2021;26(1):67-72.
10. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine. 2021;384(16):1576-1578.
11. McMahon D, Amerson E, Rosenbach M, Lipoff J, Moustafa D, Tyagi A et al. Cutaneous reactions reported after Moderna and Pfizer COVID-19 vaccination: A registry-based study of 414 cases. Journal of the American Academy of Dermatology. 2021;85(1):46-55.
12. Merchant H. CoViD vaccines and thrombotic events: EMA issued warning to patients and healthcare professionals. Journal of Pharmaceutical Policy and Practice. 2021;14(1).
13. Mantadakis E, Farmaki E, Thomaidis S, Tsalkidis A, Chatzimichael A. A Case of Immune Thrombocytopenic Purpura After Influenza Vaccination. Journal of Pediatric Hematology/Oncology. 2010;32(6):e227-e229.
14. Hamiel U, Kventsel I, Youngster I. Recurrent Immune Thrombocytopenia After Influenza Vaccination: A Case Report. PEDIATRICS. 2016;138(6):e20160124-e20160124.
15. Rinaldi, M., Perricone, C., Ortega-Hernandez, O., Perricone, R. and Shoenfeld, Y., 2014. Immune thrombocytopaenic purpura: an autoimmune cross-link between infections and vaccines. Lupus, 23(6), pp.554-567.
16. Pellegrino P, Clementi E, Radice S. On vaccine's adjuvants and autoimmunity: Current evidence and future perspectives. Autoimmunity Reviews. 2015;14(10):880-888.
17. [Internet]. 2021 [cited 12 June 2021]. Available from: https://www. jwatch.org/fw117502/2021/02/08/officials-investigatingreportsthrombocytopeniaafter
18. Wise J. Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots. BMJ. 2021;:n699.
19. Lee E, Cines D, Gernsheimer T, Kessler C, Michel M, Tarantino M et al. Thrombocytopenia following Pfizer and Moderna SARS‐CoV ‐2 vaccination. American Journal of Hematology. 2021;96(5):534-537.
20. Saudagar V, Patil S, Goh S, Pothiawala S. Vigilance regarding immune thrombocytopenic purpura after COVID-19 vaccine. Irish Journal of Medical Science (1971 -). 2021;.
21. [Internet]. 2021 [cited 12 June 2021]. Available from: https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statementjohnson-johnson-covid-19-vaccine 2021
22. Gupta A, Sardar P, Cash M, Milani R, Lavie C. Covid-19 vaccine- induced thrombosis and thrombocytopenia-a commentary on an important and practical clinical dilemma. Progress in Cardiovascular Diseases. 2021;.
23. EMA. European Medicines Agency AstraZeneca's COVID-19 Vaccine Analysis. Available at: https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood 2021.
24. Request Rejected [Internet]. Main.mohfw.gov.in. 2021 [cited 12 June 2021]. Available from: https://main.mohfw.gov.in/Organisation/Departments-of-Health-andFamily-Welfare/immunization/aefi-reports 2021
25. Logunov D, Dolzhikova I, Shcheblyakov D, Tukhvatulin A, Zubkova O, Dzharullaeva A 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. The Lancet. 2021;397(10275):671-681.
26. [Internet]. 2021 [cited 12 June 2021]. Available from: https://clinicaltrials.gov/ct2/show/ NCT04526990 2021.
27. Alimehmeti I. Efficacy and Safety of AZD1222, BNT162b2 and mRNA-1273 vaccines against SARS-CoV-2. Albanian Journal of Trauma and Emergency Surgery. 2021;5(1):791-796.
28. Association of Facial Paralysis With mRNA COVID-19 Vaccines: A Disproportionality Analysis Using the World Health Organization Pharmacovigilance Database. american medical association. 2021;.
29. Lt. Pushkar a. Pharmacovigilence analysis on cerebrovascular accidents and Corona virus disease 2019 vaccines. 2021;.
30. Jha N, Palaian S, Shankar P, Dangal G. Pharmacovigilance of COVID-19 vaccines in the context of Nepal: an assessment based on early adverse drug reaction reports. Journal of Pharmaceutical Health Services Research. 2021;.
31. Logunov, D., Dolzhikova, I., Tukhvatullin, A. and Shcheblyakov, D., 2020. Safety and efficacy of the Russian COVID-19 vaccine: more information needed – Authors’ reply. The Lancet, 396(10256), pp.e54-e55.
32. Zhu F, Li Y, Guan X, Hou L, Wang W, Li J et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. The Lancet. 2020;395(10240):1845-1854.
33. Lv G, Yuan J, Xiong X, Li M. Mortality Rate and Characteristics of Deaths Following COVID-19 Vaccination. Frontiers in Medicine. 2021;8.
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How to Cite
Navya, J. K., Jaka, A., Velpula Padma sujaya, V. P. sujaya, Rupavath, P. N., & Vaddadi, R. R. C. (2021). A review on vaccine pharmacovigilance during covid-19. Journal of Innovations in Applied Pharmaceutical Science (JIAPS), 6(2), 15-22. https://doi.org/10.37022/jiaps.v6i2.226
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