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Articles published in Drug Saf

Retrieve available abstracts of 36 articles:
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Single Articles


    December 2025
  1. WONG J, Donegan K, Harrison K, Jan T, et al
    Implementation and Results of Active Vaccine Safety Monitoring During the COVID-19 Pandemic in the UK: A Regulatory Perspective.
    Drug Saf. 2025;48:1365-1385.
    PubMed     Abstract available


  2. VAN HOLLE L
    Observed Versus Expected Analysis-How Does It Fit in the Pharmacovigilance Toolkit?
    Drug Saf. 2025;48:1325-1330.
    PubMed     Abstract available


    October 2025
  3. ORDONEZ-MENA JM, Kar D, Fan X, Ferreira F, et al
    Epidemiology of Thrombotic Thrombocytopenia Syndrome 2011 to 2022: English Sentinel Network Cohort Studies.
    Drug Saf. 2025;48:1161-1175.
    PubMed     Abstract available


    August 2025
  4. SANKAR C, Evans S, Meyer JC, Gunter HM, et al
    Signal Monitoring for Adverse Events Following Immunisation with COVID-19 Vaccines During the SARS-CoV-2 Pandemic: An Evaluation of the South African Surveillance System.
    Drug Saf. 2025;48:909-922.
    PubMed     Abstract available


    July 2025
  5. ABATE A, Poncato E, Barbieri MA, Powell G, et al
    Off-the-Shelf Large Language Models for Causality Assessment of Individual Case Safety Reports: A Proof-of-Concept with COVID-19 Vaccines.
    Drug Saf. 2025;48:805-820.
    PubMed     Abstract available


    June 2025
  6. ROQUE-PEREIRA L, Sisay MM, Ogar CK, Duran CE, et al
    Comparison of Adverse Events in Pregnant Persons Receiving COVID-19 and Influenza Vaccines: A Disproportionality Analysis Using Combined Data from US VAERS and EudraVigilance Spontaneous Report Databases.
    Drug Saf. 2025 Jun 10. doi: 10.1007/s40264-025-01561.
    PubMed     Abstract available


    May 2025
  7. HAMZAOUI H, Shaum A, Cherkaoui I, Moussa LA, et al
    Assessment of Pharmacovigilance Across University Hospitals in Morocco.
    Drug Saf. 2025;48:527-539.
    PubMed     Abstract available


    March 2025
  8. NAMBASA VP, Gunter HM, Adeyemo MB, Bhawaneedin NY, et al
    Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID-19 Vaccines Through the African Union Smart Safety Surveillance Joint Signal Management Group.
    Drug Saf. 2025;48:233-249.
    PubMed     Abstract available


  9. BOULEFAA D, Bagheri H, Salvo F, Rabier MB, et al
    Early Detection of Hearing Impairment Signals Post-mRNA COVID-19 Vaccination: A Disproportionality Analysis Study on French Pharmacovigilance Database.
    Drug Saf. 2025;48:251-263.
    PubMed     Abstract available


    November 2024
  10. MORCIANO C, Massari M, Cutillo M, Belleudi V, et al
    Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study.
    Drug Saf. 2024;47:1157-1169.
    PubMed     Abstract available


    October 2024
  11. CIAPPONI A, Berrueta M, Argento FJ, Ballivian J, et al
    Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis.
    Drug Saf. 2024;47:991-1010.
    PubMed     Abstract available


  12. YAN VKC, Yang Y, Wan EYF, Lai FTT, et al
    Real-World Effectiveness and Safety of Tixagevimab-Cilgavimab: A Target Trial Emulation Study.
    Drug Saf. 2024;47:1025-1037.
    PubMed     Abstract available


  13. BELLITTO C, Luxi N, Ciccimarra F, L'Abbate L, et al
    What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European "Covid Vaccine Monitor" Active Surveillance Study.
    Drug Saf. 2024;47:1011-1023.
    PubMed     Abstract available


    September 2024
  14. WYSZYNSKI DF, Demetriou L, Renz C, Aliabadi S, et al
    Use of Sotrovimab in Pregnancy: Experiences from the COVID-19 International Drug Pregnancy Registry.
    Drug Saf. 2024;47:843-851.
    PubMed     Abstract available


    August 2024
  15. GORDILLO-MARANON M, Szmigiel A, Yalmanova V, Caplanusi I, et al
    COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance.
    Drug Saf. 2024;47:783-798.
    PubMed     Abstract available


    July 2024
  16. GORDILLO-MARANON M, Candore G, Hedenmalm K, Browne K, et al
    Lessons Learned on Observed-to-Expected Analysis Using Spontaneous Reports During Mass Vaccination.
    Drug Saf. 2024;47:607-615.
    PubMed     Abstract available


    June 2024
  17. DE LA CUEVA IS, Gerber JE, Hastie A, Brotons C, et al
    Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season.
    Drug Saf. 2024 Jun 29. doi: 10.1007/s40264-024-01456.
    PubMed     Abstract available


    May 2024
  18. CAPLANUSI I, Szmigiel A, van der Elst M, Schougaard Christiansen ML, et al
    The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally.
    Drug Saf. 2024;47:405-418.
    PubMed     Abstract available


    March 2024
  19. DOS SANTOS G, Devadiga R, Kim CS, Bang J, et al
    An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014-2022) Following the Introduction of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged
    Drug Saf. 2024 Mar 14. doi: 10.1007/s40264-024-01395.
    PubMed     Abstract available


  20. WYSZYNSKI DF, Papageorghiou AT, Renz C, Metz TD, et al
    The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations.
    Drug Saf. 2024;47:195-204.
    PubMed     Abstract available


    February 2024
  21. MORO PL, Ennulat C, Brown H, Woody G, et al
    Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS).
    Drug Saf. 2024 Feb 27. doi: 10.1007/s40264-024-01406.
    PubMed     Abstract available


  22. QIN SX, Cheng FWT, Kwok WC, Fung LWY, et al
    Effectiveness and Respiratory Adverse Events Following Inactivated and mRNA COVID-19 Vaccines in Patients with COPD and Asthma: A Chinese Population-Based Study.
    Drug Saf. 2024;47:135-146.
    PubMed     Abstract available


  23. DONG G, Bate A, Haguinet F, Westman G, et al
    Optimizing Signal Management in a Vaccine Adverse Event Reporting System: A Proof-of-Concept with COVID-19 Vaccines Using Signs, Symptoms, and Natural Language Processing.
    Drug Saf. 2024;47:173-182.
    PubMed     Abstract available


    December 2023
  24. DE GERMAY S, Singier A, Salvo F, Pariente A, et al
    Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France.
    Drug Saf. 2023;46:1381-1389.
    PubMed     Abstract available


    November 2023
  25. MICALLEF B, Dogne JM, Sultana J, Straus SMJM, et al
    An Exploratory Study of the Impact of COVID-19 Vaccine Spontaneous Reporting on Masking Signal Detection in EudraVigilance.
    Drug Saf. 2023;46:1089-1103.
    PubMed     Abstract available


    October 2023
  26. SLINGERLAND P, van Hunsel FPAM, Lieber T, van Balveren L, et al
    The Effect of Sex on the Incidence, Latency, Duration and Perceived Burden of Adverse Events Following Seasonal Influenza Vaccination in the Netherlands.
    Drug Saf. 2023 Oct 26. doi: 10.1007/s40264-023-01356.
    PubMed     Abstract available


    September 2023
  27. WALTON M, Pletzer V, Teunissen T, Lumley T, et al
    Adverse Events Following the BNT162b2 mRNA COVID-19 Vaccine (Pfizer-BioNTech) in Aotearoa New Zealand.
    Drug Saf. 2023;46:867-879.
    PubMed     Abstract available


    June 2023
  28. KAUR U, Fatima Z, Maheshwari K, Sahni V, et al
    Long-Term Safety Analysis of the ChAdOx1-nCoV-19 Corona Virus Vaccine: Results from a Prospective Observational Study in Priority Vaccinated Groups in North India.
    Drug Saf. 2023;46:553-563.
    PubMed     Abstract available


  29. AHMADIZAR F, Luxi N, Raethke M, Schmikli S, et al
    Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials.
    Drug Saf. 2023;46:575-585.
    PubMed     Abstract available


    May 2023
  30. KRALOVA K, Wilson CA, Richebourg N, D'souza J, et al
    Quality of MedDRA((R)) Coding in a Sample of COVID-19 Vaccine Medication Error Data.
    Drug Saf. 2023;46:501-507.
    PubMed     Abstract available


    April 2023
  31. BAUCHAU V, Davis K, Frise S, Jouquelet-Royer C, et al
    Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities.
    Drug Saf. 2023;46:327-333.
    PubMed     Abstract available


  32. RAETHKE M, van Hunsel F, Thurin NH, Dureau-Pournin C, et al
    Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose.
    Drug Saf. 2023;46:391-404.
    PubMed     Abstract available


  33. OGAR CK, Quick J, Gilbert HN, Vreman RA, et al
    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;46:357-370.
    PubMed     Abstract available


    March 2023
  34. KALKNER KM, Sundstrom A, Nurminen ML, Larsson M, et al
    Optimizing Safety Surveillance for COVID-19 Vaccines at the Swedish Medical Products Agency.
    Drug Saf. 2023;46:319-321.
    PubMed    


  35. WYSZYNSKI DF, Bhattacharya M, Martinez-Perez O, Scialli AR, et al
    The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations.
    Drug Saf. 2023;46:297-308.
    PubMed     Abstract available


  36. ZAPATA-CACHAFEIRO M, Prieto-Campo A, Portela-Romero M, Carracedo-Martinez E, et al
    Effect of Previous Anticoagulant Treatment on Risk of COVID-19.
    Drug Saf. 2023;46:273-281.
    PubMed     Abstract available


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