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Articles published in
Drug Saf
    May 2024
  1. 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.
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    March 2024
  2. 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.
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  3. 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.
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    February 2024
  4. 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.
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  5. 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.
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  6. 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.
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    December 2023
  7. 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.
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    November 2023
  8. 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.
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    October 2023
  9. 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.
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    September 2023
  10. 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.
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    June 2023
  11. 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.
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  12. 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.
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    May 2023
  13. 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.
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    April 2023
  14. 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.
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  15. 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.
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  16. 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.
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    March 2023
  17. 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.
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  18. 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.
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  19. 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.
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    February 2023
  20. DIAK IL, Swank K, McCartan K, Beganovic M, et al
    The Food and Drug Administration's (FDA's) Drug Safety Surveillance During the COVID-19 Pandemic.
    Drug Saf. 2023;46:145-155.
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    January 2023
  21. OOSTERHUIS I, Scholl J, van Puijenbroek E, Kant A, et al
    Optimizing Safety Surveillance for COVID-19 Vaccines at the National Pharmacovigilance Centre Lareb: One Year of COVID-19 Vaccine Experience.
    Drug Saf. 2023;46:65-75.
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    December 2022
  22. WAN EYF, Chui CSL, Mok AHY, Xu W, et al
    mRNA (BNT162b2) and Inactivated (CoronaVac) COVID-19 Vaccination and Risk of Adverse Events and Acute Diabetic Complications in Patients with Type 2 Diabetes Mellitus: A Population-Based Study.
    Drug Saf. 2022;45:1477-1490.
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    October 2022
  23. KAUR U, K L A, Chauhan M, Joshi A, et al
    A Prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the First Real-World Safety Analysis.
    Drug Saf. 2022;45:1099-1109.
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    September 2022
  24. LANE S, Shakir S
    Assessing Case Fatality on Cases of Thrombosis with Concurrent Thrombocytopenia Following COVID-19 Vaccine AstraZeneca (Vaxzevria) in the United Kingdom: A Review of Spontaneously Reported Data.
    Drug Saf. 2022;45:1003-1008.
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    August 2022
  25. KANT A, van Hunsel F
    Authors' Reply to Mungmunpuntipantip et al.'s Comment on "Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands".
    Drug Saf. 2022;45:925-926.
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    Comment on "Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands".
    Drug Saf. 2022;45:923.
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    July 2022
  27. HARPAZ R, DuMouchel W, Van Manen R, Nip A, et al
    Signaling COVID-19 Vaccine Adverse Events.
    Drug Saf. 2022;45:765-780.
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    June 2022
  28. SHOAIBI A, Rao GA, Voss EA, Ostropolets A, et al
    Phenotype Algorithms for the Identification and Characterization of Vaccine-Induced Thrombotic Thrombocytopenia in Real World Data: A Multinational Network Cohort Study.
    Drug Saf. 2022;45:685-698.
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    May 2022
  29. MARTIN GL, Jouganous J, Savidan R, Bellec A, et al
    Validation of Artificial Intelligence to Support the Automatic Coding of Patient Adverse Drug Reaction Reports, Using Nationwide Pharmacovigilance Data.
    Drug Saf. 2022;45:535-548.
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    April 2022
  30. KANT A, Jansen J, van Balveren L, van Hunsel F, et al
    Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands.
    Drug Saf. 2022;45:319-331.
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    February 2022
  31. FERNER RE, Stevens RJ, Anton C, Aronson JK, et al
    Spontaneous Reporting to Regulatory Authorities of Suspected Adverse Drug Reactions to COVID-19 Vaccines Over Time: The Effect of Publicity.
    Drug Saf. 2022;45:137-144.
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    December 2021
  32. LUXI N, Giovanazzi A, Capuano A, Crisafulli S, et al
    COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.
    Drug Saf. 2021;44:1247-1269.
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    November 2021
  33. CLINTON JW, Kiparizoska S, Aggarwal S, Woo S, et al
    Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature.
    Drug Saf. 2021;44:1125-1149.
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  34. IGUCHI T, Umeda H, Kojima M, Kanno Y, et al
    Cumulative Adverse Event Reporting of Anaphylaxis After mRNA COVID-19 Vaccine (Pfizer-BioNTech) Injections in Japan: The First-Month Report.
    Drug Saf. 2021;44:1209-1214.
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    October 2021
  35. SALAMANCA DE LA CUEVA I, Cinconze E, Eckermann T, Nwoji U, et al
    Safety Profile of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain: Passive Enhanced Safety Surveillance Study for the 2019/2020 Influenza Season.
    Drug Saf. 2021 Oct 25. pii: 10.1007/s40264-021-01121.
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    September 2021
  36. ROCCA E, Gauffin O, Savage R, Vidlin SH, et al
    Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020.
    Drug Saf. 2021;44:987-998.
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  37. MOORE N, Bosco-Levy P, Thurin N, Blin P, et al
    NSAIDs and COVID-19: A Systematic Review and Meta-analysis.
    Drug Saf. 2021;44:929-938.
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    June 2021
  38. BHOWMICK S, Dang A, Vallish BN, Dang S, et al
    Safety and Efficacy of Ivermectin and Doxycycline Monotherapy and in Combination in the Treatment of COVID-19: A Scoping Review.
    Drug Saf. 2021;44:635-644.
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    April 2021
    Safety Consequences of Off-Label Drugs Used for COVID-19.
    Drug Saf. 2021;44:399-402.
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  40. GRANDVUILLEMIN A, Drici MD, Jonville-Bera AP, Micallef J, et al
    French Pharmacovigilance Public System and COVID-19 Pandemic.
    Drug Saf. 2021;44:405-408.
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    February 2021
  41. MARZOLINI C, Stader F, Leuppi-Taegtmeyer A, Stoeckle M, et al
    Sex Differences in Lopinavir Concentrations and Occurrence of Marked QTc Prolongation Episodes in Patients with COVID-19.
    Drug Saf. 2021;44:255-257.
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    January 2021
  42. BEYZAROV E, Chen Y, Julg R, Naim K, et al
    Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor's Perspective.
    Drug Saf. 2021;44:95-105.
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  43. SHAKIR S, Lane S, Davies M
    How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine.
    Drug Saf. 2021;44:1-5.
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    December 2020
  44. GARCIA P, Revet A, Yrondi A, Rousseau V, et al
    Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study.
    Drug Saf. 2020;43:1315-1322.
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    Assessing the Safety of COVID-19 Vaccines: A Primer.
    Drug Saf. 2020;43:1205-1210.
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  46. ZEKARIAS A, Watson S, Vidlin SH, Grundmark B, et al
    Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports.
    Drug Saf. 2020;43:1309-1314.
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  47. TRIFIRO G, Massari M, Da Cas R, Menniti Ippolito F, et al
    Renin-Angiotensin-Aldosterone System Inhibitors and Risk of Death in Patients Hospitalised with COVID-19: A Retrospective Italian Cohort Study of 43,000 Patients.
    Drug Saf. 2020;43:1297-1308.
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