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Articles published in Drug Saf

Retrieve available abstracts of 49 articles:
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Single Articles


    July 2024
  1. 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
  2. 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
  3. 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
  4. 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


  5. 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
  6. 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


  7. 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


  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
  13. 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


  14. 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
  15. 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
  16. 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


  17. 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


  18. 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
  19. 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    


  20. 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


  21. 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


    February 2023
  22. 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.
    PubMed     Abstract available


    January 2023
  23. 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.
    PubMed     Abstract available


    December 2022
  24. 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.
    PubMed     Abstract available


    October 2022
  25. 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.
    PubMed     Abstract available


    September 2022
  26. 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.
    PubMed     Abstract available


    August 2022
  27. 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.
    PubMed    


  28. MUNGMUNPUNTIPANTIP R, Wiwanitkit V
    Comment on "Description of Frequencies of Reported Adverse Events Following Immunization Among Four Different COVID-19 Vaccine Brands".
    Drug Saf. 2022;45:923.
    PubMed    


    July 2022
  29. HARPAZ R, DuMouchel W, Van Manen R, Nip A, et al
    Signaling COVID-19 Vaccine Adverse Events.
    Drug Saf. 2022;45:765-780.
    PubMed     Abstract available


    June 2022
  30. 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.
    PubMed     Abstract available


    May 2022
  31. 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.
    PubMed     Abstract available


    April 2022
  32. 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.
    PubMed     Abstract available


    February 2022
  33. 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.
    PubMed     Abstract available


    December 2021
  34. 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.
    PubMed     Abstract available


    November 2021
  35. 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.
    PubMed     Abstract available


  36. 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.
    PubMed     Abstract available


    October 2021
  37. 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.
    PubMed     Abstract available


    September 2021
  38. 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.
    PubMed     Abstract available


  39. 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.
    PubMed     Abstract available


    June 2021
  40. 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.
    PubMed     Abstract available


    April 2021
  41. DASGUPTA N
    Safety Consequences of Off-Label Drugs Used for COVID-19.
    Drug Saf. 2021;44:399-402.
    PubMed    


  42. 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.
    PubMed     Abstract available


    February 2021
  43. 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.
    PubMed    


    January 2021
  44. 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.
    PubMed     Abstract available


  45. 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.
    PubMed    


    December 2020
  46. 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.
    PubMed     Abstract available


  47. PETOUSIS-HARRIS H
    Assessing the Safety of COVID-19 Vaccines: A Primer.
    Drug Saf. 2020;43:1205-1210.
    PubMed     Abstract available


  48. 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.
    PubMed     Abstract available


  49. 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.
    PubMed     Abstract available


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