Publications

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Clinical Course, Outcomes, and Risk Factors of Myocarditis and Pericarditis Following Administration of mRNA-1273 Vaccination: A Protocol for a Federated Real-World Evidence Vaccine Safety Study Using Data from Five European Data Sources

• Author

  Laura C. Zwiers Diederick E. Grobbee Rob Schneijdenberg Corine Baljé Samantha St. Laurent Daina B. Esposito Lei Zhu Veronica V. Urdaneta Magalie Emilebacker Daniel Weibel Felipe Villalobos Carlo Alberto Bissacco Arantxa Urchueguía-Fornes Juan José Carreras-Martínez Anteneh A. Desalegn Angela Lupattelli Lei Wang Jannik Wheler Vera Ehrenstein Denise Morris Catherine Fry Marjolein Jansen Brianna M. Goodale David S. Y. Ong

  Laura Zwiers, Diederick Grobbee, Rob Schneijdenberg, Corine Baljé, Samantha St. Laurent, Daina Esposito, Lei Zhu, Veronica Urdaneta, Magalie Emilebacker, Daniel Weibel, Felipe Villalobos, Carlo Alberto Bissacco, Arantxa Urchueguía-Fornes, Juan José Carreras-Martínez, Anteneh Desalegn, Angela Lupattelli, Lei Wang, Jannik Wheler, Vera Ehrenstein, Denise Morris, Catherine Fry, Marjolein Jansen, Brianna Goodale, David Ong

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  Vaccines 2025, 13(7), 755; https://doi.org/10.3390/vaccines13070755

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Risk of Guillain-Barré syndrome after COVID-19 vaccination or SARS-CoV-2 infection: A multinational self-controlled case series study

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  Sharifa Nasreen Yannan Jiang Han Lu Arier Lee Clare L. Cutland Angela Gentile Norberto Giglio Kristine Macartney Lucy Deng Bette Liu Nicole Sonneveld Karen Bellamy Hazel J. Clothier Gonzalo Sepulveda Kattan Monika Naus Zaeema Naveed Naveed Z. Janjua Lena Nguyen Anders Hviid Eero Poukka Jori Perälä Tuija Leino Lukman Ade Chandra Jarir At Thobari Byung-Joo Park Nam-Kyong Choi Na-Young Jeongr Shabir A Madhi Felipe Villalobos Martín Solórzano Carlo Alberto Bissacco Juan José Carreras-Martínez Elisa Correcher-Martínez Arantxa Urchueguía-Fornes Debabrata Roy Alison Yeomans Taylor Aurelius Kathryn Morton Gianmarco Di Mauro Miriam CJM Sturkenboom James J. Sejvar Karina A. Top Karin Batty Luam Ghebreab Jennifer B. Griffin Helen Petousis-Harris Jim Buttery Steven Black Jeffrey C. Kwong

  Sharifa Nasreen, Yannan Jiang, Han Lu, Arier Lee, Clare L. Cutland, Angela Gentile, Norberto Giglio, Kristine Macartney, Lucy Deng, Bette Liu, Nicole Sonneveld, Karen Bellamy, Hazel Clothier, Gonzalo Sepulveda Kattan, Monika Naus, Zaeema Naveed, Naveed Janjua, Lena Nguyen, Anders Hviid, Eero Poukka, Jori Perälä, Tuija Leino, Lukman Ade Chandra, Jarir At Thobari, Byung-Joo Park, Nam-Kyong Choi, Na-Young Jeongr, Shabir Madhi, Felipe Villalobos, Martín Solórzano, Carlo Alberto Bissacco, Juan José Carreras-Martínez, Elisa Correcher-Martínez, Arantxa Urchueguía-Fornes, Debabrata Roy, Alison Yeomans, Taylor Aurelius, Kathryn Morton, Gianmarco Di Mauro, Miriam Sturkenboom, James Sejvar, Karina Top, Karin Batty, Luam Ghebreab, Jennifer Griffin, Helen Petousis-Harris, Jim Buttery, Steven Black, Jeffrey Kwong

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  Vaccine. 2025 Jul 11;60:127291. doi: 10.1016/j.vaccine.2025.127291.

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Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study

• Author

  Alison Evans Debabrata Roy Miranda Davies Sandeep Dhanda Denise Morris Taylor Aurelius Samantha Lane Catherine Fry Saad Shakir

  Alison Evans, Debabrata Roy, Miranda Davies, Sandeep Dhanda, Denise Morris, Taylor Aurelius, Samantha Lane, Catherine Fry, Saad Shakir

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  BMJ Open 2025;15:e093366. doi: 10.1136/bmjopen-2024-093366

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The safety and effectiveness of the anti-amyloid monoclonal antibody (mAb) drug Lecanemab for early Alzheimer’s disease: The pharmacovigilance perspective.

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  Amy Bobbins Alison Yeomans Miranda Davies Elizabeth Lynn Debabrata Roy Saad Shakir

  Amy Bobbins, Alison Yeomans, Miranda Davies, Elizabeth Lynn, Debabrata Roy, Saad Shakir

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  Br J Clin Pharmacol. 2025; 91(5): 1352-1360. doi:10.1002/bcp.70021

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Safety of COVID-19 vaccines among people with history of allergy: a European active surveillance study

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  Nicoletta Luxi Francesco Ciccimarra Chiara Bellitto Monika Raethke Florence van Hunsel Thomas Lieber Erik Mulder Luca L’Abbate Francisco Batel Marques Fabiana Furci Andreea Farcas Janneke Giele-Eshuis Kathryn Morton Simona Sonderlichová Nicolas H. Thurin Felipe Villalobos Fabio Riefolo Miriam Sturkenboom Gianluca Trifirò

  Nicoletta Luxi, Francesco Ciccimarra, Chiara Bellitto, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Luca L’Abbate, Francisco Batel Marques, Fabiana Furci, Andreea Farcas, Janneke Giele-Eshuis, Kathryn Morton, Simona Sonderlichová, Nicolas H. Thurin, Felipe Villalobos, Fabio Riefolo, Miriam Sturkenboom, Gianluca Trifirò

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  Vaccines 2024, 12, 1059. https://doi.org/10.3390/vaccines12091059

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Quantitative Measurement of the Direct Public Health Impact of Medicines Withdrawals in Europe: Development of a Modelling Method and Proof-of-Concept Study to Estimate the Morbidity and Mortality Prevented by Regulatory Action

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  Samantha Lane Elizabeth Lynn Saad Shakir

  Samantha Lane, Elizabeth Lynn, Saad Shakir

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  Pharmacoepidemiol Drug Saf, 33: e70003. https://doi.org/10.1002/pds.70003

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What is the safety of COVID-19 vaccines in immunocompromised patients? Results from the European “Covid Vaccine Monitor” active surveillance study.

• Author

  Chiara Bellitto Nicoletta Luxi Francesco Ciccimarra Luca L’Abbate Monika Raethke Florence van Hunsel Thomas Lieber Erik Mulder Fabio Riefolo Felipe Villalobos Nicolas H. Thurin Francisco Batel Marques Kathryn Morton Fergal O'Shaughnessy Simona Sonderlichová Andreea Farcas Janneke Giele-Eshuis Miriam Sturkenboom Gianluca Trifirò

  Chiara Bellitto, Nicoletta Luxi, Francesco Ciccimarra, Luca L’Abbate, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H. Thurin, Francisco Batel Marques, Kathryn Morton, Fergal O'Shaughnessy, Simona Sonderlichová, Andreea Farcas, Janneke Giele-Eshuis, Miriam Sturkenboom, Gianluca Trifirò

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  Drug Saf 47, 1011–1023 (2024). https://doi.org/10.1007/s40264-024-01449-x

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Frequency and timing of Adverse Reactions to COVID-19 Vaccines; a multi-country Cohort Event Monitoring Study.

• Author

  Monika Raethke Florence van Hunsel Nicoletta Luxi Thomas Lieber Chiara Bellitto Erik Mulder Francesco Ciccimarra Fabio Riefolo Nicolas H. Thurin Debabrata Roy Kathryn Morton Felipe Villalobos Francisco Batel Marques Andreea Farcas Simona Sonderlichová Svetlana Belitzer Olaf H. Klungel Gianluca Trifirò Miriam Sturkenboom

  Monika Raethke, Florence van Hunsel, Nicoletta Luxi, Thomas Lieber, Chiara Bellitto, Erik Mulder, Francesco Ciccimarra, Fabio Riefolo, Nicolas H. Thurin, Debabrata Roy, Kathryn Morton, Felipe Villalobos, Francisco Batel Marques, Andreea Farcas, Simona Sonderlichová, Svetlana Belitzer, Olaf H. Klungel, Gianluca Trifirò, Miriam Sturkenboom

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  Vaccine, Volume 42, Issue 9, 2024, Pages 2357-2369, ISSN 0264-410X, https://doi.org/10.1016/j.vaccine.2024.03.001.

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A systematic review of Flurbiprofen 8.75mg dose and risk of adverse events (excluding haemorrhagic) resulting from drug-drug interactions.

• Author

  Alison Evans Debabrata Roy Sandeep Dhanda Samantha Lane Graca Coutinho Anuradha Kulasekaran David Miller-Shakesby Nagalakshmi Ramamoorthi Saad Shakir

  Alison Evans, Debabrata Roy, Sandeep Dhanda, Samantha Lane, Graca Coutinho, Anuradha Kulasekaran, David Miller-Shakesby, Nagalakshmi Ramamoorthi, Saad Shakir

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  Front. Pharmacol. 15:1107185. doi: 10.3389/fphar.2024.1107185

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Safety monitoring of COVID-19 vaccine in person with prior SARS-COV infection: a European multi-country study.

• Author

  Francesco Ciccimarra Nicoletta Luxi Chiara Bellitto Monika Raethke Florence van Hunsel Thomas Lieber Erik Mulder Fabio Riefolo Felipe Villalobos Nicolas H. Thurin Caroline Dureau‑Pournin Francisco Batel Marques Alice P. Monnat Kathryn Morton Debabrata Roy Fergal O'Shaughnessy Simona Sonderlichová Andreea Farcas Janneke Giele-Eshuis Miriam Sturkenboom Gianluca Trifirò

  Francesco Ciccimarra, Nicoletta Luxi, Chiara Bellitto, Monika Raethke, Florence van Hunsel, Thomas Lieber, Erik Mulder, Fabio Riefolo, Felipe Villalobos, Nicolas H. Thurin, Caroline Dureau‑Pournin, Francisco Batel Marques, Alice P. Monnat, Kathryn Morton, Debabrata Roy, Fergal O'Shaughnessy, Simona Sonderlichová, Andreea Farcas, Janneke Giele-Eshuis, Miriam Sturkenboom, Gianluca Trifirò

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  Vaccines 2024, 12(3), 241; https://doi.org/10.3390/vaccines12030241

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The International Working Group on New Developments in Pharmacovigilance: Advancing Methods and Communication in Pharmacovigilance.

• Author

  Dawn Cooper Robert W. Platt Florence van Hunsel Miranda Davies Alison Yeomans Samantha Lane Saad Shakir

  Dawn Cooper, Robert W. Platt, Florence van Hunsel, Miranda Davies, Alison Yeomans, Samantha Lane, Saad Shakir

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  Clinical Therapeutics, ISSN: 0149-2918, Vol: 46, Issue: 7, Page: 565-569 DOI10.1016/j.clinthera.2023.12.008

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Cohort Event Monitoring of Adverse Reactions to COVID‑19 Vaccines in Seven European Countries: Pooled Results on First Dose.

• Author

  Monika Raethke Florence van Hunsel Nicolas H. Thurin Caroline Dureau‑Pournin Dirk Mentzer Nicoletta Luxi Nikica Mirošević Skvrce Evelien De Clercq Martine Sabbe Gianluca Trifirò Barbara Kovačić Alexia Giovanazzi Saad Shakir Olaf H. Klungel Sandor Schmikli Miriam Sturkenboom

  Monika Raethke, Florence van Hunsel, Nicolas H. Thurin, Caroline Dureau‑Pournin, Dirk Mentzer, Nicoletta Luxi, Nikica Mirošević Skvrce, Evelien De Clercq, Martine Sabbe, Gianluca Trifirò, Barbara Kovačić, Alexia Giovanazzi, Saad Shakir, Olaf H. Klungel, Sandor Schmikli, Miriam Sturkenboom

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  Drug Saf 46, 391–404 (2023). https://doi.org/10.1007/s40264-023-01281-9

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A Concept for Causality assessment and causal inference of adverse events cases.

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  Ahmed Al-Imam Ahmed Sami Samantha Lane Manal Younus

  Ahmed Al-Imam, Ahmed Sami, Samantha Lane, Manal Younus

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  Journal of Biological Research - Bollettino Della Società Italiana Di Biologia Sperimentale, 95(2). https://doi.org/10.4081/jbr.2022.10772

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Vaccine-Induced Thrombosis with Thrombocytopenia Syndrome (VITT) after the     rAd26 Sputnik V vaccine: a case report.

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  Raquel Herrera-Comoglio Samantha Lane

  Raquel Herrera-Comoglio, Samantha Lane

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  New England Journal of Medicine Volume 387 • Number 15 • October 13, 2022 Pages: 1431-1432 doi 10.1056/NEJMc2210813

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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

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  Samantha Lane Saad Shakir

  Samantha Lane, Saad Shakir

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  Drug Saf. 2022;45(9):1003-1008. doi:10.1007/s40264-022-01217-9

Systematic review of spontaneous reports of myocarditis and pericarditis in transplant recipients and immunocompromised patients following COVID-19 mRNA vaccination.

• Author

  Samantha Lane Alison Yeomans Saad Shakir

  Samantha Lane, Alison Yeomans, Saad Shakir

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  BMJ Open. 2022 Jul 1;12(7):e060425. doi: 10.1136/bmjopen-2021-060425.

Delayed pregnancy detection and return to fertility with extended levonorgestrel-containing oral contraceptives: A real world setting cohort study

• Author

  Sigal Kaplan Monica L Bertoia Amir Lass Florence T Wang Alison Evans Sandeep Dhanda Debabrata Roy John D Seeger

  Sigal Kaplan, Monica Bertoia, Amir Lass, Florence Wang, Alison Evans, Sandeep Dhanda, Debabrata Roy, John Seeger

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  Pharmacoepidemiol Drug Saf. 2022 Jun 17. doi: 10.1002/pds.5497.

Reports of myocarditis and pericarditis following mRNA COVID-19 vaccination: a systematic review of spontaneously reported data from the UK, Europe and the USA and of the scientific literature

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  Samantha Lane Alison Yeomans Saad Shakir

  Samantha Lane, Alison Yeomans, Saad Shakir

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  BMJ Open. 2022 May 25;12(5):e059223. doi: 10.1136/bmjopen-2021-059223.

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Rare Variation in Drug Metabolism and Long QTGenes and the Genetic Susceptibility to AcquiredLong QT Syndrome

• Author

  Belinda Gray Alban-Elouen Baruteau Albert A. Antolin Alan Pittman Giselle Sarganas Mariam Molokhia Marieke T. Blom Rachel Bastiaenen Abdenasser Bardai Silvia G. Priori Carlo Napolitano Peter E. Weeke Saad Shakir Wilhelm Haverkamp Jordi Mestres Bo Winkel Adam A. Witney Irina Chis-Ster Ajanthah Sangaralingam A. John Camm Jacob Tfelt-Hansen Dan Roden Hanno L. Tan Edeltraut Garbe Miriam Sturkenboom Elijah Behr

  Belinda Gray, Alban-Elouen Baruteau, Albert A. Antolin, Alan Pittman, Giselle Sarganas, Mariam Molokhia, Marieke T. Blom, Rachel Bastiaenen, Abdenasser Bardai, Silvia G. Priori, Carlo Napolitano, Peter E. Weeke, Saad Shakir, Wilhelm Haverkamp, Jordi Mestres, Bo Winkel, Adam A. Witney, Irina Chis-Ster, Ajanthah Sangaralingam, A. John Camm, Jacob Tfelt-Hansen, Dan Roden, Hanno L. Tan, Edeltraut Garbe, Miriam Sturkenboom, Elijah Behr

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  Circulation: Genomic and Precision Medicine Volume 15, Number 1 https://doi.org/10.1161/CIRCGEN.121.003391

Long-term safety of extended levonorgestrel-containing oral contraceptives in the United States

• Author

  Sigal Kaplan Monica L Bertoia Florence T Wang Li Zhou Amir Lass Alison Evans Sandeep Dhanda Debabrata Roy John D Seeger

  Sigal Kaplan, Monica Bertoia, Florence Wang, Li Zhou, Amir Lass, Alison Evans, Sandeep Dhanda, Debabrata Roy, John Seeger

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  Contraception. 2021 Sep 29:S0010-7824(21)00406-6. doi: 10.1016/j.contraception.2021.09.013.

A Systematic Review of Flurbiprofen 8.75mg Dose and Risk of Haemorrhagic Events

• Author

  Sandeep Dhanda Alison Evans Debabrata Roy Vicki Osborne Adam Townsley Graça Coutinho Anuraha Kulasekaran Saad Shakir

  Sandeep Dhanda, Alison Evans, Debabrata Roy, Vicki Osborne, Adam Townsley, Graca Coutinho, Anuraha Kulasekaran, Saad Shakir

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  Frontiers in Pharmacology. 2021 12:726141

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The Role of the Contextual Cohort to Resolve Some Challenges and Limitations of Comparisons in Pharmacoepidemiology

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  Vicki Osborne Samantha Lane Saad A W Shakir

  Vicki Osborne, Samantha Lane, Saad Shakir

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  Drug Saf. 2021 Aug;44(8):835-841. doi: 10.1007/s40264-021-01074-y. Epub 2021 May 7.

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Utilisation and Safety of Polyethylene Glycol 3350 With Electrolytes in Children Under 2 Years: A Retrospective Cohort

• Author

  Debabrata Roy Fatma Akriche Bharat Amlani Saad Shakir

  Debabrata Roy, Fatma Akriche, Bharat Amlani, Saad Shakir

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  J Pediatr Gastroenterol Nutr. 2021 May 1;72(5):683-689. doi: 10.1097/MPG.0000000000003074.

Real world utilization of 91 day extended levonorgestrel-containing combined oral contraceptives in Europe: a multinational database study

• Author

  Sigal Kaplan Massoud Toussi Alison Evans Sandeep Dhanda Debabrata Roy Amir Lass

  Sigal Kaplan, Massoud Toussi, Alison Evans, Sandeep Dhanda, Debabrata Roy, Amir Lass

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  Curr Med Res Opin. 2021 Mar;37(3):515-522. doi: 10.1080/03007995.2021.1876008.

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How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine.

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  Saad Shakir Samantha Lane Miranda Davies

  Saad Shakir, Samantha Lane, Miranda Davies

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  Drug Safety 44, 1–5 (2021). https://doi.org/10.1007/s40264-020-01018-y