Publications

Our research library includes a focus on pharmacoepidemiology and real-world evidence analysis to support safety and effectiveness research

Explore Harvard Pilgrim Health Care Institute's Work on PubMed
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Conference Abstract

Incidence Rates of Guillain-Barré Syndrome in Adult Populations in the United States: A Healthcare Database Study to Inform Vaccine Safety Studies

42nd Annual International Society for Pharmacoepidemiology Conference
September 2, 2026
Authors:

Bell EJ, Sun J, Horgan C, Back S, Emerton D, Round KE,Walsh ST, Cole DV, Rajbhandari R, Vasquez A, Xu S, Contreras R, Hsu C, Ma Q,DeVries A, Oyedele N, Djibo DA, Wentz AE, Love S-AM, Wu J, Kelly SP, Maro JC, Platt R, Cocoros NM

Capabilities:
,
Validation Studies & Algorithm Development
Expertise:
,
RWE Research & Consulting
,
Regulatory Research & Support
Conference Abstract

Risk of Myocarditis/Pericarditis After Receipt of Pfizer-BioNTech COVID-19 Vaccine: Results from a Post-approval Safety Study in the US

42nd Annual International Society for Pharmacoepidemiology Conference
September 1, 2026
Authors:

Kawai A, Fuller CC, Hawrusik R, Iyer GS, Koram N, Agan AA, Alam S, Avula R, Brown J, Burk J, Connolly JG, Daniels K, DeFor T, DeVries A, Diessner B, Djibo DA, Ezzy S, Cai B, Layton JB, Dea K, Tetreault-Langlosi P, Lyons J, Love S-AM, Mayer S, Ma Q, McMahill-Walraven CN, Nolan MB, Oyedele N, Peters A, Reynolds JS, Taggert E, Wideman K, Ziyadeh NJ, Gilsenan A, Platt R‍

Expertise:
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Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Associations of Pfizer-BioNTech COVID-19 Vaccine with Birth Outcomes: Results from a Post-approval Safety Study in the US

42nd Annual International Society for Pharmacoepidemiology Conference
September 1, 2026
Authors:

Kawai A, Bell EJ, Cosgrove A, Koram N, Avula R, Barrett K, Cai B, Daniels K, Dea K, DeFor T, DeVries A, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Kempner ME, Layton B, Love SAM, Ma Q, McMahill-Walraven CN, Messenger-Jones E, Michaelidis M, Nolan MB, Platt R, Shinde MU, Taggert E, Tetreault-Langlois P, Wang X, Wideman K, Ziyadeh NJ, Gilsenan A, Fuller CC

Capabilities:
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Pregnancy & Mother-Infant Linked Studies
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Validation of a Claims-Based Algorithm for Myocarditis/Pericarditis and Assessment of the Impact of Outcome Misclassification in a US Postapproval study of COVID-19 Vaccine Safety

42nd Annual International Society for Pharmacoepidemiology Conference
September 1, 2026
Authors:

Fuller CC, Kawai A, Daniels K, Iyer GS, Koram N, Avula R, Brown J, Cai B, Clasen SC, Hawrusik R, Layton JB, Love S-AM, Martinez K, Messenger-Jones E, Paullin M, Rabbani R, Reynolds JS, Wideman K, Uribe W, Platt R, Gilsenan A

Capabilities:
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Validation Studies & Algorithm Development
Expertise:
,
RWE Research & Consulting
,
Regulatory Research & Support
Conference Abstract

Risk-Factor-Stratified Positive Predictive Values of an Algorithm for Guillain-Barré Syndrome

42nd Annual International Society for Pharmacoepidemiology Conference
September 1, 2026
Authors:

Bell EJ, Sun JW, Xu S, Wu A, Liu J, Hsu C, Pio J, Canul NM, Garcia C, Perez R, Nolan MB, DeFor TA, Horgan C, Back S, Emerton D, Fuller CC, Round KE, Walsh ST, Cole DV, Rajbhandari R, Vasquez A, Zhang F, Weng J, Maro JC, Platt R, Cocoros NM

Capabilities:
,
Validation Studies & Algorithm Development
Expertise:
,
RWE Research & Consulting
,
Regulatory Research & Support
Conference Abstract

Pregnancy Outcomes after Pfizer-BioNTech Monovalent COVID-19 Vaccination during Pregnancy in the United States

42nd Annual International Society for Pharmacoepidemiology Conference
August 31, 2026
Authors:

Shinde MU, Kawai A, Cosgrove A, Koram N, Hawrusik R, Rajbhandari R, Kempner ME, Avula R, Barrett K, Daniels K, DeFor T, Devries A, Diessner B, Djibo DA, Ezzy S, Cai B, Layton JB, Mayer SE, Messenger-Jones E, Michaelidis M, Love S-AM, Ma Q, Nolan MB, Selvan M, Taggert E, McMahill-Walraven CN, Wang X, Wideman K, Ziyadeh NJ, Platt R, Bell EJ, Fuller CC, Gilsenan A

Capabilities:
,
Pregnancy & Mother-Infant Linked Studies
Expertise:
,
RWE Research & Consulting
,
Regulatory Research & Support
Publication

Sequential Safety Surveillance of RSVpreF Vaccination During Pregnancy Early in the Postapproval Period

JAMA Network Open
April 21, 2026
Authors:

Michnick AI, MacDonald SC, Adimadhyam S, Zhang F, Cosgrove A, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Andrade SE, Platt R, Maro JC

Capabilities:
,
Multi-Site Methods & Coordination
,
Pregnancy & Mother-Infant Linked Studies
Expertise:
,
RWE Research & Consulting
,
Regulatory Research & Support
Publication

Postmarketing Safety Surveillance for GSK's AS01ᴇ-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein-Based Vaccine in the USA: Protocol for a Non-Interventional Postauthorisation Safety Study

BMJ Open
March 19, 2026
Authors:

Adimadhyam S,  Luyts D, Oraichi D, Deraedt Q, Pircon JY, Bilker WB, Agan AA, Rajbhandari R,  Carbonari DM, Djibo DA, Wang X, Nolan MB, DeVries A, Selvan M, Ma Q, Wentz  AE, Daniels K, Platt R, Lo Re V 3rd, Cocoros NM

Capabilities:
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Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Publication

Interim Safety of RSVpreF Vaccination During Pregnancy

Journal of the American Medical Association
February 3, 2026
Authors:

Michnick AI, MacDonald SC, Cosgrove A, Adimadhyam S, Zhang F, Petrone AB, Round KE, Gandhi S, Koram N, Anastasiou OE, Rubino H, Lino MM, Djibo DA, Kuntz JL, Love SM, McMahill-Walraven CN, Palmsten K, Wentz AE, Maro JC, Platt R, Andrade SE

Capabilities:
,
Pregnancy & Mother-Infant Linked Studies
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Publication

Post-Authorization Safety Study to Assess the Risk of Diabetic Ketoacidosis Among Type 2 Diabetes Mellitus Patients Treated with Ertugliflozin Compared to Patients Treated with Other Antihyperglycemic Agents in a Medicare and Medicaid Population

Diabetic Medicine
December 15, 2025
Authors:

Rai A, Marshall J, Nandyala S, Her M, Agan AA, Huang TY, Rodriguez-Watson C, Clary A, Diessner B, Nolan MB, Djibo DA, DeVries A, Daniels K, Zhang X, Wang T, Gantz I, Shankar R, Zale MM, Ejelonu P, Frederich R, Masiukiewicz U, Toh S

Capabilities:
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Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

An Observational Postauthorization Safety Study to Assess Adverse Events of Special Interest in Recipients of Ad26.COV2.S in the United States

41st Annual International Society for Pharmacoepidemiology Conference
August 26, 2025
Authors:

Layton JB, Mayer SE, Praet N, Haynes K, Alam S, Brown JS, Calingaert B, Daniels K, Dea K, DeVries A, Diessner B, Djibo DA, Hague JC, Horgan C, Hugh C, Johannes CB, Ko J, Love S-AM, Ma Q, McMahill-Walraven CN, Moyneur E, Platt R, Selvan M, Wang X, Yost E, Ziyadeh NJ, Fuller CC, Gilsenan A

Capabilities:
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Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Post-Authorization Safety Study to Assess the Risk of Diabetic Ketoacidosis Among Type 2 Diabetes Mellitus Patients Treated with Ertugliflozin Compared to Patients Treated with Other Antihyperglycemic Agents

41st Annual International Society for Pharmacoepidemiology Conference
August 22, 2025
Authors:

Rai A, Marshall J, Nandyala S, Her M, Agan AA, Huang TY, Rodriguez-Watson C, Clary A, Diessner B, Nolan M, Djibo DA, DeVries A, Daniels K, Zhang X, Wang T, Gantz I, Shankar R, Zale MM, Ejelonu P, Toh S

Capabilities:
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Rapid Surveillance Study to Evaluate Safety of Respiratory Syncytial Virus (RSV) Vaccine (ABRYSVO) Exposure During Pregnancy in the United States

41st Annual International Society for Pharmacoepidemiology Conference
August 22, 2025
Authors:

MacDonald SC, Gandhi S, Adimadhyam S, Albert S, Anastasiou O, Andrade SE, Back S, Cosgrove A, Djibo DA, Koram N, Kuntz JL, Lino M, Love S, McElroy NP, McMahillWalraven CN, Michnick AI, Palmsten K, Petrone AB, Platt R, Round KE, Rubino H, Wentz AE, Zhang F, Maro JC

Capabilities:
,
Pregnancy & Mother-Infant Linked Studies
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Publication

Effectiveness and Safety of the Recombinant Zoster Vaccine in Adult Patients with Systemic Lupus Erythematosus: A Claims-Based Retrospective Cohort Study in the USA

RMD Open
August 7, 2025
Authors:

Mayer SE, Kluberg SA, Spence O, Oraichi D, Seifert H, Ali O, Yun H, Simon AL, Ko JS, Hugh C, Her M, Shattuck K, Jamal-Allial A, Djibo DA, Daniels K, Ma Q, McMahill-Walraven CN, Ogilvie RP, Palmsten K, Selvan M, Ziyadeh N, Ogdie A, George MD

Capabilities:
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Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Risk of Incident Supraventricular Tachycardia Following Exposure to Recombinant Zoster Vaccine in Adults >50 Years of Age in the United States

41st Annual International Society for Pharmacoepidemiology Conference
August 1, 2025
Authors:

Mayer SE, Alam S, Peters A, Messenger-Jones E, Li D, Platt R, Suleiman B, Granger CB, Moyneur E, Ma Q, Selvan M, Ogilvie RP, Ziyadeh NJ, Daniels K, Wentz A, Djibo DA, McMahillWalraven CN, Oraichi D, Seifert H, Franck V, Yun H, Spence Omareen, Kluberg SA

Capabilities:
,
Validation Studies & Algorithm Development
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Incidence Rates of Safety Events of Interest in a Post-Approval Study of Original Pfizer-BioNTech Monovalent COVID-19 Vaccine in the United States: Primary Series Analysis

41st Annual International Society for Pharmacoepidemiology Conference
August 1, 2025
Authors:

Kawai A, Fuller C, Koram N, Agan AA, Brown J, Burk J, Cai B, Calingaert B, Chomistek A, Connolly JG, Daniels K, Dea K, DeVries A, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB, Layton JB, Love S, Ma Q, Mayer SE, McMahillWalraven CN, Moyneur E, Nolan M, Rao S, Reynolds JS, Selvan M, Vetter J, Wang X, Wideman K, Zhao Y, Ziyadeh NJ, Platt R, Gilsenan A

Capabilities:
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Baseline Characteristics of Patients Included in a Post-Approval Safety Study of Pfizer-BioNTech Monovalent COVID-19 Vaccine in the United States: Results From an Interim Analysis

41st Annual International Society for Pharmacoepidemiology Conference
August 1, 2025
Authors:

Rao S, Fuller CC, Koram N, Agan AA, Brown J, Burk J, Cai B, Calingaert B, Chomistek A, Connolly JG, Daniels K, Dea K, DeVries A, Diessner B, Djibo DA, Ezzy S, Hawrusik R, Johannes CB, Kawai A, Layton JB, Love S, Ma Q, Mayer SE, McMahillWalraven CN, Moyneur E, Nolan M, Reynolds JS, Selvan M, Vetter J, Wang X, Wideman K, Zhao Y, Ziyadeh NJ, Platt R, Gilsenan A

Capabilities:
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Incidence Rates of Safety Outcomes in a Post-Approval Study of the Pfizer-BioNTech Monovalent COVID-19 Vaccine in the United States, Booster Dose Analysis

41st Annual International Society for Pharmacoepidemiology Conference
August 1, 2025
Authors:

Hawrusik R, Kawai A, Koram N, Agan AA, Avula R, Brown J, Burk J, Cai B, Calingaert B, Chomistek A, Connolly JG, Daniels K, Dea K, DeFor T, DeVries A, Diessner B, Djibo DA, Ezzy S, Johannes CB, Layton JB, Love S, Mayer S, Ma Q, Moyneur E, Nolan MB, Platt R, Rao S, Reynolds JS, Selvan M, Sharma V, McMahillWalraven CN, Vetter J, Ziyadeh NJ, Gilsenan A, Fuller CC

Capabilities:
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Incidence Rates of Myocarditis/Pericarditis after Pfizer-BioNTech COVID-19 Vaccine in the United States: Interim Results From a Postapproval Safety Study, Primary Series Analysis

41st Annual International Society for Pharmacoepidemiology Conference
August 1, 2025
Authors:

Fuller CC, Kawai A, Hawrusik R, Koram N, Agan AA, Avula R, Brown J, Burk J, Calingaert B, Chomistek A, Connolly JG, Daniels K, Dea K, DeFor T, DeVries A, Diessner B, Djibo DA, Ezzy S, Johannes CB, Cai B, Layton JB, Love S, Mayer S, Ma Q, Moyneur E, Nolan MB, Rao S, Reynolds JS, Selvan M, Sharma V, McMahillWalraven CN, Vetter J, Ziyadeh NJ, Gilsenan A, Platt R

Capabilities:
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting
Conference Abstract

Quantitative Bias Analysis to Assess the Impact of Outcome Misclassification in a US Claims-Based COVID-19 Vaccine Safety Study

41st Annual International Society for Pharmacoepidemiology Conference
August 1, 2025
Authors:

Mayer SE, Layton JB, Praet N, Haynes K, Alam SM, Bell EJ, Brown J, Coughlin K, Daniels K, Dea K, DeVries A, Diessner BJ, Djibo DA, Horgan CE, Love S, Ma Q, McMahillWalraven CN, Moyneur É, Platt R, Reynolds JS, Selvan M, Yost E, Zhao Y, Ziyadeh NJ, Fuller CC, Gilsenan A

Capabilities:
,
Multi-Site Methods & Coordination
Expertise:
,
Regulatory Research & Support
,
RWE Research & Consulting