COVID Vaccine and Cardiovascular Signals: An Analysis of Vaccine Adverse Event Reports (Preprint)

Adverse Event Reporting ◽

Event Reporting ◽

High Odds

UNSTRUCTURED Adverse events (AEs) following COVID vaccination have been intensely monitored. In our study, we analyzed data from a spontaneous reporting system - Vaccine Adverse Event Reporting System and detected signals of AEs following administration of COVID vaccines. We identified several cardiovascular and inflammatory-related AEs that demonstrated high odds ratio. We demonstrated our system can serve as a complementary system to identify and monitor AEs outside of pre-defined outcomes routinely monitored by existing databases or projects.

Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database

Drugs - Real World Outcomes ◽

10.1007/s40801-018-0134-0 ◽

2018 ◽

Vol 5 (2) ◽

pp. 117-128 ◽

Cited By ~ 15

Author(s):

Tadashi Toki ◽

Shunsuke Ono

Keyword(s):

United States ◽

Adverse Event ◽

Adverse Events ◽

Drug Administration ◽

Spontaneous Reporting ◽

Reporting System ◽

The United States ◽

Adverse Event Reporting ◽

An evaluation of potential signals for ventricular arrhythmia and cardiac arrest with dolasetron, ondansetron, and granisetron in the fda combined spontaneous reporting system/adverse event reporting system

Current Therapeutic Research ◽

10.1016/j.curtheres.2005.10.003 ◽

2005 ◽

Vol 66 (5) ◽

pp. 409-419 ◽

Cited By ~ 6

Author(s):

Frederick M. Schnell ◽

Andrew J. Coop

Keyword(s):

Adverse Event ◽

Cardiac Arrest ◽

Ventricular Arrhythmia ◽

Spontaneous Reporting ◽

Reporting System ◽

Spontaneous Reporting System ◽

Adverse Event Reporting ◽

Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

Vaccine ◽

10.1016/j.vaccine.2019.08.087 ◽

2019 ◽

Vol 37 (44) ◽

pp. 6760-6767 ◽

Cited By ~ 2

Author(s):

Michael M. McNeil ◽

Iwona Paradowska-Stankiewicz ◽

Elaine R. Miller ◽

Paige L. Marquez ◽

Srihari Seshadri ◽

...

Keyword(s):

United States ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adenovirus Type ◽

Adverse Event Reporting ◽

Descriptive epidemiology of adverse events after immunization: Reports to the Vaccine Adverse Event Reporting System (VAERS), 1991-1994

The Journal of Pediatrics ◽

10.1016/s0022-3476(97)70056-8 ◽

1997 ◽

Vol 131 (4) ◽

pp. 529-535 ◽

Cited By ~ 32

Author(s):

M.Miles Braun ◽

Susan S. Ellenberg

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting ◽

Descriptive Epidemiology ◽

Thrombocytopenia with Tedizolid and Linezolid

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01453-17 ◽

2017 ◽

Vol 62 (1) ◽

Cited By ~ 15

Author(s):

Erica Yookyung Lee ◽

Aisling R. Caffrey

Keyword(s):

Adverse Event ◽

Confidence Interval ◽

Drug Administration ◽

Odds Ratio ◽

Reporting System ◽

Adverse Event Reporting ◽

Reporting Odds Ratio ◽

Event Reporting ◽

Using Data

ABSTRACT Several studies have suggested the risk of thrombocytopenia with tedizolid, a second-in-class oxazolidinone antibiotic (approved June 2014), is less than that observed with linezolid (first-in-class oxazolidinone). Using data from the Food and Drug Administration adverse event reporting system (July 2014 through December 2016), we observed significantly increased risks of thrombocytopenia of similar magnitudes with both antibiotics: linezolid reporting odds ratio [ROR], 37.9 (95% confidence interval [CI], 20.78 to 69.17); tedizolid ROR, 34.0 (95% CI, 4.67 to 247.30).

Antidepressants-related cardiovascular adverse events using the adverse event reporting system

Psychiatry Research ◽

10.1016/j.psychres.2018.07.044 ◽

2018 ◽

Vol 268 ◽

pp. 441-446 ◽

Cited By ~ 2

Author(s):

Yoon Kyong Lee ◽

Jung Su Shin ◽

Youngwon Kim ◽

Jae Hyun Kim ◽

Yun-Kyoung Song ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting ◽

Analysis of Adverse Events Following Immunization(AEFI) Using The Korea Adverse Event Reporting System(KAERS)

Journal of the Korean society for Wellness ◽

10.21097/ksw.2016.08.11.3.459 ◽

2016 ◽

Vol 11 (3) ◽

pp. 459

Author(s):

Hye-gyeong Cha

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting ◽

Neuropsychiatric adverse events of chloroquine: a real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database

BioScience Trends ◽

10.5582/bst.2020.03082 ◽

2020 ◽

Vol 14 (2) ◽

pp. 139-143 ◽

Cited By ~ 11

Author(s):

Kenichiro Sato ◽

Tatsuo Mano ◽

Atsushi Iwata ◽

Tatsushi Toda

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Real World ◽

Reporting System ◽

Adverse Event Reporting ◽

PDG5 COMMONLY REPORTED ADVERSE EVENTS ASSOCIATED WITH ANTICOAGULANTS USING FDA ADVERSE EVENT REPORTING SYSTEM DATABASE 2012-2018

Value in Health ◽

10.1016/j.jval.2019.04.684 ◽

2019 ◽

Vol 22 ◽

pp. S163

Author(s):

L. Costa ◽

A. Hincapie ◽

J.J. Guo

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting ◽

Event Reporting ◽

System Database

Combining big data search analytics and the FDA Adverse Event Reporting System database to detect a potential safety signal of mirtazapine abuse

Health Informatics Journal ◽

10.1177/1460458219901232 ◽

2020 ◽

Vol 26 (3) ◽

pp. 2265-2279 ◽

Cited By ~ 1

Author(s):

Dimitrios Spachos ◽

Spyridon Siafis ◽

Panagiotis Bamidis ◽

Dimitrios Kouvelas ◽

Georgios Papazisis

Keyword(s):

Adverse Event ◽

Odds Ratio ◽

Reporting System ◽

Adverse Event Reporting ◽

Safety Signal ◽

Event Reporting ◽

System Database ◽

Potential Safety ◽

Different Sources

This study sought to detect a potential safety signal of mirtazapine abuse by combining two different sources of surveillance, specifically Google Analytics (Google, Inc., Mountain View, CA, USA) and the FDA Adverse Event Reporting System database. Data from the first quarter of 2004 to the second quarter of 2017 were collected and analysed. The search interest over time, the frequencies of abuse-related terms in the search analytics domain, and the odds ratio of abuse events in FDA Adverse Event Reporting System were determined. Correlations between the two aforementioned domains using quarterly data from the timeline series were also assessed. Our results suggest a positive correlation between abuse-related searches in the Google domain and abuse-related events in FDA Adverse Event Reporting System database. These results indicate that these methods can be used in combination with each other as a pharmacovigilance supplementary tool to detect drug safety signals.