Comparison of Adverse Events in Pregnant Persons Receiving COVID-19 and Influenza Vaccines: A Disproportionality Analysis Using Combined Data from US VAERS and EudraVigilance Spontaneous Report Databases

Leonardo Roque-Pereira (), Malede Mequanent Sisay (), Comfort K. Ogar (), Carlos E. Durán (), Eugene Puijenbroek (), Daniel Weibel (), Katia Verhamme () and Miriam Sturkenboom ()
Additional contact information
Leonardo Roque-Pereira: University Medical Center Utrecht
Malede Mequanent Sisay: University Medical Center Utrecht
Comfort K. Ogar: Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Carlos E. Durán: University Medical Center Utrecht
Eugene Puijenbroek: University of Groningen, Groningen Research Institute of Pharmacy
Daniel Weibel: University Medical Center Utrecht
Katia Verhamme: Erasmus University Medical Center
Miriam Sturkenboom: University Medical Center Utrecht

Drug Safety, 2025, vol. 48, issue 10, No 6, 1127-1139

Abstract: Abstract Background Although multiple post-licensure studies demonstrated that coronavirus disease-2019 (COVID-19) vaccines are safe for use during pregnancy, none of them have identified a signal of disproportionate reporting. Aim To assess the disproportionality in reported adverse events among pregnant persons receiving COVID-19 vaccination compared with influenza vaccines in spontaneous reporting databases. Methods Individual case safety reports (ICSRs) with COVID-19 vaccines (Pfizer, AstraZeneca, Moderna and Johnson & Johnson) and influenza vaccines were retrieved from spontaneous reporting databases in the Vaccine Adverse Event Report System (VAERS) and the EudraVigilance (EV) system between 1 December 2020 and 31 October 2023. Both datasets were combined through a common data model. Pregnancy-associated ICSRs were identified using adaptations to the European Medicines Agency (EMA) algorithm based on age groups and key medical conditions. We compared the disproportionate reporting of High-Level Terms (HLT) after COVID-19 vaccines of interest (e.g. mRNA vaccine) with another COVID-19 viral vector-based/protein subunit and influenza vaccines during pregnancy. The proportional reporting ratio (PRR) with 95% confidence intervals (CIs) was calculated using a combined dataset. PRR met the predefined criteria (PRR ≥ 2, lower 95% CI ≥ 2 and N ≥ 3), confirming a potential signal of disproportionate reporting (SDR). Results A total of 22,383 pregnancy-related ICSRs were included. Five associations met the PRR threshold: inborn errors of steroid synthesis 35.1 (95% CI 7.8–158.3); non-site-specific embolism and thrombosis 15.9 (95% CI 3.1–82.2); general signs and symptoms not elsewhere classified (NEC) 11.17 (95% CI 3.3–38.1); peripheral nervous system disorders congenital NEC 4.2 (95% CI 2.3–7.7); and vascular anomalies congenital NEC 3.7 (95% CI 2.4–5.6), all associated with viral vector-based/protein subunit. Conclusions Despite this analysis, several statistical disproportionalities were identified during pregnancy; the case-by-case analysis shows that embolism and thrombosis require prioritized investigation through proper causal inference studies.

Date: 2025
References: Add references at CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-025-01561-6 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:48:y:2025:i:10:d:10.1007_s40264-025-01561-6

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-025-01561-6

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().