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Pharmacovigilance analysis of vaccination errors during pregnancy using VAERS data
Kenneth L McCall1, Jae Hee Park2, Taylor M Clark1
1Binghamton University School of Pharmacy and Pharmaceutical Sciences, Johnson City, NY 13790, USA.
Vaccine
|April 10, 2026
Summary
Vaccination errors during pregnancy, including wrong product and extra doses, were identified. No severe outcomes were reported, highlighting targets for improved maternal immunization safety.
Area of Science:
- Public Health
- Vaccinology
- Pharmacovigilance
Background:
- Maternal vaccination is crucial for protecting pregnant individuals and infants.
- Real-world data on vaccination errors in pregnant populations are limited.
- The Vaccine Adverse Event Reporting System (VAERS) is a key resource for safety surveillance.
Purpose of the Study:
- To identify and characterize safety signals for vaccination errors during pregnancy.
- To analyze VAERS data for specific vaccine-error combinations in this population.
Main Methods:
- Retrospective analysis of VAERS reports from January 2023 to May 2025.
- Inclusion of vaccinations administered during pregnancy.
- Disproportionality assessment using PRR, ROR, EB05, and IC025 for error types with ≥5 reports.
Main Results:
- 1413 of 171,958 VAERS reports involved vaccinations during pregnancy.
- Significant signals for RSV-wrong product, TDAP-extra dose, TDAP-storage error, and influenza-expired product.
- Live vaccine administrations (MMR, varicella) reported, with nearly half of individuals unaware of pregnancy.
- No birth defects or deaths linked to reported vaccine errors.
Conclusions:
- Specific vaccine administration errors during pregnancy are disproportionately reported.
- RSV-wrong product, TDAP errors (extra dose, storage), and live vaccine administration are key areas for intervention.
- Findings provide practical targets for error prevention to enhance maternal immunization safety without compromising access.
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