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Report #2873383

Received Nov 18, 2025

A note on interpretation. VAERS reports are unverified and may be incomplete or coincidental. A report does not establish that a vaccine caused an event, and counts should not be used to calculate incidence or infer causation. Full disclaimer

Overview

Sex
Female
Age
0.3 yrs
State
—
Recovered
Unknown
Vaccinated
Nov 12, 2025
Onset
Nov 1, 2025
Days to onset
—
Hospital days
—

Vaccines (1)

TypeNameManufacturerDoseLotRoute / Site
DTAPIPVHIBDTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR2UK356AAIM / LL

Symptoms (2)

No adverse eventProduct preparation error

Symptom narrative

Patient, was seen in the clinic on 11/12/2025 for her 4 month well visit. Vaccines were ordered as a part of this visit, including the Pentacel vaccine. Pentacel vaccine has two portions that are combined prior to administration, a liquid and a powder portion. Vaccines were administered and patient was discharged home. Upon review of vaccine stock, it was determined that there was an extra vial of the liquid portion of the Pentacel vaccine. Upon interview with staff present that day and recall of patient's who had recently received this vaccine, it was determined that patient received the powder portion of the Pentacel vaccine which was mixed with a sterile diluent (sterile saline) intended to be used for Merck Live Virus vaccines. This was used instead of the manufacturer supplied liquid portion of the vaccine. The incident was reported to senior staff member and Sanofi (manufacturer of the vaccine). Representative from Sanofi, was consulted, and clinic was advised that patient should be re-vaccinated to ensure full immune protection. Per manufacturer, there are no clinical concerns for child receiving an additional dose of the vaccine. Manufacturer requested the following data: Patient initials, date of birth, vaccine lot number and description of the event. Family was contacted regarding the incident and manufacturer recommendations on 11/13/2025. There has been no adverse reaction reported as of this date.