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Report #2837219

Received Apr 22, 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
2 yrs
State
WA
Recovered
Unknown
Vaccinated
—
Onset
—
Days to onset
—
Hospital days
—

Vaccines (1)

TypeNameManufacturerDoseLotRoute / Site
DTAPIPVHIBDTAP + IPV + HIB (PENTACEL)SANOFI PASTEURUNKUK199AAOT

Symptoms (2)

No adverse eventProduct preparation issue

Symptom narrative

giving the Pentacel and gave the diluent only and not the actual vaccine with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient who was receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] but received the diluent only and not the actual vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, (unknown strength) lot UK199AA and expiry date 30-Apr-2026, via unknown route in unknown administration site for prophylactic vaccination (immunisation), but received the diluent only and not the actual vaccine with no reported adverse event (single component of a two-component product administered) (latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.