Report #2875796

Received Dec 1, 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: IL
Recovered: Unknown
Vaccinated: Nov 12, 2025
Onset: Nov 12, 2025
Days to onset: 0
Hospital days: —

Vaccines (1)

Type	Name	Manufacturer	Dose	Lot	Route / Site
RSV	RSV (AREXVY)	GLAXOSMITHKLINE BIOLOGICALS	UNK	B5NJ9	IM

Symptoms (1)

Product administered to patient of inappropriate age

Symptom narrative

Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number B5NJ9, expiry date 05-DEC-2026) for prophylaxis. On 12-NOV-2025, the patient received Arexvy (intramuscular) .5 ml. On 12-NOV-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK receipt date:26-NOV-2025 The reporter stated that, on 12-NOV-2025, it was mistakenly administered Arexvy vaccine to a 3-month-old female infant. The vaccine was administered in the vastus lateralis muscle.