Report #2855108

Received Aug 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: Unknown
Age: Age unknown
State: AL
Recovered: Unknown
Vaccinated: —
Onset: Aug 15, 2025
Days to onset: —
Hospital days: —

Vaccines (1)

Type	Name	Manufacturer	Dose	Lot	Route / Site
UNK	VACCINE NOT SPECIFIED (NO BRAND NAME)	UNKNOWN MANUFACTURER	UNK	Z004729	—

Symptoms (1)

Syringe issue

Symptom narrative

No AE; Finger Flange Broken - During or After Injection; following administration while applying needle safety cover , the glass PFS broke; This spontaneous report was received from a Nurse on 15-AUG-2025. The complaint description was reported as follow: Health care professional (HCP) called to report a product quality complaint (PQC) for Hepatitis B Vaccine (Recombinant) (RECOMBIVAX H) Suspension for injection (lot #Z004729, has been verified to be valid lot #, expiration date was provided and confirmed as: 04-Sep-2027). Caller reported that on 15-AUG-2025, following administration while applying needle safety cover, the glass pre-filled syringe (PFS) broke (Syringe issue). Caller stated that "it broke in half and shards were everyone". Finger flange broken, it broken into 2 pieces with multiple shards. No patient involved. No injury to patient or HCP. Product available for retrieval. No adverse event (AE) was reported. No additional PQC. Date PQC observed: 15-AUG-2025.