Report #2841193

Received May 15, 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: OH
Recovered: Unknown
Vaccinated: —
Onset: —
Days to onset: —
Hospital days: —

Vaccines (1)

Type	Name	Manufacturer	Dose	Lot	Route / Site
COVID19	COVID19 (COVID19 (PFIZER-BIONTECH))	PFIZER\BIONTECH	1	LP1776	—

Symptoms (1)

Device breakage

Symptom narrative

A broken flange was observed; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 08May2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Nurse from product quality group. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LP1776, Expiration Date: 26Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "A broken flange was observed". Additional information: NDC Number: 00069243210. A broken flange was observed during the evaluation of the returned complaint sample. The reporter considered "a broken flange was observed" not related to BNT162b2 omicron (kp.2). Causality for "a broken flange was observed" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).