Report #2868263

Overview

Sex

Unknown

Age

Age unknown

State

CA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

inspects before injecting, noticed white foreign body floating in product. This one has white floating thing inside syringe, did not dissolve when tried shaking it.; This is a spontaneous report received from a Pharmacist from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MA2519, Expiration Date: Sep2026) for immunisation, Device Lot Number: MA2519, Device Expiration Date: Sep2026. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "inspects before injecting, noticed white foreign body floating in product. This one has white floating thing inside syringe, did not dissolve when tried shaking it.". Additional information: Calling about the Prevnar 20. This is second dose, not sure if normal, pretty sure is not. Inspects before injecting, noticed white foreign body floating in product. Thought was a one off the last time, but occurred with a second dose as well. Usually inspects before injecting into patient. This one has white floating thing inside the syringe, and did not dissolve when caller tried shaking it. Confirmed this occurred with two Prevnar 20 products. Still floating. Asking if normal or not? Doesn't think normal. Confirmed no patients were administered the two Prevnar 20 products with the concern, caught before injection. Causality for "inspects before injecting, noticed white foreign body floating in product. this one has white floating thing inside syringe, did not dissolve when tried shaking it." was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500189939 same reporter/PC, different product lot;