Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4930 | — |
debris observed floating in the fluid; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4930, Expiration Date: 31Jul2026) for immunisation, Device Lot Number: LN4930, Device Expiration Date: 31Jul2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "debris observed floating in the fluid ". Causality for "debris observed floating in the fluid " was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction). Additional information: A complaint was reported regarding debris observed floating in the fluid while the product was stored and awaiting use. It appeared that some fluid may have been pushed into the needle. The product was shaken in an attempt to dissolve the particles. The patient did not miss a dose due to this issue. A photo could not be obtained