Received Nov 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LJ5283 | — |
It seems like there is something inside the vaccines; looks like there is like a piece of, not fragment but it's something in there and the vaccine that it's floating; four patients were administered with the vaccine; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in 2024 as dose number unknown, 0.5 ml single (Lot number: LJ5283, Expiration Date: May2026) for immunisation, Device Lot Number: LJ5283, Device Expiration Date: May2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious) with onset 2024, described as "It seems like there is something inside the vaccines; looks like there is like a piece of, not fragment but it's something in there and the vaccine that it's floating"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 2024, described as "four patients were administered with the vaccine". Additional information: reporter stated they got the vaccines (Prevnar 20) from a third party but it seems like there is something inside the vaccines. Reporter was not sure what it was, but was not sure, like the quality of the vaccine is good anymore. It looks like there is like a piece of, not fragment but it's something in there and the vaccine that it's floating. Most of them have them. Reporter wanted to know if they can report this and possibly get a replacement or how would that work. Reporter think it's pretty much every pack, like most vaccines have it. They thought maybe they had to wait until maybe it warms up a little bit the vaccine but it's not it because it keeps floating around. Clarified four patients received the vaccine. Patient yesterday (28Oct2025), he was pretty healthy and for the other patients, three patients that it was administered last year, during the past year. Causality for "it seems like there is something inside the vaccines; looks like there is like a piece of, not fragment but it's something in there and the vaccine that it's floating" and "four patients were administered with the vaccine" 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-202500214701 same product and event, different patient;