Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LJ5283 | — |
It seems like there is something inside the vaccines; I am not sure, like the quality of the vaccine is good anymore; It keeps floating around/four patients were administered with the vaccine; It seems like there is something inside the vaccines; I am not sure, like the quality of the vaccine is good anymore; It keeps floating around/four patients were administered with the vaccine; This is a spontaneous report received from a Consumer or other non HCP. A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 28Oct2025 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), LIQUID PRODUCT PHYSICAL ISSUE (non-serious) all with onset 28Oct2025 and all described as "It seems like there is something inside the vaccines; I am not sure, like the quality of the vaccine is good anymore; It keeps floating around/four patients were administered with the vaccine". Additional information: NDC number of Prevnar 20: 0005200010. Reporter was calling due to an issue that she/he had with the vaccines. It's Prevnar 20 vaccine. The reporter got it from a third party but it seemed like there was something inside the vaccines. The reporter was not sure what it was, but she/he was not sure, like the quality of the vaccine was good anymore. It looked like there was like a piece of, not fragment but it's something in there and the vaccine that it's floating. Most of them have them. It's like, it's pretty much every pack, like most vaccines have it. The reporter thought maybe she/he had to wait until maybe it warmed up a little bit the vaccine but it's not it because it kept floating around. The vaccines were administered to four patients, but the reporter was not sure if those patients had it with anything inside the vaccine. The reporter was only able to pay attention yesterday on 28Oct2025 when there was something on it. The reporter did not know if there was this issue before. The reporter stated, "I can't pull up at the top off of my head which patients got this vaccine last year because these were ordered and they came to us last year. I really have to figure out a way to filter and see if I can find them but honestly this was like last year and I would not know. I don't think the vaccines, probably I have no idea. I have no idea what's going on. I don't know if it's the compound of the drug, maybe if it's in the refrigerator I have no idea." For the patient yesterday (28Oct2025), he was pretty healthy and for the other patients, three patients that it was administered last year, during the past year, I can't say." The packaging was sealed and intact. Causality for "it seems like there is something inside the vaccines; i am not sure, like the quality of the vaccine is good anymore; it keeps floating around/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-202500214821 same product and event, different patient;US-PFIZER INC-202500214831 same product and event, different patient;US-PFIZER INC-202500214854 same product and event, different patient;
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None