Sex: U
Vaccine: PNC20
Symptoms: Liquid product physical issue, Poor quality product administered
Clinical narrative: Patient was given Prevnar 20 that had some kind of bubble that was not an air bubble but like an accumulation of something in there; Patient was given Prevnar 20 that had some kind of bubble that was not an air bubble but like an accumulation of something in there; This is a spontaneous report received from a contactable reporter (Nurse) from the Medical Information Team.  A patient (no qualifiers provided) received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) on 24Apr2023 as DOSE NUMBER UNKNOWN, 0.5mL SINGLE (lot number: GM9410 and expiration date: 20Aug2024) for immunization. The patient's relevant medical history and 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 24Apr2023 and all described as "Patient was given Prevnar 20 that had some kind of bubble that was not an air bubble but like an accumulation of something in there."  Additional information: Additional information: Caller is a nurse for Geriatrics and states she is calling about Prevnar 20 and as of yesterday when they pulled a syringe out to administer the vaccine, there was kind of a bubble that was not an air bubble but like an accumulation of something in there and it was small but in the solution and they would shake it and the stuff did not go away; today they were going to give another one and the other nurses have noticed that the Prevnar 20 had this in the other syringes too and they do not know what they should do with it. Stated, let her get magnifying on this as it is hard to see the NDC and she has to use the camera on it and snap the picture. For all the Prevnar 20 they have that has this reported issue, it is the same lot number due to they are from the same box; when they noticed it yesterday, she does not know how many they have or that are left out of that box but thinks maybe 5 prefilled syringes are left and there were 10 syringes for the count size. One was administered yesterday to a patient, and they had not noticed this issue before yesterday, did notice it and a patient received it yesterday; the accumulation in the syringe is kind of like a little gel bubble thing. Reporter had no patient details and that is unknown at this time. Caller told someone to take this box to put it at the back of the refrigerator and to open a new one to see what it looks like and if it looks ok they can probably go ahead and give it and asks if that is correct. She will take this box of the Prevnar 20 out of service. They are concerned about the patient that got the injection yesterday and they needed to know what to do with the other vaccines in that box; also thinks the new box of Prevnar 20 is probably going to be the same lot number because they ordered them at the same time. The new box they have all same lot, expiry date and the NDC number: 0005200001 as she provided and all of the solutions in there are clear for the new box of Prevnar 20. Product strength and count size dispensed: 0.5mL; she does not know how many they have or that are left out of that box but thinks maybe 5 prefilled syringes are left and there were 10 syringes for the count size. The sample of the product is available to be returned, if requested. Reporter is aware she may receive a prepaid withheld mailer in 3-10 business days. "Packaging sealed and intact" was reported as "Yes." The name and phone number of the supplier/distributor of the product was provided.  The information on the batch/lot number for pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300170323 same product, same event, different patient;