Received Mar 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MA2502 | — |
broken syringe, it broke off and leaked; still sealed but there liquid from the vaccine from one of the syringes; This is a spontaneous report received from a Nurse from product quality group. A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MA2502, Expiration Date: 31Oct2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "broken syringe, it broke off and leaked"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "still sealed but there liquid from the vaccine from one of the syringes". Additional information: NDC Number is 0005-2000-10. They have a broken syringe, it broke off and leaked for their prevnar 20. They have two trays that they had and went to open the second tray and before they could even open it the tip broke off and the syringe leaked within the second tray which is a 5 pack. they pulled both trays out, and have a couple of vaccines left in the first tray but in the second tray which was still sealed had noticed the tip had broken off so how or when that occurred caller is not sure but the second tray of 5 syringes is still sealed but there liquid from the vaccine from one of the syringes inside the second sealed tray with the other syringes. Caller confirmed no one came in contact with the liquid. Caller states she is calling to report, but since she is not able to use it, she is wondering can they get a credit or replacement with one dose. Never had this happen before. Sample of the product is available to be returned. Causality for "broken syringe, it broke off and leaked" and "still sealed but there liquid from the vaccine from one of the syringes" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).