Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4927 | — |
Broken upon arrival; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 23Apr2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a nurse from product quality group. A patient (age and gender not provided) received Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), as dose number unknown, single (Lot number: LN4927, Expiration Date: 30Jun2026) for immunisation, Device Lot Number: LN4927, Device Expiration Date: 30Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 23Apr2025, outcome "unknown", described as "Broken upon arrival". Causality for "broken upon arrival" was determined associated to device constituent of Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (malfunction). Additional Information: The reporting laboratory nurse was calling to report issue with Prevnar 20 vaccine (NDC Number: 0005200010). When they received shipment on 23Apr2025, one vial was broken upon arrival. She opened the box and was going to put in Accuvax but one was broken, it is a prefilled syringe that was broken. She was calling to see what the process was and if needed to return the broken Prevnar 20 prefilled syringe to the company. The sample of the product was available to be returned. She is requesting replacement and confirms no patient involvement.