Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
When opened box, one vial was broken it the box; 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 CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONTAINER ISSUE (non-serious) with onset 15Apr2025, outcome "unknown", described as "When opened box, one vial was broken it the box". Additional information: The nurse confirmed no patient involvement. She was taking the vaccine out to use and that was when she realized that the pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) was broken. Causality for "when opened box, one vial was broken it the box" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction). The lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein), was not provided and will be requested during follow up.