Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LK6655 | — |
one of the 10 vials in the box was cracked; This is a spontaneous report received from an Other HCP 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 (Lot number: LK6655, Expiration Date: 30Jun2026) for immunisation, Device Lot Number: LK6655, Device Expiration Date: 30Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "one of the 10 vials in the box was cracked". The reporter considered "one of the 10 vials in the box was cracked" not related to pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein). Causality for "one of the 10 vials in the box was cracked" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).