Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LK6653 | — |
Broken vial or broken injection of Prevnar 20; Received a broken vial in a shipment; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LK6653, Expiration Date: 30Jun2026) 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 vial or broken injection of Prevnar 20; Received a broken vial in a shipment". Additional information: The reporter stated that they received some broken vial or broken injection of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein). They wanted to know if they can get replacement. The vaccine was not given to patients. NDC Number: 00005-2000-10 The reporter considered "broken vial or broken injection of prevnar 20; received a broken vial in a shipment" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "broken vial or broken injection of prevnar 20; received a broken vial in a shipment" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Follow-up (07Apr2025): This is a follow-up report from product quality group providing investigation results. Updated information: narrative