Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LN4927 | — |
one vial was broken; The initial case was missing the following minimum criteria: product complaint only. Upon receipt of follow-up information on 28May2025, this case now contains all required information to be considered valid. This is a spontaneous report and received from Consumer or other non HCPs from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5 ml, single (Lot number: LN4927, Expiration Date: 30Jun2026) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "one vial was broken". Causality for "one vial was broken" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: NDC Number: 0005-2000-01.