Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MA2506 | — |
it was broken prefilled syringe; The initial case was missing the following minimum criteria: no Ae. Upon receipt of follow-up information on 11Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP from product quality group. This report involves pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: MA2506, Expiration Date: 31Oct2026) for immunisation. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "it was broken prefilled syringe". The reporter considered "it was broken prefilled syringe" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "it was broken prefilled syringe" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).