Received May 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LX4483 | — |
it was broken, the neck of the vial snapped off; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 23Apr2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Nurse 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: LX4483, Expiration Date: 28Feb2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "it was broken, the neck of the vial snapped off". Causality for "it was broken, the neck of the vial snapped off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: The nurse stated that she put the needle into vial and it snapped off it was not administered to the patient she used another one. Reporter stated it's 0.5 milliliters vial. NDC number is 0005200001.