Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LP4946 | OT / LL |
the vial of the glass breaking while we were giving the vaccine; the vial of the glass breaking while we were giving the vaccine; administered to the patient; This is a spontaneous report received from a Consumer or other non HCP. A 6-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Jul2025 as dose number unknown, single (Lot number: LP4946, Expiration Date: Aug2026) at the age of 6 months intramuscular, in left vastus lateral. for immunisation, Device Lot Number: LP4946, Device Expiration Date: Aug2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious) with onset 31Jul2025, described as "the vial of the glass breaking while we were giving the vaccine"; POOR QUALITY DEVICE USED (non-serious) with onset 31Jul2025, described as "the vial of the glass breaking while we were giving the vaccine; administered to the patient". Additional information: Reporter stated that medication issue they had this morning(31Jul2025) of a vial breaking while giving a vaccine. Packaging sealed and intact. It was administered to the patient and the patient got the full vaccine. Lab working (Past 2 week) was Unknown. The "lab was no" but reporter was not sure. Causality for "the vial of the glass breaking while we were giving the vaccine" and "the vial of the glass breaking while we were giving the vaccine; administered to the patient" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).