Received Dec 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | X027348 | — |
After administering the back half of the syringe came off/ it was a jagged break where the plunger broke off; After administering the back half of the syringe came off/ it was a jagged break where the plunger broke off/Functionality Issue - Syringe Barrel Broken During or After Injection; No additional AE; After administering the back half of the syringe came off/ it was a jagged break where the plunger broke off/Functionality Issue - Syringe Barrel Broken During or After Injection; it was a jagged break where the plunger broke off; This spontaneous report was received from a vaccine coordinator (Administrator/Supervisor) and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot #X027348, expiration date: 24-Jan-2026) for Prophylaxis. After administering, the back half of the syringe came off, it was near the label toward the plunger, it was a jagged break where the plunger broke off (syringe issue, device dislocation, device issue). The patient received the full dose (poor quality device used). No adverse event was reported (no adverse event). This is an invalid case due to lack of patient's identifiers. Follow up information was received on 19-DEC-2025 via Regulatory Authority. The primary reporter's qualification was updated to other health professional. The medical device's manufacturer date was 28-SEP-2023. The sample was returned. The returned photo sample was evaluated on 20-DEC-2025: 5 photos have been received which show back part of the syringe were plunger was inserted has been broken.