Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Z006889 | — |
No additional AE; Caller reported that the syringe needle leaked (about 1-2 drops) and during administration to patient, resulting in the patient receiving the less than recommended dose.; Caller reported that the syringe needle leaked (about 1-2 drops) and during administration to patient, resulting in the patient receiving the less than recommended dose.; Caller reported that the syringe needle leaked (about 1-2 drops) and during administration to patient, resulting in the patient receiving the less than recommended dose.; This spontaneous report was received from a pharmacist and refers to a specified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-Oct-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reported as CAPVAXIVE INJ 168 mcg/ml 1DS X 10 SYRINGES 00006434702) 0.5 ml/dose, quantity: 1 (lot #Z006889 with expiration date reported as and upon internal validation confirmed to be 09-Sep-2026) administered for prophylaxis (route of administration and vaccination site were not reported). The syringe needle leaked (about 1-2 drops) during the administration to the patient, resulting in the patient receiving less than the recommended dose (accidental underdose; poor quality device used; syringe issue). No symptoms were reported (no adverse event). Photos were not available to be sent. The product quality complaint (PQC) product was not available for retrieval as it was discarded after administration. No additional adverse event (AE) or PQC was noted.