Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | X022827 | — |
No additional AE/No PQC.; HCP called to report that an expired dose of PNEUMOVAX 23 was inadvertently administered to a patient.; This spontaneous report was received from a nurse and refers to a 56-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-Aug-2025, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) injection 5 mL (lot #X022827 and expiration date reported as and upon internal validation confirmed to be 14-Aug-2025) (route of administration and vaccination site were not reported) administered for prophylaxis. On that day, an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was inadvertently administered to a patient (expired product administered). The potency of the dose was supported by post-expiry memo, with an expiration date of 14-Aug-2025 and administered on 20-Aug-2025. No adverse effects were reported (no adverse event). No additional adverse event (AE) and no product quality complaint (PQC) was noted.