Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y011819 | — |
No additional AE. No PQC.; HCP called to report that a 6 month old was inadvertently administered CAPVAXIVE on 02/04/2025. No additional information was provided. Caller did not provide full patient demographic information. Permission given to contact HCP. No additional AE. No; This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2025, the patient was vaccinated with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE), strength 168 microgram per milliliter (mcg/ml) injection, (valid lot number Y011819, expiration date: 01-OCT-2025 upon internal review (reported as 11-OCT-2025, conflicting information) administered for prophylaxis (dose, anatomical location, route of administration was not provided) (product administered to patient of inappropriate age). No additional adverse event (AE).