Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | X024649 | — |
No additional AE/PQC reported.; Caller reported VARIVAX was administered after being reconstituted with expired sterile Diluent.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-Sep-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #X024649 with expiration date reported as and upon internal validation confirmed to be 11-Oct-2025) 0.5 mL (route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with expired sterile diluent, solution for injection, lot # W036917, expiration date: 21-Sep-2025 (expired product administered). No other information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported.
DILUENT MRK