Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015557 | — |
No additional AE /PQC reported; HCP calling to report T/E; Information has been received from Business Partner/CRO on 10-Apr-2025. This spontaneous report was received from a Nurse and refers to a 3-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-Mar-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) lot #Y015557, expiration date: 16-Sep-2026 (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis; The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (details not provided). The temperature excursion was: -7.8°C, time frame: 36 minutes and there was a previous temperature excursion as. (-14.4°C up to -10.4°C) -14.0C 13 minutes No adverse event provided.
Sterile diluent