Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y017915 | — |
No additional AE reported/No PQC reported.; HCP called to report a TE for VARIVAX and reported that the vaccine was administered on 11/10/2025 (excursion occurred between 11/7-10, 2025) to one patient. TE evaluation was communicated as 'Not supported' during the call. No adverse reactions we; This spontaneous report was received from a nurse and refers to a 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Between 07-Nov-1015 and 10-Nov-2025, a temperature excursion (TE) for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) occurred (temperature 47°F to 77°F (66F); time frame 77 hours, 0 minutes, 0 seconds; No previous temperature excursion). TE evaluation was communicated as 'not supported' during the call. On 10-Nov-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y017915 with valid expiration date reported as 28-Oct-2026) 0.5 mL (route of administration and vaccination site were not reported) administered for prophylaxis (product storage error). The vaccine was reconstituted with sterile diluent, solution for injection (lot # and expiration date not reported). No adverse reactions were experienced after the administered dose (no adverse event). No additional adverse event (AE) and no product quality complaint (PQC) was reported.
DILUENT MRK INJ