Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Z008196 | — |
No additional AE; HCP called to report a TE for VARIVAX. See TE Case 02867289. Caller reported that vaccine was administered to multiple patients on 8/21/2025 (see all AE cases below for reference). No additional patient information provided at the time of the call; This spontaneous report was received from a nurse practitioner and refers to a 39-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-Aug-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0,5 mL (lot #Z008196 with expiration date reported as and upon internal validation confirmed to be 30-Apr-2027) (route of administration and vaccination site were not reported) administered for prophylaxis. The reporter noted a temperature excursion (TE) for the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (temperature -11.8C; time frame: 0 hours 45 minutes 0 seconds; previous temperature excursion: no) (product storage error). The vaccine was administered to multiple patients. No additional patient information was provided at the time of the call. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). This was one of several reports received from the same reporter.
sterile diluent