Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z005233 | — |
No additional AE; HCP called to report TE occurring on 8/21/2025 for VARIVAX and PROQUAD. VARIVAX (Lot Z005233 exp 2/27/2027) was administered after the TE on 8/22/2025. No additional AE/PQC. VARIVAX Lot Z005233 exp 2/27/2027 Prior excursion: (-12.6C) for 2 hours,; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-Aug-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z005233, expiration date: 27-Feb-2027) for prophylaxis. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (expiration date, and lot # were not reported), which underwent temperature excursion (TE) on 21-Aug-2025, of 15.6 C in time of 1 hour, 3 minutes, 0 seconds (reported as current excursion); prior excursion was with temperature od -12.6 C for 2 hours, 31 minutes, 0 seconds (product storage error). No additional AE (adverse event) was reported.
MERCK STERILE DILUENT