Received Mar 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008430 | — |
No additional AE; Customer called to report TE. VARIVAX was administered; This spontaneous report was received from a nurse and refers to a 1-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-Jan-2026, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) injection (lot #Z008430 with valid expiration date reported as 06-May-2027) 0.5 mL (route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, injection, (lot # Z002901 with valid expiration date reported as 25-Nov-2027) 0.7 mL (route of administration and vaccination site were not reported). A temperature excursion (TE) was reported (temperature: 14°F up to 46°F (17.44 F); time frame for 17 hours 30 minutes 0 seconds) (product storage error). There was no previous temperature excursion. No additional adverse event (AE) and no product quality complaint (PQC) was reported (no adverse event). This was on of several cases received from the same reporter.
DILUENT MRK INJ