Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y016876 | — |
No additional adverse event; VARIVAX Y016876; HCP called to report a TE occurring on 8/18/2025 for PROQUAD and VARIVAX.; This spontaneous report was received from a physician and refers to a 3-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported. On 18-AUG-2025, a temperature excursion (TE) occurred for varicella virus vaccine live (oka-merck) (VARIVAX) at 6.9 degree Fahrenheit (F) for 1 hour, with no prior TE. On unknown date in 2025, after the TE, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) (VARIVAX), Injection, 0.5 mL, administered as prophylaxis (Lot number [Y016876] is an invalid lot number for [varicella virus vaccine live (oka-merck)]. Lot number [Y016876] is a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)], expiration date not provided but upon internal validation was established as 07-Apr-2026 (product lot number issue) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); which was reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT)(expiration date, lot number and route of administration were not reported) (product storage error). No additional adverse event was reported for the patient (no adverse event). This is one of several reports received from the same reporter.