Received Aug 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y017062 | — |
HCP called to report TE occurring on 8/13/2025 for VARIVAX that was administered to two patients (separate AE case created for other patient-see case #02857565) after TE on 8/14/2025. TE evaluation was communicated as 'supported' during the call. U; No additional AE; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 14-Aug-2025, the patient was vaccinated with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection (lot #Y017062, expiration date: 11-Oct-2026) reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot# and expiration date were not reported), 0.5 mL as prophylaxis, that underwent a temperature excursion of 5.5 F for 2 hours (on 13-Aug-2025), a previous excursion had occurred (03-Jul-2025, at 8.4F for an hour). This was one of 2 cases received by the same reporter. Lot # is being requested and will be submitted if received.
DILUENT MRK