Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015557 | — |
No additional AE /PQC reported.; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX was administered; This spontaneous report was received from a Nurse and refers to a 17-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 31-Mar-2025, the patient was vaccinated with an improperly storage dose of with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015557, expiration date: 16-Sep-2026) diluted with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) for prophylaxis. Temperature excursion occurred at -7.8C for 36 minutes. Previous temperature excursion was at (-14.4 C up to -10.4C) -14.0C for 13 minutes. No additional adverse event was reported.
Sterile diluent