Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y011019 | — |
No additional AE/PQC. No additional information; HCP called to report inadvertent administration of VARIVAX after a temperature excursion. Vaccine was administered on 27FEB2025 to a patient.; This spontaneous report was received from a nurse (registered nurse [RN]) and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 27-Feb-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), injection (valid lot #Y011019, with provided and established expiration date: 18-Jun-2026) for prophylaxis (exact dose, dose number, anatomical location, and route of administration were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (expiration date, and lot # were not reported). Administered dose of suspect vaccine was exposed to the temperature excursion on an unknown date: -12.13 Celsius degrees (C) for 0 hours 39 minutes 0 seconds (product storage error, onset date: 27-Feb-2025). Previous temperature excursion was reported as yes: -14.19 C for 9 minutes and -14.25 C for 16 minutes. There was no additional adverse event (AE) reported (no adverse event).
Sterile diluent