Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y002062 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from a nurse, concerning to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the vaccine experienced a temperature excursion (TE), at -9.6C for 40 minutes. On 09-Jul-2025, the patient started therapy with one dose of the vaccine involved in the TE Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y002062 has been verified to be valid, expiration date reported and confirmed as 09-Jan-2026), as prophylaxis; reconstituted with sterile diluent (BAXTER STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Product storage error). No additional AEs were reported (No adverse event). At the reporting time, the outcome of patient received improperly stored vaccine and No additional AEs were reported was unknown. The action taken with Varicella Virus Vaccine Live (Oka-Merck) and sterile diluent was reported as not applicable.
BAXTER STERILE DILUENT