Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y014868 | — |
No symptoms were reported by patient; HCP calling to reporting an administered VARIVAX with TE.; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions were not reported, and concomitant therapies were not reported. On 29-APR-2025, the patient started therapy with an improper storage of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE),(dose , route of administration were not reported) (lot #Y014868, expiration date: 03-SEP-2026) with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) for prophylaxis )( Product storage error). The administered doses of the vaccine experienced a temperature excursion -10 degree Celsius to 0 degree Celsius for 2 hours 43 minutes and 14 degrees Celsius to -10 degree Celsius (-14 degree Celsius) for 15 hours 6 minutes. It was unspecified if the data was recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. It was reported that the vaccine did not experience previous temperature excursion. Lot # is being requested and will be submitted if received.
Sterile diluent