Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y013350 | — |
No additional AE/No PQC.; HCP calling reporting that a patient has received an improperly stored VARIVAX. Reference TE case #02773596. HCP reported that the VARIVAX underwent a TE on 03/13/2025. HCP reported that the date of the administration was 03/17/2025. No symptoms or; This spontaneous report was received from an other health professional and refers 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 17-MAR-2025, the patient received improperly stored varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Injection, lot #Y013350 and expiration date 02-AUG-2026, 0.5 mL for prophylaxis (dose number, route and site of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were unknown). The excursion lasted for 45 minutes in temperature of 16.1 Fahrenheit degrees. There was previous excursion that lasted 1 hour in temperature of 13.6 Fahrenheit degrees (product storage error). No additional adverse event/ Product Quality Complaints reported (no adverse event).
Sterile diluent