Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y013350 | — |
there were no symptomatic events reported/No additional AE; HCP called regarding T/E for VARIVAX. See T/E case 02821980. HCP reported that there were no symptomatic events reported. HCP agrees to be primary and correspondence contact for AE case. No additional AE/No PQC. Names of vaccines involved (including; This spontaneous report was received from an other health professional and refers to a(n) 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 03-Jun-2025, the patient was vaccinated with improper stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), formulation: injection, lot #Y013350, expiration date: 02-Aug-2026, 0.5 mL (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). Administered dose of vaccine was exposed to the temperature excursion of 25.5 degrees Fahrenheit for 7 hours and 15 minutes (product storage error). There were no symptomatic events reported (no adverse event).
Sterile diluent