Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | X028612 | OT / LA |
No additional AE; Inbound call received from a nurse who said improperly stored doses of VARIVAX were administered to at least one patient.; This spontaneous report was received from a Nurse and refers to a(n) 18-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions included seizure disorder. Concomitant medications included Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid), Hbhepb (Hepatitis b vaccine;HIB vaccine) . On 05-May-2025, the patient was vaccinated with an improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #X028612, expiration date: 13-Dec-2025), dose number 1, diluted in sterile diluent (MERCK STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported) and were administered by Subcutaneous route in the Left Arm for prophylaxis. The vaccine had been exposed to a temperature of -11.31 C for 28 minutes. There were no previous temperature excursions. No adverse event was reported. This is one of two reports from the same reporter.
Seizures
Tdap; Hepatitis B; Diluent Mrk