Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Y013350 | — |
No additional AE; TE for VARIVAX that occurred on 02/24/2025 and the vaccine was also inadvertently administered on 02/26/2025; This spontaneous report was received from a health professional and refers to a 16-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-FEB-2025, a temperature excursion (TE) for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) occurred (-11.4C for 1 hour 0 minutes 0 seconds). On 26-Feb-2025, the patient was inadvertently vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0.5mL / once (lot #Y013350, expiration date: 02-Aug-2026), administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection (product storage error). The patient did not experience any adverse issues or side effects related to the administration of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (no adverse event). No prior excursions were noted. No product quality complaint (PQC) was noted.; Reporter's Comments:
Sterile diluent