Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y005919 | OT |
No patient symptoms have been reported; VARIVAX was inadvertently administered to a 2 month old on 10/20/2025; This spontaneous report was received from a medical assistant and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 20-Oct-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection, 1 dosage form, total (valid lot #Y005919, expiration date reported and confirmed as 13-Mar-2026; exact dose, route of administration, and anatomical location were not reported) as prophylaxis. The suspect vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), Solution for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) (product administered to patient of inappropriate age). No patient symptoms had been reported (no adverse event).
Sterile diluent