Received May 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | y013346 | OT |
No other AE; Inbound call from HCP stating that they administered VARIVAX to a patient who was 6 months old at the time/date of administration. The patient is now 8 months old. No further information provided. No symptoms described by HCP. No further patient info; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a 6-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 05-Mar-2025, at the age of 6 months, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 ml, lot #y013346, expiration date: 02-Aug-2026 (dose number, route of administration and anatomical location were not provided), for prophylaxis (Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported). At the reporting time, the patient was 8 months old. No further information was provided. No symptoms were described by HCP and no other adverse event was reported.
Sterile diluent