Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y019318 | — |
No additional AE; HCP reporting that a patient received a dose of improperly stored VARIVAX; This spontaneous report was received from a Nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 09-Jun-2025, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka-merck) (VARIVAX), 0.5 mL, administered as prophylaxis (Lot No. Y019318 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 21-Nov-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (Lot No., expiration date, route and indication was not provided (product storage error), after a temperature excursion of 52.2 degree Fahrenheit (F) with an unknown time frame. No previous temperature excursion was reported. No additional information or adverse events were provided (no adverse event).
Sterile diluent