Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y015108 | — |
No additional AE; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered VARIVAX.; This spontaneous report has been received from other health care professional (medical assistant) concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter. On 09-JAN-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 mL, lot# Y015108 that was verified to be a valid lot # (expiration date reported and validated as 06-SEP-2026) administered as prophylaxis (routed and anatomical location of administration were not provided). The dose was administered after underwent multiple temperature excursions (beginning on 05-DEC-2024) (product storage error). No medical concerns or symptoms from the patient involved were reported. No additional adverse event reported.
Sterile Diluent