Received Jun 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z003882 | — |
No additional AE reported; HCP called to report T/E for VARIVAX on dates 5/30/2025 and 6/10/2025. VARIVAX was administered on 6/09/2025.; This spontaneous report was received from a physician and refers to a patient of unknown age and 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 stored dose of varicella virus vaccine live (oka-merck) (VARIVAX) injection, administered as prophylaxis (Lot No. Z003882 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 03-Feb-2027)(strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (MERCK STERILE DILUENT) (indication, Lot No., and expiration date were not provided); after a temperature excursion of 8.0 degree Fahrenheit (F) during a time frame of 15 minutes that occurred (on 30-May-2025 and 10-Jun-2025). Previous temperature excursion reported of 9.0 degree Fahrenheit (F) during a time frame of 15 minutes. No additional information or adverse events or PQC were provided (no adverse event).
Sterile diluent