Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008196 | — |
No additional AE; HCP called to report a TE for VARIVAX; This spontaneous report was received from a Nurse and refers to a 25-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-AUG-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, 0.5 mL, administered as prophylaxis (lot number Z008196 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date 30-APR-2027; route of administration, dose number and anatomical site of injection were not reported), which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (expiration date and lot number were not reported). The vaccine was administered after a temperature excursion (TE) at -11.8 degree C for 45 minutes, with no previous TE (Product storage error). No additional adverse event was reported for the patient. This is one of several reports from the same reporter.
Sterile diluent