Received Jan 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Z008197 | OT / LL |
No side effects or symptoms reported; received product after it was improperly stored; This spontaneous report was received from a medical assistant and referred to a 13-month-old patient of unknown gender. The patient's medical history was not reported. The patient's past medications were not reported. The patient's concomitant medications were not reported. On 05-Nov-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection (0.50 mL, Lot Number: Z008197, expiration date 30-Apr-2027; strength and route were not reported) after it was improperly stored at -10.5C for 1 hour 0 minutes 0 seconds for prophylaxis (Product storage error). There was no previous excursion. The vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT). No side effects or symptoms reported (no adverse event). Follow up information was received on 08-Jan-2026 from the medical assistant and refers to a 13-month-old male patient. On 05-Nov-2025, the patient was vaccinated with public funds and in private doctor's office/hospital in her left thigh with the first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) subcutaneously which was improperly stored in freezer as a result of a reading from a digital data logger; the temperature excursion was on 30-OCT-2025 during a routine freezer cleaning and the excursion lasted one hour and five minutes.
sterile diluent