Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008197 | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
No side effects or symptoms reported; patient received product after it was improperly stored.; This Spontaneous report was received from a Certified Medical Assistant (CMA) concerning a 4-year-old patient of unspecified gender. The patient's medical history, past medications, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unspecified date, doses of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) underwent a temperature excursion at -10.5 degrees Celsius (C) for 1 hour, 0 minutes, 0 seconds with no previous excursions. On 17-Nov-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 mL, batch/lot number Z008197, expiration date 30-Apr-2027, which was diluted with sterile diluent (batch/lot number and expiration date were not provided) and administered as prophylaxis (dosage regimen, anatomical location and route of administration were not reported) (product storage error.) There were no side effects or symptoms reported (no adverse event.) Batch/lot# is being requested and will be submitted if received.