Received Feb 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z011601 | — |
No additional AE/no PQC reported.; Customer called to report TE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (exact dose, anatomical route of administration and frequency were not reported) (lot #Z011601, who had been verified to be a valid lot number, expiration date validated as 11-Jul-2027) for prophylaxis; and sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported). On 19-FEB-2026, the vaccine experienced temperature excursion of -14°C up to -10°C (-13.6 C) with a time frame for 2 hours 5 minutes 0 seconds. There was no information about previous temperature excursion (Product storage error). No additional adverse event or PQC reported.
Sterile diluent