Received Jun 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | z013023 | — |
No other AE; Medical assistant calling with report of a vaccine that underwent a TE being administered to a patient.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-May-2026, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #z013023 with valid expiration date reported as 12-Aug-2027) 0.5 mL once (route of administration and vaccination site were not reported) administered for prophylaxis. T =he vaccine was reconstituted with sterile diluent, solution for injection. The vaccine which was administered to the patient underwent a temperature excursion (TE) (temperature/time frame: (-10.6c) for 0 hours 28 minutes 0 seconds) (product storage issue). There was no previous temperature excursion. There was no other adverse event (AE) and no product quality complaint (PQC).
sterile diluent