Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y010184 | — |
HCP called to report TE where patient received the product. No Side effects or symptoms reported. No Additional information provided. No Additional AE/ No PQC; HCP called to report TE where patient received the product. No Side effects or symptoms reported. No Additional information provided. No Additional AE/ No PQC; 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, concurrent conditions and concomitant therapies were not reported. On 12-May-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) 0,5 mL (lot #Y010184 and expiration date reported as 31-May-2026) (route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. The reporter called to report a temperature excursion (TE) (-4.8C for 0 hours 39 minutes 0 seconds) where the patient received the product (product storage error). No previous excursions were noted. No side effects or symptoms were reported. No additional information was provided. No Additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).
Sterile diluent