Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Z010385 | — |
No additional AE.; excursion occurred from 28-NOV-2025 to 30-NOV- 2025 and one dose was administered on 30-NOV-2025; This Spontaneous report was received from health business professional (HBP) and referred to a 5-year-old male patient. 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 30-NOV-2025, the patient vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection (PROQUAD) injection (one dose, lot Number: Z010385, Expiration date: 14-Dec-2026, strength and route were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not provided). It stated that the excursion occurred from 28-NOV-2025 to 30-NOV-2025 (Product storage error). Temperature was 2.8 Degree Celsius (C), time frame was 45 Hours 5 Minutes 0 seconds. There was no previous temperature excursion. It was confirmed no symptomatic adverse events. No additional adverse event (No adverse event).
STERILE DILUENT