Received Jan 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | Z011601 | RL |
No additional AE; underwent a temperature excursion was administered; This Spontaneous report was received from Nurse and referred to a 1 -year-old patient of unknown gender. 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 05-Jan-2026, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) lyophilisate and solvent for solution for injection (VARIVAX) (0.50 mL) (total) (Batch/Lot Number: Z011601) (Expiration date: 11-Jul-2027) for prophylaxis. The vaccine was exposed to temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 30 minutes and -10 degrees Celsius to 8 degrees Celsius for 2 hours 20 minutes (Product storage error). The vaccine was reconstituted with sterile diluent Solution for injection (MERCK STERILE DILUENT) (Batch/Lot Number: Z003252) (Expiration date: 05-Dec-2027). There was no additional AE (No adverse event). Follow-up information was received from the Nurse on 13-Jan-2025. The patient was a female. On 17-Dec-2025 there was a power outage due to severe windstorm and the facility suffered a frozen vaccine excursion. There was no report of injury. The patient was vaccinated in right thigh and it was dose number 1 of the vaccine.
DILUENT MRK