Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Z008083 | OT / LL |
VARIVAX vaccine was administered after experiencing a temperature excursion assessment.; No additional AE; This spontaneous report was received from a Consumer (office manager) and refers to a 13-month-old male patient. The patient's medical history, current conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Solution for injection (exact dose was not reported) (lot #Z008083, who had been expiration date: 28-Apr-2027) administered by Intramuscular route in Left Thigh; the vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (exact dose, lot # and expiration date were not reported) as prophylaxis. The vaccine was administered with a temperature of 15F with a time frame of 0 Hours 30 Minutes 0 Seconds. There was previous temperature excursion recorded 19F for 0 Hours 30 minutes 0 Seconds; 15F for 0 Hours 15 minutes 0 Seconds; 21F for 0 Hours 45 Minutes 0 Seconds (product storage error). There was no reaction to vaccine. Child did fine. No additional adverse events reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2026-02-18 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2371712 , Central date : 2026-02-17 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number :
Sterile diluent