Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | Y010374 | OT |
No additional AE; while the dose was being administered to the patient the vaccine began leaking out of the DILUENT syringe and splattered everywhere; while the dose was being administered to the patient the vaccine began leaking out of the DILUENT syringe "and splattered everywhere".; patient received no more than 25% of the recommended dose; This spontaneous report was received from a Physician Assistant and refers to a 15-month-old patient of unknown gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On 25-FEB-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) into the patient's thigh intramuscularly, (vaccination scheme, dose description not provided, lot #Y010374, expiration date: 05-JUN-2026) with sterile diluent syringe (dose description not provided, lot # 2050911, expiration date: 11-FEB-2027) for the treatment of prophylaxis, it was states that the medical assistant reconstituted the vaccine with no issues or concerns and while the dose was being administered to the patient the vaccine began leaking out of the diluent syringe and splattered everywhere (Poor quality device used, Syringe leak); they estimate that the patient received no more than 25% of the recommended dose (Accidental underdose). No additional adverse events were reported. Follow up was received from the Physician Assistant on 05-MAR-2025. The vaccine was administered by health professional. The operator was trained.
STERILE DILUENT