Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | Y007585 | OT / RL |
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | 1 | Y017511 | OT / LL |
Caller reported vaccines administered after temperature excursions; No additional AEs; This invalid spontaneous report was received from a medical assistant and refers to patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y017511, expiration date: 15-Apr-2026) (dose, vaccination site and route of administration were not reported); and with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y011019, expiration date: 18-Jun-2026) (dose, vaccination site and route of administration were not reported) administered for prophylaxis. The vaccines were administered after temperature excursions (temperature: -9.8C; time frame: 2 hours 3 minutes) (product storage error). There was no previous temperature excursion. No other information was provided. No additional adverse events (AEs) or product quality complaint (PQC) was reported. This case was considered invalid due to lack of patients' identifiers. Follow up information was received on 25-APR-2025 via complete questionnaire and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017511, expiration date: 15-Apr-2026), dose number 1, administered by Subcutaneous route in Left Thigh, and with Hepatitis A Vaccine (previously reported as Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX)), Inactivated (lot #Y007585, expiration date: 31-Oct-2025), dose number 1, administered by Intramuscular route in Right Thigh. This is one of several reports from the same reporter.
Sterile diluent