Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | X026330 | OT / RL |
No additional AE; temperature excursion; This spontaneous report was received from a nurse on 11-Sep-2025, referring to a 1-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE), Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) and HAVRIX (Hepatitis a vaccine inact). On 08-Sep-2025, the patient was vaccinated with first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X026330, expiration date: 07-Nov-2025), 1 dosage form administered by Subcutaneous route in left upper arm, which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported) as prophylaxis after temperature excursion (product storage error). No additional AE (no adverse event). The medication error occurred at the point of storage in clinical practice. Preliminary of by VFC consult. The vaccine was resumed on 03-Sep-2025. The vaccine was used according to the instruction leaflet. Operator of vaccine was reported as healthcare professional. Temperature excursion occurred as a result of a reading from a digital data logger. Temperature excursions outside of manufacturer-recommended storage ranges. The refrigerator unit DDLs experienced temperature fluctuations outside of the recommended storage ranges due to the doors being open for brief periods of time; during each event the unit doors were kept closed until temperatures stabilized to normal storage ranges. Each event was reported to the VFC program, and approval for use was given for vaccines each time. After 2 excursions occurring within a short timeframe, It was requested inspection and maintenance services for the unit. An inspection found an issue with the thermostat sensor of the refrigerator, leading to over connection of temperature changes. The unit was repaired and the thermostat calibrated along with DDL to ensure accurate readings. No further issues with temperatures. Due to subsequent excursions, it was told to perform stability analysis on the vaccines in the refrigerator based on the cumulative times and temperature of all temperature fluctuations. Although it was previously informed that vaccines can be continued to use, it was told to wait for stability analysis.; Reporter's Comments: Keywords : MUL; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02869093-02869059 , CLIC number : , ESTAR number : , IRMS number : 500UW00000kzgvzYAA|11092025230033|1237 , Central date : 2025-09-12 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2327758 , MNSC case number : 02869093 , MNSC interaction number : 02869059 , Integration log UniqueID : 500UW00000kzgvzYAA|11092025230033|1237 , Service cloud CaseID : 500UW00000kzgvzYAA
HAVRIX; PEDVAX HIB; VARICELLA; VAXNEUVANCE; Sterile diluent