Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | X026330 | OT / LA |
No additional AE; temperature excursion; This spontaneous report was received from a nurse and referred to two patients of unknown age and gender. The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported. On unknown dates, the patients were vaccinated with dose of improper stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot # X026330, expiration date: 07-NOV-2025; dose, dose number, strength, formulation, route and anatomical site were unknown), which was reconstituted with sterile diluent (HOLLISTER-STIER STERILE DILUENT) (lot # and expiration date were not reported) for prophylaxis (product storage error). The temperature excursions occurred on 20-AUG-2025 and 02-SEP-2025. The storage temperature of the vaccine was reported as 1.2 degrees Celsius for 1 hour and 43 minutes. There was a previous temperature excursion at 10.3 degrees Celsius for 35 minutes. No additional adverse event (no adverse event). The outcome of the events was unknown. This is an invalid report due to multiple unknown patients Follow up information was received from a nurse on 11-Sep-2025, referring to the patient. The case was updated to a valid case due to patient's identifier added. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE) Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid), Menquadfi (Meningococcal vaccine A/C/Y/W conj (tet tox)), Engerix b (Hepatitis b vaccine rHBsAg (yeast)), 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). 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
TDAP; MENQUADFI; ENGERIX-B; HAVRIX; VARICELLA; Sterile diluent