Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
a change in the patient's walk; The vaccines were mixed with flu vaccine instead of the dilution solvent; This spontaneous report was received from an employee and refers to a 13-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2025, at patient's pediatric appointment for 12-month shots, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, route of administration, vaccination site, lot and expiration date were not reported); and with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (dose, route of administration, vaccination site, lot and expiration date were not reported), both administered for prophylaxis. The vaccines were mixed with flu vaccine instead of the dilution solvent (typical solution) (product preparation error). Provider spoke to "vaccine rep" who advised it should not be harmful although they did not have data on this possible interaction. The mother was to monitor the baby for 2 weeks and to call with any concerns. Per discussion the following was recommended: a booster for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Varicella Virus Vaccine Live (Oka-Merck) in 1 month in case the mixture caused the vaccine to not be as effective. Therefore, in total, the patient received 3 injections at the appointment. On 08-Sep-2025 (also reported as after this vaccination), the patient's mother noticed a change in the patient's walk (gait disturbance). The patient's walking has been affected and she was walking funny after. This has improved since the event (in the month since), but the mother was taking the patient to a neurologist for follow up today. She has since changed pediatrician providers and contacted the department of health and vaccine specialists. No additional adverse event (AE) or product quality complaint (PQC) was noted. At the time of reporting, the patient was recovering from the event of gait disturbance. The causal relationship between the event of gait disturbance and the suspect vaccines was not reported. Lot # is being requested and will be submitted if received.; Reporter's Comments: Keywords : OCL; Sender's Comments: Priority : 5 , Is case serious : No , Index user , Index date : 2025-10-03 , MNSC number : 02882925 , CLIC number : , ESTAR number : , IRMS number : 02882926 , Central date : 2025-10-03 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :