Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Dry skin, Eczema, Gait disturbance, Insomnia, Oral mucosal erythema
Clinical narrative: itchy skin because of eczema; sleep has been disturbed because of eczema for 3 days out of the week; skin has been bleeding, oozing, cracked because of eczema for 3 days out of the week; skin has been bleeding, oozing, cracked because of eczema for 3 days out of the week; skin has been bleeding, oozing, cracked because of eczema for 3 days out of the week; skin felt flaky, dry and rough because of eczema for 4 days out of the week; skin felt flaky, dry and rough because of eczema for 4 days out of the week; had redness and eczema flaring on the facial area intermittently; had redness and eczema flaring on the facial area intermittently; rash/ red bumps on body and face with itching developed/son developed rash all over his body; rash/ red bumps on body and face with itching developed; different food makes around his mouth red; speech delay; needs support walking; This spontaneous report was received from a consumer (the patient's mother) via other company letter refers to a 12-month-old male patient.  The patient's concurrent conditions included eczema infantile. The patient's medical history included skin warm, lethargy, dry skin, pruritus and dry eye. The patient's concomitant therapies were not provided.  On an unknown exact date, the patient stated therapy with dupilumab (DUPIXENT), formulation: solution for injection, at dose of 200 milligram, QM, subcutaneously (lot #, expiration date,and anatomical location were not provided) for infantile (acute) (chronic) eczema (eczema infantile).  On 17-FEB-2024, the patient received the second dose of dupilumab (DUPIXENT), formulation: solution for injection, at dose of 200 milligram, QM, subcutaneously (lot #, expiration date,and anatomical location were not provided) for infantile (acute) (chronic) eczema (eczema infantile).  On 20-FEB-2024, the body temperature was 98.8.  On 15-MAY-2024, the patient was vaccinated with the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (manufacturer, formulation, lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. According to the vaccination, the patient missed dose of dupilumab (DUPIXENT).  On 15-MAY-2024 (at the same day), the patient experienced skin swelling and rash erythematous. On an unknown exact day in May 2024, the patient recovered from the event rash erythematous (reported as: the reaction cleared after around 5 days).  On 17-JUN-2024, the patient received the next dose of dupilumab (DUPIXENT).  On 17-JUN-2024 (reported as: intermittently since the last dose of dupilumab (DUPIXENT) was administered), the patient experienced eczema and erythema. Managing successfully with Hydrocortisone ointment and Tacrolimus ointment.  On 15-JUL-2024, the patient received approximately last dose of dupilumab (DUPIXENT).  On an unknown exact day in August 2024 (unspecified, reported as: over the past week), the patient experienced sleep disorder due to a general medical condition, dry skin, skin exfoliation, skin fissures, skin weeping, skin haemorrhage and pruritus. On an unknown exact day in 2024 (unspecified), the patient experienced speech disorder developmental, oral mucosal erythema and gait disturbance. For oral mucosal erythema the patient's mother also applies Tacrolimus and Vaseline daily moisturizer. Cool showers in the morning also helps patient's eczema. On an unknown exact day in 2024, the patient recovered from the dry skin and pruritus was reported as recovered/resolved. The outcome of skin swelling, gait disturbance, speech disorder developmental, oral mucosal erythema, skin exfoliation, skin fissures, skin weeping, skin haemorrhage, sleep disorder due to a general medical condition, eczema and erythema is unknown.  The relatedness between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were not provided.; Sender's Comments:  US-009507513-2409USA004101: