Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Eye pruritus, Pneumonia, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; itchy eyes; redness around the eyes; pneumonia; fever; cough; shortness of breath; conjunctivitis; Initial information received on 17-Apr-2024 regarding an unsolicited valid non-serious case received from a patient's mother. The case became serious on 18-Jun-2024.  This case involves a 3-year-old male patient who experienced pneumonia, runny nose, redness around the eyes, itchy eyes and conjunctivitis while being treated with Dupixent [Dupilumab] delivered via prefilled pen and diphtheria, tetanus and acellular pertussis vaccine, varicella vaccine, MMR vaccine.  The patient's past medical history, medical treatment(s), concomitants, vaccination(s) and family history were not provided.  On 15-Feb-2024, the patient started taking Dupilumab Solution for injection delivered via prefilled pen (Strength: 200MG/1.14ML) at a dose of 200 mg QOW subcutaneously for Eczema. In 2024 DUPIXENT (DUPILUMAB) dosage was changed to 200 mg Q4W.  On an unknown date in Aug-2024, the patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site and dose of suspect MMR and varicella vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  Patient's mother reported patient had conjunctivitis that occurred a couple of days after the 1st shot, and was on and off for about a week, then resolved (conjunctivitis; Onset date: FEB-2024). Md (Doctor of Medicine) unaware, redness around the eyes (erythema; On 14-APR-2024; Latency: approximately 2 months) and was Resolving. MD unaware. Patient had pneumonia (pneumonia), confirmed by x-ray, that started Apr-2024 (exact date unknown; latency: approximately 2 months) with fever, cough, shortness of breath (symptoms: pyrexia; cough; dyspnea; onset date: Apr-2024; latency: approximately 2 months). Patient went to the hospital 22-Apr-2024 (discharged the same day), and was prescribed amoxicillin, and it was resolved. Prescribing MD was aware. Mother reported that the Dupilumab was due at the time of the illness (date unknown), and she rescheduled the Dupilumab injection with the MD office, resulting in a missed dose by 1.5 to 2 weeks late, as she was concerned about the patient being contagious. No ill effects reported by the mother from not taking dupixent on time. It was unknown if the patient experienced any additional symptoms/events. Mother reported that the patient has had a runny nose (rhinorrhoea) and itchy eyes (eye pruritus) (events onset: August 2024, latency: 7 months approximately) (unknown batch number, expiry date) was ongoing. md (Medical Doctor) unaware. mother reported that the patient had Tdap (Tetanus, Diphtheria, Acellular Pertussis), MMR (measles, mumps, and rubella), and varicella vaccine in August 2024, prescribing md unaware. Information regarding batch number and expiry date corresponding to the one at time of event occurrence was requested.  Action taken: Drug withdrawn on an unknown date in Apr-2024 for the event pneumonia and its symptoms (pyrexia, cough, dyspnoea) and No action taken for events rhinorrhoea, eye pruritus, conjunctivitis and erythema.  Corrective treatment: The patient was treated with Amoxicillin for pneumonia, and its symptoms (pyrexia, cough, dyspnoea) and not reported for events rhinorrhoea, eye pruritus, conjunctivitis and erythema.  Outcome: Recovered / Resolved in 2024 for the event conjunctivitis, Recovering / Resolving for the event erythema, was Recovered / Resolved on an unknown date in APR-2024 for the event pneumonia and its symptoms and not recovered for the events rhinorrhoea, eye pruritus.  Seriousness criteria: Medically significant for pneumonia and its symptoms.  Additional information was received on 18-Jun-2024 from the patient mother: Based on information received case was upgraded from non-serious to serious case.  Action taken was updated and event (pneumonia and its symptoms pyrexia, cough, dyspnea) were added and narrative amended accordingly.  Additional information was received on 18-Jun-2024 from patient's mother: concomitants, new events (rhinorrhoea, eye pruritus) were added and text amended accordingly.  Additional information was received on 03-Sep-2024 from patient's mother: Co-suspect vaccines added (diphtheria, tetanus and acellular pertussis vaccine, varicella vaccine, MMR vaccine): text amended accordingly.; Sender's Comments: Sanofi company comment updated on 03-Sep-2024: This case involves a 3-year-old male patient who experienced pneumonia, runny nose, redness around the eyes, itchy eyes and conjunctivitis while being treated with Dupixent [Dupilumab] delivered via prefilled pen and diphtheria, tetanus and acellular pertussis vaccine, varicella vaccine, MMR vaccine. The causal role of drug cannot be ignored for the events. However, lack of information regarding event details,  patient's compliance, medical history and concomitant medications, risk factors and allergy, personnel history  precludes the comprehensive assessment of the case. The case would be re-evaluated post the receipt of follow up information.