Received Jan 16, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Runny nose; itchy eyes; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of runny nose in a 3-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Co-suspect products included MMR (MMR vaccine) for prophylaxis, varicella zoster vaccine (Varicella Vaccine) for prophylaxis and dupilumab (Dupixent) for product used for unknown indication. The patient's past medical history included pneumonia (Confirmed by X ray; with fever, cough, shortness of breath), fever (Associated with pneumonia), cough (Persistent/recurrent; part of respiratory illness), shortness of breath (Associated with pneumonia), injection site erythema (red, slightly raised area formed 2cn around the injection site), red rash, chromaturia (No additional details provided), respiratory tract infection (Recurrent cough/cold symptoms), constipation (Reported by mother; no further details), hematocrit abnormal (Lab value reported; context not provided), therapeutic response shortened, erythema (Latency approximately 2 months; resolving), conjunctivitis (Occurred a few days after first shot; on and off for approximately 1 week; resolved), nasopharyngitis (Reported as part of recurrent respiratory symptoms), eye pruritus (Reported by mother; timing linked to conjunctivitis), injection site swelling (red, slightly raised area formed 2cn around the injection site), hospitalization (Same day discharge; treated with amoxicillin), injection site erythema (Around vaccine injection site) and skin lesion (Occurred 1 week before shot was due). Previously administered products included Dupixent with an associated reaction of conjunctivitis ((strength: 200mglI.14mI) at a dose of 200 mg Q4 W subcutaneously for Eczema and A topic Dermatitis delivered via Dupixent single dose), amoxicillin (Symptoms of fever, cough, and shortness of breath (Onset: Apr-2024) and the patient went to hospital on 22-Apr-2024 (discharged the same day) and prescribed amoxicillin) and iron (as negative for a urinary tract infection, and was prescribed iron drops). Additional patient notes included The patient's past medical history, medical treatments, concomitant medications and family history were not provided.. In AUG-2024, the patient received Tdap Vaccine, MMR vaccine and Varicella Vaccine. In 2024, the patient started Dupixent 300 mg. In AUG-2024, less than a month after receiving Tdap Vaccine and MMR vaccine and an unknown time after starting Varicella Vaccine and Dupixent, the patient experienced runny nose (Verbatim: Runny nose) and eye pruritus (Verbatim: itchy eyes). The action taken with Dupixent was unknown. The outcome of the runny nose and eye pruritus were not resolved. It was unknown if the reporter considered the runny nose and eye pruritus to be related to Tdap Vaccine and MMR vaccine. The reporter considered the runny nose and eye pruritus to be not reported if related to Varicella Vaccine and Dupixent. It was unknown if the company considered the runny nose and eye pruritus to be related to Tdap Vaccine and MMR vaccine. The company considered the runny nose and eye pruritus to be not reported if related to Varicella Vaccine and Dupixent. Additional Information: GSK Receipt Date: 07-JAN-2026 The mother reported that the patient had a runny nose (rhinorrhea) and itchy eyes (eye pruritus) (onset: AUG-2024; latency: approximately 7 months). The doctor of medicine was unaware. The batch number was not provided and a request for this information has been made
Medical History/Concurrent Conditions: Chromaturia (No additional details provided); Conjunctivitis (Occurred a few days after first shot; on and off for approximately 1 week; resolved); Constipation (Reported by mother; no further details); Cough (Persistent/recurrent; part of respiratory illness); Erythema (Latency approximately 2 months; resolving); Eye pruritus (Reported by mother; timing linked to conjunctivitis); Fever (Associated with pneumonia); Hematocrit abnormal (Lab value reported; context not provided); Hospitalization (Same day discharge; treated with amoxicillin); Injection site erythema (red, slightly raised area formed 2cn around the injection site); Injection site erythema (Around vaccine injection site); Injection site swelling (red, slightly raised area formed 2cn around the injection site); Nasopharyngitis (Reported as part of recurrent respiratory symptoms); Pneumonia (Confirmed by X ray; with fever, cough, shortness of breath); Red rash; Respiratory tract infection (Recurrent cough/cold symptoms); Shortness of breath (Associated with pneumonia); Skin lesion (Occurred 1 week before shot was due); Therapeutic response shortened; Comments: The patient's past medical history, medical treatments, concomitant medications and family history were not provided.
Dupixent