Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Vaccination site swelling; Still having flareup of eczema symptoms specifically on feet; area can be so itchy; It can bleed; Scratching; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site swelling in a 4-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On 06-OCT-2025, the patient received Tdap Vaccine and Flu vaccine. In 2025, an unknown time after receiving Tdap Vaccine and Flu vaccine, the patient experienced eczema (Verbatim: Still having flareup of eczema symptoms specifically on feet), pruritus (Verbatim: area can be so itchy), skin bleeding (Verbatim: It can bleed) and scratch (Verbatim: Scratching). In OCT-2025, the patient experienced injection site swelling (Verbatim: Vaccination site swelling). The patient was treated with dupilumab (Dupixent), triamcinolone, fluticasone and hydrocortisone. The outcome of the injection site swelling was unknown and the outcome of the eczema, pruritus, skin bleeding and scratch were not resolved. It was unknown if the reporter considered the injection site swelling, eczema, pruritus, skin bleeding and scratch to be related to Tdap Vaccine and Flu vaccine. It was unknown if the company considered the injection site swelling, eczema, pruritus, skin bleeding and scratch to be related to Tdap Vaccine and Flu vaccine. Additional Information: GSK Receipt Date: 17-NOV-2025 The reporter reported that a patient had started Dupixent (dupilumab) on 17-Aug-2025. On 06-Oct-2025, she received the Tdap vaccine (diphtheria toxoid, pertussis acellular, tetanus toxoid) and a flu vaccine for prophylaxis. In October 2025, she developed a non-serious reaction on her left leg near the injection site, reporting swelling after receiving the vaccines and no redness or tenderness was noted. The medical doctor was aware of the reaction, and no other adverse events were reported at that time. In 2025, the patient continued to experience flare-ups of eczema symptoms, particularly on her feet. The patient reported that the affected area was very itchy and could bleed after scratching. Pruritus, skin hemorrhage, and scratching were noted as ongoing non-serious events. Information regarding batch numbers and expiration dates of the vaccines was requested but not available. The medical doctor was aware of the patient's current symptoms. Action taken with Dupixent was unknown, but therapy remained ongoing. Action taken with the flu vaccine and Tdap was not applicable. It was not reported whether corrective treatment was given. At the time of reporting, the outcome for eczema was not recovered or not resolved, while the outcome for vaccination site swelling was unknown. The batch number was not provided and a request for this information has been made.