Received Oct 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
mild Itching and redness at the covtd shot Injection site; mild Itching and redness at the covtd shot Injection site; being about 2 days late and about 2 days early for several doses over the summer with no adverse event; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021146 (BioNTech SE), 2025SA138951 (SANOFI). Initial information received on 08May2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 74 years old female patient who reported about 2 days before every injection her itching and bumpy skin starts to return and mild itching and redness at the covid shot injection site while being treated with DUPILUMAB (DUPIXENT) via pre-filled syringe and COVID-19 vaccine, being about 2 days late and about 2 days early for several doses over the summer with no adverse event directly linked to inappropriate schedule of product administration. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In Apr2025, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 600 mg 1X followed by 300 mg QOW since 2025 (strength: 300mg/2ml) subcutaneous for atopic dermatitis via pre filled syringe. On an unknown date, the patient started taking COVID-19 vaccine (with unknown vaccine, strength, frequency, route and indication). In 2025 the patient developed a non-serious event: "about 2 days before every injection her itching and bumpy skin starts to return" (pruritus) (skin swelling) (therapeutic response shortened) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB.In 2025 the patient developed a non-serious event: "mild itching and redness at the covid shot injection site" (injection site pruritus) (injection site erythema) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 vaccine. In 2025 the patient developed a non-serious event "being about 2 days late and about 2 days early for several doses over the summer with no adverse event" (Inappropriate schedule of product administration) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "about 2 days before every injection her itching and bumpy skin starts to return (last occurrence started 06May2025, dose taken 08May2025, unknown if still ongoing; dates and duration of other occurrences unknown). Reports of pruritus (moderate) mild acne. No injection site reactions reported. Patient reports mild itching and redness at the covid shot injection site (date, onset from dose, and duration unknown). Reports similar reactions with previous covid vaccines (unknown timing and duration of therapy). Also reports being about 2 days late and about 2 days early for several doses over the summer (dates unknown) due to travel, unknown if still ongoing. No issues reported from occasional early or late dosing." Action taken with DUPILUMAB (DUPIXENT) was continued for pruritus, skin swelling; unknown for rest of the events. Action taken with COVID-19 vaccine (COVID-19 vaccine) was not applicable for pruritus, skin swelling; unknown for rest of the events. It was not reported if the patient received a corrective treatment for the events (pruritus) (skin swelling, injection site pruritus, injection site erythema). At time of reporting, the outcome was Unknown for the event pruritus, skin swelling. This suspected adverse reaction report is submitted and classified as a medically confirmed case solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification and its wording is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to blame for the occurrence of this transaction error. Additional information was received on 22Sep2025 from patient: Event injection site pruritus, injection site erythema, inappropriate schedule of product administration and co suspect was added; Text amended accordingly.
DUPIXENT