Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
skin irritation with clothing; Some injection sites reactions similar to when she gets covid shots-redness and itching; Some injection site reactions, similar to when she gets covid shots-redness and itching; yesterday around noon i started to itch again pretty badly; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA365621 (SANOFI), AE-022450 (BIONTECH). This case involves a 66 years old female patient who reported yesterday around noon i started to itch again pretty badly, skin irritation with clothing and some injection site reactions, similar to when she gets covid shots-redness and itching while being treated with DUPILUMAB [DUPIXENT] delivered via dupixent single dose prefilled pen and COVID-19 vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Seasonal allergy (allergies: mixed ragweed extract 1:20 vial) and Drug hypersensitivity. (allergies: hydroxyzine hcl 10 mg tablet) Concomitant medications included Clobetasol (Clobetasol); Nivolumab (Opdivo); Levothyroxine sodium (Levothyroxine sodium); and Hydrochlorothiazide (Hydrochlorothiazide). On 01-Dec-2025, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 300mg/2ml) at a loading dose 600 mg 1X once followed by maintenance dose 300mg Qow via subcutaneously since in Dec-2025 for Prurigo nodularis delivered via dupixent single dose prefilled pen. On an unknown date, the patient started taking COVID-19 vaccine (dose, frequency, route, frequency: unknown). On 01-Dec-2025 the patient developed a non-serious event "yesterday around noon i started to itch again pretty badly" (pruritus) (latency: same day) following the first dose intake (Batch number: 5F735A and expiry date on 31-Jan-2028) of DUPILUMAB and (unknown batch number and expiry date) of COVID-19 vaccine. On an unknown date the patient developed a non-serious event "skin irritation with clothing" (skin irritation) (unknown latency) following the first dose intake (batch number: 4F561A, expiry date on 31-Aug-2026) of DUPILUMAB and (unknown batch number and expiry date) of COVID-19 vaccine. On an unknown date the patient developed a non-serious event "some injection site reactions, similar to when she gets covid shots-redness and itching" (injection site erythema) (injection site pruritus) (unknown latency) following the first dose intake (batch number: 4F561A, expiry date on 31-Aug-2026) of DUPILUMAB and (unknown batch number and expiry date) of COVID-19 vaccine. It was reported "Patient felt pretty good after my two doses yesterday (12/01/2025) but around noon she started to itch again pretty badly. Patient reports that she has seen improvement in her skin, however, she specifically wants to know when she can see more improvements in her skin irritation with clothing. patient states she did have some injection site reactions, similar to when she gets covid shots - redness and itching. no other details were provided." Action taken for dupilumab: Unknown for all the events; however therapy was ongoing at the time of reporting. Action taken for Covid-19 vaccine: Unknown for all the events. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events. Additional information was received on 05-Jan-2026 from patient: Events skin irritation, injection site erythema and injection site pruritus added, Co-suspect covid-19 added and clinical course added for dupilumab; text amended accordingly. Batch/lot number is not provided, and it cannot be obtained. Cominaty is under agreement with BIONTECH.
Drug hypersensitivity ((allergies: hydroxyzine hcl 10 mg tablet)); Seasonal allergy ((allergies: mixed ragweed extract 1:20 vial))
CLOBETASOL; NIVOLUMAB; LEVOTHYROXINE SODIUM; HYDROCHLOROTHIAZIDE; DUPIXENT