Received May 21, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT |
eczema is exclusively on legs forming about 12 dots rapidly spreading; extremely itchy/diagnosed with grovers disease which results in itching in his upper body; This is a spontaneous report and received from Consumer or other non HCPs from License Party. Other Case identifier(s): AE-023575 (Biontech), 2025SA065976 (SANOFI). This case involves a 62-year-old male patient who experienced since last fill experiencing fatigue, since last fill experiencing headaches, lightheadedness/ dizziness happened due to diet changes and over the past month flare up of symptoms/flare-up occurs when they are closer to taking their next dose and eczema is exclusively on legs forming about 12 dots rapidly spreading and was diagnosed with grovers disease which results in itching in his upper body while being treated with DUPILUMAB [DUPIXENT] via prefilled pen and COVID-19 VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In Jun-2022, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 300 mg/2 ml) 300 mg QOW subcutaneous for atopic dermatitis, unspecified. In Feb-2025 the patient developed a non-serious event "over the past month flare up of symptoms/flare-up occurs when they are closer to taking their next dose" (dermatitis atopic) (latency: approximately 2 years 8 months) following the first dose intake (unknown batch number) of DUPILUMAB. On an unknown date the patient developed a non-serious event "since last fill experiencing fatigue" (fatigue) (unknown latency) following the first dose intake (unknown batch number) of DUPILUMAB. On an unknown date the patient developed a non-serious event "since last fill experiencing headaches" (headache) (unknown latency) following the first dose intake (unknown batch number) of DUPILUMAB. On an unknown date the patient developed a non-serious event "lightheadedness/ dizziness happened due to diet changes" (dizziness) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. On an unknown date the patient developed a non-serious event "lack of drug effect" (drug ineffective) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. On an unknown date the patient developed a non-serious event "eczema is exclusively on legs forming about 12 dots rapidly spreading" (eczema) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 VACCINE. On an unknown date the patient developed a non-serious event "extremely itchy/ has also been diagnosed with grovers disease which results in itching in his upper body" (pruritus) (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 "patient reports headache, lightheadedness happened due to diet changes, otherwise he didn't experience symptoms before counseled pt (patient) that had, dizziness as been reported with dupixent counseled pt that dehydration, bp change also can cause those symptoms, advised pt to monitor bp (blood pressure). pt vu. Pt asked if he an change dose frequency without having flareups, counseled pt that would need to speak with MD (Doctor of medicine) for further guidance on dose frequency pt says have and app with md to discuss further. Patient reports that they have experienced a flare-up of symptoms over the past month, stating that the flare-up occurs when they are closer to taking their next dose. Exact date(s) of onset, duration and/or severity of flare-up symptoms is unknown. Md is not aware. Patient's been on dupixent since late 2021 after patient developed eczema as tiny dot extremely itchy after covid vaccine. As time goes on, patient developed multiple dots at random location but then dots started to appear on patient's legs. Now eczema is exclusively on legs forming about 12 dots rapidly spreading. Patient is due for next dupixent injection and patient not sure if he should proceed since patient reported lack of efficacy of dupixent. Patient also believes that there are triggers (stress, lack of sleep, alcohol consumption) that negatively contribute to patient's skin condition". patient reported he has noticed a decreased int the efficacy with dupixent. patient stated he experiences flare ups toward the end of the 2 weeks dosing period (exact onset, duration, severity unknown). patient advised he alternates between triamcinolone cream and eucrisa cream to help with the flare ups. patient states he takes the creams in the morning and evening which does help calm the flare ups down. patient advised md is aware. patient has also been diagnosed with grovers disease which results in itching in his upper body (onset unknown) (Transient acantholytic dermatosis) (onset date and latency unknown) (batch number: 5F790A and expiry date: 30-Apr-2028). patient stated however, he does not have eczema in his upper body. no further information was provided. unknown if patient received a loading dose Action taken (DUPIXENT (DUPILUMAB)): Unknown for eczema, Transient acantholytic dermatosis, eczema and was no action taken for fatigue, Headache, Dizziness, Dermatitis atopic Action taken (with COVID-19 VACCINE): Unknown for eczema, Transient acantholytic dermatosis, eczema, fatigue, Headache, Dizziness, Dermatitis atopic. Corrective treatment: Eucrisa (Crisaborole) and Triamcinolone for dermatitis atopic and was not reported for eczema, Transient acantholytic dermatosis, eczema, fatigue, Headache, Dizziness. Outcome: Unknown for dermatitis atopic, eczema, Transient acantholytic dermatosis, eczema, fatigue, Headache, Dizziness and was not recovered for pruritus. Additional information: The nicotine use, drug abuse, pacemaker user, immunodeficiency, contraceptive user, radiotherapy, physiotherapy, special diet, implant user and metabolic disease were reported as false. Comirnaty is under agreement with Biontech. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Abstains from alcohol; Abstains from recreational drugs
DUPIXENT