Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Neurodermatitis, Pruritus, Rash, Skin exfoliation
Clinical narrative: currently areas of the skin are bleeding; currently areas of the skin are oozing; skin show mg new bumps to upper arms and back, then turns into a sore; currently areas of the skin are flaking; flare ups/ breakouts/ outbreaks which are itchy, open sores; open sores; skin showing new bumps to upper arms and back/breakout on arms, legs, and buttocks; outbreaks which are itchy, open sores; allergies are out of control this season; uasure if the medication is working for her as she still always has breakouts/ dupixent has helped, but she still has flare ups; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-016440 (LLP-Biontech), 2023SA173629 (Sanofi).  A 41-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), on 18Apr2023 as 300 mg, every other week (Lot number: 3F361A, Expiration Date: 31Jan2026) subcutaneous for dermatitis atopic, neurodermatitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VITAMINS NOS; BUPROPION HYDROCHLORIDE; SPIRONOLACTONE; MIRTAZAPINE; IRON. The following information was reported: SKIN HAEMORRHAGE (non-serious), outcome "not recovered", described as "currently areas of the skin are bleeding"; SKIN WEEPING (non-serious), outcome "not recovered", described as "currently areas of the skin are oozing"; SKIN ULCER (non-serious), outcome "unknown", described as "skin show mg new bumps to upper arms and back, then turns into a sore"; SKIN EXFOLIATION (non-serious), outcome "not recovered", described as "currently areas of the skin are flaking"; NEURODERMATITIS (non-serious), outcome "not recovered", described as "flare ups/ breakouts/ outbreaks which are itchy, open sores"; WOUND (non-serious), outcome "unknown", described as "open sores"; RASH (non-serious), outcome "unknown", described as "skin showing new bumps to upper arms and back/breakout on arms, legs, and buttocks"; PRURITUS (non-serious), outcome "unknown", described as "outbreaks which are itchy, open sores"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies are out of control this season"; THERAPEUTIC RESPONSE DECREASED (non-serious), outcome "unknown", described as "uasure if the medication is working for her as she still always has breakouts/ dupixent has helped, but she still has flare ups". The action taken for dupilumab was unknown.  Additional information: Initial information received on 02Jun2023 regarding an unsolicited valid non-serious case received from the patient. This case involves a 41 year old female patient who had currently areas of the skin are bleeding, currently areas of the skin are oozing, skin showing new bumps to upper arms and back skin showing new bumps to upper arms and back, then turns into a sore and currently areas of the skin are flaking, flare ups/breakouts /outbreaks which are itchy, open sores, allergies are out of control this season and breakout on arms legs and buttocks while being treated with DUPILUMAB[DUPIXENT] delivered via single dose pre-filled pen and COVID-19 VACCINE. On 18Apr2023, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength of 300 MG/2 ML) at a dose of 300 mg QOW (every other week) via subcutaneous route for atopic dermatitis and prurigo nodularis. On an unknown date, the patient started taking COVID-19 VACCINE with an unknown formulation, dose, frequency, route, indication. In May2023 the patient developed a non-serious event ''currently areas of the skin are bleeding'' (skin hemorrhage), ''currently areas of the skin are oozing ''(skin weeping), ''skin showing new bumps to upper arms and back'' (rash), ''showing new bumps to upper arms and back, then turns into a sore (skin ulcer), ''currently areas of the skin are flaking (skin exfoliation) (latency: approximately few days to few weeks) (unknown batch number and expiry date for all the events) following the first dose intake of DUPILUMMAB and COVID-19 VACCINE. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. On an unknown date the patient developed a non-serious event flare ups/breakouts/ outbreaks which are itchy, open sores (neurodermatitis) (unknown latency) following the first dose intake (lot:3F361A, expiry date on 31Jan2026) of DUPILUMAB and covid-19 VACCINE. On an unknown date the patient developed a non-serious event ''allergies are out of control this season'' (hypersensitivity) (unknown latency) following the first dose intake (lot:3F361A, expiry date on 31Jan2026) of DUPILUMAB and covid-19 VACCINE. On an unknown date the patient developed a non-serious event ''breakout on arms, legs, and buttocks'' (rash) (unknown latency) following the first dose intake (lot:3F361A, expiry date on 31Jan2026) of DUPILUMAB and covid-19 VACCINE. On an unknown date the patient developed a non-serious event ''unsure if the medication was working for her as she still always has breakouts / Dupixent has helped, but she still has flare ups'' (therapeutic response decreased) (unknown latency) following the first dose intake (lot:3F361A, expiry date on 31Jan2026) of DUPILUMAB and covid-19 VACCINE. On an unknown date the patient developed a non-serious event ''outbreaks which are itchy, open sores (pruritus) (unknown latency) following the first dose intake (lot:3F361A, expiry date on 31Jan2026) of DUPILUMAB and covid-19 VACCINE. It was reported, ''patient states skin showing ''new bumps'' to upper arms and back, looks like a mosquito bite at first, then turns into a sore'' currently areas of the skin are bleeding, oozing, and flaking, patient states she was on Dupixent for prurigo nodularis and she consistently was having outbreaks which are itchy, open sores. She reports her allergies are out of control this season. Patient was having a breakout on arms, legs, and buttocks. Patient reports that she is unsure if the medication was working for her as she still always has breakouts. Patient reports if she gets bug bites they turn bites they turn into welts and open sores. The Dupixent has helped, but she still has flare ups. She will get steroid injections and a steroid and cream from the doctor and it will help short term. Patient also mentioned that she believes the covid vaccine caused the condition. Doctor was aware, no other details  provided. On 02Jun2023 from other health care professional: indication was updated. Text amended accordingly. On 26Sep2024 from patient: new events of Neurodermatitis with the symptoms of Therapeutic response decreased. Pruritus. Wound, Hypersensitivity, rash, route of administration for the drug, batch number, expiry date and concomitant medication, co-suspect of covid-19 vaccine was added, Text amended accordingly.  Batch/lot number is not provided, and it cannot be obtained.