Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood pressure increased, Blood pressure measurement, Pneumonia, Pruritus
Clinical narrative: pneumonia; Alopecia; Blood pressure increased; Skin exfoliation; Pruritus; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024SA082734 (Sanofi).  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Oct2021 (Lot number: 4F463A, Expiration Date: 31Mar2026) at 300 mg (300 mg every other week), subcutaneous for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "not recovered"; ALOPECIA (non-serious), outcome "recovered"; BLOOD PRESSURE INCREASED (non-serious), outcome "recovering"; SKIN EXFOLIATION (non-serious), outcome "recovering"; PRURITUS (non-serious), outcome "recovering". The event "blood pressure increased" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: elevated. Therapeutic measures were taken as a result of pneumonia, skin exfoliation, pruritus. Clinical course: This case involved elderly female patient who had pneumonia she lost all her hair after started dupixent as well back in 2021, was in the emergency room for elevated blood pressure, medication was working for her because she had itching and peeling on the bottom of her feet while being treated with while being treated with dupilumab [Dupixentl via dupixent single dose pre filled pen and covid-19 vaccine. The patient's past medical treatment(s), vaccination(s) and family history were not provided, It was unknown if the patient had any medical history, concomitant disease or risk factor. In Oct2021, the patient started taking dupilumab Solution for injection at a strength 300mg/2ml, dose of 300 mg every other week subcutaneously for atopic dermatitis via dupixent single dose pre filled pen. On an unknown date patient stated that she was diagnosed with pneumonia (latency: unknown) (lot - 3F332A, Expiry: 30Nov2025) and on 2 antibiotics, no additional pertinent information provided. On 18Aug2024 (Latency: approximately 2 years 10 months) (with batch number:4F463A and expiry date: 31Mar2026) Patient was in the emergency room for elevated blood pressure (blood pressure increased) but wasn't admitted. Reportedly, on an unknown date (Latency: unknown) (with batch number 4F463A and expiry date: 31Mar2026) patient reported that she wasn't sure if the medication was working for her because she had itching (pruritus) (skin exfoliation) and peeling on the bottom of her feet. but they were improving some with the topicals. However, her doctor thought that dupixent was helping. Moreover, she reported that she lost all her hair (alopecia) (onset and Latency: unknown) (with batch number:4F463A and expiry date: 31Mar2026) after started dupixent as well back in 2021. She was not sure exactly when, but it grew back and no one knew if it was from dupixent or the covid vaccine. It was unknown if there were lab data/results available. Corrective treatment: unspecified antibiotics for pneumonia and topical for pruritus and skin exfoliation while not reported for rest of the events. At time of reporting, the outcome was Not Recovered for the event pneumonia; recovered on an unknown date for the event alopecia and recovering for the rest of the events. Seriousness criteria: medically significant for the event pneumonia. Company Comment (withheld) company comment dated 02Oct2024: Follow up information did not change the previous assessment. This case concerned a female patient who had pneumonia while being treated with dupilumab [Dupixent]. Based on the information received, causal role of the company suspect product cannot be denied. Further, detailed information regarding other medications, medical history, lab data, risk factors would aid in comprehensive assessment of the case.  Batch/lot number is not provided, and it cannot be obtained.