Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Knee arthroplasty, Pain, Rash, Vaccination site pain
Clinical narrative: Cataracts; Her eyes were blurry and cloudier (Vision blurred); Injection site pain (burning with the injections); Breakouts on her hands (Rash); Knee arthroplasty; Bladder disorder; Could not open or pick up anything (Grip strength decreased); Pain; Pain in stomach; the pain and burning was with every injection; Exposure to SARS-CoV-2; Red welts at the injection site (Urticaria); DUPIXENT MY WAY  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA106282 (Sanofi).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), on 22Dec2021 as 300 mg (every other week) (Batch/Lot number: unknown, Expiration Date: 31Jan2024) subcutaneous for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE URTICARIA (non-serious) with onset Dec2021, outcome "unknown", described as "Red welts at the injection site (Urticaria)"; EXPOSURE TO SARS-COV-2 (non-serious) with onset Jun2022, outcome "unknown"; CATARACT (medically significant), outcome "not recovered", described as "Cataracts"; VISION BLURRED (medically significant), outcome "recovering", described as "Her eyes were blurry and cloudier (Vision blurred)"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Injection site pain (burning with the injections)"; RASH (non-serious), outcome "recovered", described as "Breakouts on her hands (Rash)"; KNEE ARTHROPLASTY (non-serious), outcome "recovered"; BLADDER DISORDER (non-serious), outcome "unknown"; GRIP STRENGTH DECREASED (non-serious), outcome "unknown", described as "Could not open or pick up anything (Grip strength decreased)"; PAIN (non-serious), outcome "unknown"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Pain in stomach"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the pain and burning was with every injection". The events "her eyes were blurry and cloudier (vision blurred)" required physician office visit. The action taken for dupilumab was dosage permanently withdrawn. Clinical course: The patient experienced cataracts, pain and burning with every injections, lot of pain in the stomach. The consumer had red welts at the injection site and it hurt so bad. Having breakouts on her hands, rash flare up, two knee replacements hands, was having a procedure called coaptite injection into bladder that was supposed to bulk up the bladder and the urethral tissue, she had leakage. Covid exposure and hands were splitting open and she could not open or pick up anything while being treated with dupilumab (Dupixent) and with the use of medical device dupixent single dose pre-filled pen and after using tozinameran (Pfizer biontech covid-19 vaccine). On 22Dec2021, the patient started taking loading dose of dupilumab injection with the use of medical device dupixent single dose pre-filled pen of strength: 300 mg/2ml at an initial loading dose of 600 mg once subcutaneous followed by a maintenance dose 300 mg every other week. Patient stated when nurse administered, some of the medication leaked down stomach and was enough to make underwear wet. She also said that she was having a rash flare up due to possibly of not getting the full dose. Counseled on other injection sites, doctor denied to do outer upper arm and she had two knee replacements (knee arthroplasty), so they refrained from thighs, scheduled to have a cataract removal surgery on 15Jun2022, going for a preliminary procedure on 06Jun2022 and unknown which eye the cataract was from. Events were ongoing, At the time of this report, Dupixent was continued. Patient stated that the week she was having a procedure called coaptite injection into bladder that is supposed to bulk up the bladder and the urethral tissue, she had leakage (bladder disorder). She did have a missed dose 2 weeks ago (on an unknown date In Jun2022) due to Covid exposure (Exposure to SARS-CoV -2).   The reporter's assessment of the causal relationship of "cataracts", "her eyes were blurry and cloudier (vision blurred)", "bladder disorder", "exposure to sars-cov-2", "could not open or pick up anything (grip strength decreased)", "pain", "pain in stomach" and "the pain and burning was with every injection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "injection site pain (burning with the injections)", "red welts at the injection site (urticaria)", "breakouts on her hands (rash)" and "knee arthroplasty" related to BNT162b2.  Reporter causality for Dupixent: Related for Urticaria, Injection site pain, Rash and Knee arthroplasty with both drug and device and not reported for other events with both drug and device. Company causality: Reportable for injection site pain with device and not reportable for other events with both drug and device.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.