Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Echocardiogram, General physical health deterioration, Heart rate, Heart rate decreased
Clinical narrative: feet swelling/feet is periodically swelling; He feels his health is declining; his pulse oxygen could be in 50s during this; pluse decreases; O2 saturation decreased; blocked nasal passages; nasal blockage or some inflammation in nose; kidney stones; shortness of breath/short of breath; 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): 2022SA079556.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 08Sep2021 (Batch/Lot number: unknown) at 400 mg (400 mg, 1 x), subcutaneous and second regimen (Batch/Lot number: unknown) at 300 mg (300 mg, (qo w) every other week) for asthma. The patient's relevant medical history included: "Nasal disorder" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious) with onset 20Jan2022, outcome "unknown", described as "shortness of breath/short of breath"; NEPHROLITHIASIS (medically significant) with onset 09Mar2022, outcome "not recovered", described as "kidney stones"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "feet swelling/feet is periodically swelling"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "not recovered", described as "He feels his health is declining"; OXYGEN SATURATION ABNORMAL (non-serious), outcome "not recovered", described as "his pulse oxygen could be in 50s during this"; HEART RATE DECREASED (non-serious), outcome "not recovered", described as "pluse decreases"; OXYGEN SATURATION DECREASED (non-serious), outcome "not recovered", described as "O2 saturation decreased"; SINONASAL OBSTRUCTION (non-serious), outcome "unknown", described as "blocked nasal passages"; NASAL INFLAMMATION (non-serious), outcome "not recovered", described as "nasal blockage or some inflammation in nose". The patient underwent the following laboratory tests and procedures: Echocardiogram: (unspecified date) Heart and lungs are good; Heart rate: (unspecified date) Decreases; Oxygen saturation: (unspecified date) Decreases; (unspecified date) 50s during episodes; SARS-CoV-2 test: (07Mar2022) unknown results; Ultrasound scan: (unspecified date) good. The action taken for dupilumab was dosage not changed. Therapeutic measures were taken as a result of nephrolithiasis, dyspnoea, urinary tract infection, sinonasal obstruction.  The reporter's assessment of the causal relationship of "kidney stones", "shortness of breath/short of breath", "feet swelling/feet is periodically swelling", "utis/has battled with uti", "he feels his health is declining", "his pulse oxygen could be in 50s during this", "pluse decreases", "o2 saturation decreased", "blocked nasal passages" and "nasal blockage or some inflammation in nose" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.