Sex: M
Vaccine: COVID19, UNK
Symptoms: Swelling
Clinical narrative: Lack of drug effect; Covid-19; sick; coughing; sinus involvement; decreased appetite; Blood potassium decreased; Feeling of weakness; Tiredness; Lightheadedness; Cold; Back pain aggravated; Muscle pain; Swelling; Blood sugar increased; Magnesium decreased; Congestion nasal; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not available).  A 67 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; mifepristone (KORLYM), first regimen oral from 21May2019 (Batch/Lot number: unknown) to 19Jun2019 at 300 mg 1x/day, second regimen oral from 20Jun2019 (Batch/Lot number: unknown) to 24Jul2019 at 600 mg 1x/day, third regimen oral from 25Jul2021 (Batch/Lot number: unknown) to 05Oct2021 at 300 mg 1x/day and fourth regimen oral since 06Oct2021 (ongoing) (Batch/Lot number: unknown) at 600 mg 1x/day for cushing's syndrome. Relevant medical history included: "Hypertension" (ongoing); "Hyperlipidemia" (unspecified if ongoing); "Blindness" (ongoing); "Type 2 diabetes mellitus" (ongoing); "Cardiac ablation" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Dermal cyst" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "Cardiac failure congestive" (ongoing); "sebaceous cyst on forehead" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE; BUMEX; CARVEDILOL; MAGNESIUM; TRESIBA. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "Covid-19"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Lack of drug effect"; ILLNESS (non-serious), outcome "unknown", described as "sick"; COUGH (non-serious), outcome "unknown", described as "coughing"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinus involvement"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Blood potassium decreased"; ASTHENIA (non-serious), outcome "unknown", described as "Feeling of weakness"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; DIZZINESS (non-serious), outcome "unknown", described as "Lightheadedness"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Cold"; BACK PAIN (non-serious), outcome "not recovered", described as "Back pain aggravated"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; SWELLING (non-serious), outcome "recovered", described as "Swelling"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Blood sugar increased"; BLOOD MAGNESIUM DECREASED (non-serious), outcome "unknown", described as "Magnesium decreased"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "Congestion nasal". The patient underwent the following laboratory tests and procedures: blood glucose: (unspecified date) increased; blood magnesium: (Nov2021) 1.9; blood potassium: (unspecified date) 2.8; sars-cov-2 test: (unspecified date) positive. The action taken for mifepristone was dosage not changed. Therapeutic measures were taken as a result of illness, cough, sinus disorder, nasopharyngitis, back pain, myalgia, blood magnesium decreased, nasal congestion. Patient stated his back pain (AE previously reported) was worsening and now he has pain in his whole lower back. Patient was experiencing some muscle pain but no swelling unless he falls asleep on his arm and then it resolves after he wakes up. The patient's physician stopped his Spironolactone because of return of gynecomastia (occurred pre-Korlym and also previously reported) but he reported having discomfort this time that he didn't have previously. Eplerenone was ordered, but not started yet. At the time of this report, therapy with Korlym was ongoing and the outcome of events gynecomastia and discomfort were not reported. No additional information was provided.  The reporter's assessment of the causal relationship for reported events with the suspect product 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. .,Linked Report(s) : US-PFIZER_INC-202200321723 same patient, different drug/event.