Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Drug ineffective, Dry throat, Dysphonia
Clinical narrative: Mobility decreased; Joint range of motion decreased; head congestion worsened, hoarse voice worsened, low grade fever worsened, difficulty putting on socks worsened and difficulty to get up off the floor without any help from lying on back worsened; Dry throat; Sinus congestion; Hoarse voice; Fever; COVID-19 virus test positive; COVID-19 virus test positive; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4464850-00 (Company).  A 57-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 23Dec2021 (Batch/Lot number: unknown) at 40 mg (40 mg,1 in 14 d) and second regimen (Batch/Lot number: unknown) till 23Jun2022 at citrate free, all subcutaneous for rheumatoid arthritis, crohn's disease, ankylosing spondylitis. The patient's relevant medical history included: "Difficulty to bend forward from waist to pick up pen from floor without aid/get out of armless chair" (unspecified if ongoing); "Difficulty to do physically demanding activities or full days activities. Difficulty to get up off the floor without any help from lying on back" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "recovered" (Jul2022) and all described as "COVID-19 virus test positive"; DRY THROAT (non-serious) with onset 10Jul2022, outcome "recovering"; PYREXIA (non-serious) with onset 10Jul2022, outcome "unknown", described as "Fever"; DYSPHONIA (non-serious) with onset 10Jul2022, outcome "unknown", described as "Hoarse voice"; SINUS CONGESTION (non-serious) with onset 10Jul2022, outcome "unknown"; MOBILITY DECREASED (non-serious), outcome "unknown"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "head congestion worsened, hoarse voice worsened, low grade fever worsened, difficulty putting on socks worsened and difficulty to get up off the floor without any help from lying on back worsened". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive; (Jul2022) Negative. The action taken for adalimumab was dosage permanently withdrawn on 23Jun2022.  Clinical course: Floor without aid/get out of armless chair without using hands or any help/climb 12 to 15 steps without handrail/difficulty putting on socks and difficulty to get up off the floor without any help from lying on back.  The reporter's assessment of the causal relationship of "covid-19 virus test positive", "mobility decreased", "dry throat", "sinus congestion", "hoarse voice", "fever", "joint range of motion decreased" and "head congestion worsened, hoarse voice worsened, low grade fever worsened, difficulty putting on socks worsened and difficulty to get up off the floor without any help from lying on back worsened" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.