Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Investigation, Lymphadenitis, Mobility decreased, Nodule
Clinical narrative: Psoriatic arthritis aggravated; Mobility decreased; Lymph node inflammation; Jaw pain; Nodule; Ear infection; 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-163-4277625-00.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2022 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 08Sep2021 (Batch/Lot number: unknown) at 40 mg (40 mg (40 mg, 1 in 2 wk)) and second regimen (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg (40 mg, 1 in 2 wk)), all subcutaneous for rheumatoid arthritis, psoriatic arthropathy. The patient's relevant medical history included: "Knee pain" (unspecified if ongoing); "Difficulty in opening jars" (unspecified if ongoing); "Difficulty in yard work" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: MOBILITY DECREASED (non-serious) with onset Feb2022, outcome "not recovered"; PSORIATIC ARTHROPATHY (medically significant) with onset Feb2022, outcome "not recovered", described as "Psoriatic arthritis aggravated"; EAR INFECTION (non-serious) with onset 2022, outcome "not recovered"; PAIN IN JAW (non-serious) with onset 2022, outcome "not recovered", described as "Jaw pain"; LYMPHADENITIS (non-serious) with onset 2022, outcome "not recovered", described as "Lymph node inflammation"; NODULE (non-serious) with onset 2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: pain score (1-10): (Feb2022) 3; (Feb2022) Unknown results. The action taken for adalimumab was dosage not changed.  Clinical course: Patient experienced events of non-serious, difficulty getting in and out of bed/tub, difficulty climbing flight of stairs, inflamed lymph nodes, jaw hurting bad/jaw pain, knot in wrist, ear infection and flare up of Psoriatic arthritis with Humira (Adalimumab). On an unknown date, the patient experienced inflamed lymph nodes, jaw hurting bad/jaw pain, knot in wrist and ear infection. In Feb2022, the patient experienced difficulty getting in and out of bed/tub, difficulty climbing flight of stairs and flare up of psoriatic arthritis. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Patient received Pfizer Biontech Covid-19 Vaccine, dose 2 on 02Mar2022 and dose 3 (BOOSTER) on 19Mar2022, all administered intramuscular.  The reporter's assessment of the causal relationship of "psoriatic arthritis aggravated", "mobility decreased", "lymph node inflammation", "jaw pain", "nodule" and "ear infection" 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.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of difficulty getting in and out of Bed/Tub, difficulty climbing flight of stairs, Inflamed lymph nodes, jaw hurting bad/jaw pain, knot in wrist, ear infection and flare up of Psoriatic arthritis was not provided. The reporter's Causality for the event(s) of knot in wrist with Humira (Adalimumab) was a reasonable possibility.  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 available reported information, the causal association between the events psoriatic arthropathy, mobility decreased, lymphadenitis, pain in jaw, nodule and ear infection and the suspect drug BNT162B2 cannot be excluded.