Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Lymphadenitis, Mobility decreased, Nodule, Pain assessment
Clinical narrative: Psoriatic arthritis aggravated; Lymph node inflammation; Jaw pain; Nodule; Ear infection; Mobility decreased; FACILITATED COLLECT  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 02Mar2022 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 08Sep2021 at 40 mg (40 mg, 1 in 2 wk) and second regimen (ongoing), all subcutaneous for psoriatic arthropathy. The patient's relevant medical history included: "Knee pain" (unspecified if ongoing); "Difficulty in yard work" (unspecified if ongoing); "Difficulty in opening jars" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Route Of Administration: Intramuscular), administration date: 09Feb2022, when the patient was 44-year-old, for Covid-19 immunization. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis aggravated"; LYMPHADENITIS (non-serious), outcome "not recovered", described as "Lymph node inflammation"; PAIN IN JAW (non-serious), outcome "not recovered", described as "Jaw pain"; NODULE (non-serious), outcome "recovering"; EAR INFECTION (non-serious), outcome "not recovered"; MOBILITY DECREASED (non-serious), outcome "not recovered". The patient underwent the following laboratory tests and procedures: Pain assessment: (Feb2022) 3 out of 10. The action taken for adalimumab was dosage not changed. Clinical course: The patient had 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 unknown dates, the patient experienced inflamed lymph nodes, Jaw hurting bad/jaw pain, knot in wrist and ear infection. In February 2022 (as reported), the patient experienced difficulty getting in and out of bed/tub, difficulty climbing flight of stairs and flare up of psoriatic arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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, 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.  The reporter's assessment of the causal relationship of "psoriatic arthritis aggravated", "lymph node inflammation", "jaw pain", "nodule", "ear infection" and "mobility decreased" 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 available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be 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.