Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Trigger finger
Clinical narrative: Psoriatic arthritis aggravated; Skin mass; Muscle atrophy; Pain localized; Nerve pain; Trigger finger; Flu like symptoms; 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-163-4454382-00.  A 59-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 20Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 05Feb2017 (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Flu like symptoms"; PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "Psoriatic arthritis aggravated"; SKIN MASS (non-serious), outcome "not recovered"; MUSCLE ATROPHY (non-serious), outcome "not recovered"; PAIN (non-serious), outcome "not recovered", described as "Pain localized"; NEURALGIA (non-serious), outcome "not recovered", described as "Nerve pain"; TRIGGER FINGER (non-serious), outcome "unknown". On unknown dates, the patient experienced growth of pea size lump on left wrist/painful to the touch, triggered finger on right hand, muscular atrophy based on left thumb pad, psoriatic arthritis fare up, flu like symptoms and nerve pain with HUMIRA (adalimumab). In 2021, the patient experienced flu like symptoms. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. 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 growth of pea size lump on left wrist/painful to the touch unknown onset, triggered finger on right hand, muscular atrophy based on left thumb pad, flu like symptoms, growth of pea size lump on left wrist/painful to the touch unknown onset and nerve pain with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of psoriatic arthritis fare up with HUMIRA(ADALIMUMAB) was a reasonable possibility. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "psoriatic arthritis aggravated", "skin mass", "muscle atrophy", "flu like symptoms", "pain localized", "nerve pain" and "trigger finger" 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The causal association cannot be excluded between the reported events and suspect vaccine use. 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 AE. 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.