Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Investigation, Nodule, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Thyroid nodule; Dry skin; Painful nodule; Localized erythema;   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-163-4377018-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "Rheumatoid arthritis flare up"; THYROID MASS (non-serious), outcome "not recovered", described as "Thyroid nodule"; DRY SKIN (non-serious), outcome "not recovered"; NODULE (non-serious), outcome "recovering", described as "Painful nodule"; ERYTHEMA (non-serious), outcome "unknown", described as "Localized erythema". The patient underwent the following laboratory tests and procedures: Test: Five nodules on thyroid; Scan thyroid gland: Unknown Results. The action taken for adalimumab was unknown. Clinical course: Events of non-serious five nodules on thyroid/five nozzles in thyroids, dry skin, could not move or sleep due to painful nodules, rheumatoid arthritis/had flare up/affected left jaw and arm/rheumatoid arthritis flare up not as bad as before and finger and hand red at times with humira (adalimumab). 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 five nodules on thyroid/five nozzles in thyroids, dry skin, rheumatoid arthritis/had flare up/affected left jaw and arm/rheumatoid arthritis flare up not as bad as before and finger and hand red at times was not provided. The reporter's causality for the event(s) of could not move or sleep due to painful nodules with humira(adalimumab) was a reasonable possibility. The reporter considered "rheumatoid arthritis flare up", "thyroid nodule", "dry skin", "painful nodule" and "localized erythema" related to BNT162b2.  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 nature of the events Rheumatoid arthritis flare up ,dry skin,  thyroid nodule, erythema, painful nodule a causal relation between the reported events and the administration of the vaccine 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 RAs, Ethics Committees, and Investigators, as appropriate.