Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rheumatoid arthritis, Skin exfoliation, Somnolence, Urticaria
Clinical narrative: Dry skin on the hands and ankle; Itchy skin on the hands and ankle; scaly skin on the ankle; Red skin on the ankle; metallic taste; wanting to sleep; sore arm; Sick; Rheumatoid arthritis; Welt; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4301720-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2020 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single, intramuscular, administration date Mar2020 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization; adalimumab (HUMIRA), subcutaneous (Lot number: 1158187) at cf for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis"; URTICARIA (non-serious) with onset Feb2020, outcome "unknown", described as "Welt"; DRY SKIN (non-serious), outcome "recovered", described as "Dry skin on the hands and ankle"; PRURITUS (non-serious), outcome "recovered", described as "Itchy skin on the hands and ankle"; SKIN EXFOLIATION (non-serious), outcome "recovered", described as "scaly skin on the ankle"; ERYTHEMA (non-serious), outcome "recovered", described as "Red skin on the ankle"; DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste"; SOMNOLENCE (non-serious), outcome "unknown", described as "wanting to sleep"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; ILLNESS (non-serious), outcome "unknown", described as "Sick". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    Causality for BNT162B2: The reporter considered "welt" related to bnt162b2 (reported as possible) and the reporters assessment of the causal relationship of the rest of the events (rheumatoid arthritis, itchy skin on the hands and ankle, dry skin on the hands and ankle, scaly skin on the ankle, red skin on the ankle, sore arm, sick, wanting to sleep, and metallic taste) with the suspect product 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 (adalimumab) HUMIRA: The reporter's causality for the event(s) of rheumatoid arthritis, itchy skin on the hands and ankle, dry skin on the hands and ankle, scaly skin on the ankle, red skin on the ankle, sore arm, sick, wanting to sleep, metallic taste and welt with (adalimumab) HUMIRA was not provided.  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 Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available 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.