Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal disorder, Stomatitis, Systemic lupus erythematosus, Thyroid mass
Clinical narrative: thyroid masses/thyroid nodules got bigger and lupus; Rheumatoid arthritis flare up; thyroid masses/thyroid nodules got bigger and lupus; spinal issues; coughing up blood; blisters and sores in mouth; Sores in mouth; 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-163-4451639-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, on 25May2021 as dose 2, single (Batch/Lot number: unknown) and on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), 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 included: "urinary tract infections" (unspecified if ongoing); "could not get out of bed in the morning" (unspecified if ongoing); "pain in hands" (unspecified if ongoing); "rheumatoid arthritis", start date: 2019 (unspecified if ongoing); "She had five surgeries" (unspecified if ongoing), notes: She had five surgeries; "She had 15 biopsies" (unspecified if ongoing), notes: She had 15 biopsies; "Bad reaction to other medications" (unspecified if ongoing), notes: Bad reaction to other medications. The patient's concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "recovering", RHEUMATOID ARTHRITIS (medically significant), outcome "recovering" and all described as "Rheumatoid arthritis flare up"; THYROID MASS (medically significant), outcome "unknown", described as " thyroid masses/thyroid nodules got bigger and lupus"; SPINAL DISORDER (medically significant), outcome "recovering", described as "spinal issues"; HAEMOPTYSIS (medically significant), outcome "unknown", described as "coughing up blood"; ORAL MUCOSAL BLISTERING (medically significant), outcome "unknown", described as "blisters and sores in mouth"; STOMATITIS (medically significant), outcome "unknown", described as "Sores in mouth"; INFECTION (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy: Not malignant. The action taken for adalimumab was unknown. Clinical information: consumer of an adult female with events of thyroid masses/thyroid nodules got bigger and lupus and non-serious spinal issues, coughing up blood, blisters and sores in mouth, COVID second dose threw into rheumatoid arthritis flare up and mixed connective tissue caused infections with Humira (Adalimumab). On unknown dates, the patient experienced thyroid masses/thyroid nodules got bigger, lupus, spinal issues, Coughing up blood, blisters and sores in mouth, COVID second dose threw into rheumatoid arthritis flare up and mixed connective tissue caused infections. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. The patient had onset of lupus and spinal issues whole life. She was diagnosed with rheumatoid arthritis in 2019. She had to stop and start all over every time. Since Humira, she could get out of bed in the morning better and did not have to jumpstart. Thyroid nodules got bigger since she began Humira. The previous thyroid masses were removed. Pain in hands were better as of 28Jun2022. She could identify where pain came from. She had five surgeries. She had 15 biopsies. 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 thyroid masses/thyroid nodules got bigger, lupus, spinal issues, coughing up blood, blisters and sores in mouth unknown onset, blisters and sores in mouth unknown onset, COVID second dose threw into rheumatoid arthritis flare up and mixed connective tissue caused infections was not provided. Opinion is that the events of thyroid masses/thyroid nodules got bigger, coughing up blood, blisters and sores in mouth unknown onset, blisters and sores in mouth unknown onset and mixed connective tissue caused infections are not assessable. Opinion is that there was no reasonable possibility that the events of lupus, spinal issues and COVID second dose threw into rheumatoid arthritis flare up are related to Humira (Adalimumab).  The reporter's assessment of the causal relationship of " thyroid masses/thyroid nodules got bigger and lupus", "spinal issues", "coughing up blood", "blisters and sores in mouth", "sores in mouth" and "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. The reporter considered "rheumatoid arthritis flare up" 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 information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . 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.