Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep apnoea syndrome, Systemic lupus erythematosus, Trichorrhexis
Clinical narrative: Trichorrhexis; Nodule on finger; Rheumatoid nodule; Sleep apnea; Lupus syndrome; Rheumatoid arthritis flare up; Hips osteoarthritis; Vaccination related malaise; MARKETING PROGRAMME NAME IS NOT AVILABLE This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4163553-00 (Agency).  A 74-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EN9581), on 20Feb2021 as dose 2, single (Lot number: EN6198) and on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 20Jul2021 as citrate free (40 mg, 1 in 2 wk) (Lot number: 1151783) and on 22Oct2021 (ongoing) as citrate free (40 mg, 1 in 2 wk) (Lot number: 1160173), all subcutaneous for sle arthritis, osteoarthritis. The patient's relevant medical history included: "Left hip replacement", start date: 2016 (unspecified if ongoing), notes: Left hip replacement (started 2016); "Covid-19", start date: Oct2019, stop date: Dec2019, notes: Covid-19 (Oct2019 - Dec2019); "bone on bone right hip", start date: Jan2021 (unspecified if ongoing), notes: bone on bone right hip (Started Jan2021); "Non smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Insulin resistance" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE taken for rheumatoid arthritis; SULFASALAZINE taken for rheumatoid arthritis; MELOXICAM taken for rheumatoid arthritis; LISINOPRIL taken for hypertension. Past drug history included: Codeine, reaction(s): "Codeine cough syrup allergy manifested by black spots"; Codeine, reaction(s): "Codeine cough syrup allergy manifested by black spots". The following information was reported: IMMUNISATION REACTION (non-serious) with onset 2021, outcome "unknown", described as "Vaccination related malaise"; OSTEOARTHRITIS (non-serious) with onset Sep2021, outcome "recovered" (Jan2022), described as "Hips osteoarthritis"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "not recovered", described as "Lupus syndrome"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; TRICHORRHEXIS (non-serious), outcome "not recovered"; NODULE (non-serious), outcome "recovering", described as "Nodule on finger"; RHEUMATOID NODULE (non-serious), outcome "not recovered"; SLEEP APNOEA SYNDROME (non-serious), outcome "not recovered", described as "Sleep apnea". The action taken for adalimumab was unknown. events of bone on bone right hip and lupus with symptoms of hair breaking and brittle and non-serious lupus with symptoms of hair breaking and brittle, two Nodule pop up on pointer finger/joint Nodules on knuckles, Sleep apnea, Rheumatoid arthritis flare up and Pfizer Vaccination first dose caused feeling of illness with Humira 40MG/0.4ML (Adalimumab). In 2021, the patient experienced Pfizer Vaccination first dose caused feeling of illness. In Sep2021, the patient experienced bone on bone right hip.  In Jan2021, the patient was diagnosed with bone on bone on her right hip before she started taking Humira. She noted that she was treated with unknown steroid injection that did not help and her condition worsened over time. In Sep2021, she had bone on bone on right hip and her physician decided to proceed with the right hip replacement surgery on 20Sep2021 and had to be off Humira four weeks before and four weeks after. She was admitted in the hospital for a couple of days after surgery and attended physical therapy for seven days after discharge. She had multiple pre surgery test done to her, but she was unable to remember the names of those test as well as the results. The outcome for hip surgery was reported as recovered with causality probable. She had the condition of lupus with symptoms of hair breaking and brittle, sleep apnea and flare up of rheumatoid arthritis. She had nodules on knuckles. She had reaction to first dose of Pfizer vaccine which caused feeling of illness. It was unknown if she was enrolled in a Covid-19 Vaccine Trial.   The patient's past medications include: Causality for Humira 40MG/0.4ML (Adalimumab) The reporter's causality for the event(s) of bone on her right hip, lupus with symptoms of hair breaking and brittle unknown onset, lupus with symptoms hair breaking and brittle unknown onset, Sleep apnea, Rheumatoid arthritis flare up and Pfizer Vaccination first dose caused feeling of illness with Humira 40MG/0.4ML (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of two Nodule pop up on pointer finger/joint Nodules on knuckles unknown onset and two Nodule pop up on pointer finger/joint Nodules on knuckles unknown onset with Humira 40MG/0.4ML (Adalimumab) was a reasonable possibility. Agency's opinion is that there is no reasonable possibility that the events of bone on bone right hip and lupus with symptoms of hair breaking and brittle unknown onset, lupus with symptoms of hair breaking and brittle unknown unknown onset, two Nodule pop up on pointer finger/joint Nodules on knuckles unknown onset, two Nodule pop up on pointer finger/joint Nodules on knuckles unknown onset, Sleep apnea, Rheumatoid arthritis flare up and Pfizer Vaccination first dose caused feeling of illness with Humira 40MG/0.4ML (Adalimumab). Change History On 05Jan2022, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, past drug information and narrative description. The event of "bone on bone right hip" was added. The event of "hip replacement " was removed. On 12May2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The event of "two Nodule pop up on pointer finger" was added. On 17May2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of lupus with symptoms of hair breaking and brittle", "lupus with symptoms of hair breaking and brittle", "Sleep apnea, Rheumatoid arthritis flare up and Pfizer Vaccination first dose caused feeling of illness" were added. The reporter's assessment of the causal relationship of "lupus syndrome", "rheumatoid arthritis flare up", "hips osteoarthritis", "trichorrhexis", "nodule on finger", "rheumatoid nodule" and "sleep apnea" 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 "vaccination related malaise" 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 provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.