Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Positron emission tomogram
Clinical narrative: occasional aches and pains in hands and feet; pain recurring; 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-163-4440006-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2015 (ongoing) (Batch/Lot number: unknown) at 40 mg (cf (40 mg, 1 in 2 week) (40mg/0.4 ml)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "A pack of cigarettes a day", start date: 1978, stop date: 1990; "Abstains from alcohol" (unspecified if ongoing); "Latex allergy manifested by rash" (unspecified if ongoing); "Latex allergy manifested by rash" (unspecified if ongoing); "Pollen allergy manifested by cough and runny nose and itchy eye" (unspecified if ongoing); "Pollen allergy manifested by cough and runny nose and itchy eye" (unspecified if ongoing); "Pollen allergy manifested by cough and runny nose and itchy eye" (unspecified if ongoing); "Pollen allergy manifested by cough and runny nose and itchy eye" (unspecified if ongoing); "Trees allergy manifested by cough and runny nose and itchy eyes" (unspecified if ongoing); "Grass allergy manifested by cough and runny nose and itchy eyes" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Methotrexate supplement/Supplement" (unspecified if ongoing). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medication(s) included: SALBUTAMOL SULFATE taken for chronic obstructive pulmonary disease; FOLIC ACID taken for vitamin supplementation; METHOTREXATE taken for rheumatoid arthritis; TRELEGY taken for chronic obstructive pulmonary disease; VITAMIN D [COLECALCIFEROL] taken for vitamin supplementation. Vaccination history included: Bnt162b2 (Daily dose: 1) First dose (1 in 1 once), Route of Admin:  1) Intra-muscular, Therapy Dates/ Duration:  1) Jan2021 - Jan2021), administration date: Jan2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "facial paralysis on the right side", "monoclonal gammopathy of undetermined significance", "sick", "occasional aches and pains in hands and feet", "tumor in right salivary gland"; Bnt162b2 (Daily dose: 1) First dose (1 in 1 once), Route of Admin:  1) Intra-muscular, Therapy Dates/ Duration:  1) Jan2021 - Jan2021), administration date: Jan2021, for COVID-19 immunization, reaction(s): "pain recurring"; Bnt162b2 (Daily dose: 1) Second dose (1 in 1 once), Route of Admin:  1) Intra-muscular, Event onset date : ??-APR-2021 00:00 , Event outcome: Recovering/Resolving), administration date: Feb2021, for COVID-19 immunization, reaction(s): "facial paralysis on the right side"; Bnt162b2 (Daily dose: 1) Second dose (1 in 1 once), Route of Admin:  1) Intra-muscular, Event onset/Stop date : ??-DEC-2020 00:00   ??-APR-2021 00:00, Event outcome: Recovered/Resolved, Treatment Received: yes), administration date: Feb2021, for COVID-19 immunization, reaction(s): "tumor in right salivary gland". The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "occasional aches and pains in hands and feet"; PAIN (medically significant), outcome "not recovered", described as "pain recurring". The patient underwent the following laboratory tests and procedures: Positron emission tomogram: (Dec2020) Unknown results. The action taken for adalimumab was dosage not changed. Clinical course: Occasional aches and pains in hands and feet, and pain recurring with (adalimumab) HUMIRA 40mg/0.4 Ml. She was still occasionally having aches and pains in hands and feet. However, she said it did not happen too often.  Reporter seriousness: Other medically important condition. Reporter Causality for HUMIRA 40mg/ 0.4ml (adalimumab): The reporter's causality for occasional aches and pains in hands and feet was not provided. Opinion is that there is no reasonable possibility that the events of sick, fatigue, occasional aches and pains in hands and feet, nausea, headache, and pain recurring are related to HUMIRA 40mg/0.4ml (adalimumab).  The reporter's assessment of the causal relationship of "occasional aches and pains in hands and feet" and "pain recurring" 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.   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, the causal relationship between the reported events and suspect drug 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate