Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypergammaglobulinaemia benign monoclonal, Pain, Pain in extremity, Positron emission tomogram, Salivary gland neoplasm
Clinical narrative: tumor in right salivary gland; monoclonal gammopathy of undetermined significance; 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 63-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2015 (ongoing) (Batch/Lot number: unknown) at 40 mL (40 ml (40 mg (40mg/0.4ml(40 milligram, solution for injection in pre-filled syringe))), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "A pack of cigatrattes  a Day", start date: 1978, stop date: 1990, notes: A pack of cigarettes a day (1978 - 1990); "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); "Methotrexate supplement/ supplement" (unspecified if ongoing); "Grass allergy manifested by cough and runny nose and itchy eyes" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Trees allergy manifested by cough and runny nose and itchy eyes" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis; TRELEGY ELLIPTA taken for chronic obstructive pulmonary disease; ALBUTEROL [SALBUTAMOL SULFATE] taken for chronic obstructive pulmonary disease; FOLIC ACID taken for vitamin supplementation; VITAMIN D [VITAMIN D NOS] taken for vitamin supplementation. The following information was reported: HYPERGAMMAGLOBULINAEMIA BENIGN MONOCLONAL (medically significant) with onset Dec2020, outcome "not recovered", described as "monoclonal gammopathy of undetermined significance"; SALIVARY GLAND NEOPLASM (medically significant) with onset Dec2020, outcome "recovered" (Apr2021), described as "tumor in right salivary gland"; 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 unknown.  The reporter's assessment of the causal relationship of "facial paralysis on the right side", "tumor in right salivary gland", "monoclonal gammopathy of undetermined significance" and "occasional aches and pains in hands and feet" 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 "sick" and "pain recurring" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Causality for Humira 40mg/ 0.4ml (Adalimumab): The reporter's causality for the event of tumor in right salivary gland, sick, monoclonal gammopathy of undetermined significance, facial paralysis on the right side and occasional aches and pains in hands and feet was not provided. the reporter causality for the event of fatigue, nausea, headache and pain recurring with humira 40 mg/0.4ml (adalimumab) was no reasonable possibility. (Name)'s opinion is that the events of tumor in right salivary gland, monoclonal gammopathy of undetermined significance and facial paralysis on the right side are not assessable. (Name)'s 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).; Sender's Comments: Based on the nature of the events "facial paralysis on the right side", "tumor in right salivary gland", "monoclonal gammopathy of undetermined significance", "occasional aches and pains in hands and feet" , "sick" and "pain recurring", 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.