Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Positron emission tomogram, Salivary gland neoplasm
Clinical narrative: facial paralysis on the right side; tumor in right salivary gland; 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), in Feb2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2015 (ongoing) (Batch/Lot number: unknown) at 40 mg (cf (40 mg, 1 in 2 week)), 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). Concomitant medication(s) included: ALBUTEROL [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): "monoclonal gammopathy of undetermined significance", "pain recurring", "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, when the patient was 62 years old, for Covid-19 immunization, reaction(s): "facial paralysis on the right side", "sick". The following information was reported: SALIVARY GLAND NEOPLASM (medically significant) with onset Dec2020, outcome "recovered" (Apr2021), described as "tumor in right salivary gland"; FACIAL PARALYSIS (medically significant) with onset Apr2021, outcome "recovering", described as "facial paralysis on the right side". The patient underwent the following laboratory tests and procedures: Positron emission tomogram: (Dec2020) Unknown results. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of salivary gland neoplasm.  Clinical course: On unknown dates, the patient experienced occasional aches and pain in hands and feet and pain recurring. In Dec2020, the patient experienced tumor in right salivary gland and monoclonal gammopathy of undetermined significance. In Apr2021, the patient experienced facial paralysis on the right side. In Apr2021, the tumor in right salivary gland resolved. On 18May2022, the fatigue, nausea and headache resolved. in 2022, the sick resolved. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect.Patient had a surgery on Apr2021 due to remove tumor in right salivary gland. She got sick after taking the COVID 19 booster shot on 18May2022 and next day she experienced nausea, fatigue and headache that lasted a few days. She was still occasionally having aches and pains in hands and feet. However she said It did not happen too often. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Change History included on 22Jun2022, 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, laboratory/diagnostic procedure and narrative description. The event of 'tumor in salivary gland', "monoclonal gammopathy of undetermined significance "facial paralysis on the right side" and" pain recurring" were added. The event of "patient got sick after talking COVID-19 booster shot and experienced nausea, fatigue and headache" was amended to "sick". The event of "patient got sick after talking COVID-19 booster shot and experienced nausea, fatigue and headache" was amended to "nausea". The event of "patient got sick after talking COVID-19 booster shot and experienced nausea, fatigue and headache" was amended was amended to "headache"   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. Company'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. Company'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). Causality for the events with respect to BNT162B2 was Salivary gland neoplasm Fatigue, Monoclonal gammopathy of unknown significance, Facial Paralysis. Pain in limb Causality as per reporter (Drug/Vaccine) was not reported. For events Nausea, headache and pain, Sickness Causality as per reporter (Drug/Vaccine) was probable.  The reporter's assessment of the causal relationship of "facial paralysis on the right side" and "tumor in right salivary gland" 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the reported events facial paralysis on the right side and tumor in right salivary gland  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.