Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Nausea, Pain
Clinical narrative: occasional aches and pains in hands and feet; pain recurring; nausea; headache; fatigue; sickness; 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 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), in 2015 (ongoing) as 40 mg (1 in 2 wk) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "pollen allergy" (unspecified if ongoing), notes: Pollen allergy manifested by cough and runny nose and itchy eye; "trees allergy" (unspecified if ongoing), notes: Trees allergy manifested by cough and runny nose and itchy eyes; "Grass allergy" (unspecified if ongoing), notes: Grass allergy manifested by cough and runny nose and itchy eyes; "Latex allergy" (unspecified if ongoing), notes: Latex allergy manifested by rash; "A pack of cigarettes a day", start date: 1978, stop date: 1990; "Abstains from alcohol" (unspecified if ongoing); "Supplement" (unspecified if ongoing); "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Salivary gland neoplasm", start date: Dec2020, stop date: Apr2021, notes: Recovered/resolved; "Monoclonal gammopathy of unknown significance ", start date: Dec2020 (ongoing), notes: not recovered/not resolved. Concomitant medication(s) included: METHOTREXATE taken for rheumatoid arthritis; TRELEGY taken for chronic obstructive pulmonary disease; ALBUTEROL [SALBUTAMOL SULFATE] taken for chronic obstructive pulmonary disease; FOLIC ACID taken for supplementation therapy; VITAMIN D [COLECALCIFEROL] taken for supplementation therapy. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), Route of Administration: Intra-muscular), administration date: 08Oct2021, for COVID-19 Immunization; Bnt162b2 (DOSE 1, Route of Administration: Intra-muscular), administration date: Jan2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, Route of Administration: Intra-muscular, reaction started on April 2021, improved), administration date: Feb2021, for COVID-19 Immunization, reaction(s): "Facial paralysis ". The following information was reported: ILLNESS (medically significant) with onset 18May2022, outcome "recovered" (2022), described as "sickness"; FATIGUE (medically significant) with onset 19May2022, outcome "recovered" (24May2022); HEADACHE (medically significant) with onset 19May2022, outcome "recovered" (24May2022); NAUSEA (medically significant) with onset 19May2022, outcome "recovered" (24May2022); 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) Monoclonal gammopathy of undetermined significance. The action taken for adalimumab was dosage not changed. Course of events: Patient had events of tumor in right salivary gland and non-serious sick, fatigue, monoclonal gammopathy of undetermined significance, facial paralysis of the right side, occasional aches and pains in hands and feet, nausea, headache and pain recurring with Humira 40mg/0.4 Ml (Adalimumab). 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. 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). 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.  Change History 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" .  The reporter's assessment of the causal relationship of "sickness", "fatigue", "occasional aches and pains in hands and feet", "nausea", "headache" 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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event sickness", "fatigue", "occasional aches and pains in hands and feet", "nausea", "headache" and "pain recurring 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.