Age: 62.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Influenza like illness, Osteoarthritis, Pulmonary fibrosis, Rheumatoid arthritis, Shoulder arthroplasty
Clinical narrative: Fibroids in lungs; Rheumatoid arthritis flare up; Shoulder replacement; Osteoarthritis; Flu like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4194111-00.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single and intramuscular, administration date 20Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM), first regimen details not provided (Batch/Lot number: unknown) and second regimen (Batch/Lot number: unknown) at three times a week; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1154253) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: PULMONARY FIBROSIS (medically significant), outcome "not recovered", described as "Fibroids in lungs"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; SHOULDER ARTHROPLASTY (medically significant), outcome "recovered", described as "Shoulder replacement"; OSTEOARTHRITIS (non-serious), outcome "not recovered", described as "Osteoarthritis"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms". The action taken for adalimumab was dosage not changed. The action taken for methotrexate sodium was dosage permanently withdrawn. Therapeutic measures were taken as a result of shoulder arthroplasty. Clinical course: On unknown dates, the patient experienced right shoulder replaced, fibroids in lungs, osteoarthritis, flu like symptoms and rheumatoid arthritis flare up. On an unknown date, right shoulder replaced resolved. The physician reduced methotrexate to three times a week and stopped because it might be causing fibroids in lungs.  The reporter's causality for the events of right shoulder replaced, fibroids in lungs and rheumatoid arthritis flare up with HUMIRA (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of osteoarthritis and flu like symptoms with HUMIRA (ADALIMUMAB) was no reasonable possibility.   The reporter's causality for the events of right shoulder replaced, fibroids in lungs, osteoarthritis and rheumatoid arthritis flare up with PFIZER BIONTECH COVID-19 VACCINE was not reported. The reporter's causality for the event of flu like symptoms with PFIZER BIONTECH COVID-19 VACCINE was Possible.  The reporter's causality for the events of right shoulder replaced, osteoarthritis, flu like symptoms and rheumatoid arthritis flare up with METHOTREXATE was not reported. The reporter's causality for the event of Lung fibrosis with METHOTREXATE was Probable.  The reporter's assessment of the causal relationship of some events with the suspect products 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: Reported event flu like syndrome is assessed as related to both suspect drugs methotrexate and BNT162B2 based on drug safety profile. Event pulmonary fibrosis is considered  related to methotrexate as per product safety profile but unrelated to the covid19 vaccine.  Other events are considered intercurrent medical condition and are therefore not related to both products. Case to be re-assessed upon receipt of new information. 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.