Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bladder cancer, Feeling abnormal, Malaise, Musculoskeletal stiffness
Clinical narrative: the patient had surgery for cancer cell in bladder; feel really bad/did not feel good; Sick/did not feel good; hands hurts; hands were stiff with Pfizer BioNTech COVID-19 vaccine; back hurts; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female subject received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The subject's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2020, outcome "unknown", described as "Sick/did not feel good"; BACK PAIN (non-serious) with onset 2020, outcome "unknown", described as "back hurts"; FEELING ABNORMAL (non-serious) with onset 2020, outcome "unknown", described as "feel really bad/did not feel good"; PAIN IN EXTREMITY (non-serious) with onset 2020, outcome "unknown", described as "hands hurts"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2020, outcome "unknown", described as "hands were stiff with Pfizer BioNTech COVID-19 vaccine"; BLADDER CANCER (medically significant) with onset 2020, outcome "unknown", described as "the patient had surgery for cancer cell in bladder". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of bladder cancer. Clinical course: An elderly female with events of cancer cell in bladder, and non-serious back hurts, sick, feel really bad/did not feel good, hands hurts, and hands were stiff with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date, the patient experienced hands were stiff, hands hurts, cancer cell in bladder, feel really bad/did not feel good, Sick, back hurts. Pfizer/BioNTech covid-19 vaccine was also considered suspect. In 2020 (two years ago), the patient had surgery for cancer cell in bladder. She took covid shot (vaccine) but it made her feel really bad, sick and did not feel good afterwards. She was a day late with taking her HUMIRA injection and her hands were stiff. The reporter's causality for the events of sick, back hurts, cancer cell in bladder, feel really bad/did not feel good, hands hurts and hands were stiff with Adalimumab Solution for Injection was Reasonable Possibility.  The reporter's causality for the events of back hurts, cancer cell in bladder, feel really bad/did not feel good and hands hurts with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided. The reporter's causality for the events of sick and hands were stiff with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was reasonable possibility. Agency's opinion was that the causality for the events of sick, back hurts, feel really bad/did not feel good, hands hurts and hands were stiff with Adalimumab Solution for Injection was no reasonable possibility. Agency's opinion was that the causality for the events of cancer cell in bladder with Adalimumab Solution for Injection was not assessable. Agency's opinion was that the causality for the events of sick, back hurts, cancer cell in bladder, feel really bad/did not feel good, hands hurts and hands were stiff with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided. Agency's Alternative Etiology for back hurts with Adalimumab Solution for Injection: Most likely related to increased risk from underlying rheumatoid arthritis in this elderly patient. Agency's Alternative Etiology for feel really bad/did not feel good with Adalimumab Solution for Injection: Most likely related to covid-19 vaccine patient had taken. Agency's Alternative Etiology for Sick with Adalimumab Solution for Injection: Most likely related to covid-19 vaccine patient had taken. Agency's Alternative Etiology for hands hurts with Adalimumab Solution for Injection: Most likely related to increased risk from underlying rheumatoid arthritis. Agency's Alternative Etiology for hands were stiff with Adalimumab Solution for Injection: Most likely related to increased risk from underlying rheumatoid arthritis in this elderly patient.  The reporter's assessment of the causal relationship of "the patient had surgery for cancer cell in bladder", "feel really bad/did not feel good", "sick/did not feel good", "hands hurts", "hands were stiff with pfizer biontech covid-19 vaccine" and "back hurts" 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: As there is limited information in the case provided, the causal association between the Reported Events Bladder cancer, Feeling bad, Malaise, Hand pain, Limbs stiffness, Back pain and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.