Sex: U
Vaccine: COVID19, UNK
Symptoms: Influenza like illness, Pain, Peripheral swelling, Spondylitis
Clinical narrative: Generalized aching; Flu like symptoms; Peripheral swelling; Back arthritis; This is a solicited report received from contactable reporter (Consumer) for a Pfizer sponsored program (not available). The reporter is the patient.  A 50-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPONDYLITIS (medically significant) with onset Sep2021, outcome "recovered" (2021), described as "Back arthritis"; PAIN (non-serious), outcome "recovered", described as "Generalized aching"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Peripheral swelling"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms". Clinical details: On unknown dates, the patient experienced flu like symptoms and body aches and swelling of fingers and toes. In Sep2021, the patient experienced back surgery due to laminitis. In 2021, the back surgery due to laminitis resolved. On an unknown date, flu like symptoms and body aches resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of spondylitis. The reporter's causality for the event of back surgery due to laminitis, flu like symptoms and body aches unknown onset, swelling of fingers and toes and flu like symptoms and body aches unknown onset with Humira (Adalimumab) was no reasonable possibility. The reporting company's opinion is that there is no reasonable possibility that the events of back surgery due to laminitis, flu like symptoms and body aches unknown onset, swelling of fingers and toes and flu like symptoms and body aches unknown onset are related to Humira (Adalimumab).  The reporter's causality for the events of Generalized aching, Flu like symptoms with BNT162B2 was reasonable possibility.  The reporter's assessment of the causal relationship of the events Back arthritis, Peripheral swelling with the suspect product 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 possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate