Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Cartilage injury, Gait disturbance, Influenza like illness, Vaccination site pain
Clinical narrative: experienced hip arthritis; soreness arm at injection site after vaccinations; tear in labrum; trouble walking; flu like symptoms after second shot; FACILITATED COLLECT  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): 22K-163-4257413-00 (AbbVie).  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, 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. Vaccination history included: Bnt162b2 (Route of Administration: Subcutaneous), for Covid-19 Immunization. The following information was reported: ARTHRITIS (medically significant), outcome "recovering", described as "experienced hip arthritis"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "soreness arm at injection site after vaccinations"; CARTILAGE INJURY (non-serious), outcome "recovering", described as "tear in labrum"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "trouble walking"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms after second shot". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of arthritis.  Clinical course: An adult female with events of hip arthritis and non-serious soreness arm at injection site after vaccinations, tear in labrum, trouble walking and flu like symptoms after second shot with HUMIRA (ADALIMUMAB). On unknown dates, the patient experienced hip arthritis, soreness arm at injection site after vaccinations, tear in labrum, trouble walking and flu like symptoms after second shot. On an unknown date, soreness arm at injection site after vaccinations resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.  Patient underwent hip replacement surgery due to arthritis. Patient experienced tear in labrum and trouble walking. On an unknown date patient observed soreness in arm at injection site after vaccinations and flu like symptoms experience after 2nd shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of hip arthritis and soreness arm at injection site after vaccinations with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of tear in labrem, trouble walking and flu like symptoms after second shot was not provided.  AbbVie's opinion is that there is no reasonable possibility that the events of hip arthritis, soreness arm at injection site after vaccinations, tear in labrum, trouble walking and flu like symptoms after second shot are related to HUMIRA (ADALIMUMAB).  The reporter's causality for the event(s) with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) was not Related.  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 and the suspect drug BNT162B2 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 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.