Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Tendon disorder, Therapeutic response shortened, Vaccination site pain
Clinical narrative: ankylosing spondylitis flare up; vaccine caused sore arm; memory issues; issues with mobility; depression; bad mood; tight tendons; bladder infection; humira wore of around the eight day after injection with humira; 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-163-4472185-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 27Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 29Sep2021 (ongoing) (Lot number: 1160839) at unk (citrate free) and second regimen since 02Jan2014 (Lot number: 1160839) at unk (citrate free), all subcutaneous for ankylosing spondylitis; paracetamol (TYLENOL), (Batch/Lot number: unknown) for product used for unknown indication. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "ankylosing spondylitis flare up"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "vaccine caused sore arm"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "memory issues"; MOBILITY DECREASED (non-serious), outcome "not recovered", described as "issues with mobility"; DEPRESSION (non-serious), outcome "not recovered"; MOOD ALTERED (non-serious), outcome "unknown", described as "bad mood"; TENDON DISORDER (non-serious), outcome "not recovered", described as "tight tendons"; CYSTITIS (non-serious), outcome "recovering", described as "bladder infection"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "not recovered", described as "humira wore of around the eight day after injection with humira". The action taken for adalimumab was dosage not changed; for paracetamol was unknown.  The reporter's assessment of the causal relationship of "ankylosing spondylitis flare up", "memory issues", "issues with mobility", "depression", "bad mood", "tight tendons", "bladder infection" and "humira wore of around the eight day after injection with humira" 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. The reporter considered "vaccine caused sore arm" related to BNT162b2.  Clinical course: Solicited report by a consumer of an adult female with events of non-serious Vaccine Caused Sore Arm, Memory Issues, Issues with Mobility, Depression, Bad Mood, Tight Tendons, Ankylosing Spondylitis Flare Up, Bladder Infection and Humira Wore of Around the Eight Day After Injection with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced Vaccine Caused Sore Arm, Memory Issues, Issues with Mobility, Depression, Bad Mood, Tight Tendons, Ankylosing Spondylitis Flare Up, Bladder Infection and Humira Wore of Around the Eight Day After Injection. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) and TYLENOL (PARACETAMOL) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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 information provided and temporal association, a causal relationship between BNT162B2  and the reported events "ankylosing spondylitis flare up", "memory issues", "issues with mobility", "depression", "bad mood", "tight tendons", "bladder infection" and "humira wore of around the eight day after injection with humira", "vaccine caused sore arm" 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 RAs, Ethics Committees, and Investigators, as appropriate.