Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Broken hip; Spondylitis ankylosing aggravated; Unable to walk; Inability to work; Pain in hip; First dose: 01Aug2021, Second dose: 18Aug2021; 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-163-4495359-00.  A 33-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from 07Oct2021 (Lot number: 1159670) to 13Jul2022 at 40 mg (40 mg, 1 in 14 d) and second regimen since 24Jul2022 (ongoing) (Batch/Lot number: unknown) at 40 mg (40 mg, 1 in 14 d), all subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Drug: pfizer biontech covid-19 vaccine (tozinameran) (tozinameran), unknown, Daily dose: 1)first dose (1 in 1 once), Route of admin: 1)intramuscular, Indications for use: 2) covid-19 vaccination, Therapy dates/duration: 1) 01Aug2021-01Aug2021), administration date: 01Aug2021, when the patient was 33-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "First dose: 01Aug2021, Second dose: 18Aug2021"; HIP FRACTURE (medically significant) with onset 05May2022, outcome "unknown", described as "Broken hip"; IMPAIRED WORK ABILITY (non-serious) with onset 05May2022, outcome "not recovered", described as "Inability to work"; ARTHRALGIA (non-serious) with onset 05May2022, outcome "unknown", described as "Pain in hip"; ANKYLOSING SPONDYLITIS (medically significant) with onset 05May2022, outcome "unknown", described as "Spondylitis ankylosing aggravated"; GAIT INABILITY (non-serious) with onset 05May2022, outcome "unknown", described as "Unable to walk". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: COVID-19 virus test positive. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "broken hip", "spondylitis ankylosing aggravated", "unable to walk", "inability to work" and "pain in hip" 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.  Clinical course: There was no reported medical history. In Jan2022, the patient experienced covid. On 13Jul2022, the patient experienced positive for corona virus. On 24Jul2022, the positive for corona virus resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of unable to walk/unable to put weight on leg, difficulty working, hip feels broken and ankylosing spondylitis flare up was not provided. The reporter's causality for the event(s) of left hip pain with humira 40mg/0.4ml(adalimumab) was a reasonable possibility.Causality for pfizer biontech covid-19 vaccine (tozinameran) (tozinameran): The reporter's causality for the event(s) of unable to walk/unable to put weight on leg, difficulty working, hip feels broken, left hip pain and ankylosing spondylitis flare up was not reported. Concomitant drugs not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of   "broken hip", "spondylitis ankylosing aggravated,  "unable to walk", "inability to work" "pain in hip" and  Inappropriate schedule of product administration   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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.