Sex: M
Vaccine: COVID19
Symptoms: Spinal fracture, Vaccination site irritation
Clinical narrative: Irritation at covid vaccination site; Fatigue; Chronic obstructive pulmonary disease; Motor vehicle accident; Back pain; Artery in one leg was pinched; Cracked vertebrae; This is a solicited report based on the information received by Pfizer. (Manufacturer Report Number: 21K-163-4109576-00) from a contactable consumer (patient).  A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 Vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe adult crohn's disease.  Medical history included moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On unknown date, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. On unknown date, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer. On unknown dates, the patient experienced irritation at covid vaccination site, fatigue and chronic obstructive pulmonary disease. In 2021, the patient experienced artery in one leg was pinched, cracked vertebrae and back pain. On 11May2021, the patient experienced motor vehicle accident. on unknown dates, irritation at covid vaccination site and fatigue resolved. PFIZER BIONTECH COVID-19 vaccine (tozinameran) was also considered suspect. On 11 May 2021, the patient had motor vehicle accident and an artery was pinched and had undergone surgery to place stent in that artery. He also had cracked vertebrae in the accident and had back pain. He had chronic obstructive pulmonary disease. He had irritation and fatigue after third dose of Pfizer vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting. The action taken in response to the events for adalimumab was unknown. The outcome of peripheral artery occlusion, fractured vertebra, chronic obstructive pulmonary disease, back pain and motor vehicle accident was not recovered/not resolved; outcome of vaccination site irritation and fatigue was recovered/resolved on an unspecified date. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of artery in one leg was pinched, irritation at covid vaccination site, cracked vertebrae, fatigue and back pain with HUMIRA (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of chronic obstructive pulmonary disease and motor vehicle accident was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of artery in one leg was pinched, irritation at covid vaccination site, cracked vertebrae, fatigue, chronic obstructive pulmonary disease, motor vehicle accident and back pain are related to HUMIRA(ADALIMUMAB). Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the events of vaccination site irritation and fatigue was probable; the reporter's causality for the rest events was not reported. The reporter's assessment of the causal relationship of the events (except vaccination site irritation and fatigue) 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.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events spinal fracture and peripheral artery occlusion and the suspect drug "BNT162B2" cannot be completely 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.