Age: 35.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Benign lymph node neoplasm, Crohn's disease, Vaccination site pain
Clinical narrative: experienced Crohn's symptoms return; vaccine related issue/soreness at the injection site; lymph nodes from neck they were benign; 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-163-4307699-00.  A 35 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown Manufacturer, Route of Admin:Intra-muscular), administration date: Mar2021, for COVID-19 vaccination. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "experienced Crohn's symptoms return"; BENIGN LYMPH NODE NEOPLASM (medically significant) with onset 2021, outcome "unknown", described as "lymph nodes from neck they were benign"; VACCINATION SITE PAIN (medically significant) with onset Dec2021, outcome "unknown", described as "vaccine related issue/soreness at the injection site". The action taken for adalimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of benign lymph node neoplasm. In 2021, the patient had Surgery to remove lymph nodes from neck and he said they were benign. He also had crohn's symptoms return while he was off humira following the surgery. After Receiving Pfizer vaccine on Dec2021 he had issue with vaccine and had soreness at injection site. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "vaccine related issue/soreness at the injection site" related to bnt162b2. The reporter did not report the causality of lymph nodes from neck they were benign and experienced Crohn's symptoms return with bnt162b2. The reporter did not report the causality of "lymph nodes from neck they were benign", "vaccine related issue/soreness at the injection site" and "experienced Crohn's symptoms return" with adalimumab. The manufacturer assessed the causality of "lymph nodes from neck they were benign" with adalimumab as not assessable. The manufacturer assessed the causality of "vaccine related issue/soreness at the injection site" and "experienced Crohn's symptoms return" with adalimumab as no reasonable possibility.  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 in the narrative , a possible contributory role of the suspect vaccine BNT162B2 to reported event of Crohn's aggravated ,Benign lymph node neoplasm and vaccination site pain 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.