Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Crohn's disease, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: Crohn's disease aggravated; Vaccination site pain; Vaccination site rash; fever; 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-163-4287516-00.  An 18-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 18 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), Intramuscular, 20Mar2021), administration date: 20Mar2021, when the patient was 18-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), Intramuscular, 20Apr2021), administration date: 20Apr2021, when the patient was 18-year-old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "fever"; VACCINATION SITE RASH (non-serious) with onset 20Oct2021, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 28Oct2021, outcome "unknown"; CROHN'S DISEASE (medically significant), outcome "recovered", described as "Crohn's disease aggravated". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of Crohn's disease aggravated was not reported and vaccination site rash, vaccination site pain and fever with the suspect product(s) BNT162b2 was probable at the time of this report.   The reporter's assessment of the causal relationship of Crohn's disease aggravated was Reasonable possibility and vaccination site rash, vaccination site pain and fever with the suspect product HUMIRA was No reasonable possibility at the time of this report.   Follow up (20Apr2022): Follow-up solicited report based on information received by Pfizer from Agency (Mfr. Control No.: 22K-163-4287516-00). A contactable consumer (patient) reported that included: new reporter added (Institution name, Email id), study description, ''Patient tab'': Historical vaccines added, "Product tab" (Dose administration date update, Vaccination facility country, Co-suspect drug formulation, indication). "Event tab" (Event outcome and AE onset date).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow up report is being submitted to amend previous information: Amendment (Agency): Amended the updated Reporter details in slider#01 and Protect Confidentiality unticked in general tab.; Sender's Comments: Based on the information in the case report, a possible causal association between the events crohn's disease aggravated, vaccination site rash, vaccination site pain and fever  and suspect drug BNT162B2 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.