Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: Crohn's disease aggravated; Vaccination site rash; Vaccination site pain; fever; MARKETING PROGRAM NOT AVAILABLE  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-163-4287516-00 (AbbVie).  A 18 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Dec2021 (Batch/Lot number: unknown) at the age of 19 years as dose 3 (booster), single, intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohn's disease aggravated"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Vaccination site pain"; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Vaccination site rash"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Reaction Information : Seq. No. : 1, Reaction : Vaccination site pain (Vaccination site pain), Start Date: 09-Apr-2021, Stop Date: Apr2021, Seq. No. : 2, Reaction : Vaccination site rash (Vaccination site rash), Start Date: 09-Apr-2021, Stop Date: Apr2021, Seq. No. : 3, Reaction : Vaccination site pain (Vaccination site pain), Start Date: 30-Apr-2021, Stop Date: 2021, Seq. No. : 4, Reaction : Vaccination site pain (Vaccination site pain), Start Date: 28Dec2021, Stop Date:, Seq. No. : 5, Reaction : Vaccination site rash (Vaccination site rash), Start Date: 30Apr2021, Stop Date: 2021, Seq. No. : 6, Reaction : Vaccination site rash (Vaccination site rash), Start Date:  28Dec2021, Stop Date:, Seq. No. : 7, Reaction : Fever  (Pyrexia), Start Date: Dec2021, Stop Date:, Seq. No. : 8, Reaction : Fever (Pyrexia), Start Date: 2021, Stop Date: 2021, Seq. No. : 9, Reaction : Crohn's disease aggravated (Crohn's disease), Start Date: 30Apr2021, Stop Date: 2021  Causality For Humira: 1)Vaccination site pain (Vaccination site pain), Action(s) taken with drug : Dose Not Changed, Causality as per reporter (Drug/Vaccine):  No reasonable possibility, Dechallenge: N/A, 2)Vaccination site rash (Vaccination site rash), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine):  No reasonable possibility, Dechallenge:  N/A, 3)Vaccination site pain (Vaccination site pain ), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Dechallenge:  N/A, 4)Vaccination site pain (Vaccination site pain ), Action(s) taken with drug : Dose Not Changed, Causality as per reporter (Drug/Vaccine) : No reasonable possibility, Dechallenge :  N/A, 5)Vaccination site rash (Vaccination site rash), Action(s) taken with drug : Dose Not Changed, Causality as per reporter (Drug/Vaccine) :  No reasonable possibility, Dechallenge :  N/A, 6)Vaccination site rash (Vaccination site rash), Action(s) taken with drug : Dose Not Changed, Causality as per reporter (Drug/Vaccine): No reasonable possibility, Dechallenge : N/A, 7)Fever (Pyrexia), Action(s) taken with drug : Dose Not Changed, Causality as per reporter,  ia) Action(s) taken with drug : Dose Not Changed, Causality as per reporter (Drug/Vaccine) : No reasonable possibility, Dechallenge : N/A, 9)Crohn's disease aggravated (Crohn's disease), Action(s) taken with drug : Dose Not Changed, Causality as per reporter (Drug/Vaccine) : Reasonable possibility, Dechallenge??: N/A  Causality For PFIZER BIONTECH COVID-19: 1) Vaccination site pain (Vaccination site pain), Action(s) taken with drug : Unknown, Causality as per reporter (Drug/Vaccine) : Probable, Dechallenge : N/A, 2) Vaccination site rash (Vaccination site rash), Action(s) taken with drug : Unknown, Causality as per reporter (Drug/Vaccine) : Probable, Dechallenge : N/A, 3) Vaccination site pain (Vaccination site pain), Action(s) taken with drug : Unknown, Causality as per reporter (Drug/Vaccine) : Probable, Dechallenge : N/A, 4) Vaccination site pain (Vaccination site pain), Action(s) taken with drug : Unknown, Causality as per reporter (Drug/Vaccine) : Probable, Dechallenge : N/A, 5) Vaccination site rash (Vaccination site rash), Action(s) taken with drug : Unknown, Causality as per reporter (Drug/Vaccine) : Probable, Dechallenge : N/A, 6) Vaccination site rash (Vaccination ash), Action(s) taken, Causality as per reporter (Drug/Vaccine) : Probable, Dechallenge : N/A, 7) Fever (Pyrexia), Action(s) taken with drug : Unknown, Causality as per reporter (Drug/Vaccine) : Probable, Dechallenge : N/A, 8) Fever (Pyrexia), Action(s) taken with drug : Unknown, Causality as per reporter (Drug/Vaccine) : Probable, Dechallenge : N/A, 9) Crohn's disease aggravated (Crohn's disease), Action(s) taken with drug : Unknown, Causality as per reporter (Drug/Vaccine) : Not Reported, Dechallenge : N/A  The reporter's assessment of the causal relationship of the (crohn's disease, vaccination site pain, vaccination site rash, pyrexia) with the suspect product 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.  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 in the case report, a possible causal association between the events 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.