Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Crohn's disease
Clinical narrative: Crohn's flare up.; MARKETING PROGRAMME NAME 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-163-4252462-00 (Abbive). A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Feb2021 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single and intramuscular, administration date 26Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) till Dec2021 at (1 in 2 wk) and second regimen subcutaneous since Dec2021 (Batch/Lot number: unknown) at (1 in 2 wk) for crohn's disease. Relevant medical history included: "COVID-19", start date: Dec2020, stop date: Dec2020, notes: In Dec2020, the patient experienced COVID-19. The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant) with onset 2021, outcome "recovered", described as "Crohn's flare up.". The patient underwent the following laboratory tests and procedures: colonoscopy: (27Dec2021) result unknown. The action taken for adalimumab was unknown.  Causality Crohn's aggravated (Crohn's disease) Action(S) Taken With Drug: Unknown Causality as Per Reporter (Drug/Vaccine):  No reasonable possibility Dechallenge:  N/A  COVID-19 (COVID-19) Action(S) Taken With Drug: Unknown Causality as Per Reporter (Drug/Vaccine): No reasonable possibility Dechallenge: N/A  Crohn's aggravated (Crohn's disease) Action(S) Taken With Drug: Unknown Causality as Per Reporter (Drug/Vaccine):  No reasonable possibility Dechallenge:  N/A  Crohn's aggravated (Crohn's disease) Action(S) Taken With Drug: Unknown Causality as Per Reporter (Drug/Vaccine):  No reasonable possibility Dechallenge:  N/A  Seq.No: 2 PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) (Tozinameran), Unknown, Unknown, Unknown Daily dose: (1 in once) Route Of Admin: 1) Intramuscular 2) Intramuscular Therapy Dates/Duration: 1) 26Jan2021 - 26Jan2021 2) 17Feb2021 - 17Feb2021  Causality Crohn's aggravated (Crohn's disease) Action(S) Taken With Drug: Unknown Causality as Per Reporter (Drug/Vaccine):  Possible Dechallenge:  N/A  COVID-19 (COVID-19) Action(S) Taken With Drug: Unknown Causality as Per Reporter (Drug/Vaccine): Not reported Dechallenge: N/A  Crohn's aggravated (Crohn's disease) Action(S) Taken With Drug: Unknown Causality as Per Reporter (Drug/Vaccine):  Possible Dechallenge:  N/A  Crohn's aggravated (Crohn's disease) Action(S) Taken With Drug: Unknown Causality as Per Reporter (Drug/Vaccine):  Not reported Dechallenge:  N/A  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of Crohn's flare up onset in Jan2021, COVID-19, Crohn's flare up onset in Febr2021 and Crohn's flare up onset in Oct2021 with Humira (Adalimumab) was no reasonable possibility.     The reporter's assessment of the causal relationship of the (Crohn's disease) with the suspect product was reported as related, however that of Covid was  provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The reporter considered "crohn's flare up." related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up. The reporter considered "crohn's flare up." related to bnt162b2. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, crohn's disease  of the suspected vaccine 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.