Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Therapeutic product effect decreased
Clinical narrative: Crohn's disease aggravated; Drug effect decreased; 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-163-4287444-00.  A 20-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 02Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 19 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at weekly (unk unk, weekly (citrate free (1 in 1 wk))) and second regimen (Batch/Lot number: unknown) at single (unk unk, weekly (citrate free (1 in 1 wk))), all subcutaneous for crohn's disease. 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"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "recovering", described as "Drug effect decreased". The action taken for adalimumab was dosage increased.  The reporter considered "crohn's disease aggravated" and "drug effect decreased" not related to BNT162b2.  Additional information: The patient experienced Humira seemed to stop working. PFIZER BIONTECH COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality: The reporter's causality for the event(s) of HUMIRA SEEMED TO STOP WORKING with Humira (Adalimumab) was a reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was Possible.  Causality for Humira (Adalimumab)  The reporter's causality for the event(s) of Humira seemed to stop working with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Crohn's disease symptoms came back was not provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20May2022): This is a solicited follow-up report based on information received by Pfizer (Mfr. Control No.: 22K-163-4287444-00. A contactable consumer (patient) reported that: Update Information Included: New AE (Crohn's disease aggravated) added, date of dose 1,dose 2 and dose 3  added. Clinical information in the narrative have been appended accordingly.  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 available, the causal relationship between the reported 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 RAs, Ethics Committees, and Investigators, as appropriate.