Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Crohn's disease, Gastrointestinal scarring
Clinical narrative: colon scaring from crohns; Crohn's disease flare up; 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-163-4227441-00 (Agency).  A 73 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Lot number: 1155994) at weekly (unk, weekly (citrate free)) and second regimen subcutaneous (Lot number: 1155994) at weekly (unk, weekly (citrate free (1 in 1 wk))) for crohn's disease, psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route of Administration: , 1) Intra-muscular, Therapy Dates (From/to): , 1) 20Jan2021-20Jan2021), administration date: 20Jan2021, when the patient was 72 years old, for Covid-19 immunization. The following information was reported: CROHN'S DISEASE (medically significant) with onset Jan2022, outcome "recovered" (Jan2022), described as "Crohn's disease flare up"; CROHN'S DISEASE (medically significant), outcome "unknown", GASTROINTESTINAL SCARRING (non-serious), outcome "recovering" and all described as "colon scaring from crohns". The patient underwent the following laboratory tests and procedures: antibody test: building antibodies. The action taken for adalimumab was dosage permanently withdrawn.  On unknown dates, the patient experienced building antibodies to Humira and colon scaring from crohns. in Jan2022, the patient experienced crohn's disease flare up. in Jan2022, the crohn's disease flare up resolved. in Feb2022, the patient experienced got covid booster vaccine and arm was sore and chills. in Feb2022, the got covid booster vaccine and arm was sore and chills resolved. pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with Imodium.  Causality for Humira (Adalimumab)  The reporter's causality for the event(s) of building antibodies to humira, colon scaring from crohns and crohn's disease flare up with humira(adalimumab) was no reasonable possibility.  Causality for Pfizer biontech covid-19 vaccine: The reporter's causality for the event(s) of colon scaring from crohns and crohn's disease flare up was not Reported.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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