Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Large intestine perforation, Pain in extremity, Terminal state, Vaccination site erythema, Vaccination site pain
Clinical narrative: Perforation of colon; Crohns disease aggravated; Terminal state; Fatigue; Chills; Vaccination site erythema; Vaccination site pain; Localised erythema; Pain in arm; 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): 21K-163-4217719-00.  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 55 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, (citrate free) for crohn's disease. Relevant medical history included: "Perforation Of Colon", start date: 2018 (unspecified if ongoing), notes: Colonoscopy performed. The patient's concomitant medications were not reported. The following information was reported: LARGE INTESTINE PERFORATION (medically significant), outcome "recovered", described as "Perforation of colon"; CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohns disease aggravated"; TERMINAL STATE (medically significant), outcome "unknown", described as "Terminal state"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue"; CHILLS (non-serious), outcome "recovered", described as "Chills"; VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered", described as "Vaccination site erythema"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Vaccination site pain"; ERYTHEMA (non-serious), outcome "not recovered", described as "Localised erythema"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in arm". Colon was removed during A Colonoscopy. The patient underwent the following laboratory tests and procedures: colonoscopy: (2018) unknown results. The action taken for adalimumab was unknown.  Causality for HUMIRA (ADALIMUMAB): Causality for HUMIRA (ADALIMUMAB): Causality as per reporter: No reasonable possibility, causality as per Mfr.(Drug/Vaccine): No reasonable possibility for the event perforation of colon, Fatigue, Chills, Vaccination site pain. Causality as per reporter Drug/Vaccine): Not reported, Causality as per Mfr.(Drug/Vaccine) : No reasonable possibility for the events Terminal state, Crohns disease aggravated. Causality as per reporter (Drug/Vaccine): Reasonable possibility, Causality as per Mfr.(Drug/Vaccine) : Reasonable possibility for the events Localised erythema, Pain in arm.   opinion is that there is no reasonable possibility that the events of perforation of colon during a colonoscopy, almost dying, fatigue, chills, activation dormant crohns disease, red soreness at injection with vaccinations unknown onset and red soreness at injection with vaccinations unknown onset are related to humira(adalimumab).  opinion is that there is a reasonable possibility that the events of red soreness in arm from humira unknown onset and red soreness in arm from humira unknown onset are related to humira(adalimumab).  Causality for Pfizer biontech covid-19 vaccine: Causality as per reporter (Drug/Vaccine): Not reported for the events Perforation of colon, Terminal state, Fatigue, Chills, Crohns disease aggravated, Vaccination site pain, Localized erythema, Pain in arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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.