Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Large intestine perforation, Pain in extremity, Terminal state, Vaccination site erythema, Vaccination site pain
Clinical narrative: Crohns disease aggravated; perforation of colon; Terminal state; Chills; Localised erythema; Fatigue; Pain in arm; Vaccination site erythema; Vaccination site pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Available). The reporter is the patient. Other Case identifier(s): 21K-163-4217719-00 (Agency).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Aug2021 (Batch/Lot number: unknown) at the age of 57 years as dose number unknown, single and (Batch/Lot number: unknown) as dose number unknown, 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) (medically significant), notes: in 2018, the patient experienced  perforation of colon during a colonoscopy; "Colonoscopy", start date: 2018 (unspecified if ongoing), notes: in 2018, the patient experienced  perforation of colon during a colonoscopy; "crohns disease" (unspecified if ongoing), notes: dormant crohns disease. There were no concomitant medications. The following information was reported: CROHN'S DISEASE (medically significant), outcome "unknown", described as "Crohns disease aggravated"; LARGE INTESTINE PERFORATION (medically significant), outcome "recovered", described as "perforation of colon"; TERMINAL STATE (medically significant), outcome "unknown", described as "Terminal state"; CHILLS (non-serious), outcome "recovered", described as "Chills"; ERYTHEMA (non-serious), outcome "not recovered", described as "Localised erythema"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in arm"; VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered", described as "Vaccination site erythema"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Vaccination site pain". The patient underwent the following laboratory tests and procedures: colonoscopy: (2018) unknown results, notes: perforation of colon during a colonoscopy; (unspecified date) unknown results. The action taken for adalimumab was unknown. Clinical course was reported as patient reported that in 2018 she had perforation of colon during a colonoscopy activation dormant Crohn's disease and almost dying. Colon was removed. On unknown dates, patient experienced perforation of colon during a colonoscopy, fatigue, chills and red soreness at injection with vaccinations resolved. Reported that she had chills after first Pfizer/BioNTech vaccination, red soreness at injection with second Pfizer/BioNTech vaccination, and red soreness in arm from Humira. It was unknown if she was enrolled in a COVID-19 Vaccine Trial.  Causality for BNT162B2: The reporter's causality for the event(s) of perforation of colon during a colonoscopy, fatigue, chills, red soreness at injection with vaccinations unknown onset and red soreness at injection with vaccinations unknown onset with BNT162B2 was no reasonable possibility. The reporter's causality for the event(s) of almost dying and activation dormant crohns disease was not provided. The reporter's causality for the event(s) of BNT162B2 unknown onset and RED soreness in arm from humira unknown onset with humira(adalimumab) was a reasonable possibility; The reporter considered "perforation of colon", "chills", "localised erythema", "fatigue", "pain in arm", "vaccination site erythema" and "vaccination site pain" related to bnt162b2.  Agency's (Causality as per Mfr.(Drug/Vaccine)) 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 BNT162B2. Agency's opinion is that there is a reasonable possibility that the events of red soreness in arm from BNT162B2 unknown onset are related to BNT162B2.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of perforation of colon during a colonoscopy, fatigue, chills, red soreness at injection with vaccinations unknown onset and red soreness at injection with vaccinations unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of almost dying and activation dormant crohns disease was not provided. The reporter's causality for the event(s) of RED SORENESS IN ARM FROM HUMIRA unknown onset and RED soreness in arm from humira unknown onset with humira(adalimumab) was a reasonable possibility.  Agency's 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). Agency's 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).  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 CROHN'S DISEASE (medically significant), LARGE INTESTINE PERFORATION (medically significant), TERMINAL STATE (medically significant), ERYTHEMA (non-serious), chills (non-serious) FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), and the suspect drug BNT162B2