Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Colonoscopy, Intestinal operation, Investigation, Stool analysis
Clinical narrative: lower intestine removed; arm was sore; chills; 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-163-4227441-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1155994) at unk, citrate free, second regimen (Lot number: 1155994) at weekly (unk unk, weekly (citrate free (1 in 1 wk)) and third regimen (Lot number: 1161756) at unk,citrate free, all subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single; Daily Dose : 1 in 1 Once; Route of Administration: Intra-muscular), administration date: 20Jan2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Single; Daily Dose : 1 in 1 Once; Route of Administration: Intra-muscular; the patient experienced crohn's disease flare up. In Jan2022, the crohn's disease flare up resolved), administration date: 10Feb2021, when the patient was 72-year-old, for COVID-19 Immunization, reaction(s): "crohn's disease flare up", "colon scaring from crohns". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "recovered" (Feb2022), described as "arm was sore"; CHILLS (non-serious) with onset Feb2022, outcome "recovered" (Feb2022); INTESTINAL OPERATION (medically significant) with onset 07Jun2022, outcome "recovering", described as "lower intestine removed". The patient underwent the following laboratory tests and procedures: Colonoscopy: Unknown Results; Building antibodies: Unknown Results; Unknown Results; Stool analysis: Unknown Results, notes: The doctor wanted to see how everything was when they did a stool study and then later in the year a colonoscopy before putting her back on Humira. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "lower intestine removed", "arm was sore" and "chills" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical course: Causality as per Reporter for Co-Suspect drug HUMIRA (ADALIMUMAB) for the events Vaccination site pain and Chills was not reported. Causality as per Reporter for Suspect drug Pfizer biontech covid-19 vaccine for the events Vaccination site pain and Chills was not Reported. The reporters causality for the event(s) of lower intestine removed, building antibodies to Humira, colon scaring from crohns and crohn's disease flare up with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of got covid booster vaccine and arm was sore and chills was not provided. Opinion was that there was no reasonable possibility that the events of lower intestine removed, colon scaring from crohns, got covid booster vaccine and arm was sore, chills and crohn's disease flare up are related to Humira(Adalimumab). Opinion was that there was a reasonable possibility that the event of building antibodies to Humira was related to Humira(Adalimumab). On 16Feb2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrative description. The events of "building antibodies to Humira", "colon scaring from crohns", "got covid booster vaccine and arm was sore" and "chills" were added. On 25Jul2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The event of "lower intestine removed" was added. The event of "building antibodies to Humira" is now considered serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (29Jul2022): This is a solicited follow-up report based on the information received by Pfizer (Mfr Control No.: 22K-163-4227441-00). A contactable consumer reported for herself that: Updated information: New lot number of Humira added, Lab data updated, new event Intestinal operation added.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available.  The reported events - intestinal operation is mostly due to intercurrent condition or underlying condition and unlikely due to suspect drug BNT162B2. Case will be further reviewed on receipt of FU information.