Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Gastrointestinal inflammation, Inflammation, Stent placement, Weight
Clinical narrative: had a stent; Lost 30 pounds of weight; inflammation; not seeing any improvements while taking Humira; intestines became inflamed; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4147107. A 75-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for Covid-19 immunization. The following information was reported: GASTROINTESTINAL INFLAMMATION (medically significant) with onset Dec2021, outcome "unknown", described as "intestines became inflamed"; STENT PLACEMENT (medically significant), outcome "unknown", described as "had a stent"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "Lost 30 pounds of weight"; INFLAMMATION (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "not seeing any improvements while taking Humira". The patient underwent the following laboratory tests and procedures: Weight: Lost 30 pounds. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "had a stent", "lost 30 pounds of weight", "inflammation" and "not seeing any improvements while taking humira" 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. The reporter considered "intestines became inflamed" not related to BNT162b2.  Causalities: The reporter's causality for the event(s) of Lost 30 pounds of weight, had a stent, inflammation, intestines became inflamed and not seeing any improvements while taking Humira with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Lost 30 pounds of weight, had a stent, inflammation and not seeing any improvements while taking Humira with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of intestines became inflamed with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was No Reasonable Possibility.  Regulatory Authority opinion was that the causality for the event(s) of Lost 30 pounds of weight, had a stent, inflammation, intestines became inflamed and not seeing any improvements while taking Humira with Adalimumab Solution for Injection was No Reasonable Possibility  Regulatory Authority opinion was that the causality for the event(s) of Lost 30 pounds of weight, had a stent, inflammation, intestines became inflamed and not seeing any improvements while taking Humira with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Regulatory Authority Alternative Etiology for had a stent with Adalimumab Solution for Injection: Surgical procedure performed; more likely related to artery blockage in this elderly patient with underlying Crohn's disease. Regulatory Authority Alternative Etiology for inflammation with Adalimumab Solution for Injection: More likely a GI inflammation related to underlying Crohn's disease. Regulatory Authority Alternative Etiology for not seeing any improvements while taking Humira with Adalimumab Solution for Injection: Desired beneficial effect not observed. Regulatory Authority Alternative Etiology for Lost 30 pounds of weight with Adalimumab Solution for Injection: More likely related to underlying Crohn's disease in this elderly patient. Regulatory Authority Alternative Etiology for intestines became inflamed with Adalimumab Solution for Injection: More likely related to underlying Crohn's disease in this elderly patient.  Assessment Results - HUMIRA 40MG/0.4ML Lost weight, Non-Health Care Professional, Global Introspection, Not Reported - HUMIRA 40MG/0.4ML Inflammation, Non-Health Care Professional, Global Introspection, Not Reported - HUMIRA 40MG/0.4ML Stent placement, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility - HUMIRA 40MG/0.4ML Stent placement, Non-Health Care Professional, Global Introspection, Not Reported - HUMIRA 40MG/0.4ML Inflammation, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility - Pfizer/BioNTech Lack of drug effect, Market Authorization Holder (MAH) - Pfizer/BioNTech Lack of drug effect, Non-Health Care Professional, Global Introspection, Not Reported - HUMIRA 40MG/0.4ML ? Lack of drug effect, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility - HUMIRA 40MG/0.4ML ? Lack of drug effect, Non-Health Care Professional, Global Introspection, Not Reported - HUMIRA 40MG/0.4ML ? Lost weight, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility - HUMIRA 40MG/0.4ML ? Intestinal inflammation, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility - HUMIRA 40MG/0.4ML ? Intestinal inflammation, Non-Health Care Professional, Global Introspection, Not Reported - Pfizer/BioNTech ? Stent placement, Market Authorization Holder (MAH) - Pfizer/BioNTech ? Stent placement, Non-Health Care Professional, Global Introspection, Not Reported - Pfizer/BioNTech ? Inflammation, Market Authorization Holder (MAH) - Pfizer/BioNTech ? Inflammation, Non-Health Care Professional, Global Introspection, Not Reported - Pfizer/BioNTech ? Intestinal inflammation, Market Authorization Holder (MAH) - Pfizer/BioNTech ? Intestinal inflammation, Non-Health Care Professional, Global Introspection, Not Related - Pfizer/BioNTech ? Lost weight, Market Authorization Holder (MAH) - Pfizer/BioNTech ? Lost weight, Non-Health Care Professional, Global Introspection, 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 information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event STENT PLACEMENT , WEIGHT DECREASED , INFLAMMATION , DRUG INEFFECTIVE 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate. The event GASTROINTESTINAL INFLAMMATION most likely represent intercurrent medical condition ( crohn's disease) and unrelated to BNT162B2.