Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blood electrolytes decreased, Blood test, Colonoscopy, Crohn's disease, Large intestinal ulcer
Clinical narrative: Low electrolytes levels; Crohn's flare up; Three new ulcerated aeas in colon; Could not use right arm; Pain in shoulder blade; 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-163-4452082-00.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1159933) at 40 mg and second regimen (Lot number: 1159933) at 40 mg (40 mg, (1 in 1 wk)), all subcutaneous for crohn's disease; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD ELECTROLYTES DECREASED (hospitalization), outcome "unknown", described as "Low electrolytes levels"; CROHN'S DISEASE (medically significant), outcome "recovered", described as "Crohn's flare up"; LARGE INTESTINAL ULCER (medically significant), outcome "unknown", described as "Three new ulcerated aeas in colon"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "Could not use right arm"; MUSCULOSKELETAL PAIN (non-serious), outcome "unknown", described as "Pain in shoulder blade". The patient underwent the following laboratory tests and procedures: Blood test: low electrolyte levels; Colonoscopy: 3 new ulcerated areas in colon. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of blood electrolytes decreased.  Clinical course: Blood electrolytes decreased (Blood electrolytes decreased)  Unknown, Upper extremity dysfunction (Musculoskeletal disorder)  Unknown, Colon ulcer (Large intestinal ulcer)  Unknown, Drug effect decreased (Therapeutic product effect decreased) - Recovering/resolving, Shoulder blade pain (Musculoskeletal pain)  Unknown, Crohn's aggravated (Crohn's disease) - Unknown. On unknown dates, the patient experienced low electrolyte levels, could not use right arm, three new ulcerated areas in colon, Humira less effective, pain in shoulder blade and crohn's flare up. On an unknown date, crohn's flare up resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) and flu vaccine VII (influenza vaccine) were also considered suspect. The patient had colonoscopy which resulted in three new ulcerated areas in his colon. COVID-19 and flu vaccine were taken on the same day, and after about three days later he had pain in his shoulder blade and could not use his right arm. His blood work showed dangerously low electrolyte levels and he had to be hospitalized and treated. He experienced crohn's flare up which had cleared up and went away. Humira was moved to weekly dosing.  Causality for Flu vaccine VII , BNT162b2. The reporter's causality for the event(s) of low electrolyte levels, Crohn's aggravated, three new ulcerated areas in colon was not provided. Causality for pain in shoulder blade, Upper extremity dysfunction was probable.  Causality for Humira 40MG/0.4ML(Adalimumab) The reporter's causality for the event(s) of low electrolyte levels, could not use right arm, three new ulcerated areas in colon, pain in shoulder blade and crohn's flare up was not provided. The reporter's causality for the event(s) of Humira less effective with Humira 40mg/0.4ml(adalimumab) was a reasonable possibility.  The reporter's assessment of the causal relationship of "low electrolytes levels", "crohn's flare up" and "three new ulcerated areas in colon" 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 "could not use right arm" and "pain in shoulder blade" related to BNT162b2.  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 information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of Upper extremity dysfunction,Colon ulcer , Crohn's aggravated ,Blood electrolytes decreased ,Musculoskeletal pain 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.