Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time shortened, Axial spondyloarthritis, Biopsy, Blood albumin, Blood calcium
Clinical narrative: axial skeleton issue in lumbar/sacral region; frequent bowls/frequency up to 10 times day/mucus with blood loss; osteoporosis; rectal pain; frequent bowls/frequency up to 10 times day/mucus with blood loss; frequent bowls/frequency up to 10 times day/mucus with blood loss; 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-131-4428969-00 (Mfr. Control No).  A 14-year-old male patient received BNT162b2 (BNT162B2), on 23May2021 as dose 1, single (Batch/Lot number and the expiry date were unknown), on 13Jun2021 as dose 2, single (Batch/Lot number and the expiry date were unknown) and on 27Dec2021 as dose 3 (booster), single (Batch/Lot number and the expiry date were unknown), all intramuscular for covid-19 immunization; adalimumab (HUMIRA), since Aug2021 (ongoing) (Batch/Lot number and the expiry date were unknown) at 40 mg (40 mg (40 mg,1 in 2 wk)), subcutaneous for crohn's disease; azathioprine (IMURAN [AZATHIOPRINE]), from 2018 (Batch/Lot number and the expiry date were unknown) to Aug2021 at 50 mg 1x/day (50 mg, 1x/day (50 milligrams on tuesdays, 25 milligrams daily all other days (1 in 1 d))), oral for crohn's disease. The patient's relevant medical history included: "Unspecified muscle tone problem", start date: 2017 (unspecified if ongoing), notes: Unspecified muscle tone problem (started 2017); "Pediatric crohns disease", start date: 2018 (unspecified if ongoing), notes: Pediatric crohns disease (started 2018); "Second degree paternal history of crohns disease" (unspecified if ongoing), notes: Second degree paternal history of crohn's disease; "Possible autism with Aspergers (unspecified if ongoing), notes: Possible autism with Aspergers "Penicillin allergy manifested by rash" (unspecified if ongoing), notes: Penicillin allergy manifested by rash; "Penicillin allergy manifested by rash" (unspecified if ongoing), notes: Penicillin allergy manifested by rash; "Abstains from alcohol" (unspecified if ongoing); "Non tobacco user" (unspecified if ongoing), notes: Non tobacco user; "Supplement" (unspecified if ongoing), notes: Supplement. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL] oral taken for supplementation therapy, start date: 2017 (ongoing); L-CARNITINE [LEVOCARNITINE HYDROCHLORIDE] oral taken for muscle disorder, start date: 2017 (ongoing); CALCIUM oral taken for supplementation therapy, start date: 2021 (ongoing). Past drug history included: Delzicol; Solu-medrol.  The following information was reported: AXIAL SPONDYLOARTHRITIS (hospitalization, medically significant), outcome "recovered", described as "axial skeleton issue in lumbar/sacral region"; HAEMATOCHEZIA (medically significant), FREQUENT BOWEL MOVEMENTS (non-serious), MUCOUS STOOLS (non-serious), outcome "unknown" and all described as "frequent bowls/frequency up to 10 times day/mucus with blood loss"; OSTEOPOROSIS (non-serious), outcome "recovered"; PROCTALGIA (non-serious), outcome "not recovered", described as "rectal pain". The patient underwent the following laboratory tests and procedures: Activated partial thromboplastin time shortened: (unspecified date) 36 seconds; Biopsy: (unspecified date) mild ileitis, notes: mild ileitis; Blood albumin: (unspecified date) 3.0 g/dl; Blood calcium: (unspecified date) 7.5 mg/dl; Blood glucose: (unspecified date) 136 mg/dl; Blood immunoglobulin A: (unspecified date) 56.7 g/l; Blood immunoglobulin G: (unspecified date) 94.1 g/l; Blood osmolarity: (unspecified date) 274.3 mmol/L; Blood potassium: (unspecified date) 3.0 mEq/l; Blood sodium: (unspecified date) 129 mmol; Bone densitometry: (unspecified date) bones are back to normal, notes: bones are back to normal; C-reactive protein: (unspecified date) 60 mg/l; Haemoglobin: (unspecified date) 7.0 g/dl; Immunology test: (unspecified date) 40 ng/ml; Humira Trough Test: (unspecified date) 2.7, notes: mcg/ml; Mean cell volume: (unspecified date) 85, notes: Fl; Protein total increased: (unspecified date) 5.8 g/dl; Prothrombin time: (unspecified date) 16 seconds; Urogram: (unspecified date) mesenteric inflammation, dilation of biliary tree, notes: mesenteric inflammation, dilation of biliary tree; Weight: (unspecified date) 10 pounds; (01Jun2022) 10 pounds. The action taken for adalimumab was dosage not changed. The action taken for azathioprine was dosage permanently withdrawn in Aug2021.  The reporter's assessment of the causal relationship of "axial skeleton issue in lumbar/sacral region", "frequent bowls/frequency up to 10 times day/mucus with blood loss", "osteoporosis" and "rectal pain" 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: It was reported that the patient experienced the events of frequent evacuation, fatigue, frequent bowels/frequency reached up to 10 times day/mucus with the blood loss, weight loss, axial skeleton issue in lumbar/sacral region and vomiting and non-serious osteoporosis, feeling afraid to vomit, frequent bowels/frequency reached up to 10 times day/mucus with the blood loss, feeling anxious, low-grade fever and rectal pain with humira (adalimumab). information was also received from a healthcare professional. on unknown dates, the patient experienced axial skeleton issue in lumbar/sacral region, osteoporosis, frequent bowels/frequency reached up to 10 times day/mucus with the blood loss and rectal pain. in May2022, the patient experienced frequent bowels/frequency reached up to 10 times day/mucus with the blood loss, weight loss, feeling afraid to vomit and feeling anxious. on 03Jun2022, the patient experienced low grade fever. on 03Jun2022, the low grade fever resolved. on 04Jun2022, the patient experienced frequent evacuation, Fatigue and vomiting. In Jun2022, the feeling afraid to vomit and feeling anxious resolved. On unknown dates, axial skeleton issue in lumbar/sacral region and osteoporosis resolved. Imuran (azathioprine), methotrexate and medrol (methylprednisolone acetate) were also considered suspect. The primary reported said patient's bowel frequency reached up to 10 times day possibly to stretched out the supply of humira, because insurance in Puerto Rico only covers 50 percentage of the medication cost and the remaining cost was out of pocket. He lost 10 pounds over the course of seven months, then another 10 pounds in the week before he was admitted to a hospital on 01Jun2022. He had severe fatigue and he was hospitalized since 05Jun2022 and had received intravenous fluids as treatment for vomits. He had mucus with the blood. He was still in the hospital, but was down to three bowel movements daily and mild blood loss. He had a low grade fever at 17 hours one night of this hospital stay of 99 to 100 and received one dose of Tylenol. His body mass index was 16.5 as of 15Jun2022, but the height was unknown. He adjusts his diet to avoided rectal pain. He had skeletal issue occurred following the use of Imuran and caused osteoporosis, but once it was discontinued, a dual energy x-ray absorptiometry scan showed bones were back to normal, so the doctor suspected the patient was ingesting higher doses of Imuran than prescribed. The alternative etiology of frequent bowels, blood loss, weight loss, feeling afraid to vomit, feeling anxious and low-grade fever were possible lack of compliance or misadministration and for rectal pain was rice consumptions. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the packaging was discarded. The patient was treated with zoloft, flagyl, cipro and tylenol. The patient's past medications include: delzicol for unknown indication solu medrol for unknown indication causality for humira(adalimumab) the reporter's causality for the event(s) of frequent evacuation, fatigue, axial skeleton issue in lumbar/sacral region, vomiting, osteoporosis and frequent bowels/frequency reached up to 10 times day/mucus with the blood loss unknown onset was not provided. The reporter's causality for the event(s) of frequent bowels/frequency reached up to 10 times day/mucus with the blood loss onset in May2022, weight loss, frequent bowels/frequency reached up to 10 times day/mucus with the blood loss onset in May2022, feeling afraid to vomit, feeling anxious, low-grade fever and rectal pain with humira(adalimumab) was no reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of frequent evacuation, fatigue, frequent bowels/frequency reached up to 10 times day/mucus with the blood loss onset in May2022, weight loss, axial skeleton issue in lumbar/sacral region, frequent bowels/frequency reached up to 10 times day/mucus with the blood loss onset in May2022, vomiting, osteoporosis, feeling afraid to vomit, frequent bowels/frequency reached up to 10 times day/mucus with the blood loss unknown onset, feeling anxious, low grade fever and rectal pain 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 the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.