Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: CSF red blood cell count positive, Colostomy closure, Crohn's disease, Flatulence, Fungal infection
Clinical narrative: intestinal revision; ileostomy closure surgery; hernia; crohn's flare up; inflammation; knee pain; muscle aches; fungal infection; anemia; colostomy reversal; tenderness to closed stoma site; incisional pain; limitations with daily activity; hematocrit 32 with normal range 39; cyst on intestine; stent in gallbladder; resection for bowel; gas; creatinine little elevated; stomach growls or making gurgling sounds; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3922881-00.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 18May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from 03Mar2021 (Batch/Lot number: unknown) to 03Mar2021 at 160 mg single and second regimen from 17Mar2021 (Batch/Lot number: unknown) to 17Mar2021 at 80 mg single, all subcutaneous for crohn's disease; adalimumab (HUMIRA), first regimen since 31Mar2021 (Lot number: 1162623) at 40 mg (40 mg, (1 in 2 wk)), second regimen from Feb2022 (Lot number: 1162623) to 02Mar2022 at 40 mg weekly and third regimen (Lot number: 1162623) at citrate free, all subcutaneous for crohn's disease. The patient's relevant medical history included: "Anemia", start date: 2007 (unspecified if ongoing); "Dialysis", start date: 2012 (unspecified if ongoing); "Kidney failure", start date: 2012 (unspecified if ongoing); "Ileostomy", start date: 08Nov2019 (unspecified if ongoing); "Remove one foot of intestines", start date: 08Nov2019 (unspecified if ongoing); "Fungal infection" (unspecified if ongoing); "Ostomy" (unspecified if ongoing); "Disability" (unspecified if ongoing); "Right hand thumb joint pain" (unspecified if ongoing), notes: Right hand thumb joint pain; "Bowel movement more frequent than normal", start date: Sep2021 (unspecified if ongoing); "Gas" (unspecified if ongoing); "Right hand thumb joint pain" (unspecified if ongoing), notes: Right hand thumb joint pain. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose (1 in 1 Once), 1) Intramuscular, crohn's flare up), administration date: 27Apr2021, when the patient was 37-year-old, for Covid-19 immunization, reaction(s): "crohn's flare up", "Hernia", "Ileostomy closure", "Intestinal operation", "Inflammation", "Fungal infection", "knee pain", "Anaemia", "Colostomy closure", "incisional pain", "tenderness to closed stoma site", "limitations with daily activity", "hematocrit 32 with normal range 39", "Intestinal cyst", "stomach growls or making gurgling sounds", "creatinine little elevated", "gas", "resection for bowel", "stent in gallbladder". The following information was reported: GASTROINTESTINAL SOUNDS ABNORMAL (medically significant) with onset May2021, outcome "recovering", described as "stomach growls or making gurgling sounds"; CROHN'S DISEASE (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "crohn's flare up"; FUNGAL INFECTION (hospitalization, medically significant) with onset 2021, outcome "unknown"; INFLAMMATION (hospitalization, medically significant) with onset 2021, outcome "unknown"; ARTHRALGIA (hospitalization, medically significant) with onset 2021, outcome "recovered" (2021), described as "knee pain"; MYALGIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "muscle aches"; BLOOD CREATININE INCREASED (medically significant) with onset Dec2021, outcome "recovered" (Dec2021), described as "creatinine little elevated"; HERNIA (hospitalization, medically significant) with onset Mar2022, outcome "recovered" (2022); ILEOSTOMY CLOSURE (hospitalization, medically significant) with onset Mar2022, outcome "unknown", described as "ileostomy closure surgery"; INTESTINAL RESECTION (medically significant) with onset Mar2022, outcome "recovered" (2022), described as "resection for bowel"; FLATULENCE (medically significant) with onset 2022, outcome "unknown", described as "gas"; BILE DUCT STENT INSERTION (medically significant) with onset Jun2022, outcome "recovering", described as "stent in gallbladder"; INTESTINAL OPERATION (hospitalization, medically significant), outcome "unknown", described as "intestinal revision"; ANAEMIA (medically significant), outcome "not recovered", described as "anemia"; COLOSTOMY CLOSURE (medically significant), outcome "recovered", described as "colostomy reversal"; STOMA SITE PAIN (medically significant), outcome "unknown", described as "tenderness to closed stoma site"; INCISION SITE PAIN (medically significant), outcome "unknown", described as "incisional pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), outcome "unknown", described as "limitations with daily activity"; HAEMATOCRIT DECREASED (medically significant), outcome "unknown", described as "hematocrit 32 with normal range 39"; INTESTINAL CYST (medically significant), outcome "unknown", described as "cyst on intestine". The patient underwent the following laboratory tests and procedures: Blood creatinine: (2021) Little elevated but normal; (Dec2021) 1.73; (03Jan2022) 2.04; CSF red blood cell count positive (normal low range 4.20): (unspecified date) 3.8; Haematocrit (normal low range 39): (unspecified date) 32, notes: 32 with normal rang of 39.0; Haemoglobin (normal low range 13): (unspecified date) 10.8, notes: 10.8 with normal rang of 13.0; Lab work: (03Jan2022) Unknown results; X-ray: (Jan2022) cyst on intestine. The action taken for adalimumab and adalimumab was unknown.  Clinical Course:Solicited report from the country by a consumer of a 37 year old male with events of hernia, ileostomy closure surgery, intestinal revision, in hospital, anemia, stent in gallbladder, colostomy reversal and resection for bowel and non-serious incisional pain, stomach growls or making gurgling sounds, tenderness to closed stoma site, cyst on intestine, limitations with daily activity/nutrition/lifts not greater than 10 pounds/avoids high fiber diet, creatinine little elevated, inflammation, elevated creatinine, hematocrit 32 with normal range 39, gas, knee pain, muscle aches, fungal infection, crohn's flare up and covid with Humira 80MG/0.8ML (Adalimumab) and Humira 40MG/0.4ML (Adalimumab). The patient had a relevant medical history of anemia, kidney failure, remove one foot of intestines, fungal infection, ostomy, disability, bowel movement more frequent than normal and gas. On unknown dates, the patient experienced anemia, colostomy reversal, incisional pain, tenderness to closed stoma site, limitations with daily activity/nutrition/lifts not greater than 10 pounds/avoids high fiber diet and hematocrit 32 with normal range 39. In 2021, the patient experienced in hospital, inflammation, knee pain, muscle aches, fungal infection, crohn's flare up and covid. In Apr2021, the patient experienced cyst on intestine. In May2021, the patient experienced stomach growls or making gurgling sounds. In Dec2021, the patient experienced creatinine little elevated. In 2021, the knee pain resolved. In Dec2021, the creatinine little elevated resolved. In 2022, the patient experienced gas. On 03Jan2022, the patient experienced elevated creatinine. In Mar2022, the patient experienced hernia, ileostomy closure surgery, intestinal revision and resection for bowel. In Jun202~2, the patient experienced stent in gallbladder. In 2022, the hernia and resection for bowel resolved. On an unknown date, colostomy reversal resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient was on disability since his surgery on 08Nov2019 to remove one foot of intestines and had an ostomy bag. Stools were soft and he went in on 19Apr2021 to hospital to get ileostomy reversed but they went in and decided it was not time yet due to inflammation still there so physician wanted Humira to work more before attempting again. He had a four-day stay in hospital, improved and had left knee pain before Humira started and noticed in past few weeks he had not had to take any Tylenol for any knee pain, it was gone away. Rarely in past week any stomach growls or making gurgling sounds and had improved energy levels and activity with no flare ups of crohn's disease symptoms since start of therapy. He had second Covid vaccine on 18May2021 with only some muscle aches, physician aware. He reported that prior to and after start of therapy during the past week (Sep2021) a little bit and bowel or pass gas movement more frequent than usual, right hand thumb joint pain. The physician was unaware. He rarely had stomach growl/make gurgling sounds His crohn's symptoms were a lot better, more energy and able to do things activities since after start of therapy. The physician was aware. He reported that continued to take Imuran per physician and future plan to reverse ileostomy no new or worsening in symptoms reported. No further information or side effects were provided. He reported that after started of therapy nausea occurred when medications took in morning by mouth without eating and diarrhea ten percent of the time and not formed after ileostomy, Stomach growling/making gurgling sounds improved after started therapy. He had no pain, no longer tired, energy good, able to tolerate activities and overall felt much better and weight was improved. Physician decreased Immunosuppressant dose due to creatinine level little elevated, but it was back to baseline since Immunosuppressant dose was adjusted by physician. On 03Jan2022, he had elevated his creatinine to 2.04. He had cyst on intestine and his hemoglobin was decreased. He had anemia. In 2022, he had gas and diarrhea. He started new frequency of Humira 40mg/0.4mL one pen under skin once a week per physician in Feb2022. Exact start date for new Humira frequency was unknown. He had planned scheduled admission to hospital for ileostomy closure and missed 2 doses of Humira injection prior to surgery as per physician. The last dose of Humira was taken on 02Mar2022. No adverse event was noted, and physician was aware. He had hospitalization from 07Mar2022 to 13Mar2022 for ileostomy closure surgery, intestinal revision and hernia repair. He restarted Humira on 21Mar2022. He had abdominal surgical site with dressing and binder and three to four loose stools per day. He had incisional pain and tenderness to closed stoma site. He took only Tylenol as needed as per physician. His appetite had approved and less nausea following surgery. He had limitations in daily activities and nutrition such as lift no greater than ten pounds, avoid high fiber and cook vegetables well. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The patient was treated with Tylenol and Imuran. On 16Sep2021, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, treatment drug information and narrative description. On 15Dec2021, received updates to patient demographics, medical history, 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 "creatinine little elevated" was added. On 07Feb2022, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "cyst on intestine", "elevated creatinine", "hematocrit 32 with normal range 39", "anemic" and "gas" were added. On 17Mar2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "hernia repair", "ileostomy closure surgery", "intestinal revision", "incisional pain", "tenderness to closed stoma site", "limitations with daily activity/nutrition/lifts not greater than 10 pounds/avoids high fiber diet" and "3-4 loose stools per day" were added. On 29Jul2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "stent in gallbladder", "colostomy reversal" and "resection for bowel" were added. The event of "hernia repair" was amended to "hernia". the event of "anemic" was amended to "anemia". The event of "anemia" is now considered serious. The event of "3-4 loose stools per day" was removed.  Causality for Humira 80MG/0.8ML (Adalimumab): The reporter's causality for the event(s) of hernia, ileostomy closure surgery, intestinal revision, in hospital, anemia, stent in gallbladder, colostomy reversal, resection for bowel, incisional pain, stomach growls or making gurgling sounds, tenderness to closed stoma site, cyst on intestine, limitations with daily activity/nutritions/lifts not greater than 10 pounds/avoids high fiber diet, creatinine little elevated, inflammation, elevated creatinine, hematocrit 32 with normal range 39, gas, knee pain, muscle aches, fungal infection, crohn's flare up and covid was not provided. Agency's opinion is that there is no reasonable possibility that the events of hernia, ileostomy closure surgery, intestinal revision, in hospital, anemia, stent in gallbladder, colostomy reversal, resection for bowel, incisional pain, stomach growls or making gurgling sounds, tenderness to closed stoma site, cyst on intestine, limitations with daily activity/nutritions/lifts not greater than 10 pounds/avoids high fiber diet, creatinine little elevated, inflammation, elevated creatinine, hematocrit 32 with normal range 39, gas, knee pain, muscle aches, crohn's flare up and covid are related to Humira 80MG/0.8ML (adalimumab). Agency's opinion is that there is a reasonable possibility that the event of fungal infection is related to Humira 80MG/0.8ML (Adalimumab).  Causality for Humira 40MG/0.4ML (Adalimumab): The reporter's causality for the event(s) of hernia, anemia, stent in gallbladder, colostomy reversal and resection for bowel with humira 40mg/0.4ml (adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of ileostomy closure surgery, intestinal revision, in hospital, incisional pain, stomach growls or making gurgling sounds, tenderness to closed stoma site, cyst on intestine, limitations with daily activity/nutrition/lifts not greater than 10 pounds/avoids high fiber diet, creatinine little elevated, inflammation, elevated creatinine, hematocrit 32 with normal range 39, gas, knee pain, muscle aches, fungal infection, crohn's flare up and Covid was not provided. Agency's opinion is that there is no reasonable possibility that the events of hernia, ileostomy closure surgery, intestinal revision, in hospital, anemia, stent in gallbladder, colostomy reversal, resection for bowel, incisional pain, stomach growls or making gurgling sounds, tenderness to closed stoma site, cyst on intestine, limitations with daily activity/nutrition/lifts not greater than 10 pounds/avoids high fiber diet, creatinine little elevated, inflammation, elevated creatinine, hematocrit 32 with normal range 39, gas, knee pain, muscle aches, crohn's flare up and covid are related to humira 40mg/0.4ml (adalimumab). agency's opinion is that there is a reasonable possibility that the event of fungal infection is related to humira 40mg/0.4ml (adalimumab).   The reporter's assessment of the causal relationship of "crohn's flare up", "inflammation", "knee pain", "muscle aches", "fungal infection", "hernia", "intestinal revision", "ileostomy closure surgery", "anemia", "colostomy reversal", "tenderness to closed stoma site", "incisional pain", "limitations with daily activity", "hematocrit 32 with normal range 39", "cyst on intestine", "stomach growls or making gurgling sounds", "creatinine little elevated", "gas", "resection for bowel" and "stent in gallbladder" 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.  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 limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.