Age: 37.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Stoma site pain
Clinical narrative: crohn's flare up; inflammation; knee pain; muscle aches; fungal infection; hernia; ileostomy closure surgery; intestinal revision; colostomy reversal; anemia; incisional pain; tenderness to closed stoma site; limitations with daily activity; hematocrit 32 with normal range 39; stent in gallbladder; resection for bowel; gas; diarrhea; creatinine little elevated; stomach growls or making gurgling sounds; cyst on intestine; 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 (same reporter/drug with different AE/patient).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 03Mar2021 as 160 mg (160 mg, 1 in 1 once) (Batch/Lot number: unknown) and on 17Mar2021 as 80 mg (80 mg, 1 in 1 once) (Batch/Lot number: unknown), all subcutaneous for crohn's disease, crohn's disease; adalimumab (HUMIRA), on 31Mar2021 as 40 mg (40 mg, 1 in 2 wk) (Batch/Lot number: unknown), in Feb2022 as 40 mg (40 mg, 1 in 1 wk) (Batch/Lot number: unknown) and as citrate free (Batch/Lot number: unknown), all subcutaneous for crohn's disease. The patient's relevant medical history included: "Anemia", start date: 2007 (unspecified if ongoing), notes: Anemia (started 2007); "Dialysis", start date: 2012 (unspecified if ongoing), notes: Dialysis (started 2012); "Kidney failure", start date: 2012 (unspecified if ongoing), notes: Kidney failure (started 2012); "Ileostomy", start date: 08Nov2019 (unspecified if ongoing), notes: Ileostomy (started 08Nov2019); "Remove one foot of intestines", start date: 08Nov2019 (unspecified if ongoing), notes: Remove one foot of intestines (started 08Nov2019); "Fungal infection" (unspecified if ongoing); "Ostomy" (unspecified if ongoing); "Disability" (unspecified if ongoing); "Right hand thumb joint pain" (unspecified if ongoing); "Bowel movement more frequent than normal" (unspecified if ongoing); "Gas" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTESTINAL CYST (medically significant) with onset Apr2021, outcome "unknown", described as "cyst on intestine"; 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 "unknown", 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 OPERATION (hospitalization, medically significant) with onset Mar2022, outcome "unknown", described as "intestinal revision"; INTESTINAL RESECTION (medically significant) with onset Mar2022, outcome "recovered" (2022), described as "resection for bowel"; DIARRHOEA (medically significant) with onset 2022, outcome "unknown", described as "diarrhea"; 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"; COLOSTOMY CLOSURE (medically significant), outcome "recovered", described as "colostomy reversal"; ANAEMIA (medically significant), outcome "not recovered", described as "anemia"; INCISION SITE PAIN (medically significant), outcome "unknown", described as "incisional pain"; STOMA SITE PAIN (medically significant), outcome "unknown", described as "tenderness to closed stoma site"; 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". The patient was hospitalized for crohn's disease, inflammation, arthralgia, myalgia, fungal infection (start date: 2021); for hernia, ileostomy closure, intestinal operation (start date: 07Mar2022, discharge date: 13Mar2022, hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: Blood creatinine: (03Dec2012) 2.04; (2021) Little elevated but normal; (Dec2021) 1.73; (03Jan2022) 2.04; Computerised tomogram: (Jan2022) cyst on intestine; Haematocrit (normal low range 13): (unspecified date) 10.8; Haematocrit (normal low range 39): (unspecified date) 32; lab work: (03Jan2022) unknown results; Red blood cell count (normal low range 4.20): (03Jan2022) 3.8. The action taken for adalimumab and adalimumab was unknown. Therapeutic measures were taken as a result of incision site pain, stoma site pain. Clinical course: Patient reports 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 Jun2022, 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.   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.  Manufacturers 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). Manufacturer'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.  Manufacturer'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). Manufacturer's opinion is that there is a reasonable possibility that the event of fungal infection is related to humira 40mg/0.4ml (adalimumab).  Causality, Action(s) taken, Causality as per reporter (Drug/Vaccine) and Causality as per Mfr. (Drug/Vaccine) with Humira 80MG/0.8ML, for events as follows 1) Hernia (Hernia), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 2) Ileostomy closure (Ileostomy closure), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 3) Intestinal operation (Intestinal operation), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 4) Hospitalization (Hospitalization), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 5) Anemia (Anemia), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 6) Biliary stent placement (Bile duct stent insertion) Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 7) Colostomy closure (Colostomy closure), Action(s) taken with drug: Not applicable. Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 8) Bowel resection (Intestinal resection), Action(s) taken with drug: Not applicable, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 9) Incision site pain (Incision site pain), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not reported. Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 10) Gastric sounds abnormal (Gastric sounds abnormal), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 11) Stoma site pain (Stoma site pain), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 12) Intestinal cyst (Intestinal cyst). Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 13) Activities of daily living impaired (Loss of personal independence in daily activities), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 14) Creatinine increased (Blood creatinine increased), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 15) Inflammation (Inflammation) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 16) Creatinine increased (Blood creatinine increased) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 17) Hematocrit decreased (Hematocrit decreased) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 18) Gas (Flatulence) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, 19) Knee pain (Arthralgia), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 20) Muscle ache (Myalgia) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 21) Fungal infection (Fungal infection) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 22) Crohn's aggravated (Crohn's aggravated), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. 23) Covid-19 (covid-19), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Dechallenge for all events: N/A  Causality, Action(s) taken, Causality as per reporter (Drug/Vaccine) and Causality as per Mfr. (Drug/Vaccine) with Drug: Humira 40MG/0.4ML for events as follows 1) Hernia (Hernia), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Unrelated, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk, 2) Ileostomy closure (Ileostomy closure), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Unrelated, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk, 3) Intestinal operation (Intestinal operation), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Unrelated, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk, 4) Hospitalization (Hospitalization), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 5) Anemia (Anemia) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Unrelated, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 6) Biliary stent placement (Bile duct stent insertion) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Unrelated Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 7) Colostomy closure (Colostomy closure) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Unrelated, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk 8) Bowel resection (Intestinal resection) Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Unrelated Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk 9) Incision site pain (Incision site pain), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk. 10) Gastric sounds abnormal (Gastric sounds abnormal) Action(s) taken with drug: Dose Not Changed Causality as per reporter (Drug/Vaccine): Not reported Causality as per Mfr. (Drug/Vaccine): No reasonable possibility. Dechallenge: N/A. 11) Stoma site pain (Stoma site pain), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk 12) Intestinal cyst (Intestinal cyst), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A, 13) Activities of daily living impaired (Loss of personal independence in daily activities), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk, 14) Creatinine increased (Blood creatinine increased), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk. 15) Inflammation (Inflammation) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 16) Creatinine increased (Blood creatinine increased), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 17) Hematocrit decreased (Hematocrit decreased). Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not reported. Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 18) Gas (Flatulence), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A, 19) Knee pain (Arthralgia), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 20) Muscle ache (Myalgia), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 21) Fungal infection (Fungal infection), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): Reasonable possibility, Dechallenge: N/A. 22) Crohn's aggravated (Crohn's aggravated), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A. 23) Covid-19 (covid-19), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not reported, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A.   Causality, Action(s) taken, Causality as per reporter (Drug/Vaccine) and Causality as per Mfr. (Drug/Vaccine) Pfizer BioNTech covid-19 vaccine (Tozinameran) (Tozinameran) for events were as follows 1) Hernia (Hernia) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 2) Ileostomy closure (Ileostomy closure), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A, 3) Intestinal operation (Intestinal operation), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A, 4) Hospitalization (Hospitalization), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A, 5) Anemia (Anemia), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 6) Biliary stent placement (Bile duct stent insertion), Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 7) Colostomy closure (Colostomy closure), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A, 8) Bowel resection (Intestinal resection), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 9) Incision site pain (Incision site pain), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 10) Gastric sounds abnormal (Gastric sounds abnormal), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 11) Stoma site pain (Stoma site pain), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 12) Intestinal cyst (Intestinal cyst), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A, 13) Activities of daily living impaired (Loss of personal independence in daily activities), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 14) Creatinine increased (Blood creatinine increased), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 15) Inflammation (Inflammation), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 16) Creatinine increased (Blood creatinine increased), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 17) Hematocrit decreased (Hematocrit decreased), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 18) Gas (Flatulence), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 19) Knee pain (Arthralgia), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 20) Muscle ache (Myalgia), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 21) Fungal infection (Fungal infection), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A. 22) Crohn's aggravated (Crohn's aggravated), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A, 23) Covid-19 (covid-19) Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A.  The reporter's assessment of the causal relationship of "crohn's flare up", "hernia", "ileostomy closure surgery", "intestinal revision", "inflammation", "knee pain", "muscle aches", "fungal infection", "colostomy reversal", "resection for bowel", "stent in gallbladder", "anemia", "incisional pain", "tenderness to closed stoma site", "limitations with daily activity", "hematocrit 32 with normal range 39", "cyst on intestine", "stomach growls or making gurgling sounds", "creatinine little elevated", "gas" and "diarrhea" 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.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be excluded .Events related to surgical procedure are due to intercurrent condition nad assessessed unrelaed.