Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Bile duct stent insertion, Blood creatinine, Colostomy closure, Computerised tomogram
Clinical narrative: anemia; colostomy reversal; incisional pain; tenderness to closed stoma site; limitations with daily activity; hematocrit 32 with normal range 39; stent in gallbladder; gas; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 09May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from 03Mar2021 (Batch/Lot number: unknown) to 03Mar2021 at 160 mg single (160 mg, single) and second regimen from 17Mar2021 (Batch/Lot number: unknown) to 17Mar2021 at 80 mg single (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 (40 mg (1 in 1 wk)) 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), 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" (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. Vaccination history included: BNT162b2 (First Dose , Route of Admin: Intramuscular), 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"; BNT162b2 (Second Dose (1 in 1 Once), Route of Admin: Intramuscular), administration date: 18May2021, when the patient was 37-year-old, for Covid-19 immunization, reaction(s): "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 bow", "stent in gallbladder". The following information was reported: FLATULENCE (medically significant) with onset 2022, outcome "unknown", described as "gas"; ANAEMIA (medically significant), outcome "not recovered", described as "anemia"; COLOSTOMY CLOSURE (medically significant), outcome "recovered", described as "colostomy reversal"; 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"; BILE DUCT STENT INSERTION (medically significant), outcome "unknown", described as "stent in gallbladder". The patient underwent the following laboratory tests and procedures: Blood creatinine: (2021) Little elevated but normal; (Dec2021) 1.73; (03Jan2022) 2.04; Computerised tomogram: (Jan2022) cyst on intestine; Haematocrit: (unspecified date) 32 with normal rang of 39.0; Haemoglobin: (unspecified date) 10.8 with normal rang of 13.0; lab work: (03Jan2022) Unknown Results; Red blood cell count: (unspecified date) 3.8 with normal range of 4.20. The action taken for adalimumab and adalimumab was unknown.  The reporter's assessment of the causal relationship of "anemia", "colostomy reversal", "incisional pain", "tenderness to closed stoma site", "limitations with daily activity", "hematocrit 32 with normal range 39", "gas" 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.  Clinical course: 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.  Company'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). Company'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. Company'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). Company's opinion is that there is a reasonable possibility that the event of fungal infection is related to humira 40mg/0.4ml (adalimumab).  Change History: 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.  Suspect drug (information): Suspect Drug(s) (include generic name): Humira 80MG/0.8ML (80 Milligram, Solution for injection in pre-filled pen) (adalimumab), unknown, unknown, Daily dose: Day 1 (160mg, 1 in once), Route of Administration: Subcutaneous, Indications for Use: Crohn's Disease, Therapy Dates (From/to): 03Mar2021  Causality: 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, Dechallenge: N/A  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, Dechallenge: N/A 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, Dechallenge: N/A  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: N/A  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  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, Dechallenge: N/A  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 Dechallenge: N/A 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, Suspect drug (information): Suspect Drug(s) (include generic name): HUMIRA 40MG/0.4ML (40 Milligram, Solution for injection in pre-filled pen) (adalimumab), unknown, unknown.  Drug: Humira 40MG/0.4ML (40 Milligram, Solution for injection in pre-filled pen) (adalimumab), unknown, unknown Ileostomy closure (Ileostomy closure), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Related, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk  Anemia (Anemia) Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not Related, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: N/A Biliary stent placement (Bile duct stent insertion), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Related, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility,Dechallenge: N/A  Colostomy closure (Colostomy closure), Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Related, Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk  Bowel resection (Intestinal resection) Action(s) taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Related Causality as per Mfr. (Drug/Vaccine): No reasonable possibility, Dechallenge: Unk 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 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  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 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 Suspect Drug(S) (include generic name): Seq. No: 3 Drug: Pfizer BioNTech covid-19 vaccine (Tozinameran) (Tozinameran), unknown, unknown, unknown Causality: Ileostomy closure (Ileostomy closure), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A Intestinal operation (Intestinal operation), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A Hospitalization (Hospitalization), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A Anemia (Anemia)Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A Biliary stent placement (Bile duct stent insertion), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported, Dechallenge: N/A Colostomy closure (Colostomy closure), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A Bowel resection (Intestinal resection), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A Incision site pain (Incision site pain), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A  Stoma site pain (Stoma site pain), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A 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 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 Concomitant Drugs and History: Concomitant Drugs Not Reported Did event abate after stopping drug : NA  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 in the case, an association between the reported events and the suspect product bnt162b2 cannot be established