Age: 37.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood creatinine, COVID-19, Haematocrit, Haemoglobin, Laboratory test
Clinical narrative: COVID-19; COVID-19; 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 (Agency).  A 37-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 18May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from 03Mar2021 (Batch/Lot number: unknown) to 03Mar2021 at 160 mg (day 1 (1 in 1 once)), second regimen from 17Mar2021 (Batch/Lot number: unknown) to 17Mar2021 at 80 mg (day 15 (1 in 1 once)), third regimen since 31Mar2021 (Lot number: 1162623) at 40 mg (40 mg,1 in 2 wk) and fourth regimen from Feb2022 (Lot number: 1162623) to 02Mar2022 at 40 mg (40 mg,1 in 1 wk), all subcutaneous for crohn's disease, crohn's disease. The patient's relevant medical history included: "Kidney failure", start date: 2012 (unspecified if ongoing); "Ileostomy", start date: 08Nov2019 (unspecified if ongoing); "Fungal Infection" (unspecified if ongoing); "Right hand thumb joint pain" (unspecified if ongoing); "Bowel movement more frequent than normal" (unspecified if ongoing); "Gas" (unspecified if ongoing); "Anemia", start date: 2007 (unspecified if ongoing); "Dialysis", start date: 2012 (unspecified if ongoing); "remove one foot of Intestines" (unspecified if ongoing), notes: started 08Nov2019; "Disability" (unspecified if ongoing); "Ostomy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "COVID-19". The patient was hospitalized for vaccination failure, covid-19 (start date: 07Mar2022, discharge date: 13Mar2022, hospitalization duration: 6 day(s)). The patient underwent the following laboratory tests and procedures: Blood creatinine: (2021) Liiile elevated but normal; (Dec2021) 1.73; (03Jan2022) 2.04, notes: On 03Jan2022, he had elevated his creatinine to 2.04; Haematocrit: (unspecified date) Unknown results; (unspecified date) 32, notes: Hematocrit 32 with normal range 39; Haemoglobin: (unspecified date) 10.8, notes: 10.8 with normal rang of 13.0; LAB WORK: (unspecified date) Unknown results; Red blood cell analysis: (unspecified date) 3.8, notes: 3.8 with normal range of 4.20; SARS-CoV-2 test: (unspecified date) Positive; Scan: (Jan2022) cyst on intestine, notes: cyst on intestine. The action taken for adalimumab was dosage permanently withdrawn on 02Mar2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: 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.  Causality for Humira 80MG/0.8ML (Adalimumab): The reporter's causality for the event covid was not provided. Causality for Humira 40MG/0.4ML (Adalimumab): The reporter's causality for the Covid was not provided. Causality for Pfizer biontech covid-19 vaccine: The reporter's causality for the Covid was not reported  The reporter's assessment of the causal relationship of "covid-19" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.