Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, Computerised tomogram, Immunisation, Portal vein thrombosis, Venous haemorrhage
Clinical narrative: Portal vein thrombosis; portal vein bleeding; In Jun2021, he received 3rd dose COVID-19 Vaccine; This is a solicited report based on information received by Pfizer from a company (Mfr. Control No.: 21K-163-3724777-00).  A contactable consumer (patient) reported that 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 intramuscular at age of 67 years on Jun2021 (Lot Number: EW0158) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, 40MG/0.4ML), subcutaneous from 2007 (Lot Number: 1128194) and ongoing, at 40 mg,1 in 2 wk for moderate to severe adult crohn's disease, rheumatoid arthritis.  Medical history included kidney stones from 2003, tobacco use/a pack of cigarette a day from an unknown date to 2005, no alcohol use, irritable bowel syndrome from crohn's disease, gastroesophageal reflux disease, guillain-barre syndrome, high blood pressure, history of falls, non-alcoholic liver cirrhosis, primary sclerosing cholangitis. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX) given after the surgery; spironolactone (SPIRONOLACTONE) taken for water retention, start and stop date were not reported.  The patient previously took Lyrica and experienced drug allergy, mad and headaches. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on Aug2020 (lot EW0158) at age of 66 years and dose 2 on Oct2020 (lot EW0158) at age of 67 years for Covid-19 immunization and experienced Portal vein thrombosis, Thrombosis, Recurring right and left kidney stones, Headache, Renal cyst, Crohn's disease aggravated. In Jun2021, he received 3rd dose COVID-19 Vaccine. In Oct2021, the patient experienced portal vein thrombosis/bleeding (as reported). Serious criteria was Life threatening, Involved or prolonged inpatient hospitalization, Other medically important condition. Clinical course: Solicited report by a consumer with events of portal vein thrombosis/bleeding, intestinal blockage, portal vein thrombosis, two big blood clot in the lower left abdomen, intestinal blockage infection, right kidney stones and crohn's disease flare up and non-serious low iron level, low platelets, low red blood cells, bad headache, cyst on left kidney/probably benign and recurring right and left kidney stones with humira 40mg/0.4ml (adalimumab). the patient had a relevant medical history of kidney stones, drug allergy lyrica was manifested by headaches and mad, irritable bowel syndrome from crohn's disease, irritable bowel syndrome from crohn's disease, gastroesophageal reflux disease, guillain-barre syndrome, high blood pressure, non-alcoholic liver cirrhosis and primary sclerosing cholangitis. On unknown dates, the patient experienced two big blood clot in the lower left abdomen, cyst on left kidney/probably benign and recurring right and left kidney stones. In 2017, the patient experienced right kidney stones, low iron level, low platelets and low red blood cells. In Feb2020, the patient experienced intestinal blockage and intestinal blockage infection. In Mar2020, the intestinal blockage and intestinal blockage infection resolved. In Dec2020, the patient experienced crohn's disease flare up. In February 2021, the patient experienced portal vein thrombosis. On 19Mar2021, the patient experienced bad headache. On 21Mar2021, the bad headache resolved. In Oct2021, the patient experienced portal vein thrombosis/bleeding (as reported). In 2021, the portal vein thrombosis resolved. On an unknown date, crohn's disease flare up resolved. Pfizer BioNTech COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient had crohn's disease flare up in Dec2020 and was hospitalized for a week. In Feb2021, he stayed for a week in the hospital due to the blood clot that was found. The patient took WARFARIN 5 milligram every tuesday, thursday and saturday and 7.5 milligram every monday, wednesday and friday. He had a blood clot in his abdomen and was placed on COUMADIN. Apart from the medicines given, there were some medicines not stated as he did not have the list with him, and he was advised to stop some of them. On 04Feb2021, he had surgery as an outpatient procedure where laser was used to blast the kidney stones on his right kidney. He had a stent placed to removed remaining parts of the kidney stone. He was recovered from surgery. The headache usually started the next day and lasted for almost two days after the vaccine was administered. The causality as per reporter for surgery was reported as no reasonable possibility. He had cyst on his left kidney that his physician stated it was probably benign. He confirmed that there were no test or procedure done for the cyst on his left kidney. He had intestinal blockage and was hospitalized for five days. Because of postal vein thrombosis in Feb2021, he was hospitalized for four days. As of 03 Nov 2021, his kidneys were being monitored every six months because of the kidney stones. There were 25 different medications that he was taking as of 03Nov2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Aug2020, he received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNtech. In Oct2020, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNtech. In Jun2021, he received 3rd dose COVID-19 Vaccine manufactured by Pfizer/BioNtech. The patient was treated with oxycodone, coumadin, warfarin, lovenox and lidocaine. Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB): The reporter's causality for the event(s) of portal vein thrombosis/bleeding, intestinal blockage, portal vein thrombosis, right kidney stones, low iron level, low platelets, low red blood cells, cyst on left kidney/probably benign and recurring right and left kidney stones with HUMIRA 40MG/0.4ML (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of two big blood clot in the lower left abdomen and crohn's disease flare up with HUMIRA 40MG/0.4ML (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of intestinal blockage infection and bad headache was not provided. Conpany's opinion is that there is no reasonable possibility that the events of portal vein thrombosis/bleeding, intestinal blockage, portal vein thrombosis, two big blood clot in the lower left abdomen, intestinal blockage infection, right kidney stones, crohn's disease flare up, low iron level, low platelets, low red blood cells, bad headache and recurring right and left kidney stones are related to HUMIRA 40MG/0.4ML (ADALIMUMAB). Conpany's opinion is that the event of CYST ON LEFT KIDNEY/PROBABLY BENIGN is not assessable. Relevant Laboratory & Other Diagnostic Tests: Oct2021 blood works: very morning and afternoon, checking for Lidocaines. Feb2021 computed tomography of the abdomen: Huge portal thrombosis. Feb2021 computed tomography scan: In the head and neck - No significant findings. Headache was reported unrelated to BNT162B2 by reporter. The action taken in response to the events for adalimumab was dose not changed. The outcome of the events portal vein thrombosis was recovered in 2021, other events was unknown.  The reporter's assessment of the causal relationship of the events ' received 3rd dose/portal vein thrombosis/bleeding ' with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events Immunisation, Portal vein thrombosis , Venous haemorrhage was assessed as possibly related to the suspect drug BNT162B2 based on temporal association.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.