Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Body temperature, COVID-19, Colitis ulcerative, Computerised tomogram, Drug ineffective
Clinical narrative: Colitis ulcerative aggravated; Numbness; Fever; Fatigue; COVID-19; COVID-19; Obstruction; Inflammation; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4457820-00 (Agency).  A 54-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at unk (1 in 2 wk) and second regimen since 2020 (Batch/Lot number: unknown) at unk (1 in 1 wk), all subcutaneous for colitis ulcerative. The patient's relevant medical history included: "covid-19", start date: 2020 (unspecified if ongoing), notes: In 2020, she had covid-19. The patient's concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (hospitalization, medically significant) with onset 2020, outcome "unknown", described as "Colitis ulcerative aggravated"; INFLAMMATION (non-serious) with onset 2020, outcome "recovering"; OBSTRUCTION (non-serious) with onset 2020, outcome "recovering"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "recovered" and all described as "COVID-19"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; FATIGUE (non-serious), outcome "unknown". The patient was hospitalized for colitis ulcerative (start date: 2020, hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results; Computerised tomogram: (2020) Unknown results, notes: Inflammation; SARS-CoV-2 test: (unspecified date) Unknown results. The action taken for adalimumab was temporarily withdrawn.  The reporter's assessment of the causal relationship of "colitis ulcerative aggravated", "covid-19", "obstruction" and "inflammation" 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 reporter considered "numbness", "fever" and "fatigue" related to BNT162b2.  Clinical information: Solicited report by a consumer of a 54-year-old female with events of blockage, inflammation and ulcerative colitis symptoms flare up and non-serious covid, covid vaccine issue of numbness, covid vaccine issue of fever and covid vaccine issue of fatigue with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced covid vaccine issue of numbness, covid vaccine issue of fever and covid vaccine issue of fatigue. In 2020, the patient experienced blockage, inflammation, ulcerative colitis symptoms flare up and covid. In Dec2021, the patient experienced covid. On an unknown date, covid resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient was taking Humira biweekly. In 2020, she was hospitalized due to not being able to get Humira. In 2020, she had an ulcerative colitis flare that had started that resulted in hospitalization. Computerized tomography scan showed inflammation. They almost considered a blockage. She spent five days in the hospital. After hospitalization, she was on Humira weekly. She did not have any problems since then. In 2020, she had covid-19. She was hospitalized in Jul2022 due to a flare up of symptoms. She had been without medication for 2 weeks due insurance coverage. She had covid vaccine issue of numbness, fever, fatigue. She did not agree to have physician contacted. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. The lot number rationale for second regimen was Primary reporter contact for lot number information was unsuccessful. Lab Result: Test name: CT SCAN. Test date: 2020.  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 the available information in the case, the causal association between the event Colitis ulcerative aggravated, Drug ineffective, COVID-19 (Serious), Obstruction, Inflammation, Numbness, Fever, Fatigue and the suspect drug BNT162B2 cannot be 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.