Sex: M
Vaccine: COVID19
Symptoms: Haemorrhoids, Insomnia, Loss of personal independence in daily activities, Malaise, Muscle spasms
Clinical narrative: suffered with other conditions; Blood in stool; bowel movements more frequent than usual; need to have bowel movements when bowel were empty; Rectal bleeding; Anemia; lost lot of weight; rectal bleeding/hemorrhoids; tired/very much tired; Bloating; passing gas; diarrhea about three times a day; Muscle spasms; Could not keep food down; hands joint pain; trouble sleeping due to stress; Eczema; nausea; not feeling well; trouble sleeping due to stress; Feeling anxious; not able to do things that peers/friends could do; lack of appetite/loss of appetite; lacking energy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4010643-00 (AbbVie).  A 44 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous since Aug2021 (ongoing) (Lot number: 1154442;1154444) at 40 mg (40 mg (40 mg,1 in 14 d)), second regimen subcutaneous from 22Jul2021 (Lot number: 1154442) to 22Jul2021 at 80 mg (80 (80 mg,1 in 1 once),) and third regimen subcutaneous from 08Jul2021 (Lot number: 1154442) to 08Jul2021 at 160 mg (160 (160 mg,1 in 1 once)) for colitis ulcerative. Relevant medical history included: "nausea" (unspecified if ongoing); "lack of appetite" (ongoing); "felt dehydrated" (unspecified if ongoing); "felt dizzy" (unspecified if ongoing); "weight loss" (unspecified if ongoing); "felt anxious" (unspecified if ongoing); "felt sad/blue" (unspecified if ongoing); "sometimes not able to/do things peers can do" (unspecified if ongoing); "not feeling well" (unspecified if ongoing); "diarrhea" (ongoing); "sudden or intense need to had bowel movement,three to four times a day/felt backed up" (unspecified if ongoing); "constipated" (unspecified if ongoing); "rectal bleeding/hemorrhoids" (unspecified if ongoing); "bloating" (ongoing); "passing gas" (unspecified if ongoing); "tired" (ongoing); "lack of energy" (unspecified if ongoing); "trouble sleeping" (ongoing); "can't keep food down" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE (ongoing); LIALDA (ongoing); IRON (ongoing). The following information was reported: ANAEMIA (hospitalization) with onset Jul2021, outcome "recovering", described as "Anemia"; HAEMATOCHEZIA (medically significant) with onset Aug2021, outcome "unknown", described as "Blood in stool"; WEIGHT DECREASED (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "lost lot of weight"; HAEMORRHOIDS (non-serious) with onset Jul2021, outcome "not recovered", described as "rectal bleeding/hemorrhoids"; FATIGUE (non-serious) with onset Jul2021, outcome "not recovered", described as "tired/very much tired"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset Aug2021, outcome "unknown", described as "bowel movements more frequent than usual"; DEFAECATION URGENCY (non-serious) with onset Aug2021, outcome "unknown", described as "need to have bowel movements when bowel were empty"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "not able to do things that peers/friends could do"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "lack of appetite/loss of appetite"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "lacking energy"; ABDOMINAL DISTENSION (non-serious) with onset Jul2021, outcome "not recovered", described as "Bloating"; FLATULENCE (non-serious) with onset Jul2021, outcome "unknown", described as "passing gas"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling well"; STRESS (non-serious), INSOMNIA (non-serious) all with onset 2021, outcome "unknown" and all described as "trouble sleeping due to stress"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Feeling anxious"; DIARRHOEA (non-serious) with onset Jul2021, outcome "unknown", described as "diarrhea about three times a day"; MUSCLE SPASMS (non-serious) with onset Jul2021, outcome "unknown", described as "Muscle spasms"; RECTAL HAEMORRHAGE (non-serious) with onset Jul2021, outcome "unknown", described as "Rectal bleeding"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "Could not keep food down"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "hands joint pain"; ECZEMA (non-serious) with onset 2021, outcome "unknown", described as "Eczema"; UNEVALUABLE EVENT (non-serious) with onset Oct2021, outcome "unknown", described as "suffered with other conditions"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nausea". The patient was hospitalized for anaemia (hospitalization duration: 4 day(s)). The event "anemia" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Oct2021) low iron level; haemoglobin: (unspecified date) 5.3 g/dl; (unspecified date) 9.4 g/dl; sars-cov-2 test: (unspecified date) negative; weight: (unspecified date) loss. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of fatigue, decreased appetite, asthenia, abdominal distension, flatulence, malaise, stress, anxiety, diarrhoea, muscle spasms, rectal haemorrhage, vomiting, arthralgia, eczema, unevaluable event, nausea. Patient had emergency room visit.   Causality for suspect PFIZER BIONTECH COVID-19 VACCINE BNT162B2 for the events were not reported and was possible for the unevaluable event (Unevaluable event). Causality for the co-suspect as per reporter for HUMIRA was not reporter for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events. 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.