Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Mucous stools, Stress
Clinical narrative: Fatigue/tired; joint pain/ joint pain worse in wrist, knee ankles and shoulder; increased stress; Bloating; Needed to have bowel movements even when bowels were empty/more frequent bowel movement; lacking energy; passing gas more than usual; increased symptoms of ulcerative colitis; high cholesterol; Fatigue; Mucus stools; Needed to have bowel movements even when bowels were empty; Difficulty sleeping; Insomnia; Headache; Abdominal crampy pains/abdominal pain/cramping; 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-163-4173153-00.  A 42-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 30Oct2021 as 160 mg daily, (citrate free), (1 in 1 once), day 1 (Lot number: 1153257), on 14Nov2021 as 80 mg, daily, (citrate free) (1 in 1 once), day 15 (Lot number: 1158135), on 13Dec2021 as 40 mg, (citrate free), (1 in 1 once), day 29 (Lot number: 1159243) and in Dec2021 (ongoing) as 40 mg, (1 in 2 wk)) (Lot number: 1161572), all subcutaneous for colitis ulcerative. The patient's relevant medical history included: "Diarrhea" (unspecified if ongoing); "Sudden need to have bowel movements" (unspecified if ongoing), notes: Sudden need to have bowel movements; "Rectal bleeding" (unspecified if ongoing); "Pass gas" (unspecified if ongoing), notes: Pass gas; "Felt tired" (unspecified if ongoing), notes: Felt tired; "Loss of Appetite" (unspecified if ongoing), notes: Loss of Appetite; "Frequent bowel movement" (unspecified if ongoing), notes: Frequent bowel movement; "Lacking energy" (unspecified if ongoing), notes: Lacking energy; "Bloating" (unspecified if ongoing), notes: Bloating; "Joint pain", start date: 2020 (unspecified if ongoing), notes: Joint pain; "Trouble sleeping" (unspecified if ongoing), notes: Trouble sleeping; "Needed to have bowel movements when bowels were empty" (unspecified if ongoing), notes: Needed to have bowel movements when bowels were empty; "Felt sad/blue" (unspecified if ongoing), notes: Felt sad/blue; "felt scared" (unspecified if ongoing), notes: felt scared; "Feeling Anxious" (unspecified if ongoing), notes: Feeling Anxious; "abdominal pain/cramping" (unspecified if ongoing); "mucus in stool" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 2021, outcome "recovered", described as "Abdominal crampy pains/abdominal pain/cramping"; INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "Difficulty sleeping"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021); HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021); INSOMNIA (non-serious) with onset 2021, outcome "unknown"; MUCOUS STOOLS (non-serious) with onset 2021, outcome "recovered", described as "Mucus stools"; DEFAECATION URGENCY (non-serious) with onset 2021, outcome "not recovered", described as "Needed to have bowel movements even when bowels were empty"; BLOOD CHOLESTEROL INCREASED (non-serious) with onset 2022, outcome "unknown", described as "high cholesterol"; ABDOMINAL DISTENSION (non-serious) with onset Aug2022, outcome "not recovered", described as "Bloating"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset Aug2022, outcome "unknown", described as "Needed to have bowel movements even when bowels were empty/more frequent bowel movement"; COLITIS ULCERATIVE (medically significant) with onset Aug2022, outcome "unknown", described as "increased symptoms of ulcerative colitis"; ASTHENIA (non-serious) with onset Aug2022, outcome "unknown", described as "lacking energy"; FLATULENCE (non-serious) with onset Aug2022, outcome "unknown", described as "passing gas more than usual"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue/tired"; ARTHRALGIA (non-serious), outcome "not recovered", described as "joint pain/ joint pain worse in wrist, knee ankles and shoulder"; STRESS (non-serious), outcome "unknown", described as "increased stress". The patient underwent the following laboratory tests and procedures: Blood cholesterol increased: (2022) High; Colitis ulcerative: (2022) Increase. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "increased symptoms of ulcerative colitis", "mucus stools", "needed to have bowel movements even when bowels were empty", "fatigue/tired", "difficulty sleeping", "insomnia", "abdominal crampy pains/abdominal pain/cramping", "bloating", "needed to have bowel movements even when bowels were empty/more frequent bowel movement", "lacking energy", "passing gas more than usual", "joint pain/ joint pain worse in wrist, knee ankles and shoulder", "increased stress" and "high cholesterol" 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 "fatigue" and "headache" related to BNT162b2.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient reported events of non-serious fatigue, mucus in stool, needed to have bowel movements even when bowels were empty, fatigue/tired, more frequent bowel movements, lacking energy, bloating, passing gas more than usual, increased stress, joint pain worse in wrist, knee ankles and shoulder, headache, abdominal pain/cramping, high cholesterol and increased symptoms of lcerative colitis with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of joint pain, diarrhea, sudden need to have bowel movements, rectal bleeding, pass gas, abdominal pain/cramping, felt tired, mucus in stool, loss of appetite, needed to have bowel movements when bowels were empty, frequent bowel movement, lacking energy, bloating, trouble sleeping, felt sad/blue, felt scared and felt anxious. On unknown dates, the patient experienced fatigue/tired, increased stress and joint pain worse in wrist, knee ankles and shoulder. In 2021, the patient experienced fatigueol, needed to have bowel movements even when bowels were empty, headache and abdominal pain/cramping. In 2021, the fatigue and headache resolved. In 2022, the patient experienced high cholesterol. In august 2022, the patient experienced more frequent bowel movements, lacking energy, bloating, passing gas more than usual and increased symptoms of ulcerative colitis. On unknown dates, mucus in stool, fatigue/tired and abdominal pain/cramping resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect.   Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB)'s causality for the event(s) of fatigue, mucus in stool, needed to have bowel movements even when bowels were empty, fatigue/tired, more frequent bowel movements, lacking energy, bloating, passing gas more than usual, increased stress, joint pain worse in wrist, knee ankles and shoulder, headache, abdominal pain/cramping, high cholesterol and increased symptoms of ulcerative colitis was not provided. Causality of events Fatigue and Headache was possible as per reporter and for other events it was not reported with Pfizer Biontech Covid-19 Vaccine.  Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB): The reporter's causality for the event(s) of fatigue, mucus in stool, needed to have bowel movements even when bowels were empty, fatigue/tired, Bloating, Joint pain, headache and abdominal pain/cramping was not provided. The reporter's causality for the event(s) of fatigue unknown onset and insomnia with HUMIRA 40MG/0.4ML (ADALIMUMAB) was a reasonable possibility.   The reporter considered "fatigue" and "headache" related to BNT162b2. The reporter's assessment of the causal relationship of "mucus stools", "needed to have bowel movements even when bowels were empty", "fatigue/tired", "difficulty sleeping", "insomnia", "abdominal crampy pains", "bloating" and "joint pain" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (31May2022): This is a solicited follow-up report from a Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer from another company. (MFR Control No.# 21K-163-4173153-00). A contactable 42-year-old male consumer (patient) reported for herself that: Updated Information includes: RMH Felt sad/blue, Felt scared, Felt anxious and Needed to have bowel movements when bowels were empty' added. Lot numbers, route of administration and dosage regimen added for Humira. 'FACILITATED COLLECT' has been deleted from add info tab.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (06Sep2022): This is a solicited follow-up report based on the information received by Pfizer from another company (Mfr Control No.: 21K-163-4173153-00).  Updated information: relevant medical history (abdominal pain/cramping, mucus in stool), lab data, Co-suspect dose details, events (Colitis ulcerative aggravated, Frequent bowel movements, lacking energy, Flatus increased, Arthralgia aggravated, Stress and high cholesterol), For the events abdominal pain, mucous stools (outcome updated), for the event abdominal distension (start date) and clinical information were added.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Abdominal pain, headache, fatigue, defecation urgency, mucous stools, insomnia which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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