Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Antibody test, Arthritis, Blood pressure measurement, Colonoscopy
Clinical narrative: Fatigue aggravated; Postnasal drip; Ankles swollen; Weight loss; Runny nose; Difficulty sleeping; Cough; Injection site discoloration; Drug specific antibody present; Mental concentration difficulty; Injection site itching; Memory impaired; Blood in stool; Rectal bleeding; Increased stool frequency; Painful feet; Leg cramps; Hand arthritis; Abnormal stools; Injection site stinging; This is a solicited report from a non-interventional study (facilitated collect) based on information received by Pfizer from the Regulatory Authority (mfr. control no.: 20k-163-3658232-00).  A contactable consumer (patient) reported for herself, a 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 61-years-old, via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP6955) as dose 1, single; via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: ER8731) as dose 2, single for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from 04Nov2020 (Batch/Lot number was not reported) to 04Nov2020, at 40 mg/0.8 ml, subcutaneous from 18Nov2020 (Batch/Lot number was not reported) to 18Nov2020, at 40 mg/0.8 ml, subcutaneous from Nov2020 (Batch/Lot number was not reported) to Jun2021, at 40 mg/0.4 ml (1 in 2 wk.), subcutaneous from Jun2021 (Batch/Lot number was not reported) and ongoing, at 40 mg/0.4 ml (1 in 1 wk.) for moderate to severe ulcerative colitis. Medical history included acute kidney injury from 2015, mobility impairment right foot/on mobility device from 2017, Right ankle reconstruction with tendon released/injured right ankle from 2019, headache, had sweat/chills, pain in stomach, diarrhea, constipation, not feeling hungry, nausea, rectal bleeding, trouble sleeping, feeling anxious or scared or sad or blue, not able to do things that peers or friends can do, missing activities due not feeling well, blood in stool, decreased appetite, no tobacco use, no alcohol use, Augmentin allergy manifested by rash, sulfa drugs allergy manifested by rash. Concomitant medications included clonidine taken for blood pressure abnormal; amlodipine taken for blood pressure abnormal; losartan taken for blood pressure abnormal; pravastatin taken for blood cholesterol; all start and stop date were not reported. The patient previously took Augmentin [amoxicillin sodium; clavulanate potassium] and experienced rash.    The patient experienced events constipation, Not feeling hungry, stools per day five to six semi formed to diarrhea with blood/rectal bleeding, not able to Do things that peers or friends could do, not feeling well, increased fatigue, nasal drainage / post nasal drip, Ankle swelling/swelling in both ankles, weight loss, runny nose, 4-5 formed bowel movements with blood per day, trouble sleeping, feeling anxious or scared or sad or blue, stuffy nose due to allergy, cough, lack of sleep, Dark spots left at each injection site, headache, sore throat, swelling in feet, high blood pressure, injection Site bruising, antibodies developed for Humira / antibodies to Humira too high, difficulty focusing/could not Organize tasks, itch at injection site, bruising at injection site, nausea after sleeping/brief nausea in the Morning, pain in stomach/abdomen, needs to write what needs to do so would remember it, lack of focus when Increasing dosage frequency, stinging on injection, pain in feet, leg cramps, arthritis in hands and sore arm With Humira 40mg/0.8ml (adalimumab) and Humira 40mg/0.4ml (adalimumab).   On unknown dates, the patient experienced increased fatigue, nasal drainage / post nasal drip, ankle swelling/ swelling in both ankles, weight loss, runny nose, cough, lack of sleep, dark spots left at each injection site, antibodies developed for humira / antibodies to humira too high, itch at injection site, needs To write what needs to do so would remember it, lack of focus when increasing dosage frequency, stinging on Injection, pain in feet, leg cramps, arthritis in hands and sore arm.   In Nov2020, the patient Experienced constipation, not feeling hungry, stools per day five to six semi formed to diarrhea with Blood/rectal bleeding, not able to do things that peers or friends could do, not feeling well, trouble sleeping, Feeling anxious or scared or sad or blue, stuffy nose due to allergy, headache, swelling in feet, high blood pressure, difficulty focusing/could not organize tasks, bruising at injection site, nausea after sleeping/brief nausea in the morning and pain in stomach/abdomen. On 29Nov2020, the patient experienced sore throat. In Nov2020, the headache resolved. In Dec2020, the patient experienced injection site bruising. In 2021, the patient experienced 4-5 formed bowel movements with blood per day. In Jan2021, the difficulty focusing/could not organize tasks resolved.   On unknown dates, 4-5 formed bowel movements with blood per day/abnormal faeces, Lack of focus when increasing dosage frequency, stinging on injection and sore arm resolved. Pfizer biontech Covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient underwent lab test and procedures which included antibody test: antibodies had developed to humira, blood pressure: high, 150 on Nov2020, colonoscopy on Unknown date: ulcerative colitis was active, CT scan of abdomen on unknown date: negative for blood clots.   The outcome of the events bloody diarrhea, decreased appetite, Activities of daily living impaired, Feeling unwell, Fatigue aggravated, Postnasal drip, Difficulty sleeping, Feeling anxious, Feeling sad, Cough, Injection site discoloration, Swelling of feet, Drug specific antibody present, Injection site itching, Injection site bruising, Bloody diarrhea, Nausea, Abdominal pain, Painful feet, Leg cramps, Hand arthritis was not recovered; rectal bleeding, constipation, abnormal stools, Increased stool frequency, Blood in stool, Headache, Injection site stinging, Mental concentration difficulty/ Concentration loss, Injection site stinging was recovered in 2021 (also reported as improved); Ankles swollen was recovering; events Weight loss, runny nose, Nasal stuffiness, Sore throat, Blood pressure high, Allergy, Memory impaired was unknown.  Causality for humira 40mg/0.8ml(adalimumab): The reporter's causality for the event(s) of constipation, not feeling hungry, stools per day five to six semi Formed to diarrhea with blood/rectal bleeding onset in Nov2020, not able to do things that peers or friends could do, not feeling well, increased fatigue, nasal drainage / post nasal drip, ankle Swelling/swelling in both ankles, weight loss, runny nose, 4-5 formed bowel movements with blood per day onset In 2021, trouble sleeping, feeling anxious or scared or sad or blue onset in Nov2020, feeling anxious or Scared or sad or blue onset in Nov2020, stuffy nose due to allergy onset in Nov2020, cough, lack of Sleep, dark spots left at each injection site, 4-5 formed bowel movements with blood per day onset in 2021, Headache, sore throat, swelling in feet, high blood pressure, stuffy nose due to allergy onset in Nov2020, antibodies developed for humira / antibodies to humira too high, difficulty focusing/could not organize Tasks, bruising at injection site, stools per day five to six semi formed to diarrhea with blood/rectal Bleeding onset in Nov2020, stools per day five to six semi formed to diarrhea with blood/rectal bleeding Onset in Nov2020, nausea after sleeping/brief nausea in the morning, pain in stomach/abdomen, needs to Write what needs to do so would remember it, lack of focus when increasing dosage frequency, stinging on Injection, pain in feet, leg cramps, arthritis in hands and sore arm was not provided. The reporter's causality For the event(s) of injection site bruising and itch at injection site with humira 40mg/0.8ml(adalimumab) was A reasonable possibility.   Causality for humira 40mg/0.4ml (adalimumab): The reporter's causality for the event(s) of constipation, not feeling hungry, stools per day five to six semi Formed to diarrhea with blood/rectal bleeding onset in Nov2020, not able to do thbgs that peers or Friends could do, not feeling well, weight loss, runny nose, 4-5 formed bowel movements with blood per day Onset in 2021, trouble sleeping, feeling anxious or scared or sad or blue onset in Nov2020, feeling Anxious or scared or sad or blue onset in Nov2020, stuffy nose due to allergy onset in Nov2020, Headache, sore throat, high blood pressure, stuffy nose due to allergy onset in Nov 2020, injection site Bruising, stools per day five to six semi formed to diarrhea with blood/rectal bleeding onset in Nov2020, Stools per day five to six semi formed to diarrhea with blood/rectal bleeding onset in Nov2020, nausea, After sleeping/brief nausea in the morning, pain in stomach/abdomen, needs to write what needs to do so would Remember it, leg cramps and arthritis in hands was not provided. The reporter's causality for the event(s) of Increased fatigue, nasal drainage / post nasal drip, ankle swelling/swelling in both ankles, cough, lack of Sleep, dark spots left at each injection site, 4-5 formed bowel movements with blood per day onset in 2021, Swelling in feet, antibodies developed for humira / antibodies to humira too high, difficulty focusing/could Not organize tasks, itch at injection site, bruising at injection site, lack of focus when increasing dosage Frequency and stinging on injection with humira 40mg/0.4ml(adalimumab) was a reasonable possibility. The Reporter's causality for the event(s) of pain in feet and sore arm with humira 40mg/0.4ml(adalimumab) was no Reasonable possibility. Relevant laboratory & other diagnostic tests  The reporter's assessment of the casual relationship of the events 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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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.