Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Haematochezia, Pain in extremity, Vaccination site pain
Clinical narrative: Blood in stool; sore arm following vaccines; Joint pain; Vaccination site pain; 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-163-4370017-00 (AbbVie).  A 55-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 3, (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1154253), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Daily Dose:2) 2nd Dose (1 in 1 Once), Route of Admin: 2) Intramuscular), administration date: 06Feb2021, when the patient was 54-year-old, for COVID-19 Immunization; BNT162b2 (Daily Dose:1) 1st Dose (1 in 1 Once), Route of Admin: 1) Intramuscular), administration date: 16Jan2021, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "Blood in stool"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm following vaccines"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "blood in stool", "sore arm following vaccines", "joint pain" and "vaccination site 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.  Clinical information included: Patient repots events of non-serious Sore arm following vaccines, Joint Pain and Bowel Movement were more formed saw blood on the tissue when wipes with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced sore arm following vaccines, joint pain and bowel movements wer more formed saw blood on the tissue when wipes. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of sore arm following vaccines, joint pain and bowel movements were more formed saw blood on the tissue when wipes was not provided. Change History : On 23May2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of bowel movements were more formed saw blood on the tissue when wipes was added.  Follow-up (25May2022): This is a solicited follow-up report based on the information received by Pfizer from AbbVie (Mfr Control No.: 22K-163-4370017-00). A consumer reported that: New Event (Vaccination site pain, Blood in stool).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events "sore arm following vaccines" and "joint pain"  and the administration of the vaccine cannot be excluded.