Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Diarrhoea, Inflammatory marker increased, Pain, Vaccination site pain
Clinical narrative: Colitis ulcerative aggravated; covid vaccine issue/sore arm; loose stools; pain; Inflammatory marker increased; 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-163-4303698-00.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 19Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1160679) at weekly (citrate free (1 in 2 wk)) and second regimen since 22May2022 (Lot number: 1160836) at citrate free (1 in 1 wk), all subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "recovering", described as "Colitis ulcerative aggravated"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "covid vaccine issue/sore arm"; DIARRHOEA (non-serious), outcome "recovering", described as "loose stools"; PAIN (non-serious), outcome "unknown"; INFLAMMATORY MARKER INCREASED (non-serious), outcome "unknown". The action taken for adalimumab was dosage permanently withdrawn.  The reporter's assessment of the causal relationship of "colitis ulcerative aggravated", "loose stools", "pain" and "inflammatory marker increased" 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 "covid vaccine issue/sore arm" related to BNT162b2.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID vaccine issue/sore arm, elevation inflammation markers, loose stools, pain and ulcerative colitis flares was not provided.  Causality for Pfizer-BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of Vaccination site pain was probable, Inflammatory marker increased, Loose stools, Pain, Colitis ulcerative aggravated was not reported  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality as per reporter (Drug/Vaccine) for Vaccination site pain was Probable. Causality as per reporter (Drug/Vaccine): for Loose stools and Pain was Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (25Aug2022): This is a solicited follow-up report from a Non-Interventional Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer from manufacturer, MFR Control No. 22K-163-4303698-00). A contactable male consumer (patient) reported for himself that: Updated information included: New AE "Colitis ulcerative aggravated; Inflammatory marker increased " added. New Lot no. added for co-suspect. On 03May2022, received updates to event information, suspect drug information, concomitant drug information and narrative description.  On 09Jul2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The events of "COVID vaccine issue/sore arm" and "pain" were added.  On 19Aug2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The events of "elevation inflammation markers" and "ulcerative colitis flares" were added.  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 information in the case report, a possible causal relationship between the reported events: "Colitis ulcerative", "Diarrhoea", "Pain", "Inflammatory marker increased", "Vaccination site pain" and the suspect drug BNT162B2 cannot be completely excluded.