Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Crohn's disease, Frequent bowel movements
Clinical narrative: flare of crohn's disease; frequent bathroom visite to increased bowel movement; abdominal bloating; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from Abbvie (manufacturer control number: 21K-163-4073734-00).   Solicited report by a consumer of a 56-year-old male with events of frequent bathroom visits due to increased bowel movement, abdominal bloating and flare of Crohn's disease with Humira 40mg/0.4ml (Adalimumab). The patient had a relevant medical history of removed large intestine and ulcerative colitis. On 27Aug2021, the patient experienced frequent bathroom visits due to increased bowel movement, abdominal bloating, and flare of Crohn's disease. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. On 26Aug2021, the patient received third booster shot of Covid-19 vaccine. He did not pause Humira as per physician. The next day on 27Aug2021, he went out to dinner and ate foods he would normally not ate but had been able to tolerate or it would felt great while on Humira but this time he ended up getting a Crohn's disease flare and had to be on Budesonide. He had severe abdominal cramping, intestinal blockages by feeling the food getting clogged without any imaging tests done to confirm it. He had frequent bathroom visits due to increased bowel movement. He had worsened abdominal pain. He had been continuing Humira treatment, but flare was still lingering as of 09Sep2021. He was recovering from worsened abdominal pain, intestinal blockages, and abdominal cramping. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 21Feb2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number EN6200. On 13Mar2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number EN6206. On 26Aug2021, he received booster dose COVID-19 Vaccine manufactured by Pfizer, lot number FC3182.  Primary reporter did not have the lot number information, because the packaging was discarded. The patient was treated with BUDESONIDE.   Causality for Humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of frequent bathroom visits due to increased bowel movement, abdominal bloating and flare of Crohn's disease with Humira 40mg/0.4ml (adalimumab) was no reasonable possibility. (Withheld) opinion is that there is no reasonable possibility that the events of frequent bathroom visits due to increased bowel movement, abdominal bloating and flare of Crohn's disease are related to Humira 40mg/0.4ml(adalimumab). Causality for Pfizer-BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event increased bowel frequency was not reported, and for the events abdominal bloating and Crohn's disease aggravated was possible.  Other Relevant History included removed large intestine from 1988 to 1988, ulcerative colitis from 1988 to 1988, non-tobacco user, no alcohol use, moderate to severe adult Crohn's disease, cholesterol, high blood pressure, bleeding ulcers, allergies and back pain. Concomitant Drugs and dates of administration included atorvastatin for cholesterol; lisinopril for high blood pressure; amlodipine besylate for high blood pressure; NEXIUM for bleeding ulcers; CLARITIN for allergies; and duloxetine for back pain.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event of Chron's disease aggravated, abdominal distension and increased bowel movements is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient's medical history Crohn's disease ulcerative colitis. 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.