Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Magnetic resonance imaging, Small intestinal obstruction, Viral infection
Clinical narrative: Tiredness/ tired easily; Viral infection/caught a virus; Small bowel obstruction; Dose 1 on 25Mar2021; Dose 2 on 12Apr2021; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Con-trol No. # 21K-163-3926388-00).   A non-contactable consumer (patient) reported that a 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 12Apr2021 (lot number and expiry date: unknown) at the age of 34-years-old as dose 2, single;  intramuscular on 25Mar2021 (lot number and expiry date: unknown) at the age of 34-years-old as dose 1, single, for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from Mar2019 (lot number and expiry date: unknown) to 27Apr2021, at 8571 mg (40 mg,1 in 2 wk) for Crohn's disease. Medical history included tobacco user from 2004 to May2021 , alcohol user from 2008 to an unknown date, acute myeloid leukaemia from 2017 to an unknown date, smoker, small intestine resection surgery in May2021 (Patient had an inpatient small intestine resection in May2021), and stomach spasm. The patient had a family history of acute myeloid leukemia. Concomitant medications included varenicline tartrate (CHAMPIX) to quit smoking, start and stop date were not reported; metoprolol taken for high blood pressure, start and stop date were not reported; dicyclomine taken for stomach spasm, start and stop date were not reported; venlafaxine hydrochloride (EFFEXOR) taken for antidepressant; start and stop date were not reported; and Tri-Trezisem.  The patient previously took morphine and experienced allergy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, the patient was tired easily (tiredness) and caught a virus (viral infection). In Jan2021, the patient experienced small bowel obstruction. The patient was told to quit smoking and was too clean without smoking. She had small intestine re-section surgery and was told not to take HUMIRA during surgery. She also had caught a virus and got over it as of 27May2021. The patient stated that she was told by her doctor that smoking was the cause of her small bowel obstruction. The patient underwent inpatient small intestine resection in May2021. The events tiredness, small bowel obstruction and viral infection/caught a virus were considered serious due to hospitalization on unspecified date, and due to other medically important condition. The patient underwent magnetic resonance imaging in Mar2021 which showed small bowel obstruction. Outcome of the events tiredness and small bowel obstruction was recovering, while for viral infection/caught a virus was recovered on 27May2021. The last action taken in response to the events for adalimumab was dose not changed.  Causality for HUMIRA (adalimumab): The reporter's causality for the events of small intestine resection, tired easily and caught a virus was not provided. The reporter's causality for the events of small bowel obstruction with HUMIRA (ADALIMUMAB) was reported as "no reasonable possibility". The company (AbbVie Inc.) assessed that there is no reasonable possibility that the events of small intestine re-section, tired easily and small bowel obstruction are related to HUMIRA (ADALIMUMAB). The company also assessed that there is a reasonable possibility that the event of caught a virus is related to HUMIRA (adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, the events Tiredness, Viral infection, Small bowel obstruction are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of acute myeloid leukaemia  may provide an explanation for the event of Tiredness and Viral infection; Crohn's disease may provide an explanation for the event of Small bowel obstruction.  The case will be reassessed if additional information becomes available.