Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Constipation, Crohn's disease, Drug ineffective, Dyspnoea
Clinical narrative: Crohn's aggravated; Humira was not stopping problem/did not like it/Lack of drug effect; Loss of energy; Somnolence; Pain; Cramps; Sluggishness; Constipation; Feeling abnormal; feel out of breath; This is a solicited report,( Manufacturer control number: 21K-163-4027682-00) via a contactable consumer (patient).   A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) at age of 60 years old as a single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe adult Crohns disease. The patient's medical history and concomitant medications were not reported.  The patient experienced crohn's aggravated, humira was not stopping problem/did not like it/Lack of drug effect, loss of energy, somnolence, pain, cramps, sluggishness, constipation, feeling abnormal, feel out of breath, all in 2021.  The action taken in response to the events for adalimumab was unknown.  Therapeutic measures were taken as a result of all events. The outcome of loss of energy, pain, crohns aggravated, cramps, sluggishness, all was not recovered, somnolence, humira was not stopping problem/did not like it/Lack of drug effect, constipation, feeling abnormal, all was recovered in 2021, feel out of breath was unknown.  Clinical course: Solicited report by a consumer of an adult female with events of non-serious without energy, sleepy all time/drowsy, pain, Crohns flare up, cramps, Humira was not stopping problem/did not like it, sluggish, constipated and covid shot made feel out of breath with Humira (adalimumab). there was no reported medical history. on unknown dates, the patient experienced without energy, sleepy all time/drowsy, pain, Crohns flare up, cramps, Humira was not stopping problem/did not like it, sluggish, constipated and covid shot made feel out of breath. On unknown dates, sleepy all time/drowsy, Humira was not stopping problem/did not like it, constipated and covid shot made feel out of breath resolved. Pfizer Biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The patient was treated with BENTYL and PREDNISONE. Causality for HUMIRA(ADALIMUMAB): The reporters causality for the events of without energy, Crohns flare up and covid shot made feel out of breath with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of sleepy all time/drowsy, pain, cramps, Humira was not stopping problem/did not like it, sluggish and constipated with HUMIRA(ADALIMUMAB) was a reasonable possibility. Change History: On 05Sep2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. the events of Humira was not stopping problem/did not like it, sluggish, constipated and covid shot made feel out of breath were added. the event of sleepy was amended to sleepy all time/drowsy. Causality for BNT162B2: The reporters causality for the events of without energy, sleepy all time/drowsy, pain, Crohns flare up, cramps, Humira was not stopping problem/did not like it, sluggish, constipation, feel out of breath, were not reported, the reporter's causality for the event of feeling abnormal was possible.   The reporter's assessment of the causal relationship of the events (crohn's aggravated, humira was not stopping problem/did not like it/Lack of drug effect, loss of energy, somnolence, pain, cramps, sluggishness, constipation, feel out of breath) with the suspect product 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 lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case , the causal relationship between BNT162B2 and the reported events are assessed as Unrelated.