Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Headache, Illness, Malaise, Oropharyngeal pain
Clinical narrative: Crohn's; Sick; Not feeling well; Headache; Sore throat; FACILITATED COLLECT  This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from (manufacturer control number: 21K-163-4121163-00) from a contactable consumer (patient)   This 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular on 11Oct2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at  Daily Dose: Citrate Free (as reported) for Moderate to severe ulcerative colitis.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced crohn's  on an unspecified date with outcome of recovering , sick) on Oct2021 with outcome of recovering , not feeling well on Oct2021 with outcome of recovering , headache on Oct2021 with outcome of recovering , sore throat on Oct2021 with outcome of recovering.  The action taken in response to the events for adalimumab was unknown.The clinical course was reported as follows: Solicited report from the by a consumer of a 38 year old male with events of non-serious Sick, Not feeling well, Headache, Sore throat and Crohn's with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Crohn's. In Oct2021, the patient experienced Sick, Not feeling well, Headache and Sore throat . Pfizer BioNTech COVID-19 Vaccine was also considered suspect. Additional information :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 Sick, Not feeling well, Headache, Sore throat and Crohn's was not provided.  Causality for  Pfizer BioNTech COVID-19 Vaccine  The reporter's causality for the event(s) of Sick, Not feeling well, Headache, Sore throat was possible for  Crohn's was not reported.         The reporter's assessment of the causal relationship of the event Crohn's 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.                                No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between BNT162B2 and Crohn's disease, Illness, Malaise, Headache, Oropharyngeal pain cannot be completely excluded.  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.