Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Crohn's disease, Drug ineffective, Influenza, Nasopharyngitis
Clinical narrative: crohn's disease progressively worsened; during the first six months of Humira seemed to get progressively worse and worse/started felt better about a month ago; Cold; Flu; experienced COVID-19; experienced COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4261980-00 (Agency).  A 30 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular, administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since Aug2021 (ongoing) (Batch/Lot number: unknown) at citrate free for crohn's disease. Relevant medical history included: "Blood in stool", start date: 03Mar2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered" (2022) and all described as "experienced COVID-19"; CROHN'S DISEASE (medically significant), outcome "recovering", described as "crohn's disease progressively worsened"; THERAPEUTIC PRODUCT EFFECT DELAYED (non-serious), outcome "not recovered", described as "during the first six months of Humira seemed to get progressively worse and worse/started felt better about a month ago"; NASOPHARYNGITIS (non-serious), outcome "recovered", described as "Cold"; INFLUENZA (non-serious), outcome "recovered", described as "Flu". The action taken for adalimumab was dosage not changed. The reporter considered "cold" and "flu" related to bnt162b2. It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event(s) of Drug effect delayed, Crohn's disease aggravated COVID-19 was not reported,  Cold and Flu was possible. The reporter's causality for the event(s) of during the first six months of Humira seemed to get progressively worse and worse/started felt better about a month ago/ crohn's disease progressively worsened unknown onset, during the first six months of Humira seemed to get progressively worse and worse/started felt better about a month ago/ crohn's disease progressively worsened unknown onset and covid-19 with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of cold and flu with Humira (adalimumab) was no reasonable possibility.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available. 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.