Age: 82.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chills, Computerised tomogram, Crohn's disease
Clinical narrative: Crohn's aggravated; Chills; Aching joints; This is a solicited report based on the information received by Pfizer from Manufacturer (Mfr. control no.: 21K-163-3936556-00). A contactable 82-year-old male consumer (patient) and a non-contactable consumer (Patient's wife):  A 82-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on 03Feb2021 as dose 2, single for COVID-19 immunization and adalimumab (HUMIRA), subcutaneous from 2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg, 1 in 2 wk) for crohn's disease.The patient previously received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) vial intramuscular route of administration on 13Jan2021 as dose 1, single for COVID-19 immunization.The patient medical history include hypersensitivity, Crohn's disease, Anxiety, pain, Supplementation therapy. Patient's wife stated that the patient was allergic to two medications to improve his bone density but could not recall the specific medication, bone density abnormal, Abstains from alcohol, Sesame Seeds and Oil allergy manifested by red face and throat swelling and Sulfa Drugs Allergy. The patient was non-tobacco user.Concomitant medication included ciprofloxacin (CIPROFLOXACIN) for crohn's disease, azathioprine (AZATHIOPRINE) for crohn's disease, lisinopril (LISINOPRIL) for crohn's disease, balsalazide (BALSALAZIDE) for crohn's disease, venlafaxine (VENLAFAXINE) for anxiety, oxycodone (OXYCODONE) for pain, betacarotene;calcium carbonate;cyanocobalamin;folic acid;nicotinic acid;pyridoxine hydrochloride;riboflavin;sodium ascorbate;thiamine hydrochloride;tocopheryl acetate taken for supplementation therapy, hyoscyamine for crohn's disease and valsartan taken for an unspecified indication. On 04Feb2021, the patient experienced Chills, Aching joints and Crohn's aggravated.On an unknown date, the patient underwent lab tests which included computerized tomogram: unknown results. The action taken in response to the event(s), for adalimumab was unknown. On 07Feb2021, the patient recovered from chills and Aching joints and had not yet recovered from Crohn's aggravated.  Causality as per reporter for event chills and aching joints as probable and for Crohn's aggravated not reportable    No follow-up attempts are needed, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in narrative, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the reported events of Crohn's aggravated ,chills and arthralgia cannot be 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.