Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Fatigue, Pain
Clinical narrative: Crohn's disease; Tiredness; Ache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20K-163-3587994-00.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 1 , single (Batch/Lot number: unknown), as dose 2 , single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen from 2015 to Jul2020 at 40 mg (40 mg (1 in 14 d)) and second regimen since Sep2020 at 40 mg (40 mg (1 in 14 d)), all subcutaneous for crohn's disease. The patient's relevant medical history included: "Colectomy of sigmoid colon" (unspecified if ongoing), "Crohns disease" (unspecified if ongoing). The patient had been off HUMIRA since 15th July 2020 because she had a partial colectomy of the sigmoid colon for Crohns disease in 2020. She was in hospital after procedure. The outcome of surgery was recovered and causality was no reasonable possibility with regards to HUMIRA. She was achy and tired from fourth COVID shot. She had same reaction as other three COVID shots all were Pfizer. Concomitant medication(s) included: PENTASA; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [COBAMAMIDE]; LORAZEPAM A. It was unknown if she was enrolled in a COVID-19 trial. The following information was reported: CROHN'S DISEASE (medically significant),  outcome "unknown"; FATIGUE (medically significant), outcome "recovering", described as "Tiredness"; PAIN (medically significant), outcome "recovering", described as "Ache". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "crohn's disease" with the suspect product(s) BNT162b2 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 reporter considered "tiredness" and "ache" related to BNT162b2.  Causality for HUMIRA 40mg/0.8 ML (ADALIMUMAB): The reporters causality for the events of CROHNS disease was not provided. The reporters causality for the events of COVID shot booster reaction/ achy/tired unknown onset with HUMIRA 40mg/ 0.8 ML (ADALIMUMAB) was no reasonable possibility. The companies option is that there is no reasonable possibility that the events of CROHNS disease COVID shot booster reaction/achy/tired unknown onset and COVID shot booster reaction/achy/tired unknown onset are related to HUMIRA 40mg/0.8ml (ADALIMUMAB).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the events reported and the suspect drug BNT162B2  cannot be ruled out. 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