Sex: F
Vaccine: COVID19, UNK
Symptoms: Appetite disorder, Arthralgia, COVID-19, Cholecystitis, Colitis
Clinical narrative: Right hip had been sore; Colon inflamed; Acid reflux; Limitation on diet appetite was not good; Left hip replaced; Gallbladder inflammation; Dysfunctional or irritable bowel; Irritable bowel; Cold; Sore and hurt all the time; sick; tiredness; a fair amount of diarrhea; She felt always achy; COVID-19; Drug ineffective; sometimes have to stay in bed; 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): 21K-163-3975439-00.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at citrate free and second regimen subcutaneous (Batch/Lot number: unknown) at citrate free for crohn's disease. Relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (hospitalization, medically significant), outcome "not recovered", described as "Right hip had been sore"; COLITIS (hospitalization, medically significant), outcome "not recovered", described as "Colon inflamed"; GASTROOESOPHAGEAL REFLUX DISEASE (hospitalization, medically significant), outcome "not recovered", described as "Acid reflux"; APPETITE DISORDER (hospitalization, medically significant), outcome "not recovered", described as "Limitation on diet appetite was not good"; HIP ARTHROPLASTY (hospitalization, medically significant), outcome "unknown", described as "Left hip replaced"; CHOLECYSTITIS (hospitalization, medically significant), outcome "not recovered", described as "Gallbladder inflammation"; FUNCTIONAL GASTROINTESTINAL DISORDER (hospitalization, medically significant), outcome "unknown", described as "Dysfunctional or irritable bowel"; IRRITABLE BOWEL SYNDROME (hospitalization, medically significant), outcome "recovered", described as "Irritable bowel"; COVID-19 (hospitalization, medically significant) with onset Jan2022, outcome "not recovered", described as "COVID-19"; NASOPHARYNGITIS (hospitalization, medically significant), outcome "not recovered", described as "Cold"; PAIN (hospitalization, medically significant), outcome "not recovered", described as "Sore and hurt all the time"; ILLNESS (hospitalization, medically significant), outcome "unknown", described as "sick"; FATIGUE (hospitalization, medically significant), outcome "unknown", described as "tiredness"; DIARRHOEA (hospitalization, medically significant), outcome "unknown", described as "a fair amount of diarrhea"; PAIN (hospitalization, medically significant), outcome "unknown", described as "She felt always achy"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "sometimes have to stay in bed". The action taken for adalimumab was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical Course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Moderate to severe adult Crohn's disease. She felt always achy, sore, hurt all the time, as she had bed bugs at her home been lifting a lot. She had limitations on her diet as her appetite was not good. She was taking Interactive Voice Response, when she ate protein it filled her up.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of colon inflamed and dysfunctional or irritable bowel unknown onset with HUMIRA(Adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of acid reflux, limitation on diet appetite was not good, left hip replaced, gallbladder inflammation, dysfunctional or irritable bowel unknown onset, covid-19, got cold easily/seems to be colder between meals and sometimes have to stay in bed, sore and hurt all the time and right hip had been sore was not provided. Agency's opinion is that there is no reasonable possibility that the events of colon inflamed, acid reflux, limitation on diet appetite was not good, left hip replaced, gallbladder inflammation, dysfunctional or irritable bowel unknown onset, dysfunctional or irritable bowel unknown onset, covid-19, got cold easily/seems to be colder between meals and sometimes have to stay in bed, sore and hurt all the time and right hip had been sore are related to HUMIRA(Adalimumab).  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN): The reporter's causality for the event(s) of colon inflamed and dysfunctional or irritable bowel, acid reflux, limitation on diet appetite was not good, left hip replaced, gallbladder inflammation, dysfunctional or irritable bowel unknown onset, covid-19, got cold easily/seems to be colder between meals and sometimes have to stay in bed, sore and hurt all the time and right hip had been sore was not provided.; Sender's Comments: Based on the information in the case report, a causal association between reported events arthralgia, drug ineffective, Covid-19, nasopharyngitis, pain, illness, fatigue, diarrhoea, movement disorder and suspect cannot be excluded. Colitis, gastroesophageal reflux disease, appetite disorder, hip arthroplasty, cholecystitis, functional gastrointestinal disorder, irritable bowel syndrome, are considered unrelated to BNT162b2 and may be due to underlying medical condition and age related changes. 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