Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, Crohn's disease, Diarrhoea, Vaccination site pain, Vomiting
Clinical narrative: crohns disease flare ups; diarrhea; trouble with right arm where got pfizer biontech both vaccine shots arm was sore/mild pain; throwing up; abdominal pain and cramping; abdominal pain and cramping; 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-163-4323789-00.  A 37 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right (Batch/Lot number: unknown) as dose 1, single and intramuscular, administered in arm right (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159243) at citrate free for crohn's disease. Relevant medical history included: "Multiple sclerosis", start date: 2001 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "crohns disease flare ups"; DIARRHOEA (medically significant), outcome "not recovered", described as "diarrhea"; VACCINATION SITE PAIN (medically significant), outcome "recovering", described as "trouble with right arm where got pfizer biontech both vaccine shots arm was sore/mild pain"; VOMITING (medically significant), outcome "not recovered", described as "throwing up"; ABDOMINAL PAIN (medically significant), ABDOMINAL PAIN (medically significant), outcome "not recovered" and all described as "abdominal pain and cramping". The action taken for adalimumab was unknown.  Causality for Humira(Adalimumab) The reporter's causality for the event(s) of multiple sclerosis, trouble with right arm where got pfizer Biontech both vaccine shots arm was sore/mild pain and Crohn's disease flare up was not provided.Regulatory authority opinion is that the event of multiple sclerosis is not assessable. Regulatory authority opinion is that there is No reasonable possibility that the events of trouble with right arm where got Pfizer biontech both vaccine Shots arm was sore/mild pain and crohn's disease flare up are related to Humira(Adalimumab).  The reporter's assessment of the causal relationship of the events Multiple sclerosis, Crohn's disease aggravated (Crohn's disease) and Vaccination site pain with the suspect product BNT162B2 was not reported and Possible at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Clinical Course: Solicited report by a consumer of a 37-year-old female with events of multiple sclerosis and non-serious trouble with right arm where got Pfizer Biontech both vaccine shots arm was sore/mild pain and Crohn's disease flare up With Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced trouble with right arm where got Pfizer Biontech both vaccine shots arm was sore/mild pain and Crohn's disease flare up. In 2001, the patient experienced multiple sclerosis. Pfizer Biontech covid-19. Vaccine (Tozinameran) was also considered suspect. In 2001, the patient was diagnosed with multiple sclerosis. She had Crohns disease flare ups in the form of Diarrhea, throwing up, abdominal pain and cramping. She had trouble with right arm where she got both vaccine Shots and arm was sore and had mild pain.   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 information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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.