Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Psoriasis, Therapeutic response shortened, Vaccination site pain
Clinical narrative: Crohn's; covid vaccine caused sore shoulder; plaque psoriasis flare up about six to eight weeks before next skyrizi injection on face and hair line and scalp; plaque psoriasis flare up about six to eight weeks before next skyrizi injection on face and hair line and scalp; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4336950-00.  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 15Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "recovered", described as "Crohn's"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "covid vaccine caused sore shoulder"; PSORIASIS (non-serious), THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "recovered" and all described as "plaque psoriasis flare up about six to eight weeks before next skyrizi injection on face and hair line and scalp". The action taken for risankizumab was unknown. Clinical Course: The patient was adult female with events of increase of fluid being released in the ileostomy due to crohn's and non-serious covid vaccine caused sore shoulder and plaque psoriasis flare up about six to eight weeks before next SKYRIZI injection on face and hair line and scalp with SKYRIZI (RISANKIZUMAB). On unknown dates, the patient experienced increase of fluid being released in the ileostomy due to crohn's, covid vaccine caused sore shoulder and plaque psoriasis flare up about six to eight weeks before next SKYRIZI injection on face and hair line and scalp. On unknown dates, increase of fluid being released in the ileostomy due to crohn's, covid vaccine caused sore shoulder and plaque psoriasis flare up about six to eight weeks before next SKYRIZI injection on face and hair line and scalp resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient got flair up about six to eight weeks before next injection on face and hair line and scalp, topical creams help it to go away. The vaccine caused sore shoulder for 24 to 48 hours. She had noticed an increase of fluid being released in the Ileostomy due to chrohns. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of increase of fluid being released in the ileostomy due to crohn's, covid vaccine caused sore shoulder, plaque psoriasis flare up about six to eight weeks before next skyrizi injection on face and hair line and scalp unknown onset and plaque psoriasis flare up about six to eight weeks before next skyrizi injection on face and hair line and scalp unknown onset was not provided. Agency opinion is that there is no reasonable possibility that the events of increase of fluid being released in the ileostomy due to crohn's, covid vaccine caused sore shoulder, plaque psoriasis flare up about six to eight weeks before next skyrizi injection on face and hair line and scalp unknown onset and plaque psoriasis flare up about six to eight weeks before next skyrizi injection on face and hair line and scalp unknown onset are related to SKYRIZI(RISANKIZUMAB).  The reporter's assessment of the causal relationship of "crohn's" and "plaque psoriasis flare up about six to eight weeks before next skyrizi injection on face and hair line and scalp" 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 "covid vaccine caused sore shoulder" related to BNT162b2.  No Follow-up attempts are needed. Information about lot/batch cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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