Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Guttate psoriasis
Clinical narrative: guttate psoriasis attributed to Humira and Pfizer-BioNTech COVID-19 Vaccine; This is a registry report (A LONG-TERM, OBSERVATIONAL STUDY WITHIN THE CORRONA INFLAMMATORY BOWEL DISEASE (IBD) REGISTRY TO CHARACTERIZE THE SAFETY OF TOFACITINIB IN PATIENTS WITH ULCERATIVE COLITIS IN THE POST- APPROVAL SETTING) (Post Authorization Safety Study) received from a contactable reporter(s) (Other HCP).  A 46-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 12Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; adalimumab (HUMIRA), from 15Sep2021 (Batch/Lot number: unknown) to 08Apr2022 at 40 mg (40 mg, q2w) for inflammatory bowel disease. The patient's relevant medical history included: "Ulcerative Colitis", start date: 2008 (ongoing), notes: Pertinent Details: Pan-colitis; "GERD", start date: 14Sep2012 (ongoing). Concomitant medication(s) included: IMURAN [AZATHIOPRINE] taken for inflammatory bowel disease, start date: 13Nov2021, stop date: 10Mar2022; LIALDA taken for inflammatory bowel disease, start date: 10Mar2015 (ongoing). Vaccination history included: BNT162b2 (dose 1), administration date: 25Jan2021, when the patient was 45-year-old, for COVID-19 immunisation; BNT162b2 (dose 2), administration date: 15Feb2021, when the patient was 45-year-old, for COVID-19 immunisation. The following information was reported: GUTTATE PSORIASIS (medically significant) with onset 12Mar2022, outcome "recovered" (20Jul2022), described as "guttate psoriasis attributed to Humira and Pfizer-BioNTech COVID-19 Vaccine". The action taken for adalimumab was dosage permanently withdrawn on 08Apr2022. Therapeutic measures were taken as a result of guttate psoriasis. Course of the event: This patient was reported to have experienced a reaction after receiving her second Pfizer-BioNTech COVlD-19 Vaccine Booster on 12Mar2022. The patient had also received her Humira injection on 15Mar2022. Following both, the patient complained of her back, sides shoulders becoming itchy with red marks noted all over. On 25Mar2022 the patient went to her family doctor who treated her with epinephrine prescribed 20 mg Prednisone for 5 days. The patient was referred to a dermatologist that diagnosed the patient with guttate psoriasis which the dermatologist felt was caused from the Pfizer vaccine and Humira overwhelming the patient's immune system. The patient was given a steroid cream as treatment for 7 days and saw improvement. This event is considered serious as the investigator deemed is medically significant. The investigator considered the event resolved on 20Jul2022. This event was attributed to the Pfizer COVID-19 vaccine as well as Humira and Humira was permanently withdrawn. This event was not attributed to any other medication(s). COVID-19 Vaccine (Pfizer/BioNTech) dose 1: (25Jan2021). dose 2: (15Feb2021);  The reporter considered "guttate psoriasis attributed to humira and pfizer-biontech covid-19 vaccine" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.