Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Eczema, Inappropriate schedule of product administration, Rash
Clinical narrative: Crohn's disease aggravated; Eczema; Localized rash; Inappropriate schedule of drug administration; 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-163-4235783-00 (Agency).  A 76-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's disease aggravated"; ECZEMA (non-serious), outcome "not recovered"; RASH (non-serious), outcome "not recovered", described as "Localized rash"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate schedule of drug administration". The action taken for adalimumab was unknown.  The reporter considered "crohn's disease aggravated", "eczema" and "localized rash" related to BNT162b2. The reporter's assessment of the causal relationship of "inappropriate schedule of drug administration" 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.  Clinical course: Solicited report from a consumer of an elderly female with events of non-serious Eczema, Rash On Back, Arms, And Head/Entire Body, Crohn's Disease Breakout and Pfizer And Humira Therapy On Same Day/Humira Was Taken Early with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced Eczema, Rash On Back, Arms, And Head/Entire Body, Crohn's Disease Breakout and Pfizer And Humira Therapy On Same Day/Humira Was Taken Early. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with Influenza. The reporter's causality for the event(s) of Eczema and Rash On Back, Arms, And Head/Entire Body With Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Crohn's Disease Breakout and Pfizer and Humira Therapy On Same Day/Humira Was Taken Early was not provided. Suspect Drug (S) Information: The Causality for the Humira to the events reported are "Reasonable possibility " for Eczema, Localized rash (Rash) and not reported for Crohn's disease aggravated (Crohn's disease) and Inappropriate schedule of drug administration (Inappropriate schedule of product administration). The casuality for the Pfizer Biontech COVID-19 vaccine (Tozinameran) to the events reported are "Possible" for Eczema, Localized rash (Rash), Crohn's disease aggravated (Crohn's disease) and not reported for Inappropriate schedule of drug administration (Inappropriate schedule of product administration). Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event Crohn's disease aggravated", "eczema" and "localized rash" rand the suspect vaccine COMIRNATY cannot be 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.