Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Colitis ulcerative, Constipation, Depression, Hypersensitivity
Clinical narrative: does not see any drastic change; ulcerative colitis flare up; constipation; sneezing due to allergies; trouble sleeping; anxiety; depression; nausea; vomiting; rash at injection site; sneezing due to allergies; FACILITATED COLLECT  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): 20K-163-3351837-00 (AbbVie).  A 33 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as 40 mg,1 in 2 wk and subcutaneous, administration date 13Mar2020 (ongoing) (Batch/Lot number: unknown) as 40 mg,1 in 2 wk for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset 2020, outcome "not recovered", described as "ulcerative colitis flare up"; CONSTIPATION (non-serious) with onset 2020, outcome "recovering", described as "constipation"; SNEEZING (non-serious), HYPERSENSITIVITY (non-serious) all with onset 2020, outcome "not recovered" and all described as "sneezing due to allergies"; INSOMNIA (non-serious) with onset 2020, outcome "not recovered", described as "trouble sleeping"; ANXIETY (non-serious) with onset 2020, outcome "not recovered", described as "anxiety"; DEPRESSION (non-serious) with onset 2020, outcome "not recovered", described as "depression"; NAUSEA (non-serious) with onset 2020, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 2020, outcome "not recovered", described as "vomiting"; VACCINATION SITE RASH (non-serious) with onset 2020, outcome "unknown", described as "rash at injection site"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious) with onset 2020, outcome "unknown", described as "does not see any drastic change". The action taken for adalimumab was dosage not changed.  The reporter considered "ulcerative colitis flare up" not related to bnt162b2.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for 40MG/0.4ML adalimumab: The reporter's causality for the events of constipation, sneezing due to allergies onset in 2020, trouble sleeping, anxiety, depression, nausea, vomiting, rash at injection site and does not see any drastic change since starting HUMIRA was not provided. The reporter's causality for the event of ulcerative colitis flare up with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.   The reporter's assessment of the causal relationship of the events (except for ulcerative colitis flare up) with the 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events ulcerative colitis, constipation, sneezing, insomnia, anxiety, depression, nausea, vomiting, vac-cination site rash, hypersensitivity and therapeutic product effect incomplete and BNT162B2.  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.