Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Colitis ulcerative, Constipation, Fatigue, Headache
Clinical narrative: occasional ulcerative colitis flare up; red area at injection site; itchy at injection site; flare up/had issues with constipation; Headache; Fatigue; losing hair/hair breaking/brittle/falling out; losing hair/hair breaking/brittle/falling out; injections site reaction of hot; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No. :21K-163-4026605-00).  A non-contactable consumer (patient) reported a 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 20Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at Citrate free for moderate to severe ulcerative colitis.  The patient's medical history and concomitant medications was not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscularly on 20Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 vaccination. The patient experienced non-serious events red area at injection site, itchy at injection site, flare up/had issues with constipation, had covid-19 Pfizer of second injection of headache and fatigue, losing hair/hair breaking/brittle/falling out, occasional ulcerative colitis flare up and injections site reaction of hot with Humira (Adalimumab). On unknown dates, the patient experienced red area at injection site, itchy at injection site, flare up/had issues with constipation, losing hair/hair breaking/brittle/falling out, occasional ulcerative colitis flare up and injections site reaction of hot. in 2021, the patient experienced had covid-19 Pfizer of second injection of headache and fatigue. Pfizer BioNTech covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken in response to the event(s) for adalimumab was dose not changed. The outcome of occasional ulcerative colitis flare up, red area at injection site, itchy at injection site, flare up/had issues with constipation and injections site reaction of hot was not recovered. The outcome of other events was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of red area at injection site, itchy at injection site, had covid-19 Pfizer of second injection of headache and fatigue onset in 2021, had covid-19 Pfizer of second injection of headache and fatigue onset in 2021 and losing hair/hair breaking/brittle/falling out unknown onset with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of flare up/had issues with constipation, occasional ulcerative colitis flare up and injections site reaction of hot with Humira (Adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of losing hair/hair breaking/brittle/falling out unknown onset was not provided.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events ulcerative colitis aggravated, vaccination site erythema, vaccination site pruritus, UC flare up ,constipation, trichorhexis , alopecia, and injections site reaction , vaccination site warmth and suspect drug BNT162B2 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.