Age: 63.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colon cancer, Fatigue, Vaccination site pain
Clinical narrative: Cancerous tumor in colon; Slight run down feeling; Experienced soreness around shot area; 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): 21K-163-4166925-00.  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Apr2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose No: 1, Route: Intramuscular, Daily dose: (1 in 1 Once)), administration date: 26Mar2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: COLON CANCER (medically significant) with onset 28Sep2021, outcome "not recovered", described as "Cancerous tumor in colon"; VACCINATION SITE PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Experienced soreness around shot area"; FATIGUE (non-serious) with onset 27Apr2021, outcome "not recovered", described as "Slight run down feeling". The action taken for risankizumab was unknown. Additional information:  Solicited report by a consumer of a 63-year-old male with events of cancerous tumor in colon and non-serious after covid vaccination experienced soreness around shot area/slight run down feeling the next day with Skyrizi (Risankizumab). On 26Apr2021, the patient experienced after Covid vaccination, soreness around shot area/slight run down feeling the next day. On 27Apr2021, the patient experienced after Covid vaccination, experienced soreness around shot area/slight run down feeling the next day. On 28Sep2021, the patient experienced cancerous tumor in colon. Pfizer Biontech Covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 vaccine trial. On 26Mar2021, he received first dose of Covid-19 vaccine manufactured by Pfizer/Biontech. On 26Apr2021, he received second dose of covid-19 vaccine manufactured by Pfizer/Biontech.  Causality for BNT162B2: Causality for Malignant neoplasm of colon as per reporter (Drug/Vaccine) was Not Reported and causality for Vaccination site pain and Tiredness as per reporter (Drug/Vaccine) was reported as Possible. Causality for Skyrizi (Risankizumab): the reporter's causality for the event(s) of cancerous tumor in colon, after Covid vaccination experienced soreness around shot area/slight run down feeling the next day onset 26Apr2021 and after Covid vaccination experienced soreness around shot area/slight run down feeling the next day onset 27Apr2021 was not provided. Abbvie's opinion is that the event of cancerous tumor in colon is not assessable. Abbvie's opinion is that there is no reasonable possibility that the events of after covid vaccination experienced soreness around shot area/slight run down feeling the next day onset 26Apr2021 and after Covid vaccination experienced soreness around shot area/slight run down feeling the next day onset 27Apr2021 are related to Skyrizi (Risankizumab).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the events 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.