Sex: M
Vaccine: COVID19
Symptoms: Colon cancer, Needle issue, Vaccination site pain
Clinical narrative: colon cancer; Removed the cap from Humira pen the needle was bent; Covid vaccine issue/sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-ABBVIE-4132438.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 29May2021 as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1163328) at 1 DF (1 df (1 df = 40mg/0.4ml)), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Covid vaccine issue/sore arm"; COLON CANCER (medically significant), outcome "recovering"; NEEDLE ISSUE (non-serious), outcome "unknown", described as "Removed the cap from Humira pen the needle was bent". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "colon cancer" 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. The reporter considered "covid vaccine issue/sore arm" related to BNT162b2.  Clinical course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient was recovering from colon cancer. He removed the cap from his HUMIRA pen, the needle was bent. He continued with the injection and it went well. He had sore arm after receiving covid vaccine.  Causalities: The reporter's causality for the event(s) of Colon cancer, Covid vaccine issue/sore arm and removed the cap from Humira pen the needle was bent with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event(s) of Colon cancer and removed the cap from Humira pen the needle was bent with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of Covid vaccine issue/sore arm with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. Company's opinion was that the causality for the event(s) of Colon cancer, Covid vaccine issue/sore arm and removed the cap from Humira pen the needle was bent with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Company's opinion was that the causality for the event(s) of Covid vaccine issue/sore arm and removed the cap from Humira pen the needle was bent with Adalimumab Solution for Injection was No Reasonable Possibility. Company's opinion was that the causality for the event(s) of Colon cancer with Adalimumab Solution for Injection was Not Assessable. Company's Alternative Etiology for Removed the cap from Humira pen the needle was bent with Adalimumab Solution for Injection: Not related to active pharmaceutical ingredient. Company's Alternative Etiology for Covid vaccine issue/sore arm with Adalimumab Solution for Injection: Most likely related to use of the Covid vaccine.  Assessment Results: HUMIRA 40MG/0.4ML - Colon cancer, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Colon cancer, Market Authorization Holder (MAH). Pfizer BioNTech COVID-19 vaccine - Colon cancer, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine - Vaccination site pain, Market Authorization Holder (MAH). Pfizer BioNTech COVID-19 vaccine - Vaccination site pain, Non-Health Care Professional, Global Introspection, Possible. HUMIRA 40MG/0.4ML - Needle bent, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML - Needle bent, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility. HUMIRA 40MG/0.4ML - Vaccination site pain, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML - Vaccination site pain, Market Authorization Holder (MAH), Global Introspection, No Reasonable Possibility. Pfizer BioNTech COVID-19 vaccine - Needle bent, Market Authorization Holder (MAH). Pfizer BioNTech COVID-19 vaccine - Needle bent, Non-Health Care Professional, Global Introspection, Not Reported. HUMIRA 40MG/0.4ML - Colon cancer, Market Authorization Holder (MAH), Global Introspection, Not assessable.  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 available reported information, the causal association between the events and the 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.