Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Neoplasm malignant, Vaccination failure, Vaccination site pain
Clinical narrative: Cancer; COVID-19; COVID-19; Sore arm after Covid 19 vaccine; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on the information received by Pfizer from Regulatory Authority. The Manufacturer Control Number is 21K-163-4060366-00. A contactable consumer (patient himself) reported that a 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route on 14Apr2021 (Batch/Lot number was not reported) as dose 2, single; and via intramuscular route on 17Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation; adalimumab (HUMIRA) citrate free via subcutaneous route from an unspecified date (Batch/Lot number was not reported) to an unspecified date at an unspecified dose for moderate to severe Crohn's disease. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced possible cancer and abnormal test result. The patient reported that his physician found some abnormal test results and ordered a colonoscopy with contrast to get a better picture and rule out any possible cancer. In 2021, the patient experienced sore arm after Covid-19 vaccine. On 13Jul2021, the patient experienced COVID-19. The action taken in response to the events for adalimumab was unknown. In 2021, the sore arm after COVID 19 vaccine and COVID-19 resolved. On an unknown date, abnormal test result resolved. Outcome of possible cancer was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for adalimumab (HUMIRA): The reporter's causality for the events of possible cancer and sore arm after COVID 19 vaccine was not provided. The reporter's causality for the events of abnormal test result and COVID-19 with Humira(adalimumab) was a reasonable possibility. Manufacturer opinion is that the events of possible cancer and abnormal test result are not assessable. While there is no reasonable possibility that the events of sore arm after COVID 19 vaccine and COVID-19 are related to adalimumab (Humira).  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): reporter's causality for the events possible cancer, abnormal test result and COVID-19 was not reported; for sore arm after COVID 19 vaccine was possible.  The reporter's assessment of the causal relationship between the events possible cancer, abnormal test result and COVID-19 and the suspect product 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 lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "COVID-19" and "Sore arm after Covid 19 vaccine" cannot be completely excluded based on temporal association. There was not a reasonable possibility that the event "Cancer" was related to the suspect drug, but most likely represents patient intercurrent medical condition.