Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Joint pain; Vaccination site pain; Sore Arm; Adenocarcinoma gastric; nodule on liver; Cancer; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral. The patient's relevant medical history included: "Duodenal Cancer", start date: 2017 (ongoing). The patient's concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant) with onset 04May2022, outcome "unknown", described as "Cancer"; ADENOCARCINOMA GASTRIC (medically significant) with onset 18May2022, outcome "unknown"; HEPATIC MASS (non-serious) with onset 18May2022, outcome "unknown", described as "nodule on liver"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm". The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of adenocarcinoma gastric.  Clinical information: Patient experienced events of cancer and nodule on liver/gastric adenocarcinoma and non-serious joint pain and sore arm due to covid vaccine with Rinvoq (Upadacitinib). On an unknown date, the patient experienced joint pain and sore arm due to covid vaccine. on 04May2022, the patient experienced cancer. on 18May2022, the patient experienced nodule on liver/gastric adenocarcinoma. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. On 22May2022, the patient had gastric cancer surgery. Joint pain that was exascerbated by another medication that was prescribed.  Causality for Rinvoq (Upadacitinib) The reporter's causality for the event(s) of cancer, nodule on liver/gastric adenocarcinoma, joint pain and sore arm due to covid vaccine was not provided. AbbVie's opinion is that the events of cancer and nodule on liver/gastric adenocarcinoma are not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of joint pain and sore arm due to covid vaccine are related to Rinvoq(Upadacitinib).  The reporter's assessment of the causal relationship of "cancer", "adenocarcinoma gastric", "nodule on liver", "joint pain" and "sore arm" 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 "vaccination site pain" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information,  the events Neoplasm malignant, Adenocarcinoma gastric and hepatic mass is assessed as unrelated to the suspect drug BNT162b2. Based on known drug safety profile, the causal association between the events arthralgia, vaccination site pain, pain in extremity assessed and the suspect drug BNT162b2 cannot be completely excluded.