Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Polyp, Pyrexia, Tibia fracture
Clinical narrative: Tibia fracture/Broken leg; Polyp; Increased blood pressure; Fall; Feeling down; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TIBIA FRACTURE (Tibia fracture/Broken leg) and POLYP (Polyp) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukaemia.    Concurrent medical conditions included Chronic lymphocytic leukaemia.   On 09-Mar-2017, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In September 2021, the patient experienced DEPRESSED MOOD (Feeling down) and PYREXIA (Fever). On 15-Sep-2021, the patient experienced TIBIA FRACTURE (Tibia fracture/Broken leg) (seriousness criterion hospitalization) and FALL (Fall). In September 2021, the patient experienced DEPRESSED MOOD (Feeling down) and PYREXIA (Fever). On an unknown date, the patient experienced POLYP (Polyp) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Increased blood pressure). At the time of the report, TIBIA FRACTURE (Tibia fracture/Broken leg), POLYP (Polyp), FALL (Fall), BLOOD PRESSURE INCREASED (Increased blood pressure), DEPRESSED MOOD (Feeling down) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 196/99 (Increased). On an unknown date, Colonoscopy: showed no cancer.         No concomitant medication was reported. Patient reported that he had colonoscopy with polyp removed, that showed no cancer. He hold Imbruvica dose for fifteen days. On 15 SEP 2021 (reported as yesterday), he had a broken tibia/ leg due to fall and was stung by wasps. He went to Emergency Room and had increased blood pressure. In SEP 2021 (reported as two weeks ago), he had third Moderna shot, he had fever and it put him down.  The patient hospitalized one day for broken leg. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 75-year-old male patient with relevant medical history of chronic lymphocytic leukemia, who experienced the unexpected, serious (hospitalized) event of Tibia fracture and unexpected serious (medically significant) event of Polyp in the context of receiving a dose of mRNA-1273 vaccine.  The event Tibia fracture occurred about 2 weeks after receiving the 3rd dose, while the event Polyp occurred on an unknown date. Onset latency could not be determined as dates of vaccination and date of event onset (for the event Polyp) were not given.  Colonoscopy done on an unknown date showed no cancer.  A total of 3 doses of mRNA-1273 vaccine were administered on unspecified dates and intervals. Advanced age of the patient could be considered as predisposing risk factor for the events while history of chronic lymphocytic leukemia could be contributory to the clinical course of the events.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up information received wherein added seriousness criteria (hospitalization).; Sender's Comments: This spontaneous case concerns a 75-year-old male patient with relevant medical history of chronic lymphocytic leukemia, who experienced the unexpected, serious (hospitalized) event of Tibia fracture and unexpected serious (medically significant) event of Polyp in the context of receiving a dose of mRNA-1273 vaccine.  The event Tibia fracture occurred about 2 weeks after receiving the 3rd dose, while the event Polyp occurred on an unknown date. Onset latency could not be determined as dates of vaccination and date of event onset (for the event Polyp) were not given.  Colonoscopy done on an unknown date showed no cancer.  A total of 3 doses of mRNA-1273 vaccine were administered on unspecified dates and intervals. Advanced age of the patient could be considered as predisposing risk factor for the events while history of chronic lymphocytic leukemia could be contributory to the clinical course of the events.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.