Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal fracture
Clinical narrative: Skin problem/skin cancer; Bruises on left arm; Fall; Nail disorder; Diarrhea comes and goes; Sharp headache pains; Fractured vertebra; Fractured finger; Fracture of pelvis; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL FRACTURE (Fractured vertebra), HAND FRACTURE (Fractured finger), PELVIC FRACTURE (Fracture of pelvis) and SKIN CANCER (Skin problem/skin cancer) in an 81-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) tablet for CLL.    Concurrent medical conditions included CLL.   In September 2021, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 280 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (Oral) 280 milligram once a day. In 2021, the patient experienced SPINAL FRACTURE (Fractured vertebra) (seriousness criterion medically significant), HAND FRACTURE (Fractured finger) (seriousness criterion medically significant), PELVIC FRACTURE (Fracture of pelvis) (seriousness criterion medically significant), CONTUSION (Bruises on left arm), FALL (Fall), NAIL DISORDER (Nail disorder), DIARRHOEA (Diarrhea comes and goes) and HEADACHE (Sharp headache pains). On an unknown date, the patient experienced SKIN CANCER (Skin problem/skin cancer) (seriousness criterion medically significant). At the time of the report, SPINAL FRACTURE (Fractured vertebra), HAND FRACTURE (Fractured finger), PELVIC FRACTURE (Fracture of pelvis), SKIN CANCER (Skin problem/skin cancer), FALL (Fall) and HEADACHE (Sharp headache pains) outcome was unknown, CONTUSION (Bruises on left arm) and NAIL DISORDER (Nail disorder) was resolving and DIARRHOEA (Diarrhea comes and goes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Blood work has been good.. On an unknown date, Scan: Fractured vertebrae, finger and pelvis per scan at the emergency department..         Patient had a fall in the gym and suffered from fractured vertebrae, finger and pelvis as per scan done at the ER. He had third Moderna booster and after about four days, he had sharp headache pains every 18 seconds. IMBRUVICA was on hold until after the vertebroplasty. He had skin problems, skin cancer periodically and saw dermatologist. It did not have before starting IMBRUVICA. He did not take any concomitant drugs. Treatment medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of fractured vertebrae, finger and pelvis onset in 2021, Problems/cancer, issues with toenails, fall, sharp headache pains, diarrhea comes and goes and bruises on left arm was not 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 is a spontaneous case concerning an 81-year-old female patient with medical history of chronic lymphocytic leukemia, who experienced the unexpected, serious (medically significant) events of Spinal fracture, Hand fracture, Pelvic fracture and Skin cancer, after receiving a booster dose of mRNA-1273 vaccine. The patient had a fall in the gym which a scan was performed and revealed fractured vertebrae, finger and pelvis. Exact date of vaccination, onset date of the events, clinical course, other relevant diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown. History of fall remains a risk factor for the event of Fracture and medical history of chronic lymphocytic leukemia remains a risk factor for the event of Skin cancer. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow-up contains updated information on events. New event added skin cancer. Updated event verbatim of Diarrhea and Bruise.; Sender's Comments: This is a spontaneous case concerning an 81-year-old female patient with medical history of chronic lymphocytic leukemia, who experienced the unexpected, serious (medically significant) events of Spinal fracture, Hand fracture, Pelvic fracture and Skin cancer, after receiving a booster dose of mRNA-1273 vaccine. The patient had a fall in the gym which a scan was performed and revealed fractured vertebrae, finger and pelvis. Exact date of vaccination, onset date of the events, clinical course, other relevant diagnostic tests and treatment details were not provided in the case. The outcome of the events were unknown. History of fall remains a risk factor for the event of Fracture and medical history of chronic lymphocytic leukemia remains a risk factor for the event of Skin cancer. The benefit-risk relationship of mRNA-1273 is not affected by this report.