Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Inappropriate schedule of product administration, Pelvic fracture, Spinal fracture
Clinical narrative: Fracture of pelvis; Spinal fracture; Fall; Patient received 1st dose on 15-Feb-2021/2nd dose on 15-Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC FRACTURE (Fracture of pelvis) and SPINAL FRACTURE (Spinal fracture) in a 59-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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    There was no reported medical history. The patient had no known allergies.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-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 started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 15-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 15-Feb-2021/2nd dose on 15-Oct-2021). On an unknown date, the patient experienced PELVIC FRACTURE (Fracture of pelvis) (seriousness criterion medically significant), SPINAL FRACTURE (Spinal fracture) (seriousness criterion medically significant) and FALL (Fall). At the time of the report, PELVIC FRACTURE (Fracture of pelvis), SPINAL FRACTURE (Spinal fracture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 15-Feb-2021/2nd dose on 15-Oct-2021) outcome was unknown and FALL (Fall) had not resolved.            The patient was not taking any concomitant drugs.  It was reported that, the patient fell off a ladder and broke pelvis and broken back bone.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  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 reported by a consumer, concerns a 59 year old male patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of PELVIC FRACTURE (Fracture of pelvis) and SPINAL FRACTURE, unknown days after receiving the 3 dose of Moderna mRNA1273 vaccine, in the covid 19 vaccination series. Patient previously received 2dose of mRNA vaccine at an interval of about 08 months. Inappropriate schedule of product administration was reported along with the non serious event of fall. It was reported that, the patient fell off a ladder and broke pelvis and broke his back bone. It was reported that the patient had received UPADACITINIB (RINVOQ) for Rheumatoid arthritis. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. History of fall is a confounder for the events. The outcome of the events was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 59 year old male patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of PELVIC FRACTURE (Fracture of pelvis) and SPINAL FRACTURE, unknown days after receiving the 3 dose of Moderna mRNA1273 vaccine, in the covid 19 vaccination series. Patient previously received 2dose of mRNA vaccine at an interval of about 08 months. Inappropriate schedule of product administration was reported along with the non serious event of fall. It was reported that, the patient fell off a ladder and broke pelvis and broke his back bone. It was reported that the patient had received UPADACITINIB (RINVOQ) for Rheumatoid arthritis. No further clinical information on other comorbidities, risk factors, symptoms, concomitant medications and treatment medications were reported. History of fall is a confounder for the events. The outcome of the events was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.