Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Injection site erythema, Spinal fracture
Clinical narrative: Injection site redness; Fatigue; Spinal fractures; Fall; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL FRACTURE (Spinal fractures) in an 82-year-old female 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.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In June 2021, the patient experienced SPINAL FRACTURE (Spinal fractures) (seriousness criterion medically significant) and FALL (Fall). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness) and FATIGUE (Fatigue). At the time of the report, SPINAL FRACTURE (Spinal fractures) and FALL (Fall) had not resolved and INJECTION SITE ERYTHEMA (Injection site redness) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that in Jun-2021, the patient fell and broke her back. The patient was seeing a surgeon for the possibility of a surgery and to get injections for relief of pain. The patient had been still suffering from broken back and spine cracked in two places.   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 concerns an 82 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Spinal fracture, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary doses from the same vaccine on unknown dates. The patient fell, broke her back and sustained spinal fracture at 2 places. No information on detailed clinical course, relevant investigations and  treatment was available in the report. The event was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an 82 year old female patient, with concurrent condition of rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Spinal fracture, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary doses from the same vaccine on unknown dates. The patient fell, broke her back and sustained spinal fracture at 2 places. No information on detailed clinical course, relevant investigations and  treatment was available in the report. The event was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.