Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Inappropriate schedule of product administration, Pyrexia, Spinal fracture
Clinical narrative: 3 fractured vertebra; first dose on 12JAN2021 , second dose on 3MAR2021; very dizzy; was throwing up; fever after the first dose/second dose he had fever; He fell 8 times between these two doses; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SPINAL FRACTURE (3 fractured vertebra) and FALL (He fell 8 times between these two doses) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025220A and 041L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Wheelchair user.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced PYREXIA (fever after the first dose/second dose he had fever). On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 12JAN2021 , second dose on 3MAR2021). In March 2021, the patient experienced DIZZINESS (very dizzy) and VOMITING (was throwing up). In 2021, the patient experienced FALL (He fell 8 times between these two doses) (seriousness criterion medically significant). In October 2022, the patient experienced SPINAL FRACTURE (3 fractured vertebra) (seriousness criteria hospitalization and medically significant). At the time of the report, SPINAL FRACTURE (3 fractured vertebra), FALL (He fell 8 times between these two doses), DIZZINESS (very dizzy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 12JAN2021 , second dose on 3MAR2021) and VOMITING (was throwing up) outcome was unknown and PYREXIA (fever after the first dose/second dose he had fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was running a fever after the first dose, but thought that was normal because he was getting old. After the second dose he had fever, was throwing up and was becoming very dizzy. He fell 8 times between these two doses and Oct 2022. In October he went to the hospital as he had 3 fractured vertebra. He had surgery and was discharged to a nursing home. He was in the nursing home for 2 months before being sent home with home health care and he had been restricted to a wheel chair.  No treatment products reported.  Company comment: This spontaneous case concerns an elderly male patient aged 82 years with no medical history reported, who experienced the unexpected serious (Medically significant/ hospitalization) event of Spinal fracture and unexpected serious (Medically significant) event of Fall along with non-serious events of Dizziness, Vomiting and Pyrexia unspecified days after second dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events was not disclosed. Additionally, Inappropriate schedule of product administration was noted (50-day interval between first and second dose). It was reported that patient had fever after the first dose, he also had fever, vomiting and dizziness after second dose. He had multiple episodes of Fall between these two doses and about 19 months after second dose, so he went to the hospital as he had 3 fractured vertebra, underwent surgery and was discharged to a nursing home. He was in the nursing home for 2 months and discharged with home health care and has been restricted to a wheel chair. No further information on risk factors, concurrent illness, detailed clinical course, investigations and hospitalization details was available in the report. Outcome of the events Spinal fracture and Fall was not known at the time of report. Advancing age of the patient remains as risk factor to the event Spinal fracture.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly male patient aged 82 years with no medical history reported, who experienced the unexpected serious (Medically significant/ hospitalization) event of Spinal fracture and unexpected serious (Medically significant) event of Fall along with non-serious events of Dizziness, Vomiting and Pyrexia unspecified days after second dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events was not disclosed. Additionally, Inappropriate schedule of product administration was noted (50-day interval between first and second dose). It was reported that patient had fever after the first dose, he also had fever, vomiting and dizziness after second dose. He had multiple episodes of Fall between these two doses and about 19 months after second dose, so he went to the hospital as he had 3 fractured vertebra, underwent surgery and was discharged to a nursing home. He was in the nursing home for 2 months and discharged with home health care and has been restricted to a wheel chair. No further information on risk factors, concurrent illness, detailed clinical course, investigations and hospitalization details was available in the report. Outcome of the events Spinal fracture and Fall was not known at the time of report. Advancing age of the patient remains as risk factor to the event Spinal fracture.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.