Sex: M
Vaccine: COVID19
Symptoms: Fall, Magnetic resonance imaging, Rib fracture, Subdural haematoma
Clinical narrative: developed a subdural hematoma due to his fall after first dose; fractured four ribs after first dose; fall after first dose; This spontaneous case was reported by a physician and describes the occurrence of SUBDURAL HAEMATOMA (developed a subdural hematoma due to his fall after first dose), RIB FRACTURE (fractured four ribs after first dose) and FALL (fall after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUBDURAL HAEMATOMA (developed a subdural hematoma due to his fall after first dose) (seriousness criteria hospitalization and medically significant), RIB FRACTURE (fractured four ribs after first dose) (seriousness criterion hospitalization) and FALL (fall after first dose) (seriousness criterion hospitalization). The patient was treated with LIDOCAINE (transdermal) at an unspecified dose and frequency. At the time of the report, SUBDURAL HAEMATOMA (developed a subdural hematoma due to his fall after first dose), RIB FRACTURE (fractured four ribs after first dose) and FALL (fall after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: results not reported (Inconclusive) Results not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information were provided.  Caller was a physician and calling on behalf of her husband. Doctor reports her husband was scheduled for his second Moderna dose on  14 Mar 2021.  Doctor reported husband was not currently on any medication therapy other than lidocaine patches and he had not been administered any corticosteroids.  Doctor reported husband was under observation and regularly scheduled MRI's to monitor the hematoma.  Company Comment: This case concerns a male subject of an unknown age, with no relevant medical history reported in this case, who experienced the serious unexpected events of Subdural haematoma (AESI), Rib Fracture and Fall. The events occurred on an unknown date after the administration of the first dose of mRNA-1273 vaccine. At the time of the report the outcome for the event was Unknown. The rechallenge could be considered unknown, as the events happened after the first dose of the vaccine and no information from the second dose is provided. The severity criteria for all the events were reported as Hospitalized. Seriousness was manually overwritten to reflect the SD. The event of Subdural haematoma was also upgraded to serious (Medically Significant) as per Important medical event terms list and as per medical judgment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a male subject of an unknown age, with no relevant medical history reported in this case, who experienced the serious unexpected events of Subdural haematoma (AESI), Rib Fracture and Fall. The events occurred on an unknown date after the administration of the first dose of mRNA-1273 vaccine. At the time of the report the outcome for the event was Unknown. The rechallenge could be considered unknown, as the events happened after the first dose of the vaccine and no information from the second dose is provided. The severity criteria for all the events were reported as Hospitalized. Seriousness was manually overwritten to reflect the SD. The event of Subdural haematoma was also upgraded to serious (Medically Significant) as per Important medical event terms list and as per medical judgment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.