Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fall, SARS-CoV-2 test
Clinical narrative: Hospitalized after fall; Covid diagnosis; This spontaneous case was reported by an other health care professional and describes the occurrence of FALL (Hospitalized after fall) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2022, the patient experienced COVID-19 (Covid diagnosis). On an unknown date, the patient experienced FALL (Hospitalized after fall) (seriousness criterion hospitalization). At the time of the report, FALL (Hospitalized after fall) outcome was unknown and COVID-19 (Covid diagnosis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered FALL (Hospitalized after fall) to be not related. No further causality assessment was provided for COVID-19 (Covid diagnosis).    Concomitant product use was not provided by the reporter. The patient had received primary series and one booster dose; he had received his vaccines an year ago. It was reported that the call was received from Clinical Services Supervisor inquiring about waiting period or process to administer the second Moderna booster in a patient who was recovering from COVID. Treatment information was not provided. Company Comment: This spontaneous case concerns an 82 year old male patient  with no medical history reported, who experienced Serious ( hospitalization ) , unexpected event of fall  ( Hospitalized after a fall)  which occurred on an unknown date  post vaccination with the  dose 3 of mRNA-1273 vaccine..  On Aug 1, 2022 this patient experienced non-serious , unexpected , AESI of Covid 19 post vaccination  with the  dose 3 of Covid 19 vaccine.  This patient tested positive for  SARS-COV 2 test done last 1-Aug-2022 . The dose 1 and dose 2 Covid 19 vaccine of this patient were also mRNA-1273 vaccine.  Treatment information  and results of laboratories  /diagnostic procedures were not reported. Outcome of the event fall was unknown while for the event Covid 19 outcome is recovering .The age of this patient  ( elderly population prone to infection like Covid 19 due to weak immune response )  and the current Covid 19 pandemic are considered as confounders for the event Covid 19 . Event fall was reported as not related  by the reporter.   The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an 82 year old male patient  with no medical history reported, who experienced Serious ( hospitalization ) , unexpected event of fall  ( Hospitalized after a fall)  which occurred on an unknown date  post vaccination with the  dose 3 of mRNA-1273 vaccine..  On Aug 1, 2022 this patient experienced non-serious , unexpected , AESI of Covid 19 post vaccination with the  dose 3 of Covid 19 vaccine.  This patient tested positive for  SARS-COV 2 test done last 1-Aug-2022 . The dose 1 and dose 2 Covid 19 vaccine of this patient were also mRNA-1273 vaccine.  Treatment information  and results of laboratories  /diagnostic procedures were not reported. Outcome of the event fall was unknown while for the event Covid 19 outcome is recovering .The age of this patient  ( elderly population prone to infection like Covid 19 due to weak immune response )  and the current Covid 19 pandemic are considered as confounders for the event Covid 19 . Event fall was reported as not related  by the reporter.   The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.