Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Rhabdomyolysis, Rib fracture, Sepsis, Syncope
Clinical narrative: Sepsis; Right  lower lob pneumonia; NSTEMI; Rhabdomylosis; Syncope; Right rib fractures; Anemia; weakness; Recurrent falls; This spontaneous case was reported by an other health care professional and describes the occurrence of SEPSIS (Sepsis), PNEUMONIA (Right  lower lob pneumonia), ACUTE MYOCARDIAL INFARCTION (NSTEMI), RHABDOMYOLYSIS (Rhabdomylosis), SYNCOPE (Syncope), RIB FRACTURE (Right rib fractures) and ANAEMIA (Anemia) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 4052B1) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced FALL (Recurrent falls). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Right  lower lob pneumonia) (seriousness criteria hospitalization and medically significant), ACUTE MYOCARDIAL INFARCTION (NSTEMI) (seriousness criteria hospitalization and medically significant), RHABDOMYOLYSIS (Rhabdomylosis) (seriousness criteria hospitalization and medically significant), SYNCOPE (Syncope) (seriousness criteria hospitalization and medically significant), RIB FRACTURE (Right rib fractures) (seriousness criterion hospitalization), ANAEMIA (Anemia) (seriousness criterion hospitalization) and ASTHENIA (weakness). The patient was hospitalized from 18-May-2021 to 21-May-2021 due to ACUTE MYOCARDIAL INFARCTION, ANAEMIA, PNEUMONIA, RHABDOMYOLYSIS, RIB FRACTURE, SEPSIS and SYNCOPE. At the time of the report, SEPSIS (Sepsis), PNEUMONIA (Right  lower lob pneumonia), ACUTE MYOCARDIAL INFARCTION (NSTEMI), RHABDOMYOLYSIS (Rhabdomylosis), SYNCOPE (Syncope), RIB FRACTURE (Right rib fractures), ANAEMIA (Anemia), ASTHENIA (weakness) and FALL (Recurrent falls) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Lab details were not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age and possible comorbidities may serve as confounders. Unlikely, that the events are related to the vaccine. Very limited information regarding these events has been provided   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: Upon internal review on 08-DEC-2022 non-significant correction performed to update "case received from  field" to blank.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age and possible comorbidities may serve as confounders. Unlikely, that the events are related to the vaccine. Very limited information regarding these events has been provided