Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: high heart rate; Respiratory Rate in the mid twenties,; fever of 102.9 degrees Farenheight/high fever,; weak/patient reports being extremely weak; This spontaneous case was reported by a pharmacist and describes the occurrence of HEART RATE INCREASED (high heart rate), RESPIRATORY RATE INCREASED (Respiratory Rate in the mid twenties,), ASTHENIA (weak/patient reports being extremely weak) and PYREXIA (fever of 102.9 degrees Farenheight/high fever,) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (weak/patient reports being extremely weak) (seriousness criterion hospitalization). On 09-Mar-2021, the patient experienced HEART RATE INCREASED (high heart rate) (seriousness criterion hospitalization), RESPIRATORY RATE INCREASED (Respiratory Rate in the mid twenties,) (seriousness criterion hospitalization) and PYREXIA (fever of 102.9 degrees Farenheight/high fever,) (seriousness criterion hospitalization). At the time of the report, HEART RATE INCREASED (high heart rate), RESPIRATORY RATE INCREASED (Respiratory Rate in the mid twenties,), ASTHENIA (weak/patient reports being extremely weak) and PYREXIA (fever of 102.9 degrees Farenheight/high fever,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: high (High) 102.9 degrees Farenheight. On 09-Mar-2021, Heart rate: high (High) High. On 09-Mar-2021, Respiratory rate: high (High) High.     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 medications were reported. No treatment medications were reported.  Company comment: This is a spontaneous case concerning a 76-year-old male patient with no reported medical history, who experienced the serious unexpected events of heart rate increased, respiratory rate increased, asthenia and pyrexia. The events occurred within first 2 days after the first dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 76-year-old male patient with no reported medical history, who experienced the serious unexpected events of heart rate increased, respiratory rate increased, asthenia and pyrexia. The events occurred within first 2 days after the first dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Additional information has been requested.