Reporte zur Charge 000UM20A

Symptomtext

Could not get warm; Diarrhea; Extreme Chills; A spontaneous report was received from a healthcare professional concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme chills, could not get warm and diarrhea. The patient's medical history included as asthma. Concomitant medications reported were Dulera Inhaler, Albuterol Nebulizer. On 31 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 000UM20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 1 Feb 2021, the patient experienced extreme chills. could not get warm, diarrhea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of all events were considered resolved on 2 Feb 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Chills is consistent with the known safety profile of the vaccine.