Reporte zur Charge 027A21A031L20A

Symptomtext

feel freezing; temperature which read 104 degrees Fahrenheit; feel cold; she felt hot inside; A spontaneous report was received from a consumer, concerning a 69 years adult female patient, who received Moderna COVID-19 Vaccine and experienced feel freezing/ Hypothermia, temperature which read 104 degrees Fahrenheit/ Hyperpyrexia, feel cold/ Chills, she felt hot inside/ Feeling hot. The patient's medical history was not provided. On 08Feb2021, prior to the onset of events, the patient received their first of two planned A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route for prophylaxis of COVID-19 infection. On 9 Mar 2021, the patient experienced the event(s) feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit was unknown. doses of mRNA-1273 (batch number: 031L20A) via unknown route for COVID-19 infection prophylaxis. On 08Mar2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: 027A21A) via unknown route for COVID-19 infection prophylaxis. On 09Mar2021, patient began to feel cold then went to the supermarket where she began to feel freezing and left, at home although the heat was on, she still felt cold and resorted to wearing a winter jacket and two blankets still feeling freezing but oddly enough, she felt hot inside so she took her temperature which read 104 degrees Fahrenheit. She then proceeded to drink 1.5 cups of cold sparkling water and gradually these symptoms subsided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The Outcome of the event (Cold,Hyperthermia,Feeling hot, Chills) was considered to be not unknown at the time of this report.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded.