Reporte zur Charge OU520A/011520A

Symptomtext

generalized itchiness; woke up with headache; feeling fatigued; anaphylactic reaction; right arm started going numb; right arm was tingling; A spontaneous report was received from a 26-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, right arm numbness and tingling, headache, fatigue, and generalized itchiness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: OU520A/011520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Dec 2020, within minutes of receiving the vaccine, the patient experienced an anaphylactic reaction and was rushed to the emergency room (ER). When transported to the ER she began to experience throat swelling, redness of arms and chest, trouble breathing with lower chest pain shooting into lungs, and numbness with tingling in her right arm. Treatment for the event included epinephrine, steroids, and diphenhydramine. She was released from the ER on 23 Dec 2020. On 24 Dec 2020 patient awoke with a headache, fatigue, and generalized itchiness. Treatment for the event included ibuprofen and diphenhydramine. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, anaphylactic reaction, right arm numbness and tingling, were reported as resolved on 23 December 2020. The events of headache, fatigue, and generalized itchiness were considered resolving.; Reporter's Comments: This case concerns a 26-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot OU520A/011520A), and who experienced the unlisted events of anaphylactic reaction, right arm numbness and tingling, and generalized itchiness, and the listed events of headache and fatigue. The events were considered to be possibly related to the vaccine due to the temporal relationship with onset on the day of vaccination.