Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Heart rate, Heart rate increased, Injection site urticaria, Oxygen saturation
Clinical narrative: shortness of breath; throat tightness; HR 133/HR 137; diarrhea; hives around injection site; Hives around i njection site and on contralateral arm and chest; flushing sensation; felt anxious; BP 131/87/ BP 131/85/BP 145/76; A spontaneous report was received from a nurse concerning a 34-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest, diarrhea, shortness of breath, throat tightness and heart rate abnormal.  The patient's medical history included anxiety and attention deficit hyperactivity disorder. Concomitant product use was not provided.  On 09 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in her arm for prophylaxis of COVID-19 infection.   On 09 Jan 2021 at 13:30, immediately after receiving the Moderna COVID-19 vaccine, the patient reported having a flushing sensation and felt anxious. At 13:36 the patient's vital signs included blood pressure 131/87 mmHg, heart rate 99 beats/min, and oxygen saturation 99%. Doctor noted hives around the injection site and on contralateral arm and chest. Patient was moved to a separate room to lie down on a bed; on route to the new room, the patient developed diarrhea. Treatment included diphenhydramine.   At 13:49, the patient reported having shortness of breath and throat tightness. 99%. Intramuscular epinephrine was given and 911 called. The patient's vital signs included heart rate 133 beats/min and oxygen saturation  At 13:55, the patient's vital signs included blood pressure 145/76 mmHg, heart rate 137 beats/min, and oxygen saturation 99%  At 14:00, emergency medical services arrived, and patient was transferred to hospital. Patient left the office in stable condition with vital signs within expected range and fully conscious.  Action taken with mRNA-1273 in response to the events was not provided.   The events, flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest, diarrhea, shortness of breath, throat tightness and heart rate abnormal, were considered resolved.; Reporter's Comments: A spontaneous report concerns a 34-year-old, female patient who experienced serious events of shortness of breath, throat tightness and heart rate increased and non-serious events of flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest and diarrhea. The events occurred on the same day after the administration of the first dose of mRNA 1273 (Lot # 026L20A, expiration date unknown). Treatment administered include diphenhydramine and epinephrine. Outcome is resolved. Based on the information provided, which indicates a strong temporal association of the reported events with the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The event of hives around injection site is consistent with the known safety profile of mRNA 1273 vaccine