Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Myalgia, Pain, Throat tightness, Vomiting
Clinical narrative: Anaphylactic reaction; Stomach hurt; Tired; Headache; Body ache; GI issues; Shortness of breath while talking; A spontaneous report was received from a 31-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction, stomach hurt, GI issues, shortness of breath while talking, fatigue, headache and body aches.  The patient's medical history includes allergy to Tylenol, Imitrex, mango, pineapple, oranges, nuts, seafood and cinnamon. No relevant concomitant medications were reported.   On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 21 Jan 2021, 5 minutes after receiving the vaccine, the patient experienced an anaphylactic reaction. She experienced shortness of breath, coughing, vomiting, pulse rate dropped to 40 and she showed signs of anaphylactic reactions. She was administered Benadryl 50 mg IM at the 5-minute mark and 1 dose of the EpiPen at the 20 minute mark. This helped relieve some of the tightness around the throat. She experienced a secondary anaphylactic reaction 5 hours later and was rushed to the emergency room. She was hospitalized from 21 Jan 2021 to 24 Jan 2021. While in the hospital, she experienced two more anaphylactic reactions reported as similar to the previous reactions except that for the last two reactions, she could feel them coming on before her coughing and tightness started. She states "I felt very hot, clammy, and could feel the allergic reaction coming on for the last two reactions." During the hospitalization, she was administered Benadryl, Solumedrol, and EpiPen. On 26 Jan 2021, she has recovered from her anaphylactic reaction but she was tired, has shortness of breath while talking, headache, body aches, her stomach hurts, and its hard for her to eat without having some GI issues. She has never felt like this before and it is very unusual for her.   Action taken with the second dose of mRNA-1273 in response to the events were not reported.   The outcome for the event, anaphylactic reaction was considered Resolved/Recovered On 26 Jan 2021. The outcome for the events, stomach hurt, GI issues,shortness of breath while talking, fatigue, headache and body aches was unknown.; Reporter's Comments: This case concerns a 31-year-old female patient with medical history of multiple food and drug allergies,  who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of anaphylactic reaction, the non-serious listed events of Fatigue, Headache, and Myalgia, and the non-serious unlisted events of stomach ache, gastrointestinal issues, and shortness of breath while talking.  The event of anaphylactic reaction started within minutes after vaccination.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.