Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Headache, Injection site pain, Musculoskeletal stiffness, Oral pain
Clinical narrative: Anaphylactic shock; Mouth became extremely sore and tender; Stiff upper body; Headache that affected vision; Headache that affected the vision; Soreness at the injection site; A spontaneous report was received from a consumer who was also a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, mouth became extremely sore and tender, soreness at the injection site, back of her throat was tight, headache that affected her vision, and stiff upper body.  The patient's medical history, as provided by the reporter, included allergies to acetaminophen / propoxyphene (affected heart), montelukast (seizures), metoclopramide (affected nervous system), spironolactone / hydrochlorothiazide (swollen back of throat and tongue), ezetimibe (causes muscle pain, cramping, fatigue, rash, colon problems and lower back pain), ezetimibe / simvastatin (causes muscle pain, cramping, fatigue, rash, colon problems and lower back pain), meclizine (can only take a couple tablets here and there), and reacts to antibiotics (doxycycline and erythromycin). Concomitant medications reported included azelastine, rosuvastatin calcium, fexofenadine, cyclobenzaprine, multivitamin, omeprazole, potassium chloride, carmellose sodium, ciclosporin, sodium chloride, sertraline, pseudoephedrine hydrochloride, triamterene, paracetamol, fluticasone propionate, and vitamin D.   On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, prior to receiving the vaccine, she was given diphenhydramine, due to her history (not provided). After receiving the vaccine, she was observed for 15 minutes. The patient reported she had anaphylactic shock. When she got home, the left-hand side of her mouth became extremely sore and tender, particularly the roof of her mouth. She stated it felt like she had been to the dentist and they injected needles in the roof of her mouth. The soreness and pain from the injection gradually spread over to the right side of her mouth. She reported that the back of her throat was tight with a little bit of an odd sensation, which continued for 2 days, and she took more diphenhydramine. She also had soreness at the site of injection, a headache that affected her vision, and a stiff upper body. She also reported that she slept in a recliner the first night because when she tried to lay down in bed in a horizontal position, it shut her brain off and bothered the back of her throat.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylactic shock, mouth became extremely sore and tender, soreness at the injection site, back of her throat was tight, headache that affected her vision, and stiff upper body, were not reported at the time of this report.  Follow-up received on 03 Feb 2021 included concomitant medications and drug allergies.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. The patient's history of known allergies to various medications remains as a contributing factor.