Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site weakness; IInjection site feeling muscles are inflamed; Shoulders got stuck, couldn't move left arm; Whole body, jaw, neck, teeth were very sore; Feeling stiff; Tendons in the gums hurt / teeth feels it's going to fall out of head; Injection site itchiness; Exacerbation of Lupus; Serum sickness; Delayed hypersensitivity; Chills; Fatigue; Injection area tenderness; A spontaneous report was received from a nurse who was also a forty-seven-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced exacerbation of Lupus, delayed hypersensitivity, serum sickness, injection site itchiness , chills, fatigue, injection site weakness, injection site feeling muscles were inflamed, shoulders got stuck/ couldn't move arm, whole body, jaw, neck, teeth were very sore , tendons in gum hurt/ teeth feels it's going to fall out of head, feeling stiff, and injection area tenderness.  The patient's medical history, as provided by the reporter, included Lupus. Concomitant medications reported included hydroxychloroquine sulfate.  The patient received their first of two planned doses of mRNA-1273 (Batch number 037K20A) on 07 Jan 2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient experienced minor injection area tenderness, chill, and fatigue.  On 09 Jan 2021, the injection area tenderness, chill, and fatigue resolved.  On 15 Jan 2021, the patient experienced an exacerbation of lupus, delayed hypersensitivity, and serum sickness.  On an undefined date, the patient's symptoms initially started at the injection site at the left deltoid as itchiness, weakness  feeling muscles were inflamed. Her shoulders got stuck, couldn't move left arm. Injection site was not red. Whole body, jaw, neck, teeth were very sore. The tendons in the gums hurt. The patient was now stiff but could move things and could eat. Teeth still felt it's going to fall out of my head.' The patient had yellow fever vaccine in 2005 and had a similar reaction; she thought it was serum sickness. She also reported that she gets annual flu shot and tetanus/ diphtheria/ pertussis vaccines and never had issues with those.   No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events exacerbation of lupus, delayed hypersensitivity, serum sickness, injection site itchiness, injection site weakness, injection site feeling muscles were inflamed, shoulders got stuck/ couldn't move arm, whole body, jaw, neck, teeth were very sore, tendons in gum hurt/ teeth feels it's going to fall out of head, and feeling stiff, was unknown. The outcome of the events chills, fatigue and injection site tenderness, was resolved on 09 Jan 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Additional information has been requested.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.