Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pneumonia, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: COVID; Pneumonia; acute appendicitis; low grade fever; headache; muscle aches; congestion; under the weather; fatigued; extremely cold and had chills; cough; Redness; arm swelling; Soreness; slight dizziness; A spontaneous report was received from a consumer who was also an approximately 56-year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced dizziness, redness (vaccination site erythema), arm swelling (vaccination site swelling), soreness (vaccination site pain), cough, fatigue, under the weather (malaise), extremely cold and had chills (chills), headache, congestion (lower respiratory tract congestion), muscle aches (myalgia), low grade fever (pyrexia), COVID (COVID-19), pneumonia, and acute appendicitis.  The patient's medical history was not reported. Concomitant product use included lisinopril, ergocalciferol, colecalciferol/ magnesium oxide/ vitamin B1, and ascorbic acid.   On 08 Jan 2021, approximately hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 037C20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 08 Jan 2021 after receiving the first dose of Moderna COVID-19 vaccine, the patient had slight dizziness, redness, arm swelling and soreness which all went away by 10 Jan 2021.  On 10 Jan 2021 she had one cough which was nothing to be alarmed about.  On 11 Jan 2021 she started to feel fatigued, under the weather, extremely cold and had chills.  On 12 Jan 2021 the patient's workplace had her take a COVID test, which came back positive on 13 Jan 2021.  Additionally, on 12 Jan 2021, the patient started to get a headache, congestion, was still super cold and had the chills and muscle aches.  She went to a respiratory medical doctor who administered a chest x-ray and told the patient it all looked fine.  On 13 Jan 2021, she had a low grade fever of around 100.1 degrees Fahrenheit.  The following Sunday, 17 Jan 2021, the patient had abdominal pain. She went to the emergency department (ED) where they did another chest x-ray and it showed she had pneumonia.  The patient also ended up having an appendectomy (date not reported). Treatment medications included ibuprofen for pain from the surgery and guaifenesin for congestion.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events low grade fever, headache, chills, fatigue, under the weather, congestion, COVID, and pneumonia, was unknown. The outcome, of the events soreness, swelling, redness, cough, and dizziness, was considered recovered/resolved on 10 Jan 2021. The outcome of the event, muscle aches, was considered recovered/resolved on 13 Jan 2021. The outcome of the event, appendicitis, was considered resolved on an undisclosed date.; Reporter's Comments: This case concerns a 56-year-old female with serious unexpected events of abdominal pain, appendicitis, COVID-19, pneumonia and unexpected events of cough, bronchial congestion, malaise, dizziness. Cough onset day 2 after first dose mRNA-1273, with COVID-19 day 5 and hospitalization for pneumonia and appendicitis day 10. Based on the current available information and temporal association between the use of the product and the start date of some events, a causal relationship cannot be excluded.