Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Oxygen saturation, Pyrexia
Clinical narrative: Sortness of breath noted when using stairs; Chest tightness with exercise; I tested positive for COVID; loose stool all day; Dizziness; Nausea; Vomiting; Chills; unable to raise arm; Fever 101.1 F; Body aches; Remained in bed except to bathroom all day; Slight soreness of right arm with increased soreness, unable to raise arm; Headache; Extreme fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (I tested positive for COVID), MALAISE (Remained in bed except to bathroom all day), DIARRHOEA (loose stool all day), DYSPNOEA (Sortness of breath noted when using stairs) and CHEST DISCOMFORT (Chest tightness with exercise) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026620A and 032620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (> 10 years), Drug allergy (Nystatin, Sudafed), Food allergy (tree nut allergy (oral allergy syndrome),mildly allergic to apples.) and Hypertension. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for Asthma, HYDROCHLOROTHIAZIDE for Hypertension.   On 04-Jan-2021 at 6:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slight soreness of right arm with increased soreness, unable to raise arm). 04-Jan-2021, the patient experienced HEADACHE (Headache). On 05-Jan-2021, the patient experienced MALAISE (Remained in bed except to bathroom all day), MYALGIA (Body aches), PYREXIA (Fever 101.1 F), CHILLS (Chills) and VACCINATION SITE MOVEMENT IMPAIRMENT (unable to raise arm). On 06-Jan-2021, the patient experienced DIARRHOEA (loose stool all day), DIZZINESS (Dizziness) and NAUSEA (Nausea). 06-Jan-2021, the patient experienced VOMITING (Vomiting). On 07-Jan-2021, the patient experienced COVID-19 (I tested positive for COVID). On 09-Jan-2021, the patient experienced DYSPNOEA (Sortness of breath noted when using stairs) and CHEST DISCOMFORT (Chest tightness with exercise). In January 2021, the patient experienced FATIGUE (Extreme fatigue). On 06-Jan-2021, VACCINATION SITE PAIN (Slight soreness of right arm with increased soreness, unable to raise arm) and PYREXIA (Fever 101.1 F) had resolved. On 08-Jan-2021, MYALGIA (Body aches) and CHILLS (Chills) had resolved. In January 2021, HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, COVID-19 (I tested positive for COVID), MALAISE (Remained in bed except to bathroom all day), DIARRHOEA (loose stool all day), DYSPNOEA (Sortness of breath noted when using stairs), DIZZINESS (Dizziness), FATIGUE (Extreme fatigue) and VACCINATION SITE MOVEMENT IMPAIRMENT (unable to raise arm) had resolved and CHEST DISCOMFORT (Chest tightness with exercise) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2020, Influenza: negative a & b (Negative) Negative A & B. On 07-Jan-2020, SARS-CoV-2 test: positive (Positive) positive. On 05-Jan-2021, Body temperature: 101 °F (High) 101. On 05-Jan-2021, Oxygen saturation: 90-93 percent (Low) 90-93. On 09-Jan-2021, Oxygen saturation: 95% percent (normal) 95%. In January 2021, Oxygen saturation: 97-98 percent (normal) 97-98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included acetaminophen and budesonide inhaler.    Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: Follow-up information was received from the patient on 07-Jan-2021 and 08-Jan-2021 (processed as one report) adding additional events, update on condition, vaccination information. On 01-Apr-2021: On 01-Apr-2021: Added patient medical history, dosage information and concomitant medications.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The event of injection pain is possibly related to the mRNA-1273. The events of myalgia, chills, pyrexia, headache, nausea, vomiting and malaise are most likely related to COVID-19.