Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: tolerable Fatigue; chest pain; did end up getting COVID; shooting pain up left arm; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (tolerable Fatigue) and CHEST PAIN (chest pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) and Moderna COVID-19 Vaccine (Dose 1). Past adverse reactions to the above products included Fatigue with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In November 2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (shooting pain up left arm). In September 2022, the patient experienced COVID-19 (did end up getting COVID). On an unknown date, the patient experienced FATIGUE (tolerable Fatigue) (seriousness criterion hospitalization). At the time of the report, FATIGUE (tolerable Fatigue), CHEST PAIN (chest pain) and PAIN IN EXTREMITY (shooting pain up left arm) had resolved and COVID-19 (did end up getting COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Electrocardiogram: normal. In September 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events.  Treatment drug was not reported.  Company comment: This is a regulatory authority case concerning a 43-year-old female patient, with medical history of fatigue after first dose of mRNA-1273, who experienced the unexpected serious events of fatigue and chest pain. Hospitalization was reported as seriousness criteria for both events. The patient also experienced unexpected non-serious events of COVID-19 and pain in extremity. The patient received the third dose of mRNA-1273. Fatigue occurred on an unknown date, while chest pain and pain in extremity occurred on unspecified dates; thus, latency between these events' onset and third dose vaccination with mRNA-1273 cannot be established. COVID-19 occurred  approximately 10 months after the third dose vaccination with mRNA-1273. Fatigue, chest pain and pain in extremity were reported as resolved, while COVID-19 outcome was unknown. The patient's primary vaccination series included first and second dose of mRNA-1273 vaccine. Reportedly, the patient experienced fatigue after the first dose, but "3rd dose with Moderna was the least tolerable". Relevant diagnostic findings included ECG (reported as "normal"). No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-664808 (Linked Report).; Sender's Comments: This is a regulatory authority case concerning a 43-year-old female patient, with medical history of fatigue after first dose of mRNA-1273 , who experienced the unexpected serious events of fatigue and chest pain. Hospitalization was reported as seriousness criteria for both events. The patient also experienced unexpected non-serious events of COVID-19 and pain in extremity. The patient received the third dose of mRNA-1273. Fatigue occurred on an unknown date, while chest pain and pain in extremity occurred on unspecified dates; thus, latency between these events' onset and third dose vaccination with mRNA-1273 cannot be established. COVID-19 occurred  approximately 10 months after the third dose vaccination with mRNA-1273. Fatigue, chest pain and pain in extremity were reported as resolved, while COVID-19 outcome was unknown. The patient's primary vaccination series included first and second dose of mRNA-1273 vaccine. Reportedly, the patient experienced fatigue after the first dose, but "3rd dose with Moderna was the least tolerable". Relevant diagnostic findings included ECG (reported as "normal"). No further information was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-664808:Dose 3