Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chills after first and second vaccine and about 5 weeks after second shot; Ache; Extreme Fatigue after first and second vaccine and about 5 weeks after second shot; Confusion after first and second vaccine and about 5 weeks after second shot; Fever after first and second vaccine and about 5 weeks after second shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills after first and second vaccine and about 5 weeks after second shot), FATIGUE (Extreme Fatigue after first and second vaccine and about 5 weeks after second shot) and PAIN (Ache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METFORMIN, SIMVASTATIN and DIVALPROEX SODIUM for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FATIGUE (Extreme Fatigue after first and second vaccine and about 5 weeks after second shot) (seriousness criterion hospitalization). On 19-Feb-2021, the patient experienced CHILLS (Chills after first and second vaccine and about 5 weeks after second shot) (seriousness criterion hospitalization), PAIN (Ache) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion after first and second vaccine and about 5 weeks after second shot) and PYREXIA (Fever after first and second vaccine and about 5 weeks after second shot). On 24-Feb-2021, CHILLS (Chills after first and second vaccine and about 5 weeks after second shot), PAIN (Ache) and PYREXIA (Fever after first and second vaccine and about 5 weeks after second shot) had resolved. At the time of the report, FATIGUE (Extreme Fatigue after first and second vaccine and about 5 weeks after second shot) and CONFUSIONAL STATE (Confusion after first and second vaccine and about 5 weeks after second shot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-226199, US-MODERNATX, INC.-MOD-2021-226361, US-MODERNATX, INC.-MOD-2021-226399 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received contain significant information that include Patient demographic, Lab data ,Concomitant  medication, event update to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-226199:Dose 2 case US-MODERNATX, INC.-MOD-2021-226361:Same reporter US-MODERNATX, INC.-MOD-2021-226399:Same reporter