Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Fatigue, Pain, Pyrexia
Clinical narrative: Chills after first and second vaccine and about 5 weeks after second shot/ unresponsive chills; Ache; Extreme Fatigue 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; Confusion after first and second vaccine and about 5 weeks after second shot; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after first and second vaccine and about 5 weeks after second shot/ unresponsive chills), PAIN (Ache) and FATIGUE (Extreme Fatigue after first and second vaccine and about 5 weeks after second shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included METFORMIN, SIMVASTATIN and VALPROATE SODIUM, VALPROIC ACID (VALPROEX) for an unknown indication.   On 28-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) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (Chills after first and second vaccine and about 5 weeks after second shot/ unresponsive chills) (seriousness criterion hospitalization), PAIN (Ache) (seriousness criterion hospitalization), FATIGUE (Extreme Fatigue after first and second vaccine and about 5 weeks after second shot) (seriousness criterion hospitalization) and CONFUSIONAL STATE (Confusion after first and second vaccine and about 5 weeks after second shot). 19-Mar-2021, the patient experienced PYREXIA (Fever after first and second vaccine and about 5 weeks after second shot). At the time of the report, CHILLS (Chills after first and second vaccine and about 5 weeks after second shot/ unresponsive chills), PAIN (Ache), FATIGUE (Extreme Fatigue 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) had not resolved and CONFUSIONAL STATE (Confusion after first and second vaccine and about 5 weeks after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.         No treatment medications were reported.  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. However, the medical history/ occurrence of SARS-CoV-2 antibody test: positive (Positive) Positive could be a contributory factor.   This case was linked to MOD-2021-228389 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received and event are updated to seriousness, patient information,lab data and concomitant drugs added.; Sender's Comments: 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. However, the medical history/ occurrence of SARS-CoV-2 antibody test: positive (Positive) Positive could be a contributory factor.