Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disorientation, Fatigue, Feeling abnormal
Clinical narrative: Fatigue; Fever of 104 F; Chills; felt distorted; Severe leg pain; Disoriented; Headache; Nausea; Soreness in arm of injection arm (right arm); This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt distorted), PAIN IN EXTREMITY (Severe leg pain), DISORIENTATION (Disoriented), HEADACHE (Headache) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer on 06-Jun-2002 and Mastectomy. Concurrent medical conditions included Smoker, Addison's disease since 06-Jan-2004, Depression (Major depression) since 1990, Anxiety (Generalized anxiety) since 1990, Migraine since 1990, Panic attack since 1990, Allergy to antibiotic (erythromycin), Allergy to antibiotic (z-pack), Degenerative disc disease since 09-Jan-2006, Spinal stenosis cervical since 09-Jan-2006 and Spinal stenosis lumbar since 09-Jan-2006. Concomitant products included HYDROCORTISONE from 09-Jan-2004 to an unknown date for Addison's disease, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE NO. 4) from 09-Jan-2006 to an unknown date for Degenerative disc disease, ALPRAZOLAM (XANAX) for Depression, Anxiety and Panic attack, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 09-Jan-1990 to an unknown date for Depression, Anxiety and Panic disorder, ELETRIPTAN HYDROBROMIDE (RELPAX) for Migraine headache, CARISOPRODOL from 09-Jan-2006 to an unknown date for Pain management.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced FEELING ABNORMAL (felt distorted), PAIN IN EXTREMITY (Severe leg pain), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE PAIN (Soreness in arm of injection arm (right arm)), PYREXIA (Fever of 104 F) and CHILLS (Chills). 14-Jan-2021, the patient experienced DISORIENTATION (Disoriented). On 15-Jan-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN for Pain management, at a dose of 600 mg three times a day. On 19-Jan-2021, FEELING ABNORMAL (felt distorted), DISORIENTATION (Disoriented) and VACCINATION SITE PAIN (Soreness in arm of injection arm (right arm)) had resolved. On 20-Jan-2021, PAIN IN EXTREMITY (Severe leg pain), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Fever of 104 F) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 104 f (High) 104 F.         This case was linked to US-MODERNATX, INC.-MOD-2021-075349 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Patient height and weight.  Allergies.  Medical history details.  Concomitant medication added and details for previously reported updated.  Resolution date for pyrexia, chills, headache, nausea and vaccination site pain updated.  Event causality updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075349:second dose