Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Disoriented; fatigue; fever of 104 F; chills; headache; soreness in arm of injection; nausea; felt distorted; severe leg pain; 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), FATIGUE (fatigue) and PYREXIA (fever of 104 F) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer and Breast cancer (Completed mastectomy chemo in 2008) on 06-Jun-2002. Concurrent medical conditions included Addison's disease (Progression in corticosteroid therapy) since 06-Jan-2004, Smoker, Depression (Depression major) since 1990, Anxiety since 1990, Panic attack since 1990, Migraine since 1990, Drug allergy, Degenerative disc disease (Progression with pain MGMT) since 09-Jan-2006, Spinal stenosis (Progression with pain MGMT) since 09-Jan-2006 and Spinal stenosis (Progression with pain MGMT) since 09-Jan-2006. Concomitant products included HYDROCORTISONE from 07-Jan-2004 to an unknown date for Addison's disease, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, PARACETAMOL (TYLENOL) 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, IBUPROFEN from 09-Jan-2006 to an unknown date and 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 11-Feb-2021, the patient experienced FEELING ABNORMAL (felt distorted), PAIN IN EXTREMITY (severe leg pain), PYREXIA (fever of 104 F), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (soreness in arm of injection) and NAUSEA (nausea). 11-Feb-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced DISORIENTATION (Disoriented). On 16-Feb-2021, FEELING ABNORMAL (felt distorted), PAIN IN EXTREMITY (severe leg pain), FATIGUE (fatigue), PYREXIA (fever of 104 F), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (soreness in arm of injection) and NAUSEA (nausea) had resolved. At the time of the report, DISORIENTATION (Disoriented) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 104 f (High) 104 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-075322 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow-up added patient details as race, ethnic group, height weight. It also contains medical history, concomitant medication.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075322:1st dose case