Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Illness, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Is sick as a dog/very sick; Reoccurring Fever/fevers; Threw up( this was triggered by wine); Headaches; Nausea; chills; Exhausted; Shakes; no appetite; No energy; Sleeping a lot; Depressed; No quality of life can't do any of her normal activities; irritable/cranky; Sinus infection; can't sleep well; feels like she has been poisoned; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), DECREASED APPETITE (no appetite), ASTHENIA (No energy), SOMNOLENCE (Sleeping a lot) and DEPRESSION (Depressed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included IBRUTINIB (IMBRUVICA) and GAMMA GLOBULIN for an unknown indication.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced TREMOR (Shakes), DECREASED APPETITE (no appetite), ASTHENIA (No energy), SOMNOLENCE (Sleeping a lot), DEPRESSION (Depressed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (No quality of life can't do any of her normal activities), IRRITABILITY (irritable/cranky), SINUSITIS (Sinus infection), INSOMNIA (can't sleep well), FEELING ABNORMAL (feels like she has been poisoned), ILLNESS (Is sick as a dog/very sick), PYREXIA (Reoccurring Fever/fevers), VOMITING (Threw up( this was triggered by wine)), HEADACHE (Headaches), NAUSEA (Nausea), CHILLS (chills) and FATIGUE (Exhausted). On 18-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with AZITHROMYCIN (ZITHROMAX) for Sinus infection, at an unspecified dose and frequency. On 18-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, TREMOR (Shakes), DECREASED APPETITE (no appetite), ASTHENIA (No energy), SOMNOLENCE (Sleeping a lot), DEPRESSION (Depressed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (No quality of life can't do any of her normal activities), IRRITABILITY (irritable/cranky), SINUSITIS (Sinus infection), INSOMNIA (can't sleep well), FEELING ABNORMAL (feels like she has been poisoned), ILLNESS (Is sick as a dog/very sick), PYREXIA (Reoccurring Fever/fevers), VOMITING (Threw up( this was triggered by wine)), HEADACHE (Headaches), NAUSEA (Nausea), CHILLS (chills) and FATIGUE (Exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 99/60 (Low) Low blood pressure.. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. On an unknown date, Weight: decreased (abnormal) Lost 5 lbs.         It was reported that Hydration treatment given for sinus infection.   This case was linked to MOD-2021-308835 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Significant Follow up: new events (difficulty sleeping and irritable) added.