Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Anion gap, Antinuclear antibody, Aspartate aminotransferase, Asthenia
Clinical narrative: Mild Weakness; Feels like she cannot focus; Numbness/Numbness of arms and legs; Little acniness bilateral temples; Could not get out of bed/or walk across the room; Not able to open her eyes; Extreme exhaustion/ Complete exhaustion; Brain fog/Brain not working/cannot focus/feels like brain has been poisoned; SOB first 10days after vaccine, did not feel she was able to get deep breaths; Feverish for several days; decrease in appetite; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Brain fog/Brain not working/cannot focus/feels like brain has been poisoned), HYPOKINESIA (Could not get out of bed/or walk across the room), OCULAR DISCOMFORT (Not able to open her eyes), ASTHENIA (Mild Weakness) and VISION BLURRED (Feels like she cannot focus) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21, 045A21 and 002A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insomnia and Menopausal. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) from 13-Sep-2021 to an unknown date for Insomnia, ESTRADIOL (ESTRING) from 23-Sep-2021 to an unknown date for Menopausal, VITAMINS NOS and SALBUTAMOL SULFATE (PROAIR HFA) from 05-Nov-2021 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-Nov-2021, the patient experienced FEELING ABNORMAL (Brain fog/Brain not working/cannot focus/feels like brain has been poisoned). 11-Nov-2021, the patient experienced FATIGUE (Extreme exhaustion/ Complete exhaustion). On 12-Nov-2021, the patient experienced HYPOKINESIA (Could not get out of bed/or walk across the room) and OCULAR DISCOMFORT (Not able to open her eyes). In November 2021, the patient experienced DYSPNOEA (SOB first 10days after vaccine, did not feel she was able to get deep breaths) and PYREXIA (Feverish for several days). On an unknown date, the patient experienced ASTHENIA (Mild Weakness), VISION BLURRED (Feels like she cannot focus), DECREASED APPETITE (decrease in appetite), HYPOAESTHESIA (Numbness/Numbness of arms and legs) and HEADACHE (Little acniness bilateral temples). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and ZINC at an unspecified dose and frequency. In November 2021, DYSPNOEA (SOB first 10days after vaccine, did not feel she was able to get deep breaths) had resolved. At the time of the report, FEELING ABNORMAL (Brain fog/Brain not working/cannot focus/feels like brain has been poisoned), HYPOKINESIA (Could not get out of bed/or walk across the room), OCULAR DISCOMFORT (Not able to open her eyes) and FATIGUE (Extreme exhaustion/ Complete exhaustion) had not resolved, ASTHENIA (Mild Weakness), VISION BLURRED (Feels like she cannot focus), HYPOAESTHESIA (Numbness/Numbness of arms and legs) and HEADACHE (Little acniness bilateral temples) outcome was unknown, DECREASED APPETITE (decrease in appetite) was resolving and PYREXIA (Feverish for several days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, Alanine aminotransferase (14-67): 20 (normal) normal. On 03-Dec-2021, Anion gap: <6 (normal) Ref range: <15. On 03-Dec-2021, Antinuclear antibody: negative (Negative) Negative. On 03-Dec-2021, Aspartate aminotransferase (6-58): 12 (normal) normal. On 03-Dec-2021, Basophil count (0.0-0.1): 0.0 (normal) normal and 1 1. On 03-Dec-2021, Blood albumin (3.4-4.7): 3.9 (normal) normal. On 03-Dec-2021, Blood alkaline phosphatase (38-150): 55 (normal) normal. On 03-Dec-2021, Blood bilirubin (0.3-1.2): 0.4 (normal) normal. On 03-Dec-2021, Blood calcium (8.4-10.4): 9.3 (normal) normal. On 03-Dec-2021, Blood chloride (98-111): 110 (normal) normal. On 03-Dec-2021, Blood creatine phosphokinase (28-203): 53 (normal) Normal. On 03-Dec-2021, Blood creatinine (0.50-1.40): 0.73 (normal) normal. On 03-Dec-2021, Blood glucose (60-100): 95 (normal) normal. On 03-Dec-2021, Blood potassium (3.5-5.1): 4.2 (normal) normal. On 03-Dec-2021, Blood sodium (134-144): 140 (normal) normal. On 03-Dec-2021, Blood thyroid stimulating hormone (0.358-3.740): 0.924 (normal) normal. On 03-Dec-2021, Blood urea (7-31): 17 (normal) normal. On 03-Dec-2021, C-reactive protein (0.0-0.8): <0.3 (normal) <0.3. On 03-Dec-2021, Carbon dioxide (20-30): 25 (normal) normal. On 03-Dec-2021, Eosinophil count (0.0-0.3): 0.1 (normal) normal and 2 2. On 03-Dec-2021, Globulin (2.4-4.2): 3.3 (normal) normal. On 03-Dec-2021, Haematocrit (36-48): 44 (normal) normal. On 03-Dec-2021, Haemoglobin (12.0-16.0): 14.4 (normal) normal. On 03-Dec-2021, Lymphocyte count (1.0-3.4): 2.2 (normal) normal and 49 49. On 03-Dec-2021, Mean cell haemoglobin concentration (31.1-35.5): 32.5 (normal) normal. On 03-Dec-2021, Mean cell volume (81-101): 100 (normal) normal. On 03-Dec-2021, Monocyte count (0.2-0.8): 0.2 (normal) normal and 6 6. On 03-Dec-2021, Neutrophil count (1.8-7.0): 1.8 (normal) normal and 42 42. On 03-Dec-2021, Platelet count (150-400): 234 234. On 03-Dec-2021, Protein total normal (6.1-8.2): 7.2 (normal) normal. On 03-Dec-2021, Red blood cell count (4.01-5.47): 4.42 (normal) normal. On 03-Dec-2021, Red blood cell sedimentation rate normal (2-39): 6 (normal) ESR Westergren - Normal. On 03-Dec-2021, Red cell distribution width (11.0-14.5): 11.4 (normal) normal. On 03-Dec-2021, White blood cell count (4.0-11.0): 4.4 (normal) normal. On an unknown date, Physical examination: normal (normal) Respiratory and psychiatric.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient concomitant medications also included supplements. Possibly, as a part of continuing medications, instructions of the already taking medications were changed : ProAir HFA 90 - Quantity change at Qs1, Seroquel 25 mg - Quantity changed to 100 and instructions changed at QS.   The patient stated that the intensity of the extreme exhaustion and brain fog remained the same, it has not worsened or improved over the past 10 days. It was reported that the patient visited the medical services on 30-NOV-2021 at 03:45 PM under the Provider Telephone service visit type. Patient had no double vision, visual changes, cough, blood in stool or hearing noises in head.  As a part of treatment, the patient drank lots of fluids and rested.  Also that the lab results were dated by the HCP on 13-FEB-2022, Where the Other lab data included: eGFR - 87 (>60), GFR comment - For patients, eGFR must be multiplied by 1.16 to derive a race corrected eGFR.   This case was linked to MOD-2021-395717, MOD-2021-395928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2022: Follow up received contains reporter details, patient demographics, lab data, dosage details, concomitant medications, additional events, event outcome was updated and narrative was updated.