Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Cognitive disorder, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Major depressive disorder; Diagnosed with Post viral fatigue syndrome/Post viral fatigue; Chronic fatigue and she can't get rid of it, it is still currently ongoing/She states she was tired after having covid, but this is a different type of fatigue; cold sores in her whole mouth; 108 fever/high fever; Took a couple naps and still could not hold her head up; she was reading a book and everything went blurry, blurry vision, she could see out the window but could not see what was in front of her; Could not do anything; mild cognitive impairment; Crazy rashes; Had a reaction to the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MAJOR DEPRESSION (Major depressive disorder) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Cognitive impairment, Generalized anxiety disorder, Insomnia, COPD (Stage 2) and Long COVID. Concomitant products included PREGABALIN, SERTRALINE HYDROCHLORIDE (ZOLOFT), FAMCICLOVIR, AMITRIPTYLINE from 30-Jun-2021 to an unknown date, MONTELUKAST SODIUM (SINGULAIR) and BENZONATATE for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced VACCINATION COMPLICATION (Had a reaction to the Moderna Covid-19 vaccine), POSTURE ABNORMAL (Took a couple naps and still could not hold her head up), VISION BLURRED (she was reading a book and everything went blurry, blurry vision, she could see out the window but could not see what was in front of her), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not do anything) and RASH (Crazy rashes). 14-May-2021, the patient experienced COGNITIVE DISORDER (mild cognitive impairment). On 14-May-2021 at 4:00 PM, the patient experienced PYREXIA (108 fever/high fever). On 14-May-2021 at 10:00 PM, the patient experienced ORAL HERPES (cold sores in her whole mouth). On an unknown date, the patient experienced MAJOR DEPRESSION (Major depressive disorder) (seriousness criterion medically significant), POST VIRAL FATIGUE SYNDROME (Diagnosed with Post viral fatigue syndrome/Post viral fatigue) and FATIGUE (Chronic fatigue and she can't get rid of it, it is still currently ongoing/She states she was tired after having covid, but this is a different type of fatigue). The patient was treated with IBUPROFEN at a dose of 600 mg and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-May-2021, VACCINATION COMPLICATION (Had a reaction to the Moderna Covid-19 vaccine), ORAL HERPES (cold sores in her whole mouth), POSTURE ABNORMAL (Took a couple naps and still could not hold her head up), VISION BLURRED (she was reading a book and everything went blurry, blurry vision, she could see out the window but could not see what was in front of her), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not do anything), COGNITIVE DISORDER (mild cognitive impairment), RASH (Crazy rashes) and PYREXIA (108 fever/high fever) had resolved. At the time of the report, MAJOR DEPRESSION (Major depressive disorder) outcome was unknown and POST VIRAL FATIGUE SYNDROME (Diagnosed with Post viral fatigue syndrome/Post viral fatigue) and FATIGUE (Chronic fatigue and she can't get rid of it, it is still currently ongoing/She states she was tired after having covid, but this is a different type of fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 14-May-2021, Blood pressure measurement: 134/78 (High) 134/78. On 14-May-2021, Body temperature: 108 (High) High, 99.5 (High) 99.5 and 102 (High) 102.. On 14-May-2021, Oxygen saturation: 90 (Low) went down to 90. On an unknown date, Blood pressure measurement: 110/66 (normal) 110/66.         Action taken with mRNA-1273 in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.