Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Illness, Loss of consciousness, Loss of personal independence in daily activities, Memory impairment
Clinical narrative: joints hurting; headaches; very tired for almost a month/  exhausted all the time; I ended up passing out/ I was just gone; allergic reaction; face started to tingle; throat started constricting; nose felt numb; tongue felt numb like tingly sensation; tongue felt numb like tingly sensation; high blood pressure; heart started to beat irregularly; Burning sensation in face; I remember nothing; I didn't get better afterwards; not able to ride bike for 6 miles, which was a daily activity; impending sense of doom like something is horribly wrong/ didn't feel normal/ felt very strange; I had I think temperature; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (I ended up passing out/ I was just gone) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Polyethylene glycol), Seafood allergy (allergies to fake crab meat), Allergy (aspartame) and Hypertension. Concomitant products included MONTELUKAST for Allergy, LEVOTHYROXINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (I ended up passing out/ I was just gone) (seriousness criterion medically significant), HYPERSENSITIVITY (allergic reaction), PARAESTHESIA (face started to tingle), THROAT TIGHTNESS (throat started constricting), HYPOAESTHESIA (nose felt numb), HYPOAESTHESIA ORAL (tongue felt numb like tingly sensation), PARAESTHESIA ORAL (tongue felt numb like tingly sensation), HYPERTENSION (high blood pressure ), HEART RATE IRREGULAR (heart started to beat irregularly), BURNING SENSATION (Burning sensation in face), MEMORY IMPAIRMENT (I remember nothing), ILLNESS (I didn't get better afterwards), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to ride bike for 6 miles, which was a daily activity), FEELING ABNORMAL (impending sense of doom like something is horribly wrong/ didn't feel normal/ felt very strange), PYREXIA (I had I think temperature), HEADACHE (headaches) and FATIGUE ( very tired for almost a month/  exhausted all the time). On 03-Apr-2021, the patient experienced ARTHRALGIA (joints hurting). The patient was treated with PARACETAMOL (TYLENOL) (oral) on 13-Apr-2021 at a dose of 2 Tab twice a day; PARACETAMOL (TYLENOL) at a dose of 1 Tab twice a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Apr-2021 at a dose of 25 milligram twice a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram once a day. On 02-Apr-2021, LOSS OF CONSCIOUSNESS (I ended up passing out/ I was just gone) had resolved. On 02-May-2021, FATIGUE ( very tired for almost a month/  exhausted all the time) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction), PARAESTHESIA (face started to tingle), THROAT TIGHTNESS (throat started constricting), HYPOAESTHESIA (nose felt numb), HEART RATE IRREGULAR (heart started to beat irregularly), BURNING SENSATION (Burning sensation in face), MEMORY IMPAIRMENT (I remember nothing), ILLNESS (I didn't get better afterwards), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to ride bike for 6 miles, which was a daily activity), FEELING ABNORMAL (impending sense of doom like something is horribly wrong/ didn't feel normal/ felt very strange), PYREXIA (I had I think temperature), ARTHRALGIA (joints hurting) and HEADACHE (headaches) was resolving, HYPOAESTHESIA ORAL (tongue felt numb like tingly sensation) and PARAESTHESIA ORAL (tongue felt numb like tingly sensation) had resolved and HYPERTENSION (high blood pressure ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) Blood pressure was high, Systolic was 200, diastolic was also high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included anti-hypertensives.  For treatment of events, patient was prescribed Prednisone, which was not yet started.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.