Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: shortness of breath; heart racing while walking; legs were aching on and off.; I feel like I am having an out of my body experience/I feel like I am dying; shaking all over and when I get up to walk; I almost had a brain fog and prevents me from driving; it feels like my heart is going to blow out of my body; week later the injection site was solid black; I had diarrhea on fourth day after second Moderna injection; stomach cramps on third day after second Moderna injection; itching all over body after second Moderna covid-19 injection; a softball size redness to site of injection after the second Moderna Covid-19 injection; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps on third day after second Moderna injection), DIARRHOEA (I had diarrhea on fourth day after second Moderna injection), TREMOR (shaking all over and when I get up to walk), FEELING ABNORMAL (I almost had a brain fog and prevents me from driving) and CARDIAC DISCOMFORT (it feels like my heart is going to blow out of my body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DIAZEPAM (VALIUM) and TOPIRAMATE (TOPIMAX [TOPIRAMATE]) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PRURITUS (itching all over body after second Moderna covid-19 injection) and VACCINATION SITE ERYTHEMA (a softball size redness to site of injection after the second Moderna Covid-19 injection). On 29-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps on third day after second Moderna injection). On 30-Apr-2021, the patient experienced DIARRHOEA (I had diarrhea on fourth day after second Moderna injection). On 03-May-2021, the patient experienced VACCINATION SITE DISCOLOURATION (week later the injection site was solid black). On 21-May-2021, the patient experienced TREMOR (shaking all over and when I get up to walk), FEELING ABNORMAL (I almost had a brain fog and prevents me from driving) and CARDIAC DISCOMFORT (it feels like my heart is going to blow out of my body). On 22-May-2021, the patient experienced FEELING ABNORMAL (I feel like I am having an out of my body experience/I feel like I am dying). On an unknown date, the patient experienced DYSPNOEA (shortness of breath), HEART RATE INCREASED (heart racing while walking) and PAIN IN EXTREMITY (legs were aching on and off.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; HYDROXYZINE at a dose of 1 dosage form; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at a dose of 1 dosage form and HYOSCYAMINE at a dose of 125 and 10 mg. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps on third day after second Moderna injection), DIARRHOEA (I had diarrhea on fourth day after second Moderna injection), TREMOR (shaking all over and when I get up to walk), FEELING ABNORMAL (I almost had a brain fog and prevents me from driving), CARDIAC DISCOMFORT (it feels like my heart is going to blow out of my body), DYSPNOEA (shortness of breath), HEART RATE INCREASED (heart racing while walking), FEELING ABNORMAL (I feel like I am having an out of my body experience/I feel like I am dying), PAIN IN EXTREMITY (legs were aching on and off.), PRURITUS (itching all over body after second Moderna covid-19 injection), VACCINATION SITE DISCOLOURATION (week later the injection site was solid black) and VACCINATION SITE ERYTHEMA (a softball size redness to site of injection after the second Moderna Covid-19 injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-162554 (Patient Link).