Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Computerised tomogram, Dizziness, Dyspnoea, Erythema
Clinical narrative: couldn't breathe; swelling of his whole body; whole body was red and rashy; seeing flashes and black dots in his vision; vision was blurry; he lost 11 lbs of water weight; headaches; dizziness/dizzy; His legs ... changed to red and ankles swollen when he dropped them to the floor; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (couldn't breathe), SWELLING (swelling of his whole body) and ERYTHEMA (whole body was red and rashy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 017B211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (dizziness/dizzy), JOINT SWELLING (His legs ... changed to red and ankles swollen when he dropped them to the floor), VISION BLURRED (vision was blurry), WEIGHT DECREASED (he lost 11 lbs of water weight) and HEADACHE (headaches). On 28-Apr-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization), SWELLING (swelling of his whole body) (seriousness criterion hospitalization) and ERYTHEMA (whole body was red and rashy) (seriousness criterion hospitalization). On 07-Jun-2021, the patient experienced PHOTOPSIA (seeing flashes and black dots in his vision). The patient was treated with FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]) at an unspecified dose and frequency; PANTOPRAZOLE at a dose of 40 mg at bedtime; HYDROCHLOROTHIAZIDE at a dose of 45 mg in the morning; LOSARTAN POTASSIUM at a dose of 50 mg twice a day; CLOPIDOGREL at a dose of 75 mg once a day; VITAMIN B12 NOS at an unspecified dose and frequency; VITAMIN B3 at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (couldn't breathe), SWELLING (swelling of his whole body), ERYTHEMA (whole body was red and rashy), DIZZINESS (dizziness/dizzy), JOINT SWELLING (His legs .. changed to red and ankles swollen when he dropped them to the floor), PHOTOPSIA (seeing flashes and black dots in his vision) and WEIGHT DECREASED (he lost 11 lbs of water weight) outcome was unknown and VISION BLURRED (vision was blurry) and HEADACHE (headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure increased: 179/110 (High) increased. On an unknown date, Computerised tomogram: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative. On an unknown date, Weight decreased: decreased (Low) Decreased.         On 08 Jun 2021, a consumer reported that he took simvastatin for high cholesterol and baby aspirin and fish oil prophylactically. He got his first Moderna dose in his left arm on 01 Apr 2021, lot 017B211A. The next day his blood pressure skyrocketed from 100/50 normally to 179/110. He went to a heart doctor (cardiologist) on Thursday, 22 Apr 2021. His left arm had a higher blood pressure than the right arm. The doctor sent him to the emergency room as he thought he had blocked arteries. They did a computerized tomography (CT) scan and magnetic resonance imaging (MRI). The tests came back negative and he was sent home. He had headaches, dizziness and his vision was blurry. His blood pressure came down to 167/106 and stayed around that level.   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.  However, based on the reported information there might have been previously undiagnosed medical conditions of medical relevance regarding the events.   This case was linked to MOD-2021-213198 (Patient Link).; 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.  However, based on the reported information there might have been previously undiagnosed medical conditions of medical relevance regarding the events.