Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Restlessness, Swelling, Vision blurred, Visual impairment
Clinical narrative: Pressure went up/patient's blood pressure was 180 over something/blood pressure was of 204/104; Feeling restless; Her cholesterol went up/increasing cholesterol levels; Feeling something very weird on the right side of her face, arm and leg; Feeling something very weird on the right side of her face, arm and leg; Feels very weird; On the right side of her face tingling; Numbness; A bleeding in the right eye; Unusual swelling; Something on the right eye/Cloudiness; Problem seeing things with the right eye/something happened to their sight in the right side; This spontaneous case was reported by a physician and describes the occurrence of EYE HAEMORRHAGE (A bleeding in the right eye) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: High dose flu vaccine (High dose flu vaccine). Past adverse reactions to the above products included No adverse event with High dose flu vaccine. Concurrent medical conditions included Egg allergy.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, the patient experienced SWELLING (Unusual swelling), VISION BLURRED (Something on the right eye/Cloudiness) and VISUAL IMPAIRMENT (Problem seeing things with the right eye/something happened to their sight in the right side). On an unknown date, the patient experienced EYE HAEMORRHAGE (A bleeding in the right eye) (seriousness criterion medically significant), BLOOD PRESSURE INCREASED (Pressure went up/patient's blood pressure was 180 over something/blood pressure was of 204/104), RESTLESSNESS (Feeling restless), BLOOD CHOLESTEROL INCREASED (Her cholesterol went up/increasing cholesterol levels), FACIAL DISCOMFORT (Feeling something very weird on the right side of her face, arm and leg), LIMB DISCOMFORT (Feeling something very weird on the right side of her face, arm and leg), FEELING ABNORMAL (Feels very weird), PARAESTHESIA (On the right side of her face tingling) and HYPOAESTHESIA (Numbness). The patient was treated with LISINOPRIL at a dose of 20 milligram; AMLODIPINE at a dose of 10 milligram and ROSUVASTATIN CALCIUM (CRESTOR) at a dose of 5 milligram. At the time of the report, EYE HAEMORRHAGE (A bleeding in the right eye), SWELLING (Unusual swelling), VISION BLURRED (Something on the right eye/Cloudiness), VISUAL IMPAIRMENT (Problem seeing things with the right eye/something happened to their sight in the right side), RESTLESSNESS (Feeling restless), BLOOD CHOLESTEROL INCREASED (Her cholesterol went up/increasing cholesterol levels), FACIAL DISCOMFORT (Feeling something very weird on the right side of her face, arm and leg) and LIMB DISCOMFORT (Feeling something very weird on the right side of her face, arm and leg) was resolving and BLOOD PRESSURE INCREASED (Pressure went up/patient's blood pressure was 180 over something/blood pressure was of 204/104), FEELING ABNORMAL (Feels very weird), PARAESTHESIA (On the right side of her face tingling) and HYPOAESTHESIA (Numbness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High. On an unknown date, Blood pressure measurement: 180 over something and 204/104. On an unknown date, Body temperature: Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient never had COVID test or diagnosis. Patient did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine Patient received some herpes vaccine way before administration of Moderna COVID-19 vaccine. Patient never had history of high blood pressure before but now she was doing fine. No concomitant medications were reported. Patient believed she had a stroke. She underwent all kinds of tests and all came back negative. Patient already received a result of high cholesterol before administration of the second booster dose but after the second booster it went even higher. Patient never experienced a similar event in the past. Patient had better feeling in the leg and arm. Patient stated that her symptoms improved, maybe, pressure was still high and she was taking medication. Patient was treated for the blood pressure. HCP asked patient if they had a familiar history of glaucoma as they found a bleeding in the right eye.  Company comment:This is a spontaneous case concerning  a  68-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Eye haemorrhage and unexpected non-serious events of Swelling , Vision blurred, Visual impairment, Blood pressure increased, Restlessness, Blood cholesterol increased, Facial discomfort, Limb discomfort, Feeling abnormal and expected non-serious events of Paraesthesia, Hypoaesthesia. The events Swelling , Vision blurred, Visual impairment occurred on the same day after the fourth dose of mRNA-1273 Vaccine. On an unknown date, Eye haemorrhage, Blood pressure increased, Restlessness, Blood cholesterol increased, Facial discomfort, Limb discomfort, Feeling abnormal, Paraesthesia, Hypoaesthesia. Patients available diagnostics are elevated cholesterol, elevated blood pressure and normal temperature.  The patient was treated with Lisinopril at a dose of 20 milligram; Amlodipine at a dose of 10 milligram and Rosuvastatin at a dose of 5 milligram. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-602139 (Linked Report).; Sender's Comments: This is a spontaneous case concerning  a  68-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Eye haemorrhage and unexpected non-serious events of Swelling , Vision blurred, Visual impairment, Blood pressure increased, Restlessness, Blood cholesterol increased, Facial discomfort, Limb discomfort, Feeling abnormal and expected non-serious events of Paraesthesia, Hypoaesthesia. The events Swelling , Vision blurred, Visual impairment occurred on the same day after the fourth dose of mRNA-1273 Vaccine. On an unknown date, Eye haemorrhage, Blood pressure increased, Restlessness, Blood cholesterol increased, Facial discomfort, Limb discomfort, Feeling abnormal, Paraesthesia, Hypoaesthesia. Patients available diagnostics are elevated cholesterol, elevated blood pressure and normal temperature.  The patient was treated with Lisinopril at a dose of 20 milligram; Amlodipine at a dose of 10 milligram and Rosuvastatin at a dose of 5 milligram. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. US-MODERNATX, INC.-MOD-2022-602139:crosslinked case (same reporter)