Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tremor
Clinical narrative: Had a stroke in her eye causing her to lose part of her vision in her only eye which was the left eye, Was in the closest hospital for a few hours, Hospitalized overnight and throughout the day; The clot broke off and went to her eye,plaque in her eye which killed off the blood vessels and a portion of her vision; Felt miserable, felt all over terrible; Laid in bed shaking from the chills; Breathing seems to be worse; Chills and laid in bed shaking from the chills; Headaches, having headaches on a regular basis, one about every day; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Had a stroke in her eye causing her to lose part of her vision in her only eye which was the left eye, Was in the closest hospital for a few hours, Hospitalized overnight and throughout the day) and EYE HAEMORRHAGE (The clot broke off and went to her eye,plaque in her eye which killed off the blood vessels and a portion of her vision) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer resulted in losing her right eye) and Headache.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021, the patient experienced BLINDNESS UNILATERAL (Had a stroke in her eye causing her to lose part of her vision in her only eye which was the left eye, Was in the closest hospital for a few hours, Hospitalized overnight and throughout the day) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced EYE HAEMORRHAGE (The clot broke off and went to her eye,plaque in her eye which killed off the blood vessels and a portion of her vision) (seriousness criterion medically significant), FEELING ABNORMAL (Felt miserable, felt all over terrible), TREMOR (Laid in bed shaking from the chills), DYSPNOEA (Breathing seems to be worse), CHILLS (Chills and laid in bed shaking from the chills) and HEADACHE (Headaches, having headaches on a regular basis, one about every day). The patient was hospitalized from 13-Jun-2021 to 14-Jun-2021 due to BLINDNESS UNILATERAL. At the time of the report, BLINDNESS UNILATERAL (Had a stroke in her eye causing her to lose part of her vision in her only eye which was the left eye, Was in the closest hospital for a few hours, Hospitalized overnight and throughout the day), EYE HAEMORRHAGE (The clot broke off and went to her eye,plaque in her eye which killed off the blood vessels and a portion of her vision), FEELING ABNORMAL (Felt miserable, felt all over terrible), TREMOR (Laid in bed shaking from the chills), DYSPNOEA (Breathing seems to be worse), CHILLS (Chills and laid in bed shaking from the chills) and HEADACHE (Headaches, having headaches on a regular basis, one about every day) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  She went to her closest hospital and was there for a few hours which didn't have the equipment to treat her. She was transferred to the emergency room of the second hospitalization facility which kept her overnight and throughout the day. She was discharged her 4-5PM 14JUN2021. After hospitalization, patient contacted her ophthalmologist who referred her to a retinal specialist who she has been seeing since. She has also seen both a cardiologist and neurologist. Patient had one about every day. She was prescribed some new eye drops after the stroke and has been taking the same medications for years.  Company comment: 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, patient's underlying medical history remains a contributory factor.; 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, patient's underlying medical history remains a contributory factor.