Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus, Transient ischaemic attack, Vertigo
Clinical narrative: experienced vertigo from the left eye; received a diagnosis of Mini stroke in the Retina of left eye/local optometrist who saw 2 hemorrhages spots, blood pooling in the back of left retina/flickering, flashing lights, in the left eye, almost like floaters which lasted about 5 days; numbness in hands and feet on both sides, but mostly on the left side; had a summer where could barely move; tingling, constant tingling, tingling in left leg, prickling, always waking up in the morning with feeling of pins and needles in my hands and my feet; started bleeding, similar to a menstrual period for a month; was weak; really painful to the touch, anything that would touch the back of my skin, or skin on back would hurt; itching; experienced skin sensations, burning; This spontaneous case was reported by a patient and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (received a diagnosis of Mini stroke in the Retina of left eye/local optometrist who saw 2 hemorrhages spots, blood pooling in the back of left retina/flickering, flashing lights, in the left eye, almost like floaters which lasted about 5 days) and HAEMORRHAGE (started bleeding, similar to a menstrual period for a month) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 028A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOAESTHESIA (numbness in hands and feet on both sides, but mostly on the left side). In 2021, the patient experienced HAEMORRHAGE (started bleeding, similar to a menstrual period for a month) (seriousness criterion medically significant), ASTHENIA (was weak), PAIN (really painful to the touch, anything that would touch the back of my skin, or skin on back would hurt), PRURITUS (itching), BURNING SENSATION (experienced skin sensations, burning), HYPOKINESIA (had a summer where could barely move) and PARAESTHESIA (tingling, constant tingling, tingling in left leg, prickling, always waking up in the morning with feeling of pins and needles in my hands and my feet). In May 2023, the patient experienced TRANSIENT ISCHAEMIC ATTACK (received a diagnosis of Mini stroke in the Retina of left eye/local optometrist who saw 2 hemorrhages spots, blood pooling in the back of left retina/flickering, flashing lights, in the left eye, almost like floaters which lasted about 5 days) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO (experienced vertigo from the left eye). The patient was treated with PROGESTERONE for Bleeding, at an unspecified dose and frequency. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (received a diagnosis of Mini stroke in the Retina of left eye/local optometrist who saw 2 hemorrhages spots, blood pooling in the back of left retina/flickering, flashing lights, in the left eye, almost like floaters which lasted about 5 days), HAEMORRHAGE (started bleeding, similar to a menstrual period for a month), ASTHENIA (was weak), PAIN (really painful to the touch, anything that would touch the back of my skin, or skin on back would hurt), PRURITUS (itching), BURNING SENSATION (experienced skin sensations, burning), VERTIGO (experienced vertigo from the left eye), HYPOKINESIA (had a summer where could barely move), PARAESTHESIA (tingling, constant tingling, tingling in left leg, prickling, always waking up in the morning with feeling of pins and needles in my hands and my feet) and HYPOAESTHESIA (numbness in hands and feet on both sides, but mostly on the left side) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. It was reported that with dose 1 patient had bleeding and almost needed a transfusion.  It was also reported that patient saw a Neurologist as well as a MS specialist and had MRIs but no diagnosis was given. Patient never had circulatory or neurological issues before the vaccine. The symptoms were indefinite, but did subside slightly, or patient thought was used to it as it comes and goes. Patient was referred to a retina specialist, and was asked to see them that day, so that patient do not lose the vision. Patient ended up having laser treatment to prevent loss of eyesight. It was also reported that patient had COVID diagnosis in August 2021. Patient had two brain MRIs one in 2021 and one in 2022 and had a spinal MRI in 2021, all with no specific diagnosis. For bleeding patient was treated with Progesterone and another medication (unknown).  Company Comment: This is a spontaneous case concerning a 52-year-old female patient with no reported relevant medical history, who experienced the serious (due to medically significant) unexpected, events of Transient ischaemic attack (AESI) and haemorrhage. The event haemorrhage occurred on an unknown date and with unknown latency after the first dose of mRNA-1273 vaccine. Event Transient ischaemic attack occurred approximately 2 years   after the second dose of mRNA-1273 vaccine. It was reported that after first dose, patient started bleeding profusely, similar to a menstrual period for a month and was treated with progesterone. She was weak and almost needed a transfusion. Five days after receiving second booster, she started feeling neurological symptoms like tingling and numbness in hands and feet on both sides, but mostly on the left side. Currently she had tingling in left leg. She experienced skin sensations, burning, itching, prickling, painful to the touch, anything that would touch the back of her skin, or skin on back would hurt. She saw a Neurologist as well as a MS specialist and had MRIs but no diagnosis was given. Symptoms are indefinite but did subside slightly. More recently, she had experienced vertigo from the left eye. She had flickering, flashing lights, in the left eye, almost like floaters which lasted about 5 days. Approximately 2 years after 2nd dose, patient went to a local optometrist who saw 2 hemorrhages spots, blood pooling in the back of her left retina. She was referred to a retina specialist and received a diagnosis of Mini stroke in the Retina of left eye. She had a laser treatment to prevent loss of eyesight. She must follow up in 2 months. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 52-year-old female patient with no reported relevant medical history, who experienced the serious (due to medically significant) unexpected, events of Transient ischaemic attack (AESI) and haemorrhage. The event haemorrhage occurred on an unknown date and with unknown latency after the first dose of mRNA-1273 vaccine. Event Transient ischaemic attack occurred approximately 2 years   after the second dose of mRNA-1273 vaccine. It was reported that after first dose, patient started bleeding profusely, similar to a menstrual period for a month and was treated with progesterone. She was weak and almost needed a transfusion. Five days after receiving second booster, she started feeling neurological symptoms like tingling and numbness in hands and feet on both sides, but mostly on the left side. Currently she had tingling in left leg. She experienced skin sensations, burning, itching, prickling, painful to the touch, anything that would touch the back of her skin, or skin on back would hurt. She saw a Neurologist as well as a MS specialist and had MRIs but no diagnosis was given. Symptoms are indefinite but did subside slightly. More recently, she had experienced vertigo from the left eye. She had flickering, flashing lights, in the left eye, almost like floaters which lasted about 5 days. Approximately 2 years after 2nd dose, patient went to a local optometrist who saw 2 hemorrhages spots, blood pooling in the back of her left retina. She was referred to a retina specialist and received a diagnosis of Mini stroke in the Retina of left eye. She had a laser treatment to prevent loss of eyesight. She must follow up in 2 months. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.