Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident, Dyspnoea, Loss of consciousness, Memory impairment
Clinical narrative: seizure; paralyzed; heart attacks; strokes; chronic pain; forgets/He has been losing his memory; issues breathing/ barely breathe; tingling sensation; passed out; blind; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), SEIZURE (seizure), PARALYSIS (paralyzed), MYOCARDIAL INFARCTION (heart attacks), BLINDNESS (blind) and CEREBROVASCULAR ACCIDENT (strokes) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient had no relevant medical history conditions, allergy, concomitant diseases, risk factor and no previous COVID-19 diagnosis. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), PARALYSIS (paralyzed) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (heart attacks) (seriousness criterion medically significant), BLINDNESS (blind) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant), PAIN (chronic pain), MEMORY IMPAIRMENT (forgets/He has been losing his memory), DYSPNOEA (issues breathing/ barely breathe) and PARAESTHESIA (tingling sensation). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), SEIZURE (seizure), PARALYSIS (paralyzed), MYOCARDIAL INFARCTION (heart attacks), BLINDNESS (blind), CEREBROVASCULAR ACCIDENT (strokes), PAIN (chronic pain), MEMORY IMPAIRMENT (forgets/He has been losing his memory), DYSPNOEA (issues breathing/ barely breathe) and PARAESTHESIA (tingling sensation) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient had been to multiple doctors for checkups for these symptoms and they have all said that his lungs and heart were fine. However, he was still experiencing all these symptoms. He was experiencing all these symptoms and it had gotten progressively worse. No treatment medication was reported.  Company Comment: This spontaneous case concerns a 32-year-old male patient with no medical history reported, who experienced unexpected serious (medically significant) events of Loss of Consciousness, Seizure (AESI), Paralysis, Myocardial Infarction (AESI), Blindness, Cerebrovascular Accident (AESI) which occurred after receiving a dose of mRNA-1273, which was the patient's 3rd dose of COVID-19 vaccination schedule. Latency cannot be calculated due to vaccination date unknown and events onset dates unknown. Previously patient has been vaccinated with mRNA-1273 vaccine with 1st and 2nd dose of Covid-19 vaccination schedule. It was reported that upon receiving the booster dose the patient immediately passed out (approximately 15 minutes of receiving it); started having issues breathing and had a seizure at that time and tingling sensation in his body. Later on, after coming back home, was paralyzed from the neck down. She states that for the past 2 years, he has been in chronic pain ever since receiving the Moderna COVID-19 booster shot (third dose). The patient also had a couple of heart attacks, strokes, and seizures; can barely breathe. The patient visited multiple doctors for checkups for these symptoms and they have all said that his lungs and heart are fine. However, he is still experiencing all these symptoms. There are certain days where the patient forgets people's names; has been losing his memory. The patient went blind for 3 days a week after receiving the booster dose. He is experiencing all these symptoms and it has gotten progressively worse. No further details regarding clinical course, etiologic and diagnostic work-up and treatment, investigations performed are available in the report. Events of outcome was not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per the European Medicines Agency list of important medical events.; Sender's Comments: This spontaneous case concerns a 32-year-old male patient with no medical history reported, who experienced unexpected serious (medically significant) events of Loss of Consciousness, Seizure (AESI), Paralysis, Myocardial Infarction (AESI), Blindness, Cerebrovascular Accident (AESI) which occurred after receiving a dose of mRNA-1273, which was the patient's 3rd dose of COVID-19 vaccination schedule. Latency cannot be calculated due to vaccination date unknown and events onset dates unknown. Previously patient has been vaccinated with mRNA-1273 vaccine with 1st and 2nd dose of Covid-19 vaccination schedule. It was reported that upon receiving the booster dose the patient immediately passed out (approximately 15 minutes of receiving it); started having issues breathing and had a seizure at that time and tingling sensation in his body. Later on, after coming back home, was paralyzed from the neck down. She states that for the past 2 years, he has been in chronic pain ever since receiving the Moderna COVID-19 booster shot (third dose). The patient also had a couple of heart attacks, strokes, and seizures; can barely breathe. The patient visited multiple doctors for checkups for these symptoms and they have all said that his lungs and heart are fine. However, he is still experiencing all these symptoms. There are certain days where the patient forgets people's names; has been losing his memory. The patient went blind for 3 days a week after receiving the booster dose. He is experiencing all these symptoms and it has gotten progressively worse. No further details regarding clinical course, etiologic and diagnostic work-up and treatment, investigations performed are available in the report. Events of outcome was not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per the European Medicines Agency list of important medical events.