Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Facial paralysis, Hypoaesthesia, Impaired driving ability, Intraocular pressure increased
Clinical narrative: Pressure in my right eye was 34 or 35, pressure in eft eye was 28; Numbness on right side; Tingling on my right side; Vision was distorted for almost 3 weeks; Vision was blurred; was not able to drive for 3 weeks; Vertigo-type symptoms; Throw up; would get nauseated; Face was drooping back and forth, like a Bell's Palsy situation; Small amount of fluid around my heart; Lost vision in my left eye; Cluster of migraines,over a 14-day period,she had 10 migraines in 14 days,the last one put her in the hospital; Her doctor advised her not to receive the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Cluster of migraines,over a 14-day period,she had 10 migraines in 14 days,the last one put her in the hospital), FACIAL PARALYSIS (Face was drooping back and forth, like a Bell's Palsy situation), PERICARDIAL EFFUSION (Small amount of fluid around my heart), BLINDNESS (Lost vision in my left eye), INTRAOCULAR PRESSURE INCREASED (Pressure in my right eye was 34 or 35, pressure in eft eye was 28), HYPOAESTHESIA (Numbness on right side), PARAESTHESIA (Tingling on my right side), METAMORPHOPSIA (Vision was distorted for almost 3 weeks), VISION BLURRED (Vision was blurred), IMPAIRED DRIVING ABILITY (was not able to drive for 3 weeks), VERTIGO (Vertigo-type symptoms), VOMITING (Throw up) and NAUSEA (would get nauseated) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Anaphylactic reaction: TETANUS VACCINE (they determined she was allergic to something in the vaccine and not tetanus itself.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced MIGRAINE (Cluster of migraines,over a 14-day period,she had 10 migraines in 14 days,the last one put her in the hospital) (seriousness criterion hospitalization). On 09-Feb-2021, the patient experienced BLINDNESS (Lost vision in my left eye) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FACIAL PARALYSIS (Face was drooping back and forth, like a Bell's Palsy situation) (seriousness criteria hospitalization and medically significant), PERICARDIAL EFFUSION (Small amount of fluid around my heart) (seriousness criteria hospitalization and medically significant), INTRAOCULAR PRESSURE INCREASED (Pressure in my right eye was 34 or 35, pressure in eft eye was 28) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness on right side) (seriousness criterion hospitalization), PARAESTHESIA (Tingling on my right side) (seriousness criterion hospitalization), METAMORPHOPSIA (Vision was distorted for almost 3 weeks) (seriousness criterion hospitalization), VISION BLURRED (Vision was blurred) (seriousness criterion hospitalization), IMPAIRED DRIVING ABILITY (was not able to drive for 3 weeks) (seriousness criterion hospitalization), VERTIGO (Vertigo-type symptoms) (seriousness criterion hospitalization), VOMITING (Throw up) (seriousness criterion hospitalization), NAUSEA (would get nauseated) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Her doctor advised her not to receive the second dose). The patient was hospitalized on 09-Feb-2021 due to BLINDNESS, FACIAL PARALYSIS, HYPOAESTHESIA, IMPAIRED DRIVING ABILITY, INTRAOCULAR PRESSURE INCREASED, METAMORPHOPSIA, MIGRAINE, NAUSEA, PARAESTHESIA, PERICARDIAL EFFUSION, VERTIGO, VISION BLURRED and VOMITING. The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Cluster of migraines,over a 14-day period,she had 10 migraines in 14 days,the last one put her in the hospital), FACIAL PARALYSIS (Face was drooping back and forth, like a Bell's Palsy situation), PERICARDIAL EFFUSION (Small amount of fluid around my heart), BLINDNESS (Lost vision in my left eye), INTRAOCULAR PRESSURE INCREASED (Pressure in my right eye was 34 or 35, pressure in eft eye was 28), HYPOAESTHESIA (Numbness on right side), PARAESTHESIA (Tingling on my right side), METAMORPHOPSIA (Vision was distorted for almost 3 weeks), VISION BLURRED (Vision was blurred), IMPAIRED DRIVING ABILITY (was not able to drive for 3 weeks), VERTIGO (Vertigo-type symptoms), VOMITING (Throw up) and NAUSEA (would get nauseated) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Her doctor advised her not to receive the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) Patient had amount of fluid around her heart from her heart ultrasound.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  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.; 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.