Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Cerebral disorder, Dizziness, Gait disturbance, Head banging
Clinical narrative: lost visibility; cannot sit down/cannot stand up/cannot function/disabilities; when I stand up everything moves; vision not stable; loss of focus; cannot do any activities, was out of work for two days and can't look down; constantly drowsy; something is wrong with my brain; dizziness; lost my senses; neck is constantly hurting; when I stand up everything moves; major headaches/head is constantly hurting; body aches; fever; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (lost visibility) and GAIT DISTURBANCE (cannot sit down/cannot stand up/cannot function/disabilities) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), MYALGIA (body aches) and PYREXIA (fever). On an unknown date, the patient experienced BLINDNESS (lost visibility) (seriousness criteria disability and medically significant), GAIT DISTURBANCE (cannot sit down/cannot stand up/cannot function/disabilities) (seriousness criterion disability), VERTIGO (when I stand up everything moves), VISUAL IMPAIRMENT (vision not stable), VISION BLURRED (loss of focus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot do any activities, was out of work for two days and can't look down), SOMNOLENCE (constantly drowsy), CEREBRAL DISORDER (something is wrong with my brain), DIZZINESS (dizziness), SENSORY LOSS (lost my senses), NECK PAIN (neck is constantly hurting), HEAD BANGING (when I stand up everything moves) and HEADACHE (major headaches/head is constantly hurting). At the time of the report, BLINDNESS (lost visibility), GAIT DISTURBANCE (cannot sit down/cannot stand up/cannot function/disabilities), VISUAL IMPAIRMENT (vision not stable), VISION BLURRED (loss of focus), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot do any activities, was out of work for two days and can't look down), SOMNOLENCE (constantly drowsy), CEREBRAL DISORDER (something is wrong with my brain), DIZZINESS (dizziness), SENSORY LOSS (lost my senses), NECK PAIN (neck is constantly hurting), HEAD BANGING (when I stand up everything moves) and HEADACHE (major headaches/head is constantly hurting) had not resolved, VERTIGO (when I stand up everything moves) outcome was unknown and OROPHARYNGEAL PAIN (sore throat), MYALGIA (body aches) and PYREXIA (fever) had resolved.            Concomitant product use was not provided by the reporter. Patient was experienced adverse events including disabilities after second dose of vaccination.  Company comment: This case concerns a 39-year-old, female patient with no reported medical history, who experienced serious unexpected events of Blindness and gait disturbance. The events occurred on an unknown date after second dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable, as no additional dose is expected. The benefit risk relationship of vaccine is not affected by this report. Events Blindness and gait disturbance were automatically upgraded as Serious events as per IME list and kept as serious, with IME and disabling seriousness criteria, as per medical judgement, despite they were reported as non-serious. Further information is expected.; Sender's Comments: This case concerns a 39-year-old, female patient with no reported medical history, who experienced serious unexpected events of Blindness and gait disturbance. The events occurred on an unknown date after second dose of mRNA-1273 (Moderna COVID-19 vaccine). The rechallenge was not applicable, as no additional dose is expected. The benefit risk relationship of vaccine is not affected by this report. Events Blindness and gait disturbance were automatically upgraded as Serious events as per IME list and kept as serious, with IME and disabling seriousness criteria, as per medical judgement, despite they were reported as non-serious. Further information is expected.