Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Fall, Nasopharyngeal swab, Vestibular disorder, Visual impairment
Clinical narrative: Fallen +10 times vestibular defects; Fallen +10 times vestibular defects/Extreme dizziness since injection's 24/7; Vision impaired; Cognitive decline; This spontaneous case was reported by a patient and describes the occurrence of FALL (Fallen +10 times vestibular defects), VESTIBULAR DISORDER (Fallen +10 times vestibular defects/Extreme dizziness since injection's 24/7), VISUAL IMPAIRMENT (Vision impaired) and COGNITIVE DISORDER (Cognitive decline) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 prophylaxis.     The patient's past medical history included Thoracic outlet syndrome. Previously administered products included for COVID-19 prophylaxis: Moderna (Dose number: 1, batch/lot no: 044A21A, location of injection: arm right, vaccine administration time: 01:15 PM) on 13-Mar-2021, Moderna (Dose number: 2, batch/lot no: 040B21A, location of injection: arm right and vaccine administration time: 12:30 AM) on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with Moderna and Moderna. Concurrent medical conditions included Post treatment Lyme disease syndrome. Concomitant products included VITAMIN D [VITAMIN D NOS] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 03-Feb-2022 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (Fallen +10 times vestibular defects) (seriousness criteria hospitalization and disability), VESTIBULAR DISORDER (Fallen +10 times vestibular defects/Extreme dizziness since injection's 24/7) (seriousness criteria hospitalization and disability), VISUAL IMPAIRMENT (Vision impaired) (seriousness criteria hospitalization and disability) and COGNITIVE DISORDER (Cognitive decline) (seriousness criteria hospitalization and disability). The patient was hospitalized for 3 days due to COGNITIVE DISORDER, FALL, VESTIBULAR DISORDER and VISUAL IMPAIRMENT. At the time of the report, FALL (Fallen +10 times vestibular defects), VESTIBULAR DISORDER (Fallen +10 times vestibular defects/Extreme dizziness since injection's 24/7), VISUAL IMPAIRMENT (Vision impaired) and COGNITIVE DISORDER (Cognitive decline) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Nasopharyngeal swab: (Negative) Negative.         The patient received past drug (not specified) and reaction to it was reported as allergy. Event Dizziness was the reported symptoms under the event Vestibular disorder.  The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  The patient was seeing multiple specialists without resolution and can't continue to survive this way.  Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient received multiple treatments (not specified) to rule out symptoms.  Company comment: This spontaneous case concerns a 72-year-old, female patient with chronic medical history of Lyme disease syndrome, who experienced the unexpected, serious (Hospitalization, Disability) events of Fall, Vestibular disorder, Visual impairment and Cognitive disorder. The exact date of onset of the events was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed, the initial two doses of Moderna were given approximately 9 months prior, the interval between the two doses is 28 days. It has been reported that the patient experienced persistent extreme dizziness after vaccination resulting to episodes of fall (>10), impairment of vision and decline in cognition. The patient is currently consulting various specialists, but his condition has not resolved. On an unknown date, nasopharyngeal swab was done which yielded a negative result. Details of concomitant medications, medical history, clinical course and treatment were not provided. The events have not resolved at the time of the report. The patient's medical history of Lyme disease syndrome could be a confounder to the event Cognitive disorder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.; Sender's Comments: This spontaneous case concerns a 72-year-old, female patient with chronic medical history of Lyme disease syndrome, who experienced the unexpected, serious (Hospitalization, Disability) events of Fall, Vestibular disorder, Visual impairment and Cognitive disorder. The exact date of onset of the events was not specified in respect to the administration of third dose of mRNA-1273, hence latency could not be assessed, the initial two doses of Moderna were given approximately 9 months prior, the interval between the two doses is 28 days. It has been reported that the patient experienced persistent extreme dizziness after vaccination resulting to episodes of fall (>10), impairment of vision and decline in cognition. The patient is currently consulting various specialists, but his condition has not resolved. On an unknown date, nasopharyngeal swab was done which yielded a negative result. Details of concomitant medications, medical history, clinical course and treatment were not provided. The events have not resolved at the time of the report. The patient's medical history of Lyme disease syndrome could be a confounder to the event Cognitive disorder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness retained as per medical judgment.