Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Visual impairment
Clinical narrative: her legs stopped working; She reports it has been very hard, it is debilitating that she can be standing, and all of a sudden she collapses; balance instability; neck stiffness; wants to sleep a lot; She also noticed a strange vision change in far left eye; This week she reports that if she turns she gets so dizzy that she has to steady herself; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (her legs stopped working) and SYNCOPE (She reports it has been very hard, it is debilitating that she can be standing, and all of a sudden she collapses) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LAMOTRIGINE (LAMICTAL) and GABAPENTIN for an unknown indication.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced MUSCULAR WEAKNESS (her legs stopped working) (seriousness criterion hospitalization). In March 2022, the patient experienced DIZZINESS (This week she reports that if she turns she gets so dizzy that she has to steady herself). On an unknown date, the patient experienced SYNCOPE (She reports it has been very hard, it is debilitating that she can be standing, and all of a sudden she collapses) (seriousness criterion medically significant), BALANCE DISORDER (balance instability), MUSCULOSKELETAL STIFFNESS (neck stiffness), SOMNOLENCE (wants to sleep a lot) and VISUAL IMPAIRMENT (She also noticed a strange vision change in far left eye). The patient was treated with Rehabilitation therapy (Patient received vestibular therapy.) for Balance disorder. At the time of the report, MUSCULAR WEAKNESS (her legs stopped working) had resolved, SYNCOPE (She reports it has been very hard, it is debilitating that she can be standing, and all of a sudden she collapses) had not resolved and BALANCE DISORDER (balance instability), MUSCULOSKELETAL STIFFNESS (neck stiffness), SOMNOLENCE (wants to sleep a lot), VISUAL IMPAIRMENT (She also noticed a strange vision change in far left eye) and DIZZINESS (This week she reports that if she turns she gets so dizzy that she has to steady herself) outcome was unknown.            It was reported that after her Moderna COVID-19 booster dose on 23Oct2021, within 24 hours, her legs stopped working. She reported she had to crawl to her neighbor's apartment who called an ambulance. She went to the emergency room and got IV fluids and some other medications. It kind of resolved itself, but then now she reported every day when she gets up, she has a problem. She reported neck stiffness, wants to sleep a lot, it was all very acute. It did become a little tolerable, but it hit like a bag of bricks. She reported she had other health issues in the past, but as she has gotten older, she has gotten to know her body better, and she did not think these symptoms were a coincidence, she thinks it has to do with the vaccine. She reported there should be no interaction with anything, and she did not take any alcohol or drugs either. Company comment: This case concerns a 54-year-old female patient, with no reported medical history, who experienced, unexpected, serious (Hospitalized) event of Muscular weakness and Syncope, after receiving a third dose of mRNA-1273.  Within 24 hours, after receiving mRNA-1273, the patient experienced Muscular weakness (reported as her legs stopped working) prompting an ED consult.   She was treated with unknown IV fluids and other unrecalled medications. Her Muscular weakness spontaneously resolved, however, she started experiencing symptoms of Musculoskeletal stiffness, Balance disorder, Somnolence, Visual impairment and Syncope (reported as She reports it has been very hard, it is debilitating that she can be standing, and all of a sudden she collapses) on unknown dates. Five months after vaccination, she reported experiencing Dizziness.  At the time of the report, the outcome of the event Muscular Weakness had resolved, Syncope had not resolved and the out   This case was linked to MOD-2022-522955, MOD-2022-522960 (Patient Link).; Sender's Comments: This case concerns a 54-year-old female patient, with no reported medical history, who experienced, unexpected, serious (Hospitalized) event of Muscular weakness and Syncope, after receiving a third dose of mRNA-1273.  Within 24 hours, after receiving mRNA-1273, the patient experienced Muscular weakness (reported as her legs stopped working) prompting an ED consult.   She was treated with unknown IV fluids and other unrecalled medications. Her Muscular weakness spontaneously resolved, however, she started experiencing symptoms of Musculoskeletal stiffness, Balance disorder, Somnolence, Visual impairment and Syncope (reported as She reports it has been very hard, it is debilitating that she can be standing, and all of a sudden she collapses) on unknown dates. Five months after vaccination, she reported experiencing Dizziness.  At the time of the report, the outcome of the event Muscular Weakness had resolved, Syncope had not resolved and the outcome of the rest of the events were unknown.  The benefit-risk relationship of mRNA-1273 is not affected by this report.