Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood test, Guillain-Barre syndrome, Hemiparesis, Impaired work ability, Lumbar puncture
Clinical narrative: On a walker/Cannot walk without walker; Cannot write with her right hand; weakness on my right side; Vertigo; Felt dizzy; Multiple sclerosis; No longer able to work at my job; Suspicion of guillain-barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Felt dizzy), GAIT DISTURBANCE (On a walker/Cannot walk without walker), DYSGRAPHIA (Cannot write with her right hand), HEMIPARESIS (weakness on my right side), MULTIPLE SCLEROSIS (Multiple sclerosis), IMPAIRED WORK ABILITY (No longer able to work at my job) and GUILLAIN-BARRE SYNDROME (Suspicion of guillain-barre syndrome) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 014C21A) for COVID-19 vaccination.    Co-suspect product included non-company product MECLIZINE [MECLOZINE] for Vertigo.    Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started MECLIZINE [MECLOZINE] (unknown route) at an unspecified dose. On 28-May-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion hospitalization), DIZZINESS (Felt dizzy) (seriousness criterion hospitalization) and HEMIPARESIS (weakness on my right side) (seriousness criteria hospitalization and medically significant). In June 2021, the patient experienced GUILLAIN-BARRE SYNDROME (Suspicion of guillain-barre syndrome) (seriousness criterion medically significant). On an unknown date, the patient experienced GAIT DISTURBANCE (On a walker/Cannot walk without walker) (seriousness criterion hospitalization), DYSGRAPHIA (Cannot write with her right hand) (seriousness criterion hospitalization), MULTIPLE SCLEROSIS (Multiple sclerosis) (seriousness criterion medically significant) and IMPAIRED WORK ABILITY (No longer able to work at my job) (seriousness criterion medically significant). The patient was hospitalized on sometime in June 2021 due to DIZZINESS and VERTIGO. At the time of the report, VERTIGO (Vertigo), DIZZINESS (Felt dizzy), GAIT DISTURBANCE (On a walker/Cannot walk without walker), DYSGRAPHIA (Cannot write with her right hand), HEMIPARESIS (weakness on my right side), MULTIPLE SCLEROSIS (Multiple sclerosis), IMPAIRED WORK ABILITY (No longer able to work at my job) and GUILLAIN-BARRE SYNDROME (Suspicion of guillain-barre syndrome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high (High) high. On an unknown date, Lumbar puncture: inconclusive (Inconclusive) Inconclusive. On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Patient is waiting on results for Guillain barre syndrome and multiple sclerosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was advised to get occupational therapist and physical therapist as she cannot walk without the walker and cannot write with her right hand. Patient said that meclizine made everything worse.  Action taken with mRNA-1273 in response to the event was not applicable  Patient was also referred to their neurologist  patient was sent home with meclizine for vertigo which made things worse after she took it.  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. Meclizine is a confounder.   This case was linked to MOD-2021-233401 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-Jun-2021 included new event weakness; 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. Meclizine is a confounder.