Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Body temperature, Dizziness, Ear pain
Clinical narrative: Diagnosed with Vestibular Neuritis after booster/He statesthat the vaccine affected his right vestibular node.; Difficult time keeping his  balance after booster/ still difficult keeping his balance; Very Dizzy after booster/A few days later, again he woke up very Dizzy; Vertigo after booster; Almost dropped on the floor after booster,Crawled from breakfast table to bedroom after booster; Nausea after booster; Severe pain in the right ear after booster; Neuralgia in the right ear after booster/He informed the patient that he has Neuralgia; He woke up around 1 PM with muscle pain on the left arm; Body temperature  was 100.1 F after booster; Debilitating after booster/He states that it has been debilitating; This spontaneous case was reported by a physician and describes the occurrence of VESTIBULAR NEURONITIS (Diagnosed with Vestibular Neuritis after booster/He statesthat the vaccine affected his right vestibular node.), BALANCE DISORDER (Difficult time keeping his  balance after booster/ still difficult keeping his balance), DIZZINESS (Very Dizzy after booster/A few days later, again he woke up very Dizzy), VERTIGO (Vertigo after booster), NEURALGIA (Neuralgia in the right ear after booster/He informed the patient that he has Neuralgia) and ASTHENIA (Debilitating after booster/He states that it has been debilitating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0614002F21A, 039K20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Debilitating after booster/He states that it has been debilitating) (seriousness criterion disability). On 15-Aug-2021, the patient experienced MYALGIA (He woke up around 1 PM with muscle pain on the left arm) and PYREXIA (Body temperature  was 100.1 F after booster). On 17-Aug-2021, the patient experienced NEURALGIA (Neuralgia in the right ear after booster/He informed the patient that he has Neuralgia) (seriousness criterion disability) and EAR PAIN (Severe pain in the right ear after booster). On 01-Sep-2021, the patient experienced BALANCE DISORDER (Difficult time keeping his  balance after booster/ still difficult keeping his balance) (seriousness criteria disability and medically significant). 01-Sep-2021, the patient experienced DIZZINESS (Very Dizzy after booster/A few days later, again he woke up very Dizzy) (seriousness criterion disability), VERTIGO (Vertigo after booster) (seriousness criterion disability), FALL (Almost dropped on the floor after booster,Crawled from breakfast table to bedroom after booster) and NAUSEA (Nausea after booster). On 05-Sep-2021, the patient experienced VESTIBULAR NEURONITIS (Diagnosed with Vestibular Neuritis after booster/He statesthat the vaccine affected his right vestibular node.) (seriousness criteria disability and medically significant). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Pain in ear, at an unspecified dose and frequency; MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and Physical therapy (recommended Physical Therapy for vestibular rehabilitation.) for Vestibular neuronitis. On 16-Aug-2021, MYALGIA (He woke up around 1 PM with muscle pain on the left arm) and PYREXIA (Body temperature  was 100.1 F after booster) had resolved. On 20-Aug-2021, NEURALGIA (Neuralgia in the right ear after booster/He informed the patient that he has Neuralgia) and EAR PAIN (Severe pain in the right ear after booster) had resolved. At the time of the report, VESTIBULAR NEURONITIS (Diagnosed with Vestibular Neuritis after booster/He statesthat the vaccine affected his right vestibular node.), VERTIGO (Vertigo after booster), FALL (Almost dropped on the floor after booster,Crawled from breakfast table to bedroom after booster) and NAUSEA (Nausea after booster) outcome was unknown and BALANCE DISORDER (Difficult time keeping his  balance after booster/ still difficult keeping his balance), DIZZINESS (Very Dizzy after booster/A few days later, again he woke up very Dizzy) and ASTHENIA (Debilitating after booster/He states that it has been debilitating) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: normal (normal) normal. On 14-Aug-2021, Body temperature: 100.1 (High) Body temperature was 100.1 F after booster.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported. Neurologist scheduled an MRA contrast medium to the patient but results are not in yet. Patient stated that he was unable to drive and needs the help of others to function. Company Comment: This case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Vestibular neuronitis, Balance disorder, Dizziness, Vertigo, Neuralgia, Asthenia, the unexpected events of Fall and Ear pain, and the expected events of Nausea, Myalgia and Pyrexia .The events occurred within 3 weeks after the third dose of mRNA-1273 Vaccine which resulted in disability. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-406568, MOD-2021-406527 (Patient Link).; Sender's Comments: This case concerns a 78-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Vestibular neuronitis, Balance disorder, Dizziness, Vertigo, Neuralgia, Asthenia, the unexpected events of Fall and Ear pain, and the expected events of Nausea, Myalgia and Pyrexia .The events occurred within 3 weeks after the third dose of mRNA-1273 Vaccine which resulted in disability. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.