Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: inflammation in her spine; inflammation in her brain and spine; bruise easily; Tinnitus; severe fatigue; Paralysis of arms; injection site was twitching; Vaccination site hypoaesthesia; tingling; paresthesia down left arm/pins and needle feeling in feet; loss feeling in feet; burning sensation; losing mobility; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (Paralysis of arms), MYELITIS (inflammation in her spine) and ENCEPHALITIS (inflammation in her brain and spine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concurrent medical conditions included Thyroid disorder NOS and Depression. Concomitant products included SPIRONOLACTONE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced DIPLEGIA (Paralysis of arms) (seriousness criterion medically significant), MUSCLE TWITCHING (injection site was twitching), VACCINATION SITE HYPOAESTHESIA (Vaccination site hypoaesthesia), VACCINATION SITE PARAESTHESIA (tingling), PARAESTHESIA (paresthesia down left arm/pins and needle feeling in feet), HYPOAESTHESIA (loss feeling in feet), BURNING SENSATION (burning sensation) and MOBILITY DECREASED (losing mobility). On an unknown date, the patient experienced MYELITIS (inflammation in her spine) (seriousness criterion medically significant), ENCEPHALITIS (inflammation in her brain and spine) (seriousness criterion medically significant), CONTUSION (bruise easily), TINNITUS (Tinnitus) and FATIGUE (severe fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Inflammation, at an unspecified dose and frequency and GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, DIPLEGIA (Paralysis of arms), MYELITIS (inflammation in her spine), ENCEPHALITIS (inflammation in her brain and spine), MUSCLE TWITCHING (injection site was twitching), VACCINATION SITE HYPOAESTHESIA (Vaccination site hypoaesthesia), VACCINATION SITE PARAESTHESIA (tingling), PARAESTHESIA (paresthesia down left arm/pins and needle feeling in feet), HYPOAESTHESIA (loss feeling in feet), BURNING SENSATION (burning sensation), MOBILITY DECREASED (losing mobility), CONTUSION (bruise easily), TINNITUS (Tinnitus) and FATIGUE (severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was severely ill since, 7 days post vaccine the injection site was twitching, numbness , tingling, paresthesia down left arm, felt paralyzed. The patient also reported loss feeling in feet, pins and needle feeling in feet, burning sensation, losing mobility. The patient was hospitalized from  06-Apr-2021 to 07-Apr-2021 to do testing to figure out what neurological issues the patient had. Patient reports being on low dose thyroid, antidepressant and spironolactone before patient received the vaccine The patient also had inflammation in brain and spine, severe fatigue, bruise easily and tinnitus. Treatment medication included 1250 mg of steroids for 3 days to try and bring down inflammation.  Company comment: This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected events of Diplegia, Myelitis (inflammation in spine), and Encephalitis (inflammation in brain). The event of Diplegia occurred approximately 7 days after the first dose of mRNA-1273 (Moderna covid-19 vaccine); while Encephalitis and Myelitis occurred at unspecified interval. The patient presented with twitching, numbness, tingling, paresthesia down the arm, needle feeling in feet, burning sensation, and losing mobility. Neurologist consulted attributed the inflammation to the vaccine; and patient was treated with Ibuprofen and Gabapentin. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected events of Diplegia, Myelitis (inflammation in spine), and Encephalitis (inflammation in brain). The event of Diplegia occurred approximately 7 days after the first dose of mRNA-1273 (Moderna covid-19 vaccine); while Encephalitis and Myelitis occurred at unspecified interval. The patient presented with twitching, numbness, tingling, paresthesia down the arm, needle feeling in feet, burning sensation, and losing mobility. Neurologist consulted attributed the inflammation to the vaccine; and patient was treated with Ibuprofen and Gabapentin. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.