Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Noninfective encephalitis, Product dose omission issue, Pyrexia
Clinical narrative: patient has not received the second dose of the vaccine; was very sick with all the symptoms; chills; high fever; nauseous; dizzy; ringing in the ears; They noticed an Inflammation in left side of her brain; They noticed an Inflammation in left side of her brain that was causing weakness in left side; This spontaneous case was reported by a consumer and describes the occurrence of NONINFECTIVE ENCEPHALITIS (They noticed an Inflammation in left side of her brain) and HEMIPARESIS (They noticed an Inflammation in left side of her brain that was causing weakness in left side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (having covid tested positive 8-MAR-2020) on 08-Mar-2020. Concurrent medical conditions included Drug allergy (allergy to a lot of medications.) and General physical condition normal (She states she is a healthy person with no secondary conditions).    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced DIZZINESS (dizzy), TINNITUS (ringing in the ears) and NAUSEA (nauseous). On 11-May-2021, the patient experienced ILLNESS (was very sick with all the symptoms), CHILLS (chills) and PYREXIA (high fever). In May 2021, the patient experienced NONINFECTIVE ENCEPHALITIS (They noticed an Inflammation in left side of her brain) (seriousness criterion medically significant) and HEMIPARESIS (They noticed an Inflammation in left side of her brain that was causing weakness in left side) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine). On 12-May-2021, DIZZINESS (dizzy), TINNITUS (ringing in the ears), ILLNESS (was very sick with all the symptoms) and NAUSEA (nauseous) had resolved. On 13-May-2021, CHILLS (chills) and PYREXIA (high fever) had resolved. At the time of the report, NONINFECTIVE ENCEPHALITIS (They noticed an Inflammation in left side of her brain) was resolving, HEMIPARESIS (They noticed an Inflammation in left side of her brain that was causing weakness in left side) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Antibody test: 20 (High) 20. On an unknown date, Blood pressure measurement: 120/60 (normal) 120/60 mmHg.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient had an MRI of her brain, neck, and back. Patient  was stated that  no secondary conditions Concomitant products were not provided. Treatment medication were not reported.  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. Further information has been requested.; 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. Further information has been requested.