Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Arthralgia, Balance disorder, Blood test, Cardiovascular evaluation
Clinical narrative: tingling of mouth; Numbness in shoulder; tingling down his left arm/tingling in left shoulder; Cold; Clammy; Shaky; Has unsteady balance; Changes in consciousness; Left shoulder pain; Mouth was numb; Headaches; Felt faint/ felt dizzy; Fell to the ground; This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Changes in consciousness), ARTHRALGIA (Left shoulder pain), HEADACHE (Headaches), HYPOAESTHESIA ORAL (Mouth was numb), PARAESTHESIA ORAL (tingling of mouth), HYPOAESTHESIA (Numbness in shoulder), PARAESTHESIA (tingling down his left arm/tingling in left shoulder), NASOPHARYNGITIS (Cold), COLD SWEAT (Clammy), TREMOR (Shaky) and BALANCE DISORDER (Has unsteady balance) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Hydrocephalus on 02-Dec-1987, Focal seizures (Right), Hemiparesis (right), Ventriculo-peritoneal shunt and Vagal nerve stimulator implantation. Concurrent medical conditions included Cerebral palsy (Mild on right side).  On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (Headaches) (seriousness criterion hospitalization). On 04-May-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Changes in consciousness) (seriousness criteria hospitalization and medically significant), ARTHRALGIA (Left shoulder pain) (seriousness criterion hospitalization), HYPOAESTHESIA ORAL (Mouth was numb) (seriousness criterion hospitalization), PARAESTHESIA ORAL (tingling of mouth) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness in shoulder) (seriousness criterion hospitalization), PARAESTHESIA (tingling down his left arm/tingling in left shoulder) (seriousness criterion hospitalization), NASOPHARYNGITIS (Cold) (seriousness criterion hospitalization), COLD SWEAT (Clammy) (seriousness criterion hospitalization), TREMOR (Shaky) (seriousness criterion hospitalization) and BALANCE DISORDER (Has unsteady balance) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIZZINESS (Felt faint/ felt dizzy) and FALL (Fell to the ground). The patient was hospitalized on 18-May-2021 due to ALTERED STATE OF CONSCIOUSNESS, ARTHRALGIA, BALANCE DISORDER, COLD SWEAT, HEADACHE, HYPOAESTHESIA, HYPOAESTHESIA ORAL, NASOPHARYNGITIS, PARAESTHESIA, PARAESTHESIA ORAL and TREMOR. At the time of the report, ALTERED STATE OF CONSCIOUSNESS (Changes in consciousness), ARTHRALGIA (Left shoulder pain), HEADACHE (Headaches), HYPOAESTHESIA ORAL (Mouth was numb), PARAESTHESIA ORAL (tingling of mouth), HYPOAESTHESIA (Numbness in shoulder), PARAESTHESIA (tingling down his left arm/tingling in left shoulder), NASOPHARYNGITIS (Cold), COLD SWEAT (Clammy), TREMOR (Shaky), BALANCE DISORDER (Has unsteady balance), DIZZINESS (Felt faint/ felt dizzy) and FALL (Fell to the ground) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood test: normal (normal) Normal. On 04-May-2021, Computerised tomogram: normal (normal) normal. On 04-May-2021, Echocardiogram: normal (normal) normal. On 18-May-2021, Blood test: normal (normal) No Vitamin deficiency. On 18-May-2021, Cardiovascular evaluation: normal (normal) normal. On 18-May-2021, Electroencephalogram: normal (normal) normal. On 18-May-2021, Neurological examination: normal (normal) normal. On 18-May-2021, Thyroid function test: normal (normal) normal. On 26-May-2021, Magnetic resonance imaging: abnormal (abnormal) Chiari malformation type 2 sequelae. On an unknown date, Echocardiogram: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) 4 EKGs were normal.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable  Patient was 'doing great' until 3 weeks after the vaccine. No relevant concomitant medications were reported. No treatment information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 01-Jul-2021: contains no new information (NNI).; 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