Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: have not received second dose; terrible feeling/ feeling off; No strength; No strength to walk; lethargic; had vomited; lost control of bowels; tingling all over my body; Stroke; completely lost consciousness; Seizure; barely move her arm; lightheaded; sick to my stomach/ Stomach issues; arm was painful; interrupted her sleep; vaccination was given directly into the infected area; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (completely lost consciousness) and SEIZURE (Seizure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Spider bite.    On 15-Apr-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was painful), INSOMNIA (interrupted her sleep), DIZZINESS (lightheaded), GASTROINTESTINAL DISORDER (sick to my stomach/ Stomach issues), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given directly into the infected area) and HEADACHE (headache). On 16-Apr-2021, the patient experienced MONOPARESIS (barely move her arm). On 17-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (completely lost consciousness) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant), PARAESTHESIA (tingling all over my body) and ANAL INCONTINENCE (lost control of bowels). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received second dose), FEELING ABNORMAL (terrible feeling/ feeling off), ASTHENIA (No strength), GAIT DISTURBANCE (No strength to walk), LETHARGY (lethargic) and VOMITING (had vomited). On 15-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given directly into the infected area) had resolved. On 16-Apr-2021, INSOMNIA (interrupted her sleep) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (completely lost consciousness), SEIZURE (Seizure), DIZZINESS (lightheaded), FEELING ABNORMAL (terrible feeling/ feeling off), GASTROINTESTINAL DISORDER (sick to my stomach/ Stomach issues), ASTHENIA (No strength), PARAESTHESIA (tingling all over my body), GAIT DISTURBANCE (No strength to walk), ANAL INCONTINENCE (lost control of bowels), LETHARGY (lethargic), HEADACHE (headache) and VOMITING (had vomited) outcome was unknown, PRODUCT DOSE OMISSION ISSUE (have not received second dose) had resolved and PAIN IN EXTREMITY (arm was painful) and MONOPARESIS (barely move her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: inconclusive (Inconclusive) inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient's left arm was already itchy and swollen from a spider bite. Pharmacist injected arm where the spider bite was located, even though she noted the spider bite. During the night her arm was painful and interrupted her sleep. The next day, she could barely move her arm and it was very painful.  The patient was transported to hospital emergency room.  IVs and CT scan for over two weeks followed were performed.  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.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient demographics, new serious events ,new non serious events added. event outcome of painful arm( unknown to not recovered), and arm discomfort( unknown to not recovered) were changed.; 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.