Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Brain oedema, Cerebral haemorrhage, Confusional state, Coordination abnormal
Clinical narrative: Brain hemorrhage (inflammation, swelling); Dizziness; Difficulty with coordination; Difficulty with balance; Vision changes in left eye; Drift in left arm; Issues going through daily routine; Neurological symptoms; Was confused; Headaches; Very nauseous; A spontaneous report was received from a consumer, who was a 25-years-old, white female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, very nauseous, neurological symptoms, headaches, dizziness, difficulty with coordination, difficulty with balance, vision changes in left eye, drift in left arm, issues going through daily routine, confusion, and brain bleed.  The patient's medical history, as provided by the reporter, included gluten allergy. Products known to have been used by the patient, within two weeks prior to the event, included ethinylestradiol/ ferrous fumarate/ norethindrone acetate.   On 06 Jan 2021 at 10:30am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, after receiving the vaccine, the patient became very nauseous through 08 Jan 2021.  On 09 Jan 2021, the patient started having neurological symptoms. She started having headaches, dizziness, difficulty with coordination and balance, and vision changes in the left eye (not specified). She reported that she had a "drift" in the left arm and described it as "when you try to manipulate the arm, but it does not go where you want it to go".   On 11 Jan 2021, the patient still had neurological symptoms, issues moving left arm, colliding with objects all day, and issues going through daily routine.  On 12 Jan 2021, the patient was seen by a neurologist and magnetic resonance imagining (MRI) was scheduled. The MRI revealed inflammation, and brain bleed and swelling. The patient was sent to the emergency room and admitted on 19 Jan 2021.  Treatment for the events included calcium carbonate for nausea, ibuprofen for headaches and diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.  The event, very nauseous, was considered resolved on 08 Jan 2021. The events, neurological symptoms, headaches, dizziness, difficulty with coordination, difficulty with balance, vision changes in left eye, drift in left arm and issues going through daily routine, confusion, and brain bleed were considered not resolved.   Follow-up received on 23 Jan 2021 included patient details, medical history, lab tests, concomitant medications, hospitalization, and updated events.; Reporter's Comments: This case concerns a female patient, who experienced a non-serious unexpected event of dizziness, coordination abnormal, balance disorder, visual impairment, movement disorder, loss of personal independence in daily activities, and neurological symptom, and non-serious expected event of nausea, and headaches. The events of nausea occurred 1 day (same day) after first dose of mRNA-1273, lot # unknown. The event of neurological symptoms, dizziness, coordination abnormal, balance disorder, visual impairment, loss of personal independence in daily activities, and movement disorder occurred 3 days after first dose of mRNA-1273, lot # unknown. Treatment for the events included, Tums, nauseam, ibuprofen and Benadryl. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.