Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Blood pressure measurement, Gait disturbance, Hypotension, Intentional product use issue
Clinical narrative: Blood pressure was very low; Lost her voice; Difficulty talking; Can not walk properly; Can not do any house work; Tremors; Seizures; Patient took first dose on 23 April and did not take second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure was very low), APHONIA (Lost her voice), SPEECH DISORDER (Difficulty talking), GAIT DISTURBANCE (Can not walk properly), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not do any house work), TREMOR (Tremors) and SEIZURE (Seizures) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOTENSION (Blood pressure was very low) (seriousness criterion life threatening), APHONIA (Lost her voice) (seriousness criterion life threatening), SPEECH DISORDER (Difficulty talking) (seriousness criterion life threatening), GAIT DISTURBANCE (Can not walk properly) (seriousness criterion life threatening), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not do any house work) (seriousness criterion life threatening), TREMOR (Tremors) (seriousness criterion life threatening), SEIZURE (Seizures) (seriousness criteria medically significant and life threatening) and INTENTIONAL PRODUCT USE ISSUE (Patient took first dose on 23 April and did not take second dose yet). At the time of the report, HYPOTENSION (Blood pressure was very low), APHONIA (Lost her voice), SPEECH DISORDER (Difficulty talking), GAIT DISTURBANCE (Can not walk properly), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can not do any house work), TREMOR (Tremors) and SEIZURE (Seizures) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Patient took first dose on 23 April and did not take second dose yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Blood pressure was so low. On an unknown date, Thyroid function test: abnormal (abnormal) Thyroid was gone and lost voice.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided by the reporter. Treatment involves steroids and allergy medicine. Patient received the 1st dose on the 23 April 2021 that was administered on right upper arm with unknown lot. Patient stated that after getting the vaccine, two hours later while sitting on the couch started having reaction and rushed to the hospital. Patient stated that blood pressure was so low. Then after leaving the hospital doctor told to go back to get more test done. Patient stated that got thyroid test, thyroid was gone and lost voice. Patient states about having difficulty talking, can't walk properly, can't do any housework, having tremors, having seizures. Sometime the seizures were lasting 10 minutes, 10-14 minutes, or 20 minutes. Patient states about still experiencing the adverse event. Patient stated about never ever having such adverse event before.  Company comment: Limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time.  Further information has been requested.