Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Electric shock sensation, Facial paralysis, Heart rate
Clinical narrative: Seizures; Stroke; Partial facial paralysis; Sensation of internal electric shocks; Muscle weakness; Intense thirst; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizures), CEREBROVASCULAR ACCIDENT (Stroke) and FACIAL PARALYSIS (Partial facial paralysis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), FACIAL PARALYSIS (Partial facial paralysis) (seriousness criterion medically significant), ELECTRIC SHOCK SENSATION (Sensation of internal electric shocks), MUSCULAR WEAKNESS (Muscle weakness) and THIRST (Intense thirst). At the time of the report, SEIZURE (Seizures), CEREBROVASCULAR ACCIDENT (Stroke), FACIAL PARALYSIS (Partial facial paralysis), ELECTRIC SHOCK SENSATION (Sensation of internal electric shocks), MUSCULAR WEAKNESS (Muscle weakness) and THIRST (Intense thirst) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Wild swing in blood pressure. On an unknown date, Heart rate: Wild swing in heart rate. On an unknown date, Laboratory test: Tests found nothing wrong.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The patient felt caught. After receiving a single dose of the Moderna vaccine, the patient developed symptoms that included the sensation of internal electric shocks, partial facial paralysis, and muscle weakness that left the patient terrified. She was also having seizures or a stroke, intense thirst, and wild swings in heart rate and blood pressure. The physicians dismissed the patient, saying that the tests found nothing wrong. Patient did research and realized her symptoms overlapped with a hormonal system called the renin-angiotensin-aldosterone system that regulates blood pressure and fluid balance and in which ACE2 played a key role. Patient had recently connected with physicians who were trying to learn whether the auto-antibodies targeting that system might be causing symptoms.  The reporter still thinks that the vaccines were great and the mRNA technology had so much potential. The side effects for the patient had improved somewhat but have not disappeared and should be acknowledged as described by the reporter.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732177 (Linked Report).  Company Comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) events of seizure (AESI), cerebrovascular accident (AESI) and expected, serious event of facial paralysis (AESI) which occurred after mRNA-1273 dose administration, which was unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to vaccination and event onset dates unknown. It was described that after vaccination the patient developed the sensation of internal electric shocks, partial facial paralysis, and muscle weakness that left the patient terrified who was also having seizures or a stroke, intense thirst, and wild swings in heart rate and blood pressure. The physicians dismissed the patient, saying that the tests found nothing wrong. Currently other physicians make efforts to investigate whether the auto-antibodies targeting renin-angiotensin-aldosterone system might be causing symptoms. No further clinical information or details about course of the events, diagnostic work up and treatment were provided for medical review. Events outcome was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per the Agency list of important medical events.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious (medically significant) events of seizure (AESI), cerebrovascular accident (AESI) and expected, serious event of facial paralysis (AESI) which occurred after mRNA-1273 dose administration, which was unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to vaccination and event onset dates unknown. It was described that after vaccination the patient developed the sensation of internal electric shocks, partial facial paralysis, and muscle weakness that left the patient terrified who was also having seizures or a stroke, intense thirst, and wild swings in heart rate and blood pressure. The physicians dismissed the patient, saying that the tests found nothing wrong. Currently other physicians make efforts to investigate whether the auto-antibodies targeting renin-angiotensin-aldosterone system might be causing symptoms. No further clinical information or details about course of the events, diagnostic work up and treatment were provided for medical review. Events outcome was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per the Agency list of important medical events. US-MODERNATX, INC.-MOD-2023-732177:Same reporter/other manufacturer