Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dystonia, Facial paralysis, Fatigue, Headache, Heart rate
Clinical narrative: body contracted again, started in calves and feet and hands, went into neck and face; full body tetany; Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted; Terrible headache/ massive headache/ headache around back of head persisted; Ringing in ears; Shortness of breath; Sometimes dizzy; Fatigue; lumbar puncture relieved excess CSF and reduced pressure; Couldn't move left side; elevated BP persisted; Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up; Could be a Tetany or dystonic reaction to the vaccine due to timing of everything; passed out immediately following vaccine; Blood pressure was still high pulse was high 120/ BP went sky high (196/148)/ BP remained high; Fainted when she got the shot; Hyperventilation syndrome; Whole body hurt/ very sore body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted), HEMIPLEGIA (Couldn't move left side), HEADACHE (Terrible headache/ massive headache/ headache around back of head persisted), DYSTONIA (body contracted again, started in calves and feet and hands, went into neck and face), TETANY (full body tetany), HYPERTENSION (elevated BP persisted), DYSTONIA (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up), SYNCOPE (Fainted when she got the shot) and LOSS OF CONSCIOUSNESS (passed out immediately following vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia on 08-Oct-2020. Concurrent medical conditions included COVID-19 (Positive for COVID; Sick for 5 weeks followed with pneumonia, long COVID-19) since 19-Sep-2020, Fainting (History of Fainting; reported as normal for the patent), Drug allergy, Blood pressure high since 19-Sep-2020, Oxygen saturation decreased (2 L via nasal cannula on night) since 19-Sep-2020, Dizziness since 19-Sep-2020 and Headache since 19-Sep-2020. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from 16-Jan-2021 to an unknown date for Attention deficit hyperactivity disorder, CLONAZEPAM for Sleep disorder NOS.    On 16-Jan-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HEADACHE (Terrible headache/ massive headache/ headache around back of head persisted) (seriousness criterion hospitalization) and PAIN (Whole body hurt/ very sore body). 16-Jan-2021, the patient experienced SYNCOPE (Fainted when she got the shot) (seriousness criterion medically significant) and HYPERVENTILATION (Hyperventilation syndrome). On 16-Jan-2021 at 12:15 PM, the patient experienced LOSS OF CONSCIOUSNESS (passed out immediately following vaccine) (seriousness criterion medically significant) and HYPERTENSION (Blood pressure was still high pulse was high 120/ BP went sky high (196/148)/ BP remained high). On 16-Jan-2021 at 12:30 PM, the patient experienced DYSTONIA (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up) (seriousness criterion medically significant). 16-Jan-2021 at 12:30 PM, the patient experienced TETANY (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything). On 17-Jan-2021, the patient experienced FACIAL PARALYSIS (Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted) (seriousness criterion hospitalization), HEMIPLEGIA (Couldn't move left side) (seriousness criterion hospitalization) and HYPERTENSION (elevated BP persisted) (seriousness criterion hospitalization). On 17-Jan-2021 at 7:00 PM, the patient experienced DYSTONIA (body contracted again, started in calves and feet and hands, went into neck and face) (seriousness criterion hospitalization) and TETANY (full body tetany) (seriousness criterion hospitalization). On 05-Feb-2021, the patient experienced LUMBAR PUNCTURE (lumbar puncture relieved excess CSF and reduced pressure). On an unknown date, the patient experienced TINNITUS (Ringing in ears), DYSPNOEA (Shortness of breath), DIZZINESS (Sometimes dizzy) and FATIGUE (Fatigue). The patient was hospitalized from 17-Jan-2021 to 18-Jan-2021 due to DYSTONIA, FACIAL PARALYSIS, HEADACHE, HYPERTENSION and TETANY, and then on 17-Jan-2021 due to HEMIPLEGIA. On 16-Jan-2021, DYSTONIA (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up), LOSS OF CONSCIOUSNESS (passed out immediately following vaccine) and TETANY (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything) had resolved. On 18-Jan-2021, FACIAL PARALYSIS (Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted), DYSTONIA (body contracted again, started in calves and feet and hands, went into neck and face), TETANY (full body tetany) and HYPERTENSION (elevated BP persisted) had resolved. On 05-Feb-2021, HEADACHE (Terrible headache/ massive headache/ headache around back of head persisted) and LUMBAR PUNCTURE (lumbar puncture relieved excess CSF and reduced pressure) had resolved. At the time of the report, HEMIPLEGIA (Couldn't move left side), SYNCOPE (Fainted when she got the shot), TINNITUS (Ringing in ears), HYPERVENTILATION (Hyperventilation syndrome) and PAIN (Whole body hurt/ very sore body) outcome was unknown, HYPERTENSION (Blood pressure was still high pulse was high 120/ BP went sky high (196/148)/ BP remained high) had resolved and DYSPNOEA (Shortness of breath), DIZZINESS (Sometimes dizzy) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood pressure measurement: 196/148 High. On 16-Jan-2021, Blood test: normal normal. On 16-Jan-2021, Heart rate: 120 High. On 16-Jan-2021, Magnetic resonance imaging: normal normal. On 17-Jan-2021, Blood pressure measurement: 190/140 High. On 17-Jan-2021, Computerised tomogram: ruled out stroke normal. On an unknown date, Blood pressure measurement: 192/144 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FACIAL PARALYSIS (Left side of face cured up/ left side of my face was drooping, could not smile/ happened again in the ER around 1:15 AM so i was admitted), HEADACHE (Terrible headache/ massive headache/ headache around back of head persisted), DYSTONIA (body contracted again, started in calves and feet and hands, went into neck and face), TETANY (full body tetany), HYPERTENSION (elevated BP persisted), DYSTONIA (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything/ Muscless tightened all over body/ within minutes after vaccination hands/ feet/ legs contracted/ curled up), LOSS OF CONSCIOUSNESS (passed out immediately following vaccine), HYPERTENSION (Blood pressure was still high pulse was high 120/ BP went sky high (196/148)/ BP remained high), TETANY (Could be a Tetany or dystonic reaction to the vaccine due to timing of everything), PAIN (Whole body hurt/ very sore body) and LUMBAR PUNCTURE (lumbar puncture relieved excess CSF and reduced pressure) to be possibly related. No further causality assessments were provided for HEMIPLEGIA (Couldn't move left side), SYNCOPE (Fainted when she got the shot), TINNITUS (Ringing in ears), HYPERVENTILATION (Hyperventilation syndrome), DYSPNOEA (Shortness of breath), DIZZINESS (Sometimes dizzy) and FATIGUE (Fatigue).    Treatment medication included: Injections of Benadryl and IV Benadryl en route to hospital, Ibuprofen daily as needed and a shot of Toradol.  Case Comment/Sender's Comment - This case concerns a 44 year old, female patient, with history of fainting, COVID-19 (September 2020), who experienced a serious unexpected event of syncope, hemiplegia, facial paralysis and dystonia among others, 2 day after receiving 1st dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Updated patient medical history, concomitant medications, treatment medication, new events, outcome and causality.; Reporter's Comments: This case concerns a 44 year old, female patient, with history of fainting, COVID-19 (September 2020), who experienced a serious unexpected event of syncope, hemiplegia, facial paralysis and dystonia among others, 2 day after receiving 1st dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.