Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Seizure, Swollen tongue
Clinical narrative: Seizures; Diagnosed with numbness; Couldn't breath / she was having trouble breathing; Tingling skin/ legs felt like tingling; She believes that she passed out and does not remember much from that time / just blacks out and doesn't remember what's happening; Spasms; Started experiencing a lot of brightness in eyes; Was experiencing a stuffy nose; Face was turning purple and rash on her face / red dots all over the body; Body was getting stiff; Light headed; Feels like the tongue was swollen; This spontaneous case was reported by a physician and describes the occurrence of SEIZURE (Seizures), HYPOAESTHESIA (Diagnosed with numbness), DYSPNOEA (Couldn't breath / she was having trouble breathing), PARAESTHESIA (Tingling skin/ legs felt like tingling), LOSS OF CONSCIOUSNESS (She believes that she passed out and does not remember much from that time / just blacks out and doesn't remember what's happening), MUSCLE SPASMS (Spasms), EYE DISORDER (Started experiencing a lot of brightness in eyes), NASAL CONGESTION (Was experiencing a stuffy nose) and RASH (Face was turning purple and rash on her face / red dots all over the body) in a 34-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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Diagnosed with numbness) (seriousness criterion hospitalization), DYSPNOEA (Couldn't breath / she was having trouble breathing) (seriousness criterion hospitalization), PARAESTHESIA (Tingling skin/ legs felt like tingling) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (She believes that she passed out and does not remember much from that time / just blacks out and doesn't remember what's happening) (seriousness criteria hospitalization and medically significant), MUSCLE SPASMS (Spasms) (seriousness criterion hospitalization), EYE DISORDER (Started experiencing a lot of brightness in eyes) (seriousness criterion hospitalization), NASAL CONGESTION (Was experiencing a stuffy nose) (seriousness criterion hospitalization) and RASH (Face was turning purple and rash on her face / red dots all over the body) (seriousness criterion hospitalization). On 16-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Body was getting stiff) and SWOLLEN TONGUE (Feels like the tongue was swollen). 16-Jun-2021, the patient experienced DIZZINESS (Light headed). The patient was treated with EPINEPHRINE (EPIPEN) for Difficulty breathing, at a dose of 2 doses. At the time of the report, SEIZURE (Seizures), HYPOAESTHESIA (Diagnosed with numbness), DYSPNOEA (Couldn't breath / she was having trouble breathing), PARAESTHESIA (Tingling skin/ legs felt like tingling), LOSS OF CONSCIOUSNESS (She believes that she passed out and does not remember much from that time / just blacks out and doesn't remember what's happening), MUSCLE SPASMS (Spasms), EYE DISORDER (Started experiencing a lot of brightness in eyes), NASAL CONGESTION (Was experiencing a stuffy nose), RASH (Face was turning purple and rash on her face / red dots all over the body), MUSCULOSKELETAL STIFFNESS (Body was getting stiff), DIZZINESS (Light headed) and SWOLLEN TONGUE (Feels like the tongue was swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: inconclusive (Inconclusive) Reported that all blood work came in order and results were not reported..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were administered by the patient.  The reporter stated that the patient was admitted on ER on 17 Jun 2021 for the second time. The patient was administered with muscle relaxer and benzodiazepines for seizures and spasms. This spasms like seizures has prevented the patient to been able to go to work and was happening constantly every hour of the day. The patient was given two shots of Epipen and was transferred to hospital in an ambulance and kept in ICU for one day. The following day, she was transferred to another hospital where she stayed for four days. On 16-Jun-2021 the patient had one of the worst episodes and went back to hospital.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up document was received on 17-Jun-2021 and had significant information. The expiration date, anatomical location of the drug was added and new events were updated. On 18-Jun-2021: Follow-up document was received: contained no new information.