Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Seizure, Tremor
Clinical narrative: Anxiety is really bad; severe allergic reaction; seizure like activity; significant amount of shaking and diaphoresis; significant amount of shaking and diaphoresis; afraid to receive the second shot; This spontaneous case was reported by a nurse and describes the occurrence of ALLERGY TO VACCINE (severe allergic reaction), SEIZURE (seizure like activity), TREMOR (significant amount of shaking and diaphoresis), HYPERHIDROSIS (significant amount of shaking and diaphoresis) and ANXIETY (Anxiety is really bad) in a 19-year-old male 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction) (seriousness criteria hospitalization and life threatening), SEIZURE (seizure like activity) (seriousness criteria hospitalization, medically significant and life threatening), TREMOR (significant amount of shaking and diaphoresis) (seriousness criterion hospitalization) and HYPERHIDROSIS (significant amount of shaking and diaphoresis) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANXIETY (Anxiety is really bad) (seriousness criterion hospitalization) and INTENTIONAL PRODUCT USE ISSUE (afraid to receive the second shot). The patient was hospitalized on sometime in April 2021 due to ALLERGY TO VACCINE, HYPERHIDROSIS, SEIZURE and TREMOR. The patient was treated with EPINEPHRINE (EPIPEN) in April 2021 for Allergy to vaccine, at a dose of 1 dosage form, unknown. At the time of the report, ALLERGY TO VACCINE (severe allergic reaction), SEIZURE (seizure like activity), TREMOR (significant amount of shaking and diaphoresis), HYPERHIDROSIS (significant amount of shaking and diaphoresis) and ANXIETY (Anxiety is really bad) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (afraid to receive the second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: went way up (High) went way up. In April 2021, Heart rate: went way up (High) went way up.     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.   Concomitant medications were not provided by the reporter. The patient received his first Moderna vaccine dose on maybe 02-Apr-2021 or 03-Apr-2021, possibly in his right arm. Within 5-10 minutes, he had a severe allergic reaction which consisted of seizure-like activities. The patient was treated with an EpiPen shot and sent to the emergency room. It was reported the patient had anxiety which was really bad and he was now being treated with an unspecified anti-anxiety medication to help.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.