Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Nausea, Pulmonary function test decreased, Pyrexia, Tremor
Clinical narrative: very bad reaction; Shaky hands; Shortness of breath; Difficulty sleeping; Lungs functioning at 50% per healthcare professional; One day feels better, then worse again; Dizzy; Nausea; throwing up; Fever; Memory lapse; It was so horrible, they thought they were going to died; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very bad reaction), TREMOR (Shaky hands), DYSPNOEA (Shortness of breath), INSOMNIA (Difficulty sleeping), PULMONARY FUNCTION TEST DECREASED (Lungs functioning at 50% per healthcare professional) and FEELING ABNORMAL (One day feels better, then worse again) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ANXIETY (It was so horrible, they thought they were going to died). On 16-Apr-2021, the patient experienced TREMOR (Shaky hands) (seriousness criterion hospitalization), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), INSOMNIA (Difficulty sleeping) (seriousness criterion hospitalization), PULMONARY FUNCTION TEST DECREASED (Lungs functioning at 50% per healthcare professional) (seriousness criterion hospitalization) and FEELING ABNORMAL (One day feels better, then worse again) (seriousness criterion hospitalization). On 17-Apr-2021, the patient experienced MEMORY IMPAIRMENT (Memory lapse). On an unknown date, the patient experienced VACCINATION COMPLICATION (very bad reaction) (seriousness criterion hospitalization), DIZZINESS (Dizzy), NAUSEA (Nausea), VOMITING (throwing up) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for Adverse event, at an unspecified dose and frequency. On 11-May-2021, TREMOR (Shaky hands) and DYSPNOEA (Shortness of breath) had resolved. At the time of the report, VACCINATION COMPLICATION (very bad reaction), INSOMNIA (Difficulty sleeping), PULMONARY FUNCTION TEST DECREASED (Lungs functioning at 50% per healthcare professional) and FEELING ABNORMAL (One day feels better, then worse again) outcome was unknown, MEMORY IMPAIRMENT (Memory lapse) had not resolved and ANXIETY (It was so horrible, they thought they were going to died), DIZZINESS (Dizzy), NAUSEA (Nausea), VOMITING (throwing up) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  This case concerns a 39-year-old female patient with no details previous relevant medical history, who experienced the unexpected events of Tremor, Dyspnoea, Lung function decreased and Insomnia after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the events occurred approximately 1 day after the first dose of Spikevax, with Hospitalization as an outcome. Additional non serious adverse events were reported. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Significant follow-up added to updated reporter's address, new adverse events .added, treatment details added from initial SD and events tremor, dyspnoea, insomnia, pulmonary  function test decreased, memory impairment  and feeling abnormal were marked hospitalization from initial version. On 15-Sep-2021: Follow up received and new serious event "vaccination complication" added.; Sender's Comments: This case concerns a 39-year-old female patient with no details previous relevant medical history, who experienced the unexpected events of Tremor, Dyspnoea, Lung function decreased and Insomnia after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The onset of the events occurred approximately 1 day after the first dose of Spikevax, with Hospitalization as an outcome. Additional non serious adverse events were reported. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report