Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haematocrit, Vitreous floaters
Clinical narrative: Lightheadedness; Drug ineffective; Anxiety aggravated; Eye floaters; Fatigue aggravated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lightheadedness) in a 59-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.     The patient's past medical history included Sinusitis and Gastroparesis. Concurrent medical conditions included Penicillin allergy (MANIFESTED BY RASH AND BREATHING), Drug allergy (sulfa drug allergy), Drug allergy (demerol), Drug allergy (vancomycin allergy), Drug allergy (levofloxacin allergy), Crohn's disease, Blood pressure and Cholesterol. Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety and Depression, LISINOPRIL and METOPROLOL for Blood pressure high, SIMVASTATIN for High cholesterol, GABAPENTIN for Restless legs, IPRATROPIUM BROMIDE (ATROVENT HFA), DOXYCYCLINE HYCLATE and ADALIMUMAB (HUMIRA) from 01-Apr-2021 to an unknown date for an unknown indication.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced FATIGUE (Fatigue aggravated). On 21-Jun-2021, the patient experienced DIZZINESS (Lightheadedness) (seriousness criterion hospitalization). 21-Jun-2021, the patient experienced VITREOUS FLOATERS (Eye floaters). On an unknown date, the patient experienced DRUG INEFFECTIVE (Drug ineffective) and ANXIETY (Anxiety aggravated). The patient was hospitalized on 21-Jun-2021 due to DIZZINESS. The patient was treated with HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) at an unspecified dose and frequency and MECLIZINE [MECLOZINE] ongoing since an unknown date at a dose of 1 dosage form. On 21-Jun-2021, DIZZINESS (Lightheadedness) and VITREOUS FLOATERS (Eye floaters) had resolved. At the time of the report, DRUG INEFFECTIVE (Drug ineffective) and ANXIETY (Anxiety aggravated) had not resolved and FATIGUE (Fatigue aggravated) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Blood pressure measurement: increased (High) Blood pressure increased. On 21-Jun-2021, Blood sodium: decreased (Low) Low. On 21-Jun-2021, Haematocrit: decreased (Low) Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Humira was ineffective in treating chron's and low sodium levels.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment. However, the patient's age and comorbidities may be confounding factors for causality assessment.   Reporter did not allow further contact; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. However, the patient's age and comorbidities may be confounding factors for causality assessment.